CurrentPremera BluecrossPolicy N/A

7.01.522 Gastric Electrical Stimulation

Defines medical necessity and investigational uses of implantable gastric electrical stimulation for gastroparesis, obesity, and other indications, plus documentation and coding requirements for Premera Bluecross.

Policy Summary

PayerPremera Bluecross

Policy7.01.522 Gastric Electrical Stimulation

Policy CodePolicy N/A

Change TypeAnnual review; coding updates

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit medical records that document ALL policy medical necessity criteria including diagnosis, scintigraphic evidence of delayed gastric emptying, prior intolerance or failure of prokinetic and antiemetic medications, and nutritional status indicating imminent need for TPN.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 64590 to support policy criteria (04/01/26).

Annual Review approved April 13, 2026; literature review through December 23, 2025; policy statements unchanged (05/01/26).

Added HCPCS codes C1767, C1778, L8679 for Enterra device and removed E0765 earlier (12/01/24).

1Medically Necessary Indications (gastroparesis diabetic/idiopathic)

1Investigational Indications (obesity)

8Relevant CPT/HCPCS codes listed

Coverage Summary

Defines medical necessity and investigational uses of implantable gastric electrical stimulation (GES) for gastroparesis, obesity, and other indications, and includes documentation and coding requirements for Premera Blue Cross. Gastric electrical stimulation may be considered medically necessary for chronic, intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology when all specified criteria are met (see policy criteria).

GES (Enterra Therapy System) is an implantable pulse generator connected to intramuscular stomach leads, approved by the FDA via a Humanitarian Device Exemption for treatment of gastroparesis. The device has been investigated for obesity, but randomized trial evidence (SHAPE) and systematic reviews do not demonstrate efficacy for weight loss, and GES for obesity is considered investigational.

Key thresholds and dates

Documentation of delayed gastric emptyingStandard scintigraphic imaging (gastric emptying scan) demonstrating significantly delayed gastric emptying

Nutritional status thresholdNutritional status sufficiently low that total parenteral nutrition (TPN) is likely to become medically necessary

Policy effective dateMay 1, 2026

Last review / approval dateApr. 13, 2026

Coding

Covered / Relevant CPT codesCPTCovered

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.

Relevant HCPCS / Implantable device codesHCPCSCovered

C1767	Generator, neurostimulator (implantable), nonrechargeable.
C1778	Lead, neurostimulator (implantable).
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, nonrechargeable, includes extension.

Provider Actions

Documentation Required

Submit medical records to document criteria

Medical records submitted for review must document all policy medical necessity criteria. Required documentation should include the diagnosis (diabetic or idiopathic gastroparesis), objective scintigraphic evidence of significantly delayed gastric emptying (standard gastric emptying scan), prior intolerance or failure of prokinetic and antiemetic medications, and the individual's nutritional status indicating that total parenteral nutrition (TPN) is likely to become medically necessary.

Diagnosis specifying diabetic or idiopathic gastroparesis
Standard scintigraphic imaging (gastric emptying scan) demonstrating significantly delayed gastric emptying
Documentation of trial and failure or intolerance of prokinetic and antiemetic medications
Clinical/nutritional assessment showing nutritional status sufficiently low that TPN is likely to become necessary
Complete medical record notes and relevant test reports to support all above criteria

Billing Rule

Use specified CPT/HCPCS codes

Report procedures and implantable device components using the specified CPT and HCPCS codes as appropriate for implantation, revision, removal, and device components of gastric electrical stimulation systems.

43647
43648
43881
43882
64590
C1767
C1778
L8679
L8680
L8685
L8686
L8687
L8688

Background & Evidence Summary

The Enterra Therapy System is an implantable gastric electrical stimulator consisting of an implanted pulse generator, intramuscular stomach leads, a programmer, and a memory cartridge; it was approved by the FDA in 2000 via the Humanitarian Device Exemption (HDE) for treatment of gastroparesis.

GES is used to reduce drug-refractory nausea and vomiting in gastroparesis. It has also been investigated as a treatment for obesity; however, the SHAPE trial did not show significant improvement in weight loss compared with sham, and no GES device is FDA-approved for obesity.

Study / Source	Summary
2017 meta-analysis (5 RCTs)
No significant benefit of GES on severity of gastroparesis symptoms; improvement occurred whether device was on or off suggesting placebo effect.

Definitions

Gastroparesis: Chronic disorder of gastric motility characterized by delayed emptying of a solid meal from the stomach; symptoms include bloating, distension, nausea, and vomiting.

Enterra Therapy System: A gastric electrical stimulator system approved by FDA via Humanitarian Device Exemption for treatment of gastroparesis; consists of an implanted pulse generator, intramuscular leads, programmer, and memory cartridge.

Revision History

04/01/26coding update

Added CPT code 64590 to support policy criteria.

12/01/24coding update

HCPCS codes C1767, C1778, and L8679 were added for the Enterra device and HCPCS E0765 was removed.

05/01/26annual reviewLatest

Annual Review approved April 13, 2026; literature review through December 23, 2025; policy statements unchanged.