Gastric Electrical Stimulation for the Treatment of Gastroparesis (43647, 43648, 43881, 43882)

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. Gastric electrical stimulation that is not approved by a Medical Director will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

For electronic analysis of implanted neurostimulator pulse generator system, gastric neurostimulation pulse generator/transmitter; intraoperative, with programming or subsequent electronic analysis with or without reprogramming, use codes 95980-95982, as appropriate.

Gastric Electrical Stimulation for the Treatment of Obesity (0155T, 0156T, 0157T, 0158T, 0162T)

The Transcend implantable gastric stimulation device, manufactured by Transneuronix Corporation, is a device currently being investigated for treatment of obesity.  However, there is a lack of randomized control trials on gastric electrical stimulation for the treatment of obesity.  Further studies are needed as the currently available data are insufficient to permit scientific conclusions.  Therefore, this procedure is considered experimental/investigational and not covered. A participating, preferred, or network provider can bill the member for the denied service.

For insertion of a gastric neurostimulator pulse generator, use code 64590.  For revision or removal of a gastric neurostimulator pulse generator, use code 64595.  Any of these procedures performed in conjunction with the ineligible procedures (0155T-0158T, 0162T) should be denied as experimental/investigational.  A participating, preferred, or network provider can bill the member for the denied service.  For surgical implantation or replacement of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity), use codes 0155T or 0157T.  Use codes 0156T or 0158T to report revision or removal of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity).  For electronic analysis, programming, and re-programming of gastric stimulator (i.e., morbid obesity) use code 0162T.

Date Last Reviewed: 06/2008

Please refer to Medical Policy Bulletin G-24 for additional information on the treatment of obesity.

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 glycolic 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 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.

Gastric electrical stimulation or gastric pacing is being investigated for the treatment of morbid obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. This procedure employs an implantable, pacemaker like device to deliver low-level stimulation to the stomach. The Transcend IGS system consists of a battery-powered pulse generator, two leads with bipolar electrodes, and a remote handheld programmer. The pulse generator, which is about the size of a pocket watch, is implanted under the skin of the abdomen, and the leads and electrodes are inserted into the stomach wall and sutured to the stomach muscles. The minimally invasive surgical implantation procedure is usually performed laparoscopically in an outpatient setting and takes less than 1 hour. A few weeks after surgery, the stimulator is activated by the physician, who uses the handheld programmer to deliver patterned and adjustable electrical pulses to the stomach wall. Electrostimulation then induces an artificial feeling of fullness (satiety), which should result in reduced calorie consumption. The stimulator battery lasts 3 to 5 years, after which patients must have a minor surgical procedure to replace the battery. The mechanism of action for induced satiety is not yet fully understood, and may involve neurological processes, changes in digestive hormones, or altered gastrointestinal motility.  Currently, the Transcend IGS system is not FDA approved and is undergoing clinical trials in the United States. 

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.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

National Blue Cross Blue Shield Association Medical Policy 7.01.73, Gastric Electrical Stimulation,
04/2008

Gastrointestinal Electrical Stimulation for Treatment of Gastrointestinal Disorders: Gastroparesis, Obesity, Fecal Incontinence, and Constipation, Gastroenterology Clinics, Volume 36, Number 3, 09/2007

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

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