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Gastric Electrical Stimulation (Enterra™), Gastric Pacing
11.03.15m

Policy

​MEDICALLY NECESSARY

Gastric electrical stimulation (i.e., Enterra therapy system) is considered medically necessary and, therefore, covered for the following humanitarian device exemption (HDE) indication granted by the US Food and Drug Administration (FDA):
  • The treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology​
An HDE device may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).​

EXPERIMENTAL/INVESTIGATIONAL​

Gastric electrical stimulation with Enterra therapy for any indication not listed above is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of those uses cannot be established by review of the available published peer-reviewed literature.​

Gastric electrical stimulation using any other device (e.g., Transcend implantable gastric stimulator [IGS], Tantalus​ System, or Exilis GES System) is considered experimental/investigational for all indications and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

​Temporary gastric electrical stimulation​ is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.​

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the US Food and Drug Administration (FDA)-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

Subject to the terms and conditions of the applicable benefit contract, gastric electrical stimulation (Enterra) for all other uses is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

On May 31, 2000, the Enterra gastric electrical stimulator (Medtronic, Inc., Minneapolis, MN) was approved by the FDA under the HDE process for use in individuals with chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

WARNINGS ISSUED FROM THE MANUFACTURER AND THE FDA

Magnetic resonance imaging (MRI) is not compatible with the neurostimulator and leads.

Use of diathermy in an individual with an implantable gastric electrical stimulator is contraindicated per the manufacturer’s literature because the energy produced by diathermy can be transferred through the implant system or any of the device components. This may contribute to tissue damage that could result in severe injury or death. Diathermy can also damage parts of the stimulation system.

The system may be affected by or may adversely affect cardiac pacemakers or therapies, cardioverter defibrillators, electrocautery, external defibrillators, ultrasonic equipment, radiation therapy, theft detectors, and screening devices. The safety and effectiveness of this device for children and pregnant women have not been established. Leads may fail to function for a variety of reasons including, but not limited to: medical complications, body rejection phenomena, lead breakage, breech of lead insulation covering, fibrotic tissue, or improper handling or use.

Description

Gastric electrical stimulation uses an implantable electric stimulator (or pacemaker) on the stomach musculature to aid in the management of gastroparesis. Gastroparesis is defined as delayed gastric emptying without evidence of obstruction; it is most notable with solid foods. This condition mainly affects individuals with diabetes, but it can also be found in individuals with connective tissue disorders, Parkinson disease, chronic pseudo-obstruction, or in those who have undergone gastric surgery (e.g., vagotomy). Gastroparesis can also be idiopathic in origin. In individuals with diabetes, gastroparesis is the result of gastroneuropathy and is associated with injury to the vagus nerve. The symptoms of gastroparesis include bloating, belching, distention, nausea, vomiting, and early satiety. The chronic nausea and frequent episodes of vomiting associated with chronic or severe gastroparesis can lead to dehydration, malnutrition, and, in individuals with diabetes, poor glycemic control. Intractable nausea and vomiting refers to nausea and vomiting that is difficult to control; it does not lessen with time or with the use of traditional medical management (e.g., dietary restrictions or medications). Intractable vomiting is often accompanied by nausea (when an individual constantly feels as if they are about to vomit).​

Medical management of gastroparesis begins with dietary recommendations for frequent smaller meals that are low in fat and fiber, because fat can delay gastric emptying and fiber can be difficult to digest. If stomach emptying is delayed, undigested fiber may be retained and accumulate to form a bezoar (hardened mass). When dietary measures alone are not sufficient to alleviate the symptoms of gastroparesis, pharmaceutical management with antiemetics to control nausea (e.g., metoclopramide, granisetron, ondansetron) and prokinetics to promote gastric emptying (e.g., metoclopramide, erythromycin) are used with some success. However, many of these medications are associated with unwanted side effects that limit their use. In severe cases of gastroparesis, enteral or total parenteral nutrition may be required. Surgical management (e.g., insertion of a gastrostomy tube and/or feeding jejunostomy tube, pyloroplasty, gastrectomy, or gastrojejunostomy) may be utilized when gastroparesis remains refractory.

