Medical Policy: 07.01.62
Original Effective Date: January 2014
Reviewed: November 2014
Revised: February 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Gastric Electrical Stimulation
Gastric electrical stimulation (GES) is performed to treat chronic drug refractory nausea and vomiting secondary to gastroparesis of diabetic, idiopathic, or postsurgical etiology. Gastric electrical stimulation/pacing has also been investigated as a treatment of obesity. The device may also be referred to as a gastric pacemaker.
Gastric electrical stimulation uses an implantable electric stimulator that helps control the chronic nausea and vomiting associated with gastroparesis by stimulating the smooth muscles of the lower stomach. A small, battery powered gastric neurostimulator is implanted beneath the skin in the lower abdominal region. Leads deliver mild, controlled electrical pulses to the antrum portion of the stomach muscle wall.
The effect of the high frequency/low energy pacing on gastric contractility is unclear, as is the mechanism of action in decreasing symptomology. It has been hypothesized that the symptomatic improvement that has been observed is caused by modulation of enteric or afferent neural activity that influences symptom perception or that influences a central nausea and vomiting control mechanism. Also, there has been recent reports that indicate that GES therapy changes various electrogastrography parameters, fundic relaxation, the autonomic nervous system and gastrointestinal hormone levels. These processes may play some role in the effect of GES.
Gastroparesis is defined as delayed gastric emptying of solids in the absence of mechanical obstruction. It can frequently result from longstanding diabetes mellitus and vagal nerve injury, or can be idiopathic in nature. Gastroparesis leads to postprandial nausea and vomiting, bloating, early satiety and discomfort. In severe cases, nausea and vomiting may cause weight loss, dehydration, electrolyte disturbances and malnutrition due to inadequate caloric and fluid intake.
Management of gastroparesis consists of supportive measures to include hydration, nutrition, optimizing glycemic control in patients with diabetes mellitus, medications (prokinetic drugs used to improve the rate of stomach emptying and antiemetic drugs used to control nausea and vomiting), occasional surgical therapy and gastric electrical stimulation.
Currently, only one gastric electrical stimulator has received approval from the U.S. Food and Drug Administration (FDA), the Enterra™ Therapy System, manufactured by Medtronic and it was cleared by the FDA as a humanitarian use device.
This system delivers a high frequency (12 cycles per minute), low energy stimulation to the stomach.
The FDA labeling for Enterra™ Therapy System indicates the use of this system for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Practice Guidelines and Position Statements
The American College of Gastroenterology
2013 Clinical Guideline: Management of Gastroparesis
Gastric electrical stimulation may be considered for compassionate treatment in patients with refractory symptoms, particularly nausea and vomiting. Symptom severity and gastric emptying have been shown to improve in patients with diabetic gastroporesis, but not in patients with idiopathic gastroparesis or post surgical gastroparesis. (conditional recommendation, moderate level of evidence).
National Institute for Health and Care Excellence (NICE)
Guideline published May 2014, Gastroelectrical Stimulation for Gastroparesis states the current evidence on the efficacy and safety of gastric electrical stimulation for treating chronic, intractable nausea and vomiting secondary to gastroparesis is adequate to support the use of this procedure.
Gastric pacing (gastric pacemaker) entails the use of a set of pacing wires attached to the stomach and an external electrical device that provides a low frequency, high energy stimulation to entrain the stomach at a rhythm of 3 cycles per minute. However, the gastric pacemaker is cumbersome and problematic for chronic use because of external leads.
Obesity is a major health problem among adults in the United States. It is also an increasing health concern among American children as well as adolescents. Various methods are employed in the management of obesity. One of the new approaches is gastric pacing, which is intended to induce early satiety through electrical stimulation of the gastric wall. However, the effectiveness of this technique in the treatment obesity has not been established. There is insufficient evidence on the short term and long term benefit of gastric pacing for obesity and therefore, is considered investigational.
