CurrentCentenePolicy CP.MP.40

Clinical Policy: Gastric Electrical Stimulation

Defines medical necessity criteria for implantation/use of gastric electrical stimulation (GES) devices for diabetic and idiopathic gastroparesis, lists excluded/unsupported indications, and provides coding/billing guidance for related CPT/HCPCS/HCPCS II and C-codes.

Policy Summary

PayerCentene

PolicyClinical Policy: Gastric Electrical Stimulation

Policy CodePolicy CP.MP.40

Change TypeNon-material revisions (language updates, added codes, age requirement)

Effective DateJan 1, 2025

Next Review Date

Key ActionDocument diagnosis by gastric emptying scintigraphy and documented intolerance/failure of antiemetic, dietary modifications, and prokinetic therapy.

POLICY UPDATE CHANGES

Modified language regarding trial of antiemetic and prokinetic drug therapy; added dietary modifications and FDA specifications language.

Added age requirement 'Member/enrollee is ≥ 18 years of age' and clarified I.B. to include diabetic gastroparesis.

1Covered clinical indications (diabetic or idiopathic gastroparesis)

3Common symptoms targeted (nausea, vomiting, quality-of-life improvement)

0Evidence-supported use for obesity

Coverage Summary

Policy Number: CP.MP.40. Subject: Gastric Electrical Stimulation (GES) for gastroparesis. Status: CURRENT. Effective Date: 2025-01-01. Scope: Defines medical necessity criteria for implantation/use of GES devices for diabetic and idiopathic gastroparesis, lists excluded/unsupported indications, and provides coding/billing guidance. High-level stance: mixed coverage — GES is covered (medically necessary) for selected adult patients with diabetic or idiopathic gastroparesis who meet specific criteria, but is not supported for other indications such as pain/fullness/bloating/acid reflux or obesity.

Policy summary — key facts

Policy numberCP.MP.40

Effective date2025-01-01

Last review2025-01-01

Coverage stancemixed

Primary indications coveredDiabetic or idiopathic gastroparesis with chronic intractable (drug refractory) nausea and vomiting; criteria require gastric emptying scintigraphy confirmation, trial failure/intolerance of antiemetic, dietary modifications, and prokinetic therapy, age ≥18, not pregnant, and HDE compliance

Coding

Surgical/Procedure CPT codes referencedCPT

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 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 generator/pulse.
95980	Electronic analysis of implanted neurostimulator generator system, intraoperative, with programming.
95981	Electronic analysis of implanted neurostimulator generator system; subsequent, without reprogramming.
95982	Electronic analysis of implanted neurostimulator generator system; subsequent, with reprogramming.

Implantable device C-codesCPT

C1767	Generator, neurostimulator (implantable); non-rechargeable.
C1778	Lead, neurostimulator (implantable).

HCPCS / Level II device codesHCPCS

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

Note: CPT/HCPCS codes L8685-L8687 were added in the most recent non-material revision (01/25) as documented in the changes/revision log.

Provider Actions & Requirements

Documentation Required

Confirmatory diagnostic documentation

Document diagnosis of diabetic or idiopathic gastroparesis confirmed by gastric emptying scintigraphy and chronic intractable (drug refractory) nausea and vomiting.

Documentation Required

Therapy trial documentation

Document intolerance or failure of a trial of antiemetic, dietary modifications, and prokinetic drug therapy (current recommended combination includes metoclopramide and erythromycin and centrally acting antidepressants as symptom modulators).

Documentation Required

Age and pregnancy status

Document that the member/enrollee is ≥ 18 years of age and is not currently pregnant.

Prior Authorization

HDE compliance and IRB/committee oversight

Ensure device use complies with the U.S. Food and Drug Administration Humanitarian Device Exemption (HDE) specifications and that the facility has established institutional review board (IRB) supervision/approval (or appropriate local committee approval) as required by HDE guidance.

Background & Evidence

Background: GES involves implantation of leads in the gastric muscularis propria connected to a subcutaneous pulse generator; leads are typically placed on the greater curvature approximately 10 cm proximal to the pylorus and connected to an external programming device that controls stimulation parameters. It has been used as compassionate care for patients refractory to conventional treatment as an alternative to more invasive surgery. The stimulation has not consistently improved gastric emptying but has been shown to benefit patients whose primary symptoms are nausea and vomiting. Humanitarian Device Exemption (HDE) devices have regulatory restrictions and require facility IRB oversight and approval.

Evidence summary: Multiple studies report improvement in quality-of-life scores for patients receiving GES despite average gastric emptying not changing. Reported benefits include reductions in the use of prokinetic and antiemetic medications and decreases in hospitalizations, with improvements in nausea and vomiting lasting at least one year in some series.

Definitions

ref

Definitions

Humanitarian Device Exemption (HDE)FDA pathway for devices intended to benefit patients with conditions affecting fewer than 8,000 individuals annually; use requires facility IRB oversight and approval

Chronic intractable (drug refractory) nausea and vomitingPersistent nausea and vomiting not responding to or intolerant of appropriate medical therapy including antiemetics and prokinetic agents

Revision History

01/25annual_reviewLatest

Annual review updated description/background with no clinical significance; revised I.C. to 'Chronic intractable (drug refractory) nausea and vomiting', revised verbiage in notes, and added HCPCS codes L8685, L8686, and L8687 to the HCPCS table. Changes marked non-material.

02/24annual_review

Annual review updated description/background with no clinical significance; added I.A. age requirement 'Member/enrollee is ≥ 18 years of age' and updated I.B. to include diabetic gastroparesis; changed I.C. wording to 'Chronic intractable (drug refractory) nausea and vomiting'.

02/23annual_review

Annual review: 'Dietary modifications' added to I.C. and 'FDA specifications' added as I.E.; updated verbiage in note at end of criteria and added additional note about humanitarian device exemptions.

09/21annual_review

Annual review: updated description with no impact on criteria; references reviewed, reformatted, and updated; specialist reviewed.

09/11revision

Modified language regarding trial of antiemetic and prokinetic drug therapy; references reviewed and updated.

Policy Summary

PayerCentene

PolicyClinical Policy: Gastric Electrical Stimulation

Policy CodePolicy CP.MP.40

Change TypeNon-material revisions (language updates, added codes, age requirement)

Effective DateJan 1, 2025

Next Review Date

Key ActionDocument diagnosis by gastric emptying scintigraphy and documented intolerance/failure of antiemetic, dietary modifications, and prokinetic therapy.

On This Page

OpenPayer

Clinical Policy: Gastric Electrical Stimulation

Coverage Summary

Medically Necessary Criteria

Not Medically Necessary / Not Supported Indications

Coding

Provider Actions & Requirements

Background & Evidence

Revision History