When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Abell T, Lou J, Tabbaa M, et al. Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate and long-term follow-up. J Parenter Enteral Nutr. 2003;27(4):277-281.
Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003;125(2):421-428.
Anand C, Al-Juburi A, Familoni B, et al. Gastric electrical stimulation is safe and effective: a long-term study in patients with drug-refractory gastroparesis in three regional centers. Digestion. 2007;75(2-3):83-89.
Andersson S, Ringstrom G, Elfvin A, et al. Temporary percutaneous gastric electrical stimulation: a novel technique tested in patients with non-established indications for gastric electrical stimulation. Digestion. 2011;83(1-2):3-12.
Ang D, Tack J. Gastric electrical stimulation for the treatment of gastroparesis: ready for prime time? Digestion. 2007;75(2-3):80-82.
Brody F, Vaziri K, Saddler A, et al. Gastric electrical stimulation for gastroparesis. J Am Coll Surg. 2008;207(4):533-538.
Brody F, Zettervall SL, Richards NG, et al. Follow-up after gastric electrical stimulation for gastroparesis. J Am Coll Surg. 2015;220(1):57-63.
Camilleri M, Parkman HP, Shafi MA et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013; 108(1):18-37.
Chu H, Lin Z, Zhong L et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J Gastroenterol Hepatol. 2012; 27(6):1017-26.
Cigaina V. Gastric pacing as therapy for morbid obesity: Preliminary results. Obes Surg. 2002;12(suppl 1):12S-16S.
Cigaina V, Hirschberg AL. Gastric pacing for morbid obesity: Plasma levels of gastrointestinal peptides and leptin. Obes Res. 2003;11(12):1456-1462.
D'Argent J. Gastric electrical stimulation as therapy of morbid obesity: Preliminary results from the French study. Obes Surg. 2002;12(suppl 1):21S-25S.
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. 2004;14(suppl 1):S33-S39.
Elfvin A, Gothberg G, Lonroth H, et al. Temporary percutaneous and permanent gastric electrical stimulation in children younger than 3 years with chronic vomiting. J Pediatr Surg. 2011;46(4):655-661.
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. 2004;14(5):666-670.
Forster J, Sarosiek I, Lin Z, et al. Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surg. 2003;186(6):690-695.
Gourcerol G, Leblanc I, Leroi AM, et al. Gastric electrical stimulation in medically refractory nausea and vomiting. Eur J Gastroenterol Hepatol. 2007;19(1):29-35.
Harrison NS, Williams PA, Walker MR, et al. Evaluation and Treatment of Gastric Stimulator Failure in Patients With Gastroparesis. Surg Innov. 2013;21(3):244-249.
Hayes, Inc. Hayes Medical Technology Directory. Gastric Electrical Stimulation for Gastroparesis. Lansdale, PA: Hayes, Inc.; July 2004 (updated July 2005).
Jayanthi NV, Dexter SP, Sarela AI, et al. Gastric electrical stimulation for treatment of clinically severe gastroparesis. J Minim Access Surg. 2013;9(4):163-167.
Lahr CJ, Griffith J, Subramony C, et al. Gastric electrical stimulation for abdominal pain in patients with symptoms of gastroparesis. Am Surg. 2013;79(5):457-64.
Lal N, Livemore S, Dunne D, et al. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015;2015:762972.
Levinthal DJ, Bielefeldt K. Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. Auton Neurosci. 2017;202:45-55.
Lin Z, Forster J, Sarosiek I, McCallum RW. Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. Diabetes Care. 2004;27(5):1071-1076.
Lin Z, Sarosiek I, Forster J, McCallum RW. Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis. Neurogastroenterol Motil. 2006;18(1):18-27.
Lu PL, Teich S, Di Lorenzo C, et al. Improvement of quality of life and symptoms after gastric electrical stimulation in children with functional dyspepsia. Neurogastroenterol Motil. 2013;25(7):567-e456.
Mason RJ, Lipham J, Eckerling G, Schwartz A, Demeester TR. Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. Arch Surg. 2005;140(9):841-846.
McCallum RW, Lin Z, Forster J, et al. Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. Clin Gastroenterol Hepatol. 2011;9(4):314-319.
McCallum RW, Sarosiek I, Parkman HP, et al. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. 2013;25(10):815-e636.
McCallum RW, Snape W, Brody F, et al. Gastric electrical stimulation with Enterra™ therapy improves symptoms from diabetic gastroparesis in prospective study. Clin Gastroenterol Hepatol. 2010;8(11):947-954.
McElhinny C, Sarosiek I, Lin Z, et al. Comparison of hospitalization, medications and quality of life in patients receiving gastric electrical stimulation (GES) therapy for severe gastroparesis. Gastroenterology. 2002;122:A82.
Medtronic. What is gastric electrical stimulation? [Medtronic Web site]. Available at: http://www.medtronic.com/us-en/patients/treatments-therapies/neurostimulator-gastroparesis/what-is-it.html. Accessed June 14, 2018.
National Institute for Clinical Excellence. Gastroelectrical stimulation for gastroparesis. May 2014. Available online at: https://www.nice.org.uk/guidance/IPG489/chapter/1-Recommendations. Accessed June 14, 2018.
Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology. 2004:127(5):1589-1591.
Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg. 2004;14(4):545-548.
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):31-37.
Teich S, Mousa HM, Punati J, et al. Efficacy of permanent gastric electrical stimulation for the treatment of gastroparesis and functional dyspepsia in children and adolescents. J Pediatr Surg. 2013;48(1):178-183.
Timratana P, El-Hayek K, Shimizu H, et al. Laparoscopic gastric electrical stimulation for medically refractory diabetic and idiopathic gastroparesis. J Gastrointest Surg. 2013;17(3):461-470.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FDA dockets management branch re: citizen's petition to transfer from humanitarian device exemption (HDE) to premarket approval (PMA) for Enterra™ Therapy System. [FDA Web site]. 11/04/04. Available at: http://www.fda.gov/ohrms/dockets/dailys/04/nov04/110504/04p-0091-pdn00001-vol1.pdf. Accessed June 14, 2018.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Summary of Safety and Probable Benefit. Enterra Therapy System. [FDA Web site]. 09/23/1999. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H990014b.pdf. Accessed June 14, 2018.
van der Voort IR, Becker JC, Dietl KH, et al. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005;113(1):38-42.
Zehetner J, Ravari F, Ayazi S, et al. Minimally invasive surgical approach for the treatment of gastroparesis. Surg Endosc. 2013;27(1):61-6.
E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting
Policy: 11.03.02r:Bariatric Surgery