Gastric electrical stimulation, also referred to as a gastric pacemaker or gastric pacing, is an alternative surgery to treat gastroparesis that remains refractory to medical management. An electrical stimulator (pulse generator) is inserted either by laparoscopy or laparotomy into a subcutaneous pocket and connects to unipolar leads (electrodes) that are sutured to the greater curvature of the stomach muscle. An external stimulator programmer is used to set or adjust the settings or to turn the stimulator on and off. The procedure can be done on an inpatient or outpatient basis.

The Enterra therapy system (Medtronic Inc., Minneapolis, MN) is currently the only gastric electrical stimulator approved by the US Food and Drug Administration (FDA) under a humanitarian device exemption (HDE). Enterra therapy received FDA approval on March 31, 2000, as a humanitarian use device (HUD) for the "treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology." The FDA has not demonstrated the efficacy of Enterra therapy for this use.

The Transcend implantable gastric stimulator (IGS) (Medtronic, Inc., Minneapolis, MN) is currently available in Europe for the treatment for obesity. Presently, there are no gastric electrical stimulators with FDA approval for this use. The mechanism of action for gastric pacing for weight loss is not fully known, but it is believed that early satiety is produced by either a neurohormonal modulation or by stimulation of the stomach muscle. There is insufficient peer-reviewed literature and scientific evidence to draw conclusions about the safety and efficacy of this procedure and its long-term effects. More research is needed to support gastric electrical stimulation as a treatment for obesity. Tantalus System by MetaCure has been investigated in the treatment of obese/overweight patients with Type II Diabetes in non-randomized trials-- ​more data of sufficient quality is needed to establish efficacy. The evidence for another device, Exilis GES System, includes a phase I prospective feasibility trial that investigated whether the settings of the device could be adjusted for chronic use in individuals with morbid obesity. The authors concluded the Exilis GES system​ can be used safely without inducing discomfort in the participants; however, generation of evidence evaluating efficacy is needed.​

In 2025, the American Gastroenterological Association (AGA) recommended against the use of gastric electrical stimulation among individuals with refractory gastroparesis.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s HUD designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4000 individuals annually. Because clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

TEMPORARY GASTRIC ELECTRICAL STIMULATION

Various techniques for placement of the GES device have been explored, such as placement via percutaneous endoscopic gastrostomy (PEG) tube, endoscopic placement of leads, or laparoscopic placement of leads. Advantages of temporary GES include trying different lead locations, trialing different energy settings, and evaluating the overall efficacy before a permanent device is placed that requires surgery (Abell, 2023). The American Gastroenterological Association (AGA) claims, "Temporary electrical stimulation may predict response to GES and should be offered if available," citing a randomized controlled trial that reported null results. The literature investigating the temporary endoscopic approach includes a nonsurvival pig study (Deb et al., 2012); a case report (Daram et al. 2011); a nonrandomized comparative study (Ayinala et al., 2005); a prospective cohort trial (Singh et al., 2015), and a double-masked, randomized, placebo-controlled trial (Abell et al., 2011).


To extrapolate on the best available literature, the prospective cohort trial by Singh et al. (2015) included individuals with gastroparesis-like symptoms but negative endoscopy results who underwent gastric scintigraphy. They were classified into three groups: delayed gastric emptying (GE), normal GE, and rapid GE. Of 551 participants, 379 received an endoscopic implantation of temporary GES. The authors reported that gastric retention was significantly reduced for all groups 2 hours post-temporary GES implantation; however, at last follow-up (4 hours post-implant), the delayed GES group did not have a significant reduction in gastric retention.


The double-masked, randomized, placebo-controlled trial by Abell et al. (2011) conducted a crossover trial of two consecutive, 4-day sessions (session 1 and session 2), enrolling 58 participants. For 72 continuous hours, temporary, endoscopically placed GES was provided for group A during session 1, and for group B during session 2. The overall estimate for treatment effect across sessions 1 and 2 of this crossover study was a slight, nonsignificant decrease in average vomiting score of −0.12 per day (95% CI, −0.68 to 0.92; P=0.762). Electrode dislodgment occurred in 22% (13 of the 58 participants enrolled). A limitation of this study is that scores did not return to baseline for either group during the washout period, indicating that the washout period was not sufficient to minimize carryover effects, which was seen in the next day for Group A. The authors noted there were physiological imbalances at baseline between the two groups, and they acknowledged the general concern of GES which is that outcomes may be influenced by the placebo effect.


