Gastric Electrical Stimulation

Policy Number: MA 2.069

Effective Date: 2/1/2026

Policy

Gastric electrical stimulation is considered investigational for the treatment of gastroparesis of diabetic, idiopathic, or postsurgical etiology. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Gastric electrical stimulation is considered investigational for the treatment of obesity. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Gastroparesis

Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal. Symptoms include bloating, distension, nausea, and vomiting. When severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status, and poor glycemic control in diabetic patients. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathologic conditions. Some cases may not be associated with an identifiable cause and are referred to as idiopathic gastroparesis. Treatment of gastroparesis includes prokinetic agents (e.g., metoclopramide, granisetron, ondansetron). Severe cases require enteral or total parenteral nutrition.

Treatment

Gastric electrical stimulation (GES), also referred to as gastric pacing, using an implantable device, has been investigated primarily as a treatment for gastroparesis. Currently available devices consist of a pulse generator, which can be programmed to provide electrical stimulation at different frequencies, connected to intramuscular stomach leads, which are implanted during laparoscopy or open laparotomy (see Regulatory Status section).

Obesity

GES has also been investigated as a treatment of obesity. It is used to increase a feeling of satiety with subsequent reduction in food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neurohormonal modulation and/or stomach muscle stimulation.

Regulatory Status

In 2000, the Gastric Electrical Stimulator system (now called Enterra™ Therapy System; Medtronic) was approved by the U.S. Food and Drug Administration through the humanitarian device exemption process (H990014) for the treatment of gastroparesis. The GES system consists of 4 components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. With the exception of the intramuscular leads, all other components have been used in other implantable neurologic stimulators, such as spinal cord or sacral nerve stimulation. The intramuscular stomach leads are implanted either laparoscopically or during laparotomy and are connected to the pulse generator, which is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an “on” time of 0.1 seconds alternating with an “off” time of 5.0 seconds.

Currently, no GES devices have been approved by the Food and Drug Administration for the treatment of obesity. The Transcend^® (Transneuronix; acquired by Medtronic in 2005), an implantable gastric stimulation device, is available in Europe for treatment of obesity.

Rationale

Summary of Evidence

For individuals who have gastroparesis who receive GES, the evidence includes randomized controlled trials (RCTs), nonrandomized studies, and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. Five crossover RCTs have been published. A 2017 meta-analysis of these 5 RCTs did not find a significant benefit of GES on the severity of symptoms associated with gastroparesis. Patients generally reported improved symptoms at follow-up whether or not the device was turned on, suggesting a placebo effect.

For individuals who have obesity who receive GES, the evidence includes an RCT. Relevant outcomes are change in disease status and treatment-related morbidity. The Screened Health Assessment and Pacer Evaluation (SHAPE) trial did not show significant improvement in weight loss using GES compared with sham stimulation. The evidence is insufficient to determine the effects of this technology on health outcomes.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Investigational, and therefore not covered:

References

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2. Chu H, Lin Z, Zhong L, et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J Gastroenterol Hepatol. Jun 2012; 27(6): 1017-26. PMID 22128901
3. Lal N, Livemore S, Dunne D, et al. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015; 2015: 762972. PMID 26246804
4. Saleem S, Aziz M, Khan AA, et al. Gastric Electrical Stimulation for the Treatment of Gastroparesis or Gastroparesis-like Symptoms: A Systemic Review and Meta-analysis. Neuromodulation. Dec 02 2022. PMID 36464562
5. Ducrotte P, Coffin B, Bonaz B, et al. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. Feb 2020; 158(3): 506-514.e2. PMID 31647902
6. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. Aug 2003; 125(2): 421-8. PMID 12891544
7. U.S. Food and Drug Administration. Summary of Safety and Probable Benefit: EnterraTM Therapy System. 2010; http://www.accessdata.fda.gov/cdrh_docs/pdf/H990014b.pdf. Accessed December 27, 2022.
8. McCallum RW, Snape W, Brody F, et al. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. Nov 2010; 8(11): 947-54; quiz e116. PMID 20538073
9. McCallum RW, Sarosiek I, Parkman HP, et al. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. Oct 2013; 25(10): 815-e636. PMID 23895180
10. Samaan JS, Toubat O, Alicuben ET, et al. Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis. Surg Endosc. Oct 2022; 36(10): 7561-7568. PMID 35338403
11. Laine M, Sirén J, Koskenpato J, et al. Outcomes of High-Frequency Gastric Electric Stimulation for the Treatment of Severe, Medically Refractory Gastroparesis in Finland. Scand J Surg. Jun 2018; 107(2): 124-129. PMID 29268656
12. Shada A, Nielsen A, Marowski S, et al. Wisconsin's Enterra Therapy Experience: A multi-institutional review of gastric electrical stimulation for medically refractory gastroparesis. Surgery. Oct 2018; 164(4): 760-765. PMID 30072246
13. Shikora SA, Bergenstal R, Bessler M, et al. Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis. 2009; 5(1): 31-7. PMID 19071066
14. Cigaina V, Hirschberg AL. Gastric pacing for morbid obesity: plasma levels of gastrointestinal peptides and leptin. Obes Res. Dec 2003; 11(12): 1456-62. PMID 14694209
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17. De Luca M, Segato G, Busetto L, et al. Progress in implantable gastric stimulation: summary of results of the European multi-center study. Obes Surg. Sep 2004; 14 Suppl 1: S33-9. PMID 15479588
18. Favretti F, De Luca M, Segato G, et al. Treatment of morbid obesity with the Transcend Implantable Gastric Stimulator (IGS): a prospective survey. Obes Surg. May 2004; 14(5): 666-70. PMID 15186636
19. Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg. Apr 2004; 14(4): 545-8. PMID 15130236
20. National Institute of Health and Care Excellence. Gastroelectrical stimulation for gastroparesis [IPG489 ]. 2014
21. Camilleri M, Kuo B, Nguyen L, et al. ACG Clinical Guideline: Gastroparesis. Am J Gastroenterol. Aug 01 2022; 117(8): 1197-1220. PMID 35926490
22. Reddymasu SC, Sarosiek I, McCallum RW. Severe gastroparesis: medical therapy or gastric electrical stimulation. Clin Gastroenterol Hepatol. 2010;8(2):117-124. doi:10.1016/j.cgh.2009.09.010
23. InterQual® Level of Care Criteria 2025. Acute Care Adult. CP:Procedures Gastric Stimulation. Change Healthcare.
24. Mekaroonkamol P, Tiankanon K, Rerknimitr R. A New Paradigm Shift in Gastroparesis Management. Gut Liver. 2022;16(6):825-839. doi:10.5009/gnl210309. PMID: 35670120
25. Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review. Clin Gastroenterol Hepatol. 2022;20(3):491-500. doi:10.1016/j.cgh.2021.10.038 PMID: 34757197
26. Taclob JA, Lee BJ, Ortega AJ, Sarosiek I, McCallum RW. Gastric Electrical Stimulation as a New Treatment Modality for Refractory Nausea and Vomiting with Normal Gastric Emptying. J Investig Med High Impact Case Rep. 2023;11:23247096231201214. PMID: 37731269
27. Maisiyiti A, Chen JD. Systematic review on gastric electrical stimulation in obesity treatment. Expert Rev Med Devices. 2019;16(10):855-861. PMID: 31570014
28. Clipper F. Young, Marianne Moussa, Jay H. Shubrook; Diabetic Gastroparesis: A Review. Diabetes Spectr 1 August 2020; 33 (3): 290–297
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Policy History

• MA 2.069
• 10/06/2025 New policy.