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DESCRIPTIONGastric electrical stimulation is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic, idiopathic, or post-surgical etiology. The device may be referred to as a gastric pacemaker.
Gastroparesis is a chronic disorder of gastric motility characterized by delaying 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 pathologic conditions. Some cases may not be associated with an identifiable cause, and are referred to as idiopathic gastroparesis. Treatment of gastroparesis includes prokinetic agents, such as metoclopramide, and antiemetic agents, such as metoclopramide, granisetron, or odansetron. Severe cases may require enteral or total parenteral nutrition.
Gastric electrical stimulation, also referred to as gastric pacing, using an implantable device, has been investigated primarily as a treatment for gastroparesis. Currently available devices consist of a pulse generator, which can be programmed to provide electrical stimulation at different frequencies, connected to intramuscular stomach leads that are implanted during laparoscopy or open laparotomy.
Gastric electrical stimulation has also 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 and acquired by Medtronic in 2005, is currently available in Europe for treatment of obesity. Medtronic announced in December 2005 that the preliminary results of the Screened Health Assessment and Pacer Evaluation, or SHAPE trial, which was initiated by Transneuronix using the Transcend device, "did not meet the efficacy endpoint of a difference in mean excess weight loss at one year."
Currently, there is only one gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA) (see note below), the Gastric Electrical Stimulator (GES) System (now called Enterra™ Therapy System), manufactured by Medtronic. The GES system consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. With the exception of the intramuscular leads, all other components have been used in other implantable neurological stimulators, such as spinal cord or sacral nerve stimulation. The intramuscular stomach leads are implanted either laparoscopically or during a 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 sec alternating with an "off" time of 5.0 sec.
Note: 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 less 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.
POLICYGastric electrical stimulation is considered investigational for the treatment of gastroparesis of diabetic, idiopathic, or post-surgical etiology.
Gastric electrical stimulation is considered investigational for the treatment of obesity.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2001: Approved by Medical Policy Advisory Committee (MPAC)
2/13/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
3/25/2004: Reviewed by MPAC, remains investigational, Sources updated
5/19/2004: Code Reference section completed
12/13/2006: Policy reviewed, no changes
12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions
3/5/2007: Code Reference section updated per quarterly HCPCS revisions
12/18/2007: Coding updated per 2008 CPT/HCPCS revisions
2/19/2008: Policy reviewed, no changes
12/31/2008: Code reference section updated per CPT/HCPCS revisions
7/8/2009: Policy reviewed, description re-written with added information about Transneuronix
12/29/2010: Policy statement and description unchanged. Removed deleted procedure codes 0162T and S2213 from the Code Reference section.
12/01/2011: Policy reviewed. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from Sources section.
12/13/2012: Added "or post-surgical etiology" to the first investigational policy statement.
11/15/2013: Policy reviewed; no changes.
10/09/2014: Policy reviewed; description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.73
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.