CurrentArizona Complete HealthPolicy CP.MP.40

Gastric Electrical Stimulation

Criteria and coding guidance for coverage of gastric electrical stimulation for gastroparesis for health plans affiliated with Centene Corporation, governing clinical medical necessity and exclusions for enrolled members and provider billing.

Policy Summary

PayerArizona Complete Health

PolicyGastric Electrical Stimulation

Policy CodePolicy CP.MP.40

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age ≥18, gastric emptying scintigraphy confirming diabetic or idiopathic gastroparesis, drug‑refractory chronic nausea and vomiting, and trials/failure or intolerance of antiemetic, dietary, and prokinetic therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum patient age for coverage

diabetic/idiopathiceligible gastroparesis types

HDEregulatory pathway

CPT/HCPCScoding referenced

Coverage Criteria for Gastric Electrical Stimulation

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Initial Therapy/Covered Indication

Covered when ALL of the following are met

GES medical necessity criteria: Member/enrollee is ≥ 18 years of age

GES medical necessity criteria: Diagnosis of diabetic or idiopathic gastroparesis confirmed by gastric emptying scintigraphy

GES medical necessity criteria: Chronic intractable (drug refractory) nausea and vomiting

GES medical necessity criteria: Documented intolerance or failure of a trial of antiemetic, dietary modifications, and prokinetic drug therapy

Recommended combination prokinetic therapy includes metoclopramide and erythromycin; centrally acting antidepressants may be used as symptom modulators

GES medical necessity criteria: Not currently pregnant

GES medical necessity criteria: Technology is provided in accordance with the FDA Humanitarian Device Exemption (HDE) specifications

Use limited to HDE-specified indications and institutional IRB oversight as applicable

GES is covered only when the medical necessity criteria in this policy are met. Use of gastric electrical stimulation for indications not supported by the evidence is considered outside the scope of coverage. Specifically, GES is not medically necessary for reduction of pain, fullness, bloating, or acid reflux, and current evidence does not support its use for other indications including treatment of obesity.

Requests for GES when intended to treat symptoms other than nausea and vomiting (for example, pain, early satiety/fullness, bloating, or acid reflux) should be denied as not medically necessary because there is no evidence to support benefit. Similarly, use of GES for the treatment of obesity or any other non–evidence‑based indication is considered not medically necessary.

Procedure and Supply Codes

Covered CPT and HCPCS procedure and supply codesmixed

43647	Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum.
43648	Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum.
43881	Implantation or replacement of gastric neurostimulator electrodes, antrum, open.
43882	Revision or removal of gastric neurostimulator electrodes, antrum, open.
64590	Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver.
64595	Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array.
95980	Electronic analysis of implanted neurostimulator pulse generator system, gastric neurostimulator pulse generator/transmitter, intraoperative, with programming.
95981	Electronic analysis of implanted neurostimulator pulse generator system; subsequent, without reprogramming.
95982	Electronic analysis of implanted neurostimulator pulse generator system; subsequent, with reprogramming.
C1767	Generator, neurostimulator (implantable), non-rechargeable.

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HCPCS supply codesHCPCS

L8679	Implantable neurostimulator, pulse generator, any type.
L8680	Implantable neurostimulator electrode, each.
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension.

FDA HDE patient population cap

HDE patient population capIntended for diseases affecting fewer than 8,000 individuals in the United States annually

Facility oversight requirementMay only be used in facilities with an institutional review board (IRB) to supervise clinical testing of devices

Local approval requirementUse permitted after IRB or an appropriate local committee has approved the device for the specific disease

Provider Requirements, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantation, revision, removal, pulse generator procedures and associated HCPCS/CPT supplies for gastric electrical stimulation (GES). Requests must include documentation that the member meets medical necessity criteria (age, diagnostic confirmation, chronic drug‑refractory symptoms, and prior therapy trials).

Affected CPT: 43647, 43648, 43881, 43882, 64590, 64595, 95980, 95981, 95982
Affected HCPCS/Codes: C1767, C1778, L8679, L8680, L8685, L8686, L8687, L8688

Step Therapy

Required Medication / Dietary Therapy Trials

A trial and documented intolerance or failure of combination prokinetic and antiemetic therapy plus dietary modifications is required prior to approval of GES. Current recommended combination prokinetic therapy includes metoclopramide and erythromycin; centrally acting antidepressants may be used as symptom modulators. Documentation must show trial duration, agents tried, reasons for intolerance or failure, and that dietary modification efforts were attempted.

Required medication trial: combination prokinetic (e.g., metoclopramide + erythromycin) and antiemetic therapy
Required adjuncts: dietary modifications and use of centrally acting antidepressants as symptom modulators where applicable
Documentation: dates of trials, dosages, response, and documented intolerance or failure

Denial Risk

Denial Triggers for Unmet Medical Necessity Criteria

Requests will be denied when medical necessity criteria are not met. Denial triggers include: member < 18 years old; no gastric emptying scintigraphy confirming diabetic or idiopathic gastroparesis; symptoms not chronic intractable (not drug‑refractory); lack of documented trial and failure/intolerance of antiemetic, prokinetic therapy and dietary modifications; current pregnancy; or device use outside the FDA Humanitarian Device Exemption (HDE) specifications. GES requested for unsupported indications (reduction of pain, fullness, bloating, acid reflux, obesity, or other non‑supported indications) is not medically necessary and may be denied.

Denial triggers: age < 18, no confirmatory gastric emptying scintigraphy for diabetic/idiopathic gastroparesis
Denial triggers: symptoms not documented as chronic intractable (drug‑refractory) or lack of documented failed/intolerant trials of required therapies
Denial triggers: pregnancy or request for indications outside HDE (including pain, fullness, bloating, reflux, obesity)
Operational note: include clear medical record documentation of trials, diagnostic testing, symptom history, and pregnancy status to avoid denial

Key Definitions

Gastric electrical stimulation (GES)

DefinitionImplantation of leads in the muscularis propria of the stomach connected to a subcutaneous pulse generator to deliver electrical stimulation aimed at reducing symptoms (primarily nausea and vomiting) in refractory gastroparesis

Lead placementPair of leads placed in the gastric muscularis on the greater curvature about 10 cm proximal to the pylorus

Pulse generator locationPulse generator typically placed subcutaneously in the right or left upper quadrant of the abdomen

Clinical effectHas not shown significant improvement in gastric emptying on average but can reduce nausea and vomiting and improve quality of life

Humanitarian Device Exemption (HDE)

HDE purposeFDA designation permitting use of devices intended to benefit patients with diseases affecting fewer than 8,000 individuals in the U.S. annually

IRB oversightA Humanitarian Use Device may only be used in facilities that have an established institutional review board (IRB) to supervise clinical testing

Approval prerequisiteUse requires IRB or an appropriate local committee approval for treatment or diagnosis of the specific disease

Background on Gastroparesis and GES

Gastroparesis is delayed gastric emptying without mechanical obstruction and most commonly occurs in idiopathic and diabetic forms. Patients typically present with nausea and vomiting and may also experience early satiety, bloating, and abdominal discomfort; these symptoms can lead to weight loss and malnutrition. Gastric electrical stimulation (GES) involves implantation of leads into the gastric muscularis connected to a subcutaneous pulse generator to deliver electrical stimulation aimed primarily at reducing refractory nausea and vomiting, although it typically does not normalize gastric emptying and is intended for symptom control in selected, treatment‑refractory patients.