Description

Gastric pacing (also known as gastric electrical stimulation) is a treatment for an individual with chronic, intractable or drug-refractory nausea and vomiting secondary to gastroparesis, which could be caused by diabetes or idiopathic (unknown) reasons. A gastric pacing system delivers electrical stimulation to the gastric muscles by means of two leads that are implanted directly into the stomach and connected to a generator that is implanted into the abdominal area. The electrical impulses that are delivered to the gastric muscles are intended to stimulate gastric myoelectric activity with the goal of improving stomach emptying and relieving symptoms.

The device is regulated by an external programmer that noninvasively adjusts the level of gastric stimulation and allows the device to be completely turned off at any time. Internal battery replacement is required every 5 to 10 years.

Effective Date: 03/23/2023
Revision Date: 03/23/2023
Review Date: 03/23/2023
Policy Number: HUM-0388-022

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The Enterra Therapy II system is approved under a Humanitarian Device Exemption (HDE) by the US Food & Drug Administration (FDA) and is the only gastric pacing system approved for marketing.

A temporary trial of gastric pacing is being investigated to determine the response and benefit of this treatment prior to placing a permanent device. A cannula with an internal needle is inserted through the skin and placed in the gastric submucosa. A self-anchoring electrode is passed through the needle, which delivers electrical stimulation up to 8 weeks. (Refer to Coverage Limitations section)

For information regarding vagus/vagal nerve blocks or vagal blocking for obesity control, please refer to Bariatric Surgery Medical Coverage Policy.

Coverage Determination

Commercial Plan members: requests for gastric pacing require review by a medical director.

Humana members may be eligible under the Plan for gastric pacing when the following criteria are met:

• 18 through 70 years of age; AND
• Chronic, intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology; AND
• Diagnosis confirmed by gastric emptying scintigraphy and/or radiopaque marker testing; AND
• Refractory or intolerant to diet modification and pharmaceutical therapy (eg, antiemetics, prokinetics)

Humana members may be eligible under the Plan for gastric pacing revision or removal of previously approved implantation for complications associated with gastric pacing (eg, bowel obstruction, gastric wall perforation, infection, lead dislodgement or lead erosion into the small intestine).

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for replacement of a gastric pacing device if required for battery depletion (generally no more frequently than every 5 to 10 years).

Coverage Limitations

Humana members may NOT be eligible under the Plan for gastric pacing for any indications other than those listed above including, but may not be limited to:

• Initial treatment for gastroparesis; OR
• Temporary trial of gastric pacing; OR
• Treatment of obesity

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about gastroparesis may be found from the following websites:

Background

• American College of Gastroenterology
• National Library of Medicine

Medical Alternatives

Alternatives to gastric pacing include, but may not be limited to, the following:

• Surgical intervention, such as the placement of a feeding tube

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.