Medical Policy: 07.01.62
Original Effective Date: January 2014
Reviewed: October 2015
Revised: October 2015
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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, intractable 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.
Primary medical management for gastroparesis includes dietary modification and pharmacologic therapy with prokinetic (metoclopramide and erythromycin) and antiemetic agents. Patients refractory to treatment are difficult to manage. Treatment may involve changing or combining medications; placement of gastrostomy or jejunostomy tube for enteral feedings, or in severe cases, total parenteral nutrition (TPN) for brief periods. Some patients, however, remain refractory to gastroparesis treatment.
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.
Gastric Pacing
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 of 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.
Summary
Based on the peer reviewed medical literature gastric electrical stimulation (GES) may be safe and effective option for those patients with intractable nausea and vomiting secondary to gastroparesis who have failed all other treatments. The use of GES or gastric pacing of the treatment of all other indications remains unproven, optimal patient selection criteria, electrode position, lead number and stimulation patterns have not yet been determined. Additional well designed studies are not needed to demonstrate the safety and effectiveness of GES for these indications.
Practice Guidelines and Position Statements
The American College of Gastroenterology
The American College of Gastroenterology published a clinical practice guideline on the management of gastroparesis in 2013. The recommendations for these guidelines were based on review of the evidence base through 2011. The evidence on GES consisted of 2 randomized crossover trials and the case series. The recommendation for GES was that “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 (DG), but not in patients with idiopathic gastroparesis (IG) or postsurgical gastroparesis (PSG). (Conditional recommendation (there is uncertainty about trade-offs), moderate level of evidence (further research would be likely to have an impact on the confidence in the estimate of effect)
National Institute for Health and Care Excellence (NICE)
In 2014, the National Institute for Health and Care Excellence issued guidelines on gastroelectrical stimulation for gastroparesis that made the following recommendation:
Regulatory Status
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.
Not applicable.
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) may be considered medically necessary and, therefore, covered for the following humanitarian device exemption (HDE) indication granted by the US Food and Drug Administration (FDA):
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. Documentation of IRB approval may be requested to ensure compliance with such indications.
FDA-labeled HDE indication(s)External Site
Gastric electrical stimulation and gastric pacing would be considered investigational for all other indications, including but not limited to the following because the safety and effectiveness of this service cannot be established by review of the available published medical literature:
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