The Enterra™ Therapy 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 phase is similar to that of a premarket approval application (PMA) but is exempt from the effectiveness requirements of a PMA. The application is not required to include results of scientifically valid clinical investigations but must contain sufficient information for the FDA to determine that the device does not post 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.
See also Humanitarian Use Devices medical policy 10.01.14
See also Vagus Nerve Stimulation (VNS) medical policy 07.01.60
Gastric electrical stimulation (eg, Enterra™ Therapy) is considered medically necessary and, therefore, covered for the following humanitarian device exemption (HDE) indication granted by the US Food and Drug Administration (FDA):
- For the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology
An institutional review board (IRB) must approve the use of gastric electrical stimulation for the treatment of gastroparesis to ensure that it will be used in accordance with the HDE indication(s) granted by the FDA.
FDA-labeled HDE indication(s) is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm.
Gastric electrical stimulation and gastric pacing would be considered investigational for all other indications including but not limited to the following because their effectiveness for these indications has not been established:
- As an initial treatment for gastroparesis
- For treatment of diabetes mellitus in persons without gastroparesis
- For the treatment of obesity
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 43647: Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
- 43648: revision or removal of gastric neurostimulator electrodes, antrum
- 43881: Implantation or replacement of gastric neurostimulator electrodes, antrum, open
- 43882: Revision or removal of gastric neurostimulator electrodes, antrum, open
- 64590: Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling.
- 64595: Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver.
- 95980 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedence and patient measurements) gastric neurstimulator pulse generator/transmitter; intraoperative, with programming.
- 95981 subsequent, without programming
- 95982 subsequent with reprogramming
- C1767 Generator, neurostimulator (implantable), nonrechargeable
- C1778 Lead, neurostimulator
- C1787 Patient programmer, neurostimulator
- C1816 Receiver and/or transmitter neurostimulator (implantable)
- C1820 Generator neurostimulator (implantable, with rechargeable battery and charging system)
- C1897 Lead neurostimulator test kit (implantable)
- L8679 Implantable neurostimulator, pulse generator any type
- L8680 Implantable neurostimulator electrode, each
- L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
- L8682 Implantable neurostimulator radiofrequency receiver
- L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
- L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
- L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
- L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
- L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
- L8689 External recharging system for battery, (internal) for use with implantable neurostimulator, replacement only
Wellmark's policy is based on:
- National Institute of Clinical Excellence (NICE). Gastroelectrical Stimulation for Gastroparesis. December 2004.
- 2013 Clinical Guideline: Management of Gastroparesis. The American College of Gastroenterology. Michael Camilleri, M.D., Henry P. Parkman, M.D., Mehnaz A. Shafti, M.D., Thomas L. Abell, M.D. and Laruen Gerson, M.D., MSc. AmJGastroenterol 2013; 108:18-37;doi:10.1038/ajg.2012.373.
- UpToDate. Treatment of Gastroparesis. Michael Camilleri, M.D.. July 17, 2013.
- UpToDate. Electrical Stimulation for Gastroparesis. William L. Hasler, M.D. August 20, 2012.
- ECRI. Product Brief. Enterra Therapy System (Medtronic, Inc) for Treating Gastroparesis. July 2013.
- Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Frequently Asked Questions About Medical Devices
- HDE Approvals, Listing of CDRH Humanitarian Device Exemptions.
- Soffer Edy E. Gastric Electrical Stimulation for Gastroparesis, J Neurogastroenterol Motil, Vol. 18 No. 2 April 2012. Also available at http://dx.doi.org/10.5056/jnm.2012.18.2.131
- National Institute for Clinical Excellence (NICE). Interventional Procedures Guidance (IPG489), Published May 2014. Gastroelectrical Stimulation for Gastroparesis. Also available at https://www.nice.org.uk/guidance/IPG489
- UpToDate. Electrical Stimulation for Gastroparesis. William L. Hasler, M.D., Topic last updated March 6, 2014. Also available at www.uptodate.com
Date Reason Action
January 2014 New Policy Created
November 2014 Annual review Policy revised
February 2015 Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.