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.

Gastric Electrical Stimulation may be considered medically necessary when ALL of the following criteria are met:

• The U.S. Food and Drug Administration (FDA) has designated the device as a Humanitarian Use Device (HUD); and
• The FDA has approved the device for marketing under the Humanitarian Device Exemption (HDE); and
• The device has local Institutional Review Board (IRB) approval; and
• Appropriate informed consent has been obtained from the individual; and
• The device is not specifically excluded from coverage.

Gastric electrical stimulation may be considered medically necessary when provided in accordance with the HDE specifications of the FDA for the treatment of chronic intractable nausea and vomiting secondary to severe gastroparesis of diabetic or idiopathic etiology when ALL of the following criteria are met:

• Significant delayed gastric emptying as documented by standard scintigraphic imaging of solid food; and
• Individual is refractory to or intolerant of at least two (2) anti-emetic and prokinetic drug classes; and
• No mechanical obstruction is found on diagnostic testing; and
• Individual's nutritional status is sufficiently low that ALL of the following criteria for total parenteral nutrition are met: 
  • Adequate trials of dietary adjustment, oral supplements, or tube enteral nutrition have been demonstrated that the individual can receive less than or equal to 30% of his/her caloric needs orally and/or tube; and
  • The individual must be in a stage of wasting as indicated by:
    • Weight loss greater than 10% within six (6) months; and
    • Serum albumin is less than 3.4 grams; and
    • Blood urea nitrogen (BUN) level is less than ten (10) mg; and
    • Phosphorus level is less than 2.5 mg (normal phosphorous is 3-4.5 mg).

Gastric electrical stimulation is considered experimental/investigational and, therefore, non-covered for all other indications including, but not limited to, initial treatment of gastroparesis and treatment of obesity. The safety and/or effectiveness of this service cannot be established by review of the available published literature.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Gastric Electrical Stimulation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

01/2016, Criteria Revised for Gastric Electrical Stimulation, Gastric Pacing

• Link to Diagnosis Codes

• Link to References