CurrentCapital BluecrossPolicy MP 2.069

Gastric Electrical Stimulation

Policy governs use of implantable gastric electrical stimulation (GES) devices for chronic intractable nausea and vomiting due to severe diabetic or idiopathic gastroparesis and specifies clinical criteria and coding guidance for Capital BlueCross products.

Policy Summary

PayerCapital Bluecross

PolicyGastric Electrical Stimulation

Policy CodePolicy MP 2.069

Change TypeNo material change

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization with clinical documentation demonstrating scintigraphic (or breath) evidence of delayed gastric emptying, trials of ≥2 antiemetic/prokinetic drug classes totaling ≥12 weeks, dietary modification attempts, and symptom severity meeting policy thresholds.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

HDE-approvedFDA pathway

>=2Drug-class trials

>=12 wksMedication duration

>=7/wkSymptom threshold

>=10%

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Weight-loss threshold

CoveredCoverage stance

Coverage and Medical Necessity

Medical necessity criteria for GES

Covered when ALL of the following are met for chronic intractable nausea and vomiting secondary to severe diabetic or idiopathic gastroparesis:

Main criterion: Significant delayed gastric emptying documented by standard scintigraphic imaging of solid food (or breath testing if scintigraphy is contraindicated)

Document diagnostic testing results (scintigraphy preferred; breath testing acceptable if contraindicated)

Medication trials: Refractory to or intolerant of at least two antiemetic and/or prokinetic drug classes for a total duration of greater than or equal to 12 weeks

Document medication names, classes, durations, and reason for discontinuation (failure or intolerance)

Dietary modifications: Tried and failed dietary modifications

Examples include frequent small meals, liquid supplements, low fat/low fiber diet per policy guidelines

Obstruction excluded: No mechanical obstruction identified on diagnostic testing

Document imaging/endoscopic evaluation excluding obstruction

Symptom or severity markers: Either nausea or vomiting greater than or equal to 7 episodes per week OR one or more severity markers

Severity markers: need for enteral or parenteral nutrition; weight loss >=10% within 6 months; inability to achieve glycemic control; >=2 ED visits or hospital admissions within 1 year

Device compatibility: No implanted cardiac pacemaker, implantable cardioverter defibrillator (ICD), or other neurostimulators present

Document device history and compatibility assessment

Exclusionary history: No history of gastric resection and no systemic motility disorder

Systemic motility disorder examples include Systemic Lupus Erythematosus, Amyloidosis, Scleroderma, Neurofibromatosis, Parkinson's disease, Muscular Dystrophies, Thyroid Disease

Investigational indications

Not covered/Investigational:

Obesity indication: GES is considered investigational for the treatment of obesity

Evidence for obesity indications (including SHAPE and other studies) is insufficient to support coverage

Covered Indications (summary from document)

As noted in prior revisions and summary notes

Covered indication summary: GES is covered for severe, medically refractory gastroparesis of diabetic or idiopathic etiology when the specific medical necessity criteria are met

Policy history: coverage for severe diabetic or idiopathic gastroparesis and coding updates (including addition of HCPCS C1767 and C1778 and ICD-10 code additions) were added in prior revisions

Gastric electrical stimulation (GES) is considered investigational for the treatment of obesity. This policy does not support GES as a covered therapy for weight loss or cosmetic/weight‑reduction indications.

GES has been studied as a therapy for morbid obesity, including randomized and nonrandomized trials such as the SHAPE trial. The SHAPE randomized trial did not demonstrate a significant weight‑loss benefit with active GES versus sham stimulation, and other published series and device evaluations (including early implantable gastric stimulators and multicenter surveys) have been reported in the literature.

Overall evidence for GES is mixed and does not definitively establish benefit across all indications. The policy states there is insufficient evidence to support a general conclusion concerning health outcomes for GES overall, with randomized trials and a 2017 meta-analysis showing inconsistent symptomatic benefit and potential placebo effects in gastroparesis studies.

Implantable gastric stimulation for morbid obesity has been evaluated in multiple studies and series (for example, early Transcend and other implantable gastric stimulators and European multicenter reports). These sources are referenced in the literature but do not change the policy position that GES for morbid obesity is investigational and not a covered indication under this policy.

