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Gastric electrical stimulation (GES) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic, idiopathic, or postsurgical etiology. GES has also been investigated as a treatment of obesity. The device may be referred to as a gastric pacemaker.
A gastric electrical stimulator system called Enterra™ Therapy System (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption process for the treatment of gastroparesis. The GES system consists of 4 components: the implanted pulse generator, 2 unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. 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 second alternating with an “off” time of 5.0 seconds. Currently, no GES devices have been approved by the FDA for the treatment of obesity.
I. Gastric electrical stimulation using an FDA-approved device may be considered MEDICALLY NECESSARY AND APPROPRIATE in 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:
II. Gastric electrical stimulation is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes, including but not limited to the treatment of:
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Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.