Gastric Electrical Stimulation

POLICY NUMBER

A.7.01.73

DESCRIPTION

Gastric 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. Gastric electrical stimulation has also been investigated as a treatment of obesity.The device may be referred to as a gastric pacemaker.

Treatment

GastroparesisGastroparesis 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 diabetic patients. 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. Gastric electrical stimulation (GES), 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, which are implanted during laparoscopy or open laparotomy.

ObesityGastric electrical stimulation has also been investigated as a treatment of obesity. It is used to increase a feeling of satiety with subsequent reduction in food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neurohormonal modulation and/or stomach muscle stimulation.

In 2000, the Gastric Electrical Stimulator system (now called Enterra™ Therapy System; Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption process (H990014) for the treatment of gastroparesis. 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 neurologic 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 which is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an "on" time of 0.1 seconds alternating with an "off" time of 5.0 seconds. The Enterra II system features no magnetic activation switch which reduces electromagnetic interference.

Currently, no gastric electrical stimulation devices have been approved by the FDA for the treatment of obesity. The Transcend® (Transneuronix; acquired by Medtronic in 2005), an implantable gastric stimulation device, is available in Europe for treatment of obesity.

POLICY

Gastric 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 EXCEPTIONS

Federal 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.

State Health Plan (State and School Employees):

Effective 03/01/2017:

SHP considers gastric pacing (gastric pacemaker) and gastric electrical stimulation medically necessary for the treatment of symptoms of nausea and vomiting from chronic gastroparesis, where the diagnosis is confirmed by gastric emptying scintigraphy, that is refractory to medical management (including dietary modification, antiemetics, and prokinetics).

SHP considers revision or replacement of a previously approved gastric stimulator implant medically necessary for complications associated with gastric pacing (eg, bowel obstruction, gastric wall perforation, infection, lead dislodgement or lead erosion into the small intestine).

SHP considers gastric pacing and gastric electrical stimulation experimental and investigational for all other indications including the following because their effectiveness for these indications has not been established (not an all-inclusive list):

• As an initial treatment for gastroparesis

• For the treatment of cyclic vomiting syndrome 

• For the treatment of diabetes mellitus in persons without gastroparesis 

• For the treatment of gastrointestinal dysmotility disorders other than gastroparesis 

• For the treatment of obesity.

Note: The use of a second gastric electrical stimulator for the treatment of symptoms of nausea and vomiting from chronic gastroparesis is considered experimental and investigational.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2001: 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.

07/20/2015: Code Reference section updated for ICD-10.

01/13/2016: Policy reviewed; no changes. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.73 added.

02/27/2017: Policy description updated regarding devices. Policy statements unchanged. Policy Exceptions section updated to add medically necessary/investigational criteria for State Health Plan members, effective 03/01/2017.

03/01/2018: Policy description updated. Policy statements unchanged.

03/25/2019: Policy reviewed; no changes.

03/10/2020: Policy description updated to remove information regarding gastroparesis. Policy statements unchanged.

04/06/2021: Policy reviewed; no changes.

04/22/2022: Policy description updated regarding gastroparesis. Policy statements unchanged.

03/22/2023: Policy description updated regarding devices. Policy statements unchanged.

12/21/2023: Code Reference section updated to revise the code descriptions for CPT codes 64590 and 64595, effective 01/01/2024.

03/20/2024: Policy reviewed; no changes.

04/14/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.73

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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