CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Gastric Electrical Stimulation Policy

Defines coverage and medical necessity for implantation, programming, and related procedures for gastric electrical stimulation devices for gastroparesis and obesity for Blue Cross Blue Shield - Rhode Island Medicare Advantage and Commercial products. States device implantation is not covered/not medically necessary for any indication.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGastric Electrical Stimulation Policy

Policy CodePolicy N/A

Change TypeClarified - not covered / not medically necessary

Effective DateOct 1, 2021

Next Review Date

Key ActionIf removal of a gastric electrical stimulation device is performed, providers must refer to and follow the 'Removal of Non-Covered Implantable Devices' policy for coverage and billing guidance.

SourceLink

POLICY UPDATE CHANGES

Policy states implantation of gastric electrical stimulation devices is not covered / not medically necessary for any indication.

1Overall coverage stance (not covered)

7CPT codes listed as not covered or for guidance

8ICD-10 codes referenced

Coverage Summary & Determination

Gastric electrical stimulation (GES) is an implantable pulse generator with intramuscular gastric leads designed to deliver electrical stimulation to the stomach and has been investigated primarily for drug-refractory gastroparesis and also studied for obesity. The Enterra™ Therapy System received FDA approval through the humanitarian device exemption (HDE) process for the treatment of gastroparesis. Evidence from randomized controlled trials and systematic reviews, including a 2017 meta-analysis, has not demonstrated a consistent benefit over sham for gastroparesis symptoms and suggests possible placebo effects; evidence for obesity (including the SHAPE trial) is insufficient to show improved weight loss versus sham. Scope: this policy applies to Blue Cross Blue Shield - Rhode Island Medicare Advantage and Commercial products and addresses implantation, programming, and related procedures for GES devices, with device implantation considered not covered / not medically necessary for any indication.

Coverage Determination

Policy coverage statement:

Medicare Advantage coverage: Implantation of a gastric electrical stimulation device for any indication is not covered for Medicare Advantage Plans because the evidence is insufficient to determine the effects of the technology on health outcomes.
Medicare Advantage specific statement
Commercial coverage: Implantation of a gastric electrical stimulation device for any indication is considered not medically necessary for Commercial Products because the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial product specific statement

Prior Authorization

Policy prior authorization statement:

Prior authorization: Not applicable.

Medical Necessity / Not Medically Necessary

Not Medically Necessary / Not Covered

Medicare Advantage statement: Implantation of a gastric electrical stimulation device for any indication is not covered for Medicare Advantage Plans because the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial statement: Implantation of a gastric electrical stimulation device for any indication is considered not medically necessary for Commercial Products because the evidence is insufficient to determine the effects of the technology on health outcomes.

CPT & ICD-10 Codes (grouped by guidance/status)

Not covered / Not medically necessary procedures (Medicare Advantage & Commercial)CPTNot Covered

43647	Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
43881	Implantation or replacement of gastric neurostimulator electrodes, antrum, open
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 ..., gastric neurostimulator pulse generator/transmitter; subsequent, without reprogramming
95982	Electronic analysis of implanted neurostimulator pulse generator system ..., gastric neurostimulator pulse generator/transmitter; subsequent, with reprogramming

Not covered / Not medically necessary - Obesity-related procedure coding guidance (Medicare Advantage & Commercial)CPTNot Covered

43659	Unlisted laparoscopy procedure, stomach (to be used to report laparoscopic procedures related to gastric stimulation electrodes for morbid obesity)
43999	Unlisted procedure, stomach (to be used to report laparotomy procedures related to gastric stimulation electrodes for morbid obesity)
64590	Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling (not covered when used for gastric electrical stimulation and filed with listed diagnosis codes)

ICD-10 Diagnosis Codes referencedICD-10

E08.43	Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy; gastroparesis
E09.43	Drug or chemical induced diabetes mellitus with diabetic autonomic (poly)neuropathy; gastroparesis
E10.43	Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy; gastroparesis
E11.43	Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy; gastroparesis
E13.43	Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy; gastroparesis
E66.01-E66.9	Range of obesity codes referenced
K31.89	Other diseases of stomach and duodenum (used in policy context)

Billing, Documentation & Operational Guidance

Documentation Required

Refer to Removal Policy if device removal performed

If removal of a gastric electrical stimulation device is performed, providers must refer to and follow the 'Removal of Non-Covered Implantable Devices' policy for coverage and billing guidance.

Billing Rule

Use unlisted procedure codes for obesity-related gastric stimulation procedures

For morbid obesity gastric stimulation procedures, report laparoscopic procedures with CPT 43659 and laparotomy procedures with CPT 43999 as instructed; do not report 43647/43881 for obesity indication.

43659
43999

Billing Rule

Certain neurostimulator codes not covered when used for GES

CPT 64590 is not covered when used for gastric electrical stimulation and filed with the policy-listed diagnosis codes.

64590

Clinical Evidence & Background

Randomized controlled trials and meta-analyses have not shown consistent benefit of GES for gastroparesis; a 2017 meta-analysis of five crossover RCTs did not find a significant improvement in gastroparesis symptom severity and noted symptom improvement whether the device was on or off, suggesting a placebo effect. For obesity, the SHAPE randomized trial did not demonstrate significant weight loss benefit with GES versus sham, and no GES devices are FDA-approved for obesity. The Enterra Therapy System is approved under the FDA humanitarian device exemption for gastroparesis. Given the insufficient evidence to determine effects on health outcomes, implantation and associated procedural codes are designated not covered / not medically necessary for the referenced products.

Study / Source	Key Finding
2017 meta-analysis	Did not find a significant benefit of GES on the severity of gastroparesis symptoms; patients reported improved symptoms whether or not device was on, suggesting a placebo effect.
SHAPE trial (obesity)	Did not show significant improvement in weight loss using GES compared with sham stimulation.

Definitions

Gastric electrical stimulation (GES)An implantable device (pulse generator and intramuscular stomach leads) that delivers electrical stimulation to the stomach to treat gastroparesis or investigated for obesity.

Not medically necessaryService that is not considered necessary to diagnose or treat an illness or injury based on evidence of effectiveness.

Policy Changes

2021-10-01policy_effectiveLatest

Consolidated Medicare Advantage and Commercial coverage determinations: implantation of gastric electrical stimulation devices is not covered / not medically necessary for any indication due to insufficient evidence.

2021-05-05policy_updated

Policy clarified that implantation of a gastric electrical stimulation device for any indication is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products because evidence is insufficient to determine effects on health outcomes.

2000regulatory_approval

Enterra Therapy System (Gastric Electrical Stimulator) received FDA humanitarian device exemption for treatment of gastroparesis.

2017evidence_update

A 2017 meta-analysis of randomized trials did not find a significant benefit of gastric electrical stimulation on severity of gastroparesis symptoms; symptom improvements occurred whether or not device was turned on, suggesting a placebo effect.

2009clinical_trial

SHAPE trial (obesity) did not show significant improvement in weight loss with gastric electrical stimulation compared with sham; evidence insufficient for obesity indication.

2021-10-01coding_policyLatest

Specified CPT codes 43647, 43881, 95980-95982 are not covered/not medically necessary for GES implantation and programming; for obesity-related procedures, laparoscopic 43659 and laparotomy 43999 should be used and CPT 64590 is not covered when used for GES with listed diagnosis codes.