Coverage Policy Manual
Policy #: 2007009
Category: Surgery
Initiated: May 2007
Last Review: September 2023
  Gastric Neurostimulation for Morbid Obesity
Description:
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
 
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 (FDA) through the humanitarian device exemption process (H990014) for the treatment of gastroparesis. The GES system consists of 4 components: the implanted pulse generator, 2 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 FDA 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.
 
Coverage of gastric neurostimulation for any reason other than obesity is addressed in policy #2003045
Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Group contracts furnished on or after July 1, 2004, consider gastric electrical stimulation a contract exclusion
 
Gastric neurostimulation for the treatment of morbid obesity does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, gastric neurostimulation for the treatment of morbid obesity is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Electronic analysis and programming or reprogramming of a gastric neurostimulator for the treatment of morbid obesity does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, electronic analysis and programming or reprogramming of a gastric neurostimulator for the treatment of morbid obesity is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
There are no published randomized controlled trials on gastric electrical stimulation (GES) for the treatment of obesity. Small clinical trials have reported positive outcomes in weight loss and maintenance of weight loss along with minimal complications.  However, further study is needed as the currently available data are insufficient to permit scientific conclusions.
  
Two manufacturer-sponsored trials, started in 2004 and 2005, are no longer recruiting patients but trial results have not yet been published.  The manufacturer's website indicates the site will be updated when enrollment begins for the next clinical study.
 
2009 Update
As of September 2009, the two clinical trials referenced above (NCT 00200083 and NCT 00200018) have been completed but no results have been published.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  There were no new randomized trials identified assessing the use of gastric electrical stimulation for the treatment of obesity. No information was identified that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
There has only been one published randomized study on gastric electrical stimulation for the treatment of obesity (the SHAPE trial), which did not show any improvement in weight loss with gastric electrical stimulation. Case series publications are limited and insufficient to draw conclusions on health outcomes.
Given the results of the SHAPE trial, gastric electrical stimulation for the treatment of obesity is considered investigational.
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2015, Brody and colleagues reported on 79 patients refractory to nonoperative gastroparesis treatments who underwent GES implantation (Brody, 2015).  After 1 year, 16 of 52 patients with available data (30.8%) had at least a25% reduction in pain, and 23 of 52 (44.2%) had at least a 25% reduction in functional symptom severity, compared with baseline. Eighteen patients had 4- to 8-year follow-up data. Compared with baseline, 6 of 18 (33.3%) reported at least a 25% in pain, and 12 (66.7%) reported at least a 25% in functional symptom severity. There was no 30-day mortality, but 11 patients (14%) died over the 10-year study period. None of the deaths were GES-related.
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2015 systematic review by Lal and colleagues identified 21 studies with at least 10 participants who were treated with GES for gastroparesis and followed for at least 6 months (Lal, 2015). Most of the studies were observational. Outcome measures varied and the authors did not pool study findings. The authors reported that most studies reported a reduction in symptom severity, but changes in gastric emptying were variable and generally were not correlated with symptom improvement.
 
Brody and colleagues reported on 79 patients who were refractory to nonoperative gastroparesis treatments who underwent GES implantation (Brody, 2015).  After 1 year, 16 of 52 patients with available data (30.8%) had at least a 25% reduction in pain, and 23 of 52 (44.2%) had at least a 25% reduction in functional symptom severity, compared with baseline. Eighteen patients had 4- to 8-year follow-up data. Compared with baseline, 6 of 18 (33.3%) reported at least a 25% in pain, and 12 (66.7%) reported at least a 25% in functional symptom severity. There was no 30-day mortality, but 11 patients (14%) died over the 10-year study period. None of the deaths were GES-related.
 
2017 Update
A literature search conducted through September 2017 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Several systematic reviews of studies on gastric electrical stimulation (GES) for gastroparesis have been published, the most recent and comprehensive of which is a systematic review and meta-analysis published by Levinthal and colleagues (Levinthal, 2017). To be included in the Levinthal review, studies had to include adults with established gastroparesis, report patient symptom scores and administer treatment for at least 1 week. Five randomized controlled trials (RCTs) and 13 non-RCTs meeting criteria were identified. Pooled analysis of data from the 5 RCTs (n=185 patients) did not find a statistically significant difference in symptom severity when the GES was turned on versus off (standardized mean difference [SMD], 0.17; 95% confidence interval [CI], -0.06 to 0.40; p=0.15). Another pooled analysis did not find a statistically significant difference in nausea severity scores when the GES was on or off (SMD = -0.143; 95% CI, -0.50 to 0.22; p=0.45). In a pooled analysis of 13 open-label single-arm studies and data from open-label extensions of 3 RCTs, mean total symptom severity score decreased 2.68 (95% CI, 2.04 to 3.32) at follow-up from a mean of 6.85 (95% CI, 6.28 to 7.42) at baseline. The rate of adverse events in the immediate postoperative period (reported in 7 studies) was 8.7% (95% CI, 4.3% to 17.1%). The in-hospital mortality rate within 30 days of surgery was 1.4% (95% CI, 0.8% to 2.5%), the rate of reoperations (up to 10 years of follow-up) was 11.1% (95% CI, 8.7% to 14.1%), and the rate of device removal was 8.4% (95% CI, 5.7% to 12.2%).
 