These two studies used an FDA-approved temporary cardiac pacing lead (Medtronic model 6416), and an FDA-approved implantable pulse generator (Medtronic 3116) to achieve temporary pacing.


There is inconclusive support for temporary GES in the clinical community, and only some centers use temporary stimulating electrodes to predict response. Placing temporary GES is not standard practice. The evidence is insufficient to determine whether temporary leads predict success of a permanent GES device or provide temporary relief from gastroparesis symptoms.​

References

Abell TL, Camilleri M, Donohoe K, et al. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Am J Gastroenterol. 2008;103(3):753-763. 


Abell TL. Gastric Electrical Stimulation: Overview and Summary. J Transl Int Med. 2023;10(4):286-289. 


Abell TL, Johnson WD, Kedar A, et al. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011;74(3):496-503.


Abell TL, 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 TL, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003;125(2):421-428.

 

Abell, TL. National Organization for Rare Disorders. Gastroparesis. Last Updated March 16, 2012. Gastroparesis - Symptoms, Causes, Treatment | NORD. Accessed March 19, 2025.

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.

 

Ayinala S, Batista O, Goyal A, et al. Temporary gastric electrical stimulation with orally or PEG-placed electrodes in patients with drug refractory gastroparesis. Gastrointest Endosc. 2005;61:455-461. 

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 Gas troenterol. 2013;108(1):18-37.


Cha R, Marescaux J, Diana M. Updates on gastric electrical stimulation to treat obesity: Systematic review and future perspectives. World J Gastrointest Endosc. 2014;6(9):419-431. 


Chu H, Lin Z, Zhong L, et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J Gastroenterol Hepatol. 2012;27(6):1017-1026.


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.

 

Daram SR, Tang SJ, Abell TL. Video: temporary gastric electrical stimulation for gastroparesis: endoscopic placement of electrodes (ENDOstim). Surg Endosc. 2011;25(10):3444-3445. 

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.

 

Deb S, Tang SJ, Abell TL, et al. An endoscopic wireless gastrostimulator (with video). Gastrointest Endosc. 2012;75(2):411-415.e1. 


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.

 

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.  

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):457-464.

Laine M, Siren J, Koskenpato J, et al. Outcomes of high-frequency stimulation gastric electric stimulation for the treatment of severe, medically refractory gastroparesis in Finland. Scand J Surg. 2018;107(2):124-129.

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):e567-e456.

Mason RJ, Lipham J, Eckerling G, et al. 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):e815-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.

National Institute for Health and Care Excellence (NICE). Gastroelectrical stimulation for gastroparesis [IPG489]. May 2014. Available online at: https://www.nice.org.uk/guidance/IPG489/chapter/1-Recommendations. Accessed March 19, 2025.

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.


Paulus GF, van Avesaat M, van Rijn S, et al. Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System. Obes Surg. 2020;30(5):1952-1960. 


Sanmiguel CP, Conklin JL, Cunneen SA, et al. Gastric electrical stimulation with the TANTALUS System in obese type 2 diabetes patients: effect on weight and glycemic control. J Diabetes Sci Technol. 2009;3(4):964-970. 


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. 2018;164(4):760-765.


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.


Singh S, McCrary J, Kedar A, et al. Temporary Endoscopic Stimulation in Gastroparesis-like Syndrome. J Neurogastroenterol Motil. 2015;21(4):520-527. 


Staller K, Parkman HP, Greer KB, et al. AGA Clinical Practice Guideline on Management of Gastroparesis. Gastroenterology. 2025;169(5):828-861.

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. 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 March 19, 2025.


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):61-66.

