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 are met:
- Failure to meet adequate caloric needs despite adequate trials of dietary adjustment, oral supplements, or tube enteral nutrition and
- The individual must be in a stage of wasting as indicated by AT LEAST ONE of the following:
- Weight loss greater than 10% within six (6) months; or
- Serum albumin is less than 3.4 grams; or
- Blood urea nitrogen (BUN) level is less than ten (10) mg; or
- 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 because the safety and/or effectiveness of this service cannot be established by review of the available published literature.