Currently, the Gastric Electrical Stimulator (GES) System/Enterra Therapy System, manufactured by Medtronic is the only gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA). The GES system consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. The intramuscular leads are implanted either laparoscopically or during laparotomy and are connected to the pulse generator that is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an on time of 0.1 second alternating with an off time of 5.0 seconds.

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 device may only be used in facilities that have an Institutional Review Board (IRB) to supervise clinical testing of the device.

Claims reporting gastric electrical stimulation will be reviewed on an individual consideration basis by the appropriate Medical Director, Physician Advisor, or Professional Consultant. Gastric electrical stimulation that is not approved by a Medical Director or Physician Advisor will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

Description

Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal. Symptoms include bloating, distension, nausea and vomiting. When severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status, and poor glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathology. Treatment of gastroparesis includes dietary and pharmacological approaches, such as prokinetic agents, and antiemetic agents. Severe cases may require enteral or total parenteral nutrition. Gastric electrical stimulation is another option that may be considered for refractory cases.

Gastric electrical stimulation (S2213) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The procedure may also be referred to as gastric pacing or Enterra Therapy.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

PRN References

12/2002, Gastric Electrical Stimulation

National Blue Cross Blue Shield Association Medical Policy 7.01.73, Gastric Electrical Stimulation, 12/2000

Motility Disorders, Pediatric Clinics of North America, Volume 49, No. 1, 02/2002

EUS Guidance in Gastric Pacemaker Implantation, Gastrointestinal Endoscopy, Volume 55, No. 6, 05/2002