Coding

CPT Procedure Code Number(s)
​MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT INSERTION, REPLACEMENT, REVISION, OR REMOVAL OF THE GASTRIC ELECTRICAL STIMULATOR FOR THE TREATMENT OF NAUSEA AND VOMITING SECONDARY TO GASTROPARESIS (I.E., ENTERRA THERAPY SYSTEM):

43647
43648
43881
43882
64590
64595

THE FOLLOWING CODES ARE USED TO REPRESENT THE ELECTRONIC ANALYSIS AND PROGRAMMING OF A GASTRIC ELECTRICAL STIMULATOR THAT IS APPROVED BY THE FDA HDE FOR THE TREATMENT OF NAUSEA AND VOMITING SECONDARY TO GASTROPARESIS:

95980
95981
95982

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODES ARE USED TO REPRESENT TEMPORARY GASTRIC ELECTRICAL STIMULATION​:​

43659
43999

THE FOLLOWING CODES ARE USED TO REPRESENT GASTRIC ELECTRICAL STIMULA​​TION APPLIED TO REGIONS OTHER THAN THE ANTRUM (E.G., TRANSCEND IMPLANTABLE GASTRIC STIMULATOR [IGS]):​

43659
43999

THE FOLLOWING CODES ARE USED TO REPRESENT INSERTION, REPLACEMENT, REVISION, OR REMOVAL OF ALL OTHER GASTRIC ELECTRICAL STIMULATORS (E.G, TANTALUS SYSTEM, EXILIS GES SYSTEM):

43647
43648
43881
43882
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
​K31.84 Gastroparesis​
HCPCS Level II Code Number(s)
MEDICALLY NECESSARY​

C1767 Generator, neurostimulator (implantable), non-rechargeable

C1778 Lead, neurostimulator (implantable) 

E0765 FDA approved nerve stimulator, for treatment of nausea and vomiting

L8678 Electrical stimulator supplies (external) for use with implantable neurostimulator, per month​​

L8679 Implantable neurostimulator pulse generator, any type

L8680 Implantable neurostimulator electrode, each 

L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686 Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension​

L8688 Implantable neurostimulator pulse generator, dual array,  non-rechargeable, includes extension​
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From 11.03.15m:​
06/10/2026

​This policy has been reviewed and reissued to communicate the Company’s continuing position on Gastric Electrical Stimulation (Enterra™), Gastric Pacing.​
​
10/01/2025​Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.

This policy has been identified for the HCPCS code update, effective 10/01/2025.​
​
The following HCPCS code narrative has been revised in this policy:
  • ​​E0765​
    • ​FROM: FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting
    • TO: FDA approved nerve stimulator, for treatment of nausea and vomiting​

Revisions From 11.03.15l:​​
07/14/2025​

​This version of the policy will become effective 07/14/2025.

The following criteria have been added to this policy as experimental/investigational (E/I):
  • All other uses for Enterra therapy system is E/I
  • Gastric electrical stimulation (GES) with all other devices is E/I for all indications​
  • Temporary GES

Revisions From 11.03.15k:​
​03/20/2024

​This policy has been reviewed and reissued to communicate the Company’s continuing position on Gastric Electrical Stimulation (Enterra™), Gastric Pacing.
01/02​/​2024​This policy has been identified for the CPT code update, effective 01/02/2024.

The following CPT Code narratives have been revised in this policy: 64590, 64595

Revisions From 11.03.15j:
04/01​/​2023​This policy has been identified for the HCPCS code update, effective 04/01/2023.

The following HCPCS Code has been added to this policy:

​L8678 Electrical stimulator supplies (external) for use with implantable neurostimulator, per month

Revisions From 11.03.15i:
03/22​/​2023​This policy has been reviewed and reissued to communicate the Company’s continuing position on Gastric Electrical Stimulation (Enterra™), Gastric Pacing.​
​05/18/2022
​This policy has been reissued in accordance with the Company’s annual review process.
​06/16/2021
​This policy has been reissued in accordance with the Company’s annual review process.​
​11/30/2020
​This version of the policy will become effective 11/30/2020.

​Coding:

​The following HCPCS codes were added to the policy: C1767, C1778, L8679, L8680, L8685, L8686, L8687, L8688

Revisions From 11.03.15h:
11/06/2019This policy has been reviewed and reissued to communicate the Company’s continuing position on Gastric Electrical Stimulation (Enterra™), Gastric Pacing.
07/18/2018As of 07/18/2018, this policy has been reviewed and reissued to communicate the Company’s continuing position on gastric electrical stimulation (Enterra™), gastric pacing.

Effective 10/05/2017 this policy has been updated to the new policy template format.
10/1/2025
10/2/2025
6/10/2026
11.03.15
Medical Policy Bulletin
Commercial
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