Coding and Diagnosis Guidance

Covered procedure/device codesmixedCovered

C1767
C1778
L8679
L8680
L8685
L8686
L8687
L8688
43647
43648

1–10 of 17

1/2

Relevant ICD-10 diagnosis codesICD-10

E08.43	Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy
E09.43	Drug or chemical induced diabetes mellitus with neurological complications with autonomic (poly)neuropathy
E10.43	Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy
E11.43	Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy
E13.43	Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy
K31.84	Gastroparesis

Updated coding table entriesmixed

C1767	Unspecified description (code added to coding table)
C1778	Unspecified description (code added to coding table)
K31.A0	Listed as new code added (format in document)
K31.A11	Listed as new code added (format in document)
K31.A12	Listed as new code added (format in document)
K31.A13	Listed as new code added (format in document)
K31.A14	Listed as new code added (format in document)
K31.A15	Listed as new code added (format in document)
K31.A19	Listed as new code added (format in document)
K31.A21	Listed as new code added (format in document)

1–10 of 12

1/2

External policy cross-referencemixed

7.01.73

BCBSA Medical Policy Reference Manual: Gastric Electrical Stimulation (March 2024)

inv-12: Symptom frequency — numeric threshold for nausea/vomiting frequency

Symptom frequency thresholdNausea or vomiting greater than or equal to 7 episodes per week

Alternative symptom marker (ED/hospital utilization)>= 2 emergency department visits or hospital admissions within 1 year

Glycemic control markerUnable to achieve glycemic control (as a severity marker)

inv-13: Medication trial duration — required total duration and classes of antiemetic/prokinetic therapy

Required medication trial durationTotal of >= 12 weeks across medication trials

Required number of medication classes

Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed codes. Submit supporting clinical documentation with the prior authorization request to demonstrate that the individual meets the policy’s medical necessity criteria (including diagnostic testing, medication/dietary trials, and symptom burden).

Affected codes: see coding table in policy (includes C1767, C1778 and associated CPT/HCPCS codes)
Include copies of relevant medical records and test reports with the PA submission

Billing Rule

PA and Coding Updates

Prior authorization approvals and coding are contingent on submission of complete, current documentation. Coding/HCPCS updates in the policy must be used when filing claims. Claims submitted with outdated or incorrect codes may delay processing or be denied.

Clinical Background and Context

Gastroparesis is a chronic gastric motility disorder characterized by delayed gastric emptying that commonly causes bloating, early satiety, abdominal distension, nausea, and vomiting. Severe cases can result in dehydration, malnutrition, need for enteral or parenteral nutrition, and difficulty with glycemic control in persons with diabetes. GES (gastric pacing) uses an implanted pulse generator and intramuscular gastric leads to deliver electrical stimulation and has been investigated primarily for medically refractory gastroparesis when conservative therapies have failed.

Key Terms and Definitions

inv-24: Antiemetic — definition

DefinitionAntiemetic: an agent that prevents or relieves nausea or vomiting

Clinical roleUsed to manage symptoms of nausea and vomiting in gastroparesis prior to consideration of GES

Examples (policy context)Antiemetic drug classes referenced as part of required prior medication trials (document trials of >=2 classes)

inv-25: Enteral — definition

DefinitionEnteral: within or by way of the intestine

Clinical contextRequirement for enteral nutrition is listed as a severity marker for coverage when individuals require enteral support

Policy Revision History

2024-04-23Consensus Review - references updatedLatest

Consensus review with no change to policy stance; references were updated.

2023-03-31Minor Review - policy/guideline updates

Breath testing accepted as an alternative to scintigraphy; dietary modification requirements expanded; policy guidelines added and C1767 and C1778 added to coding table.

2022-05-27Consensus Review - coding/reference updates

Policy Summary

PayerCapital Bluecross

PolicyGastric Electrical Stimulation

Policy CodePolicy MP 2.069

Change TypeNo material change

Effective DateMay 1, 2025

Next Review Date

SourceLink

On This Page

>= 2 antiemetic and/or prokinetic drug classes (refractory to or intolerant of)

Documentation requirementProvider must document trials and durations of the medications in clinical records submitted for prior authorization

inv-14: Weight loss severity — alternate severity criterion (percent weight loss within timeframe)

Weight loss severity criterion>= 10% weight loss within a 6-month timeframe

Context of criterionCounts as an alternative severity marker to meet coverage (one or more severity markers may substitute for symptom frequency)

Documentation requirementWeight loss must be documented in the medical record within the specified 6-month period

Verify and use the most recent CPT/HCPCS/ICD-10 codes listed in the policy coding section
Report diagnosis codes that support etiology (e.g., K31.84 for gastroparesis; relevant diabetes codes E08.43–E13.43)

Documentation Required

Medication and Dietary Trial Requirements

Documented attempts at dietary modification and pharmacologic therapy are required before gastric electrical stimulation is considered. The medical record must show that the individual has tried and failed recommended dietary changes and at least two different anti-emetic and/or prokinetic medication classes for a combined duration of ≥ 12 weeks.

