Gastric Electrical Stimulation, Gastric Pacing

Section: Surgery
Effective Date: July 01, 2018
Revised Date: May 14, 2018

Description

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. 

Criteria

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.

Procedure Codes 

43647   43648 43881 43882

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.

Procedure Codes 

43647 43648 43881 43882 64590
64595 95980 95981 95982

Outpatient HCPCS (C Codes) 

C1767   C1778

Diagnosis Codes

Covered Diagnosis Code for Procedure Codes 43647, 43881, C1767 and C1778

K31.84

Links

S-155

  1. InterQual® Level of Care Criteria 2017. Acute Care Adult. McKesson Health Solutions, LLC.
  2. Farrugia G. Histologic changes in diabetic gastroparesis. Gastroenterology Clinics of North America. 2015;44(1):31-38. 
  3. Horbach T, Thalheimer A, Seyfried F, et al. abiliti® closed-loop gastric electrical stimulation system for treatment of obesity: Clinical results with a 27-month follow-up. Obesity Surgery. 2015;25(10):1779–1787. 
  4. Brody F, Zettervall S, Richards N, et al. Follow-Up after Gastric Electrical Stimulation for Gastroparesis. JACS. 2015;220(1):57-63. 
  5. Hayes, Inc. Hayes Medical Technology Directory Pocket Summary. Gastric Electrical Stimulation for Gastroparesis. Lansdale, PA: Hayes, Inc.; October, 2017. 
  6. Klinge MW, Rask P, Mortensen LS, et al. Early assessment of cost-effectiveness of gastric electrical stimulation for diabetic nausea and vomiting. J Neurogastroenterol Motil. 2017; 23(4): p.541. 
  7. Heckert J, Sankineni A, Hughes WB, et al. Gastric electric stimulation for refractory gastroparesis: a prospective analysis of 151 patients at a single center. Dig Dis Sci. 2016; 61(1): pp.168-175. 
  8. Ross J, Masrur M, Gonzalez-Heredia R, et al. Effectiveness of gastric neurostimulation in patients with gastroparesis. JSLS. 2014;18(3). 
  9.  Hayes, Inc. Hayes Medical Technology Report. Gastric Electrical Stimulation for Gastroparesis. Lansdale, Pa: Hayes, Inc.; October, 2018. 
  10. National Institute of Health and Care Excellence. Gastroelectrical stimulation for gastroparesis. 2014. Accessed May 15, 2019. 
  11. Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013; 108(1):18-37. Accessed May 15, 2019.