CurrentCentenePolicy N/A

Gastric Electrical Stimulation (GES) — Coverage Criteria

Defines Centene-affiliated health plan medical necessity and coding guidance for gastric electrical stimulation for gastroparesis, including eligibility criteria and non-covered indications; affects providers seeking prior authorization and billing for GES procedures.

Policy Summary

PayerCentene

PolicyGastric Electrical Stimulation (GES) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review Date01/25

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

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age

diabetic or idiopathiccovered etiologies

HDEFDA status

11 codesprocedure codes

Coverage and Medical Necessity Criteria

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Initial therapy (medical necessity)

GES is medically necessary for diabetic and idiopathic gastroparesis when ALL of the following are met:

Eligibility: Member/enrollee is >= 18 years of age

Diagnosis confirmation: Diagnosis of diabetic or idiopathic gastroparesis confirmed by gastric emptying scintigraphy

Symptoms: Chronic intractable (drug refractory) nausea and vomiting

Conservative therapy failure: 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

Pregnancy: Not currently pregnant

Device regulatory status: Technology is provided in accordance with the FDA Humanitarian Device Exemption (HDE) specifications

HDE use requires appropriate IRB oversight per policy notes

Procedure, Supply, and Coding Information

Procedure and supply codes (CPT/C) from policymixed

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; 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.

1–10 of 11

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HCPCS implantable neurostimulator 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.

Age — minimum age requirement

Minimum ageMember must be at least 18 years of age (>= 18 years)

Documentation required for ageAge must be documented in submitted medical records to support medical necessity

Denial risk if underageClaims may be denied if member is under 18 years

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for gastric electrical stimulation (GES). Submit prior authorization requests including relevant diagnosis, supporting diagnostic testing, and documentation of prior conservative therapy trials.

Affected codes: CPT 43647, 43648, 43881, 43882, 64590, 64595, 95980-95982; HCPCS L8679, L8680, L8685-L8688; C-codes C1767, C1778
Include member age and confirmation that member is ≥ 18 years
Document diagnosis of diabetic or idiopathic gastroparesis confirmed by gastric emptying scintigraphy
Include chronicity and description of drug-refractory nausea/vomiting
Confirm device meets FDA HDE specifications

Denial Risk

Denial Triggers

Denial may be issued if required diagnostic testing or documentation is missing, if the member does not meet age or diagnosis criteria, or if conservative therapy trials are not documented or failed/intolerant.

Trigger for denial: Member is < 18 years of age
Trigger for denial: Diagnosis other than diabetic or idiopathic gastroparesis (non-covered indication)
Trigger for denial: Lack of confirmatory gastric emptying scintigraphy
Trigger for denial: Missing documentation of chronic intractable (drug refractory) nausea and vomiting
Trigger for denial: No documentation of failed or intolerant trial of antiemetic, dietary modifications, and prokinetic therapy
Trigger for denial: Member is currently pregnant
Trigger for denial: Device not provided per FDA HDE specifications

Step Therapy

Required Trial of Conservative Therapy

A documented trial of conservative therapy is required prior to approval. The trial must show failure or intolerance to each of the following: antiemetic therapy, dietary modifications, and prokinetic drug therapy.

Required trial: Antiemetic therapy — document agents used, duration, and reason for failure or intolerance
Required trial: Dietary modifications — document interventions (eg, small frequent meals, low-fat/low-fiber diet), duration, and response
Required trial: Prokinetic drug therapy — document agents (eg, metoclopramide and erythromycin), duration, and reason for failure or intolerance
Documentation should include dates, dosages, adverse effects, and clinician notes evidencing inadequate symptom control
If centrally acting antidepressants or other symptom modulators were used, document role as adjunctive therapy and treatment response

Documentation Required

Documentation Requirements

When submitting requests include the following required documentation elements to support medical necessity: age, confirmed diagnosis with test date and results, description of chronicity and severity of symptoms, and detailed records of conservative therapy trials.

Required documentation: Member age (must be ≥ 18)
Required documentation: Gastric emptying scintigraphy report with date and results confirming delayed gastric emptying
Required documentation: Clinical history documenting chronic intractable (drug refractory) nausea and vomiting
Required documentation: Detailed records of trials of antiemetic, dietary, and prokinetic therapies including dates, agents, doses, durations, and reasons for discontinuation
Required documentation: Pregnancy status
Required documentation: Evidence that device use aligns with FDA HDE specifications

Definitions and Regulatory Status

GES — definition (Gastric Electrical Stimulation)

DefinitionGastric Electrical Stimulation (GES): an implanted system of leads placed in the gastric muscularis and a subcutaneous pulse generator that delivers electrical stimulation to reduce symptoms (primarily nausea and vomiting) in gastroparesis patients.

Procedure componentsGES device includes a pair of leads placed in the greater curvature of the stomach and a pulse generator placed subcutaneously in the abdominal wall

Clinical effectGES has not shown a significant improvement in gastric emptying but has demonstrated benefit for nausea and vomiting and reduced medication use and hospitalizations

Typical placement siteLeads are placed about ten centimeters proximal to the pylorus in the muscularis propria of the greater curvature

HDE/HUD — Humanitarian Device Exemption / Humanitarian Use Device

DefinitionHumanitarian Device Exemption (HDE) / Humanitarian Use Device (HUD): an FDA designation for devices intended to benefit patients with conditions affecting fewer than 8,000 individuals in the United States annually; HDE/HUD use requires institutional review board (IRB) oversight and approval.

Policy requirementGES technology must be provided in accordance with FDA HDE specifications as stated in the policy

Operational noteUse of an HDE/HUD may only occur in facilities with an established IRB to supervise device use and after IRB or appropriate local committee approval

Reference guidanceFDA guidance on the HDE program is cited in the policy (FDA HDE Program guidance, Sept 2019)

OpenPayer

Gastric Electrical Stimulation (GES) — Coverage Criteria

Coverage and Medical Necessity Criteria

Procedure, Supply, and Coding Information

Prior Authorization, Documentation, and Denial Triggers

Definitions and Regulatory Status

Background and Disease Overview