Dietary modifications to document: frequent smaller meals, liquid nutritional supplements, low-fat/low-fiber diet, cessation of alcohol and tobacco; glucose control monitored in persons with diabetes
Medication trial documentation: names of agents, classes, durations, reasons for discontinuation (inefficacy or intolerance)

Documentation Required

Medical Records and Diagnostic Testing

Provide complete medical records, including clinic notes, procedure reports, hospital records, nutrition counseling notes, and relevant device documentation to support coverage determinations. Failure to include required documentation may result in denial or request for additional information.

Include diagnostic testing results (scintigraphic gastric emptying study or breath testing if scintigraphy contraindicated)
Include documentation of absence of mechanical obstruction and any prior GI surgical history (e.g., gastric resection)

Denial Risk

Failure to Meet Medical Necessity Criteria

Claims that do not meet the documented coverage criteria or lack adequate supporting documentation are subject to non-coverage and denial. If required elements (diagnostic confirmation, medication/dietary trials, symptom thresholds, or specified exclusions) are absent, the claim will not be considered medically necessary.

Denial risk factors: missing gastric emptying test, undocumented 12-week medication trials, no record of dietary modification attempts, lack of symptom frequency/severity documentation (e.g., ≥7 vomiting episodes/week)
Provider may appeal with additional documentation showing criteria were met

Contrast with parenteral

Enteral refers to intestinal feeding as opposed to intravenous (parenteral) nutrition

inv-26: Prokinetic — definition

DefinitionProkinetic: the stimulation of gastrointestinal activity

Clinical roleProkinetic agents are used to enhance gastric motility and are required to be tried (as part of >=2 drug classes) before GES

DocumentationRecord classes and duration of prokinetic therapy when requesting prior authorization

inv-27: Total parenteral nutrition — definition

DefinitionTotal parenteral nutrition: intravenous provision of dextrose, amino acids, emulsified fats, trace elements, vitamins, and minerals to patients who are unable to assimilate adequate nutrition by mouth

Clinical contextParenteral nutrition is listed as a severity marker qualifying for coverage when individuals require parenteral support

DistinctionTotal parenteral nutrition is intravenous (parenteral) as opposed to enteral (intestinal) feeding

inv-28: Enterra — definition and regulatory/clinical context for the Enterra Therapy/System

DefinitionEnterra Therapy/System: an implantable gastric electrical stimulation system (Enterra) evaluated in multiple studies and summarized by the FDA in a Summary of Safety and Probable Benefit

Regulatory contextEnterra has an FDA Humanitarian Device Exemption (HDE) pathway referenced in the policy and FDA summary of safety and probable benefit

Clinical contextEnterra therapy is cited in clinical studies and policy references as the evaluated implantable GES system for medically refractory gastroparesis

inv-29: Medically refractory gastroparesis — definition noting etiologies and refractory status

DefinitionMedically refractory gastroparesis: gastroparesis not responsive to or intolerant of medical therapy (e.g., failure of dietary modifications and >=2 antiemetic/prokinetic drug classes), typically of diabetic or idiopathic etiology

Etiologies notedPolicy references diabetic and idiopathic etiologies as primary indications for coverage when medically refractory

Refractory status criteriaRefractory includes failure of dietary modifications and medication trials totaling >=12 weeks, exclusion of mechanical obstruction, and presence of required symptom/severity markers

Consensus review with updates to FEP, coding tables, and references.

2021-09-07Administrative Update - coding added

New codes K31.A0, K31.A11, K31.A12, K31.A13, K31.A14, K31.A15, K31.A19, K31.A21, K31.A22, and K31.A29 were added effective 2021-10-01.

2021-06-03Consensus Review - rationale/coding/references updated

Consensus review with updated rationale, references, and coding.

2020-05-22Minor Review - coverage stance added

GES coverage for severe gastroparesis of diabetic or idiopathic etiology was added with accompanying criteria, references, and coding updates (policy MP 2.069 effective 2020-05-22).