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in September 2017 did not identify any ongoing or unpublished trials that would likely influence this review.  
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Gastric Electrical Stimulation for Gastroparesis
Laine et al published a retrospective, multicenter analysis of patients with severe, medically refractory gastroparesis who received GES (Laine, 2018). Fourteen patients (11 diabetic, 1 idiopathic, and 2 postoperative) treated in Finland between 2007 and 2015 were included; median follow-up was 3 years. Eight (57.1%) patients experience marked relief of gastroparesis symptoms, while 3 (21.4%) patients experience partial relief. There was a median weight gain of 5.1 kg in 11 (78.6%) patients after GES implantation, and, at last possible follow-up, 5 out of 10 (50%) patients were without medication for gastroparesis. The study was limited by its retrospective nature, small population size, and relatively short follow-up time.
 
Shada et al published a prospective study of patients with medically refractory gastroparesis who underwent implantation of GES between 2005 and 2016 (Shada, 2018). One hundred nineteen patients (64 diabetic, 55 idiopathic), with mean follow-up of 39.0 ± 32.0 months, were included in the analysis. Before GES placement, operatively placed feeding tubes were present in 22% of diabetic and 17% of idiopathic patients, however, after GES placement, 67% of feeding tubes were removed. Due to a perceived lack of benefit, 8 patients decided to have their GES device removed after a mean time of 36 ± 29 months. Also, there was significant improvement in GCSI scores for both diabetic (p=0.01) and idiopathic (p=0.003) subgroups at ≥2 years after implantation. The study was limited by its retrospective nature, not all patients being administered the GCSI before GES, and a number of patients being lost to follow-up.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
43647Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
43648Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum
43881Implantation or replacement of gastric neurostimulator electrodes, antrum, open
43882Revision or removal of gastric neurostimulator electrodes, antrum, open
64590Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
64595Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
95980Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; intraoperative, with programming
95981Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, without reprogramming
95982Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, with reprogramming
References: Brody F, Zettervall SL, Richards NG, et al.(2015) Follow-up after gastric electrical stimulation for gastroparesis. J Am Coll Surg. Jan 2015;220(1):57-63. PMID 25458798

Brody F, Zettervall SL, Richards NG, et al.(2015) Follow-up after gastric electrical stimulation for gastroparesis. J Am Coll Surg. Jan 2015;220(1):57-63. PMID 25458798

Champion JK, Williams M, et al.(2006) Implantable gastric stimulation to achieve weight loss in patients with low body mass index: early clinical trial results. Surg Endosc, 2006; 20:444-7.

Cigaina V, Hirschberg AL.(2003) Gastric pacing for morbid obestiy: plasma levels of gastrointestinal peptides and leptin. Obes Res, 2003; 11:1456-62.

Cigaina V.(2002) Gastric pacing as therapy for morbid obesity: preliminary results. Obes Surg, 2002; 12 suppl 1:12S-16S.

Cigaina V.(2004) Long-term follow-up of gastric stimulation for obesity: the Mestre 8-year experience. Obes Surg, 2004; 14 suppl 1:S14-22.

D'Argent J.(2002) Gastric electrical stimulation as therapy of morbid obesity: preliminary results from the French study. Obes Surg, 2002; 12 suppl 1: 21S-25S.

DeLuca M, Segato G, et al.(2004) Progress in implantable gastric stiumlation: summary of results of the European multi-center study. Obes Surg, 2004; 14 suppl 1:S33-9.

Favretti F, DeLuca M, et al.(2004) Treatment of morbid obesity with the Transcend implantable gastric stimulator (IGS): a prospective survey. Obes Surg, 2004; 14:666-70.

Laine M, Siren J, Koskenpato J, et al.(2018) 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

Lal N, Livemore S, Dunne D, et al.(2015) Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015;2015:762972. PMID 26246804

Levinthal DJ, Bielefeldt K.(2017) Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. Auton Neurosci. Jan 2017;202:45-55. PMID 27085627

Miller K, Hoeller E, Aigner F.(2006) The implantable gastric stimulator for obesity: an update of the European experience in the LOSS (Laparoscopic Obesity Stimulation Survey) study. Treat Endocrinol, 2006; 5:53-8.

Shada A, Nielsen A, Marowski S, et al.(2018) 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

Shikora SA, Bergenstal R, Bessler M, et al.(2009) Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis. Jan-Feb 2009;5(1):31- 37. PMID 19071066

Shikora SA.(2004) "What are the yanks doing?" the U.S. experience with implantable gastric stimulation (IGS) for the treatment of obesity - update on the ongoing clinical trials. Obes Surg, 2004; 14 suppl 1:S40-8.

Shikora SA.(2004) Implantable gastric stimulation for the treatment of severe obesity. Obes Surg, 2004; 14:545-8.

Zhang J, Chen JD.(2006) Systematic review: applications and future of gastric electrical stimulation. Aliment Pharmacol Ther, 2006; 24:991-1002.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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