Coverage Policy Manual
Policy #: 2007009
Category: Surgery
Initiated: May 2007
Last Review: October 2018
  Gastric Neurostimulation for Morbid Obesity

Description:
Gastric electrical stimulation has been investigated as a treatment of obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neuro-hormonal modulation and/or stomach muscle stimulation. There are no gastric electrical stimulation devices approved by the FDA for the treatment of obesity. However, the Transcend implantable gastric stimulation device, manufactured by Transneuronix Corporation, is currently available in Europe for treatment of obesity. Transneuronix is currently funding clinical trials in the United States, and the company hopes to obtain FDA approval in a couple of years for use of the Transcend device to promote weight loss in the management of obesity
 
Note: It should be noted that the GES system received FDA approval through a “humanitarian device exemption.” This regulatory category was established in 1996 and only applies to devices intended to benefit fewer than 4,000 patients. The approval process is similar to that of a premarket approval application (PMA) but is exempt from the effectiveness requirements of a PMA. Thus the application is not required to provide results of scientifically valid clinical investigations, but must contain sufficient information for the FDA to determine that the device does not pose unreasonable or significant risk of illness or injury. A humanitarian use device may only be used in facilities that have an Institutional Review Board (IRB) to supervise clinical testing of the device.
 
Coverage of gastric neurostimulation for any reason other than obesity is addressed in policy #2003045.

Policy/
Coverage:
Group contracts furnished on or after July 1, 2004 consider gastric electrical stimulation a contract exclusion.
 
Gastric neurostimulation for the treatment of morbid obesity is not covered since there is no FDA approved device for this indication.
 
Gastric neurostimulation for the treatment of morbid obesity is considered investigational and is not covered by contracts without primary coverage criteria.  Investigational services are excluded in the member benefit certificate.  
 
Electronic analysis and programming or reprogramming of a gastric neurostimulator for the treatment of morbid obesity is also not covered since gastric neurostimulation for obesity is not covered.

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.  

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.

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.

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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