DESCRIPTION
Gastric electrical stimulation (GES), also referred to as gastric pacing, has been investigated primarily as a treatment for drug-refractory nausea/vomiting secondary to gastroparesis of diabetic, idiopathic, or postsurgical etiology. Available devices (The Enterra™ Therapy System) consist of a pulse generator that can be programmed to provide electrical stimulation at different frequencies and are connected by intramuscular stomach leads that have been implanted either by laparoscopy or open laparotomy.
GES has also been investigated as a treatment for obesity by increasing a feeling of satiety, ultimately leading to a reduction in food intake and eventually weight loss. There is currently no FDA approved device available for the treatment of obesity.
POLICY
Gastric Electrical Stimulation (gastric pacemaker) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Gastric Electrical Stimulation for the treatment of other conditions/diseases, including, but not limited to, the treatment of obesity is considered investigational.
MEDICAL APPROPRIATENESS
Gastric Electrical Stimulation is considered medically appropriate if ALL the following are met:
Individual has chronic, intractable nausea and vomiting and ALL the following:
Gastroparesis secondary to diabetic, idiopathic, or postsurgical etiology
Has failed conservative treatment (i.e., dietary modifications, prokinetic & antiemetic medications)
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The evidence is insufficient to determine significant improvements in weight loss using gastric electrical stimulation. It includes a randomized controlled trial, several small case series, and uncontrolled prospective trials. The Screened Health Assessment and Pacer Evaluation (SHAPE) trial did not show significant improvement in weight loss using GES.
SOURCES
American College of Gastroenterology. (2022, June). ACG clinical guideline: gastroparesis. Retrieved October 6, 2023 from https://gi.org/guidelines/.
American Gastroenterology Association. (2022, March). AGA clinical practice update on management of medically refractory gastroparesis: expert review. Retrieved August 17, 2022 from https://www.cghjournal.org.
BlueCross BlueShield Association. Evidence Positioning system. (3.2023). Gastric electrical stimulation (7.01.73). Retrieved September 27, 2023 from https://www.evidencepositioningsystem.com/. (21 articles and/or guidelines reviewed)
Ducrotte, P., Coffin, B., Bonaz, B., Fontaine, S., Varannes, S., Zerbib, F., et al. (2020). Gastric electrical stimulation reduces refractory vomiting in a randomized crossover trial. Gastroenterology, 158, 506 – 514. (Level 2 evidence)
Lal, N., Livemore, S., Dunne, D., & Khan, I. (2015). Gastric electrical stimulation with the enterra system: A systematic review. Gastroenterology Research and Practice, doi: 10.1155/2015/762972. (Level 3 evidence)
Levinthal, D.J., & Bielefeldt, K. (2017). Systematic review and meta-analysis: gastric electrical stimulation for gastroparesis. Autonomic Neuroscience: basic & clinical, 202, 45-55. Abstract retrieved August 22, 2022 from PubMed database.
Maisiyiti, A., & Chen, J.D. (2019). Systematic review on gastric electrical stimulation in obesity treatment. Expert Review of Medical Devices, 16 (10), 855-861. (Level 3 evidence)
National Institute of Health and Care Excellence (NICE). (2014, May). Gastroelectrical stimulation for gastroparesis. Retrieved August 18, 2022 from http://www.nice.org.uk.
U.S. Food and Drug Administration. (2000, March). Center for Devices and Radiological Health. Humanitarian device approval for March 2000. Retrieved August 22, 2022 from https://www.accessdata.fda.gov/cdrh_docs/pdf/H990014A.pdf.
Winifred S. Hayes, Inc. Health Technology Assessment. (2018, December; last update search December 2022). Gastric electrical stimulation for gastroparesis. Retrieved October 6, 2023 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)
Zoll, B., Zhao, H., Edwards, A.M., Petrov, R., Schey, R., & Parkman, H.P. (2018). Outcomes of surgical intervention for refractory gastroparesis: a systematic review. The Journal of Surgical Research, 231, 263-269. Abstract retrieved August 22, 2022 from PubMed database.
ORIGINAL EFFECTIVE DATE: 12/31/2022
MOST RECENT REVIEW DATE: 11/9/2023
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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