Gastric Electrical Stimulation, Gastric Pacing

Policy ID: S-155-029

Section: Surgery

Effective Date: July 01, 2018

Revised Date: June 15, 2023

Revision Effective Date: July 03, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

Gastric electrical stimulation is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The procedure may also be referred to as gastric pacing or Enterra Therapy.

Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal. Symptoms include bloating, distention, nausea and vomiting. When severe, gastroparesis can be associated with dehydration, poor nutritional status and poor glycemic control in diabetic individuals.

Criteria

Gastric Electrical Stimulation may be considered medically necessary when ALL of the following criteria are met:

The United States Food and Drug Administration (U.S. FDA) has designated the device as a Humanitarian Use Device (HUD); and
The U.S. FDA has approved the device for marketing under the Humanitarian Device Exemption (HDE); and
The device has local Institutional Review Board (IRB) approval; and
Appropriate informed consent has been obtained from the individual; and
The device is not specifically excluded from coverage.

Gastric electrical stimulation not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

Procedure Codes

43647

43648

43881

43882

Gastric electrical stimulation may be considered medically necessary when provided in accordance with the HDE specifications of the U.S. FDA for the treatment of chronic intractable nausea and vomiting secondary to severe gastroparesis of diabetic or idiopathic etiology when ALL of the following criteria are met:

Significant delayed gastric emptying as documented by standard scintigraphic imaging of solid food; and
Individual is refractory to or intolerant of at least two (2) anti-emetic and prokinetic drug classes; and
No mechanical obstruction is found on diagnostic testing; and
Individual's nutritional status is sufficiently low that ALL of the following criteria are met:
- Failure to meet adequate caloric needs despite adequate trials of dietary adjustment, oral supplements, or tube enteral nutrition and
- The individual must be in a stage of wasting as indicated by AT LEAST ONE of the following:
  - Weight loss greater than 10% within six (6) months; or
  - Serum albumin is less than 3.4 grams; or
  - Blood urea nitrogen (BUN) level is less than ten (10) mg; or
  - Phosphorus level is less than 2.5 mg (normal phosphorous is 3-4.5 mg).

Gastric electrical stimulation not meeting the criteria as indicated in the policy is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature for all other indications including, but not limited to, initial treatment of gastroparesis and treatment of obesity.

Procedure Codes

43647

43648

43881

43882

64590

64595

95980

95981

95982

Outpatient HCPCS (C Codes)

C1767

C1778

C9787

Diagnosis Codes

Covered Diagnosis Code for Procedure Codes 43647, 43648, 43881, 43882, C1767 and C1778

K31.84

T85.518A

T85.518D

T85.518S

T85.528A

T85.528D

T85.528S

T85.598S

T85.598D

T85.598S

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2020 Adding Diagnosis codes

Internal Medical Policy Committee 7-22-2021 Annual Review

Internal Medical Policy Committee 9-21-2021 Revision of policy with coding update:

Removed diagnosis codes: E08.43; E09.43; E10.43; E11.43; E13.43.
Added diagnosis codes T85.518A; T85.518D; T85.518S; T85.528A; T85.528D; T85.528S; T85.598A; T85.598D; T85.598S

Internal Medical Policy Committee 9-28-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 5-23-2023 Annual Review-no changes in criteria

Internal Medical Policy Committee 7-26-2023 Coding update

Added procedure code C9787

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-155-026

Section: Surgery

Effective Date: July 01, 2018

Revised Date: July 22, 2020

Revision Effective Date: October 05, 2020

Last Reviewed: July 22, 2021

Archived Date: October 31, 2021

Applies To: Commercial Only

Description

Criteria

Gastric Electrical Stimulation may be considered medically necessary when ALL of the following criteria are met:

The U.S. Food and Drug Administration (FDA) has designated the device as a Humanitarian Use Device (HUD); and
The FDA has approved the device for marketing under the Humanitarian Device Exemption (HDE); and
The device has local Institutional Review Board (IRB) approval; and
Appropriate informed consent has been obtained from the individual; and
The device is not specifically excluded from coverage.

Gastric electrical stimulation not meeting the criteria above is considered experimental/investigational and therefore, non-covered becausethe safety and/or effectiveness of this service cannot be established by review of the available published literature.

Procedure Codes

43647

43648

43881

43882

Gastric electrical stimulation may be considered medically necessary when provided in accordance with the HDE specifications of the FDA for the treatment of chronic intractable nausea and vomiting secondary to severe gastroparesis of diabetic or idiopathic etiology when ALL of the following criteria are met:

Significant delayed gastric emptying as documented by standard scintigraphic imaging of solid food; and
Individual is refractory to or intolerant of at least two (2) anti-emetic and prokinetic drug classes; and
No mechanical obstruction is found on diagnostic testing; and
Individual’s nutritional status is sufficiently low that ALL of the following criteria are met:
- Failure to meet adequate caloric needs despite adequate trials of dietary adjustment, oral supplements, or tube enteral nutrition and
- The individual must be in a stage of wasting as indicated by AT LEAST ONE of the following:
  - Weight loss greater than 10% within six (6) months; or
  - Serum albumin is less than 3.4 grams; or
  - Blood urea nitrogen (BUN) level is less than ten (10) mg; or
  - Phosphorus level is less than 2.5 mg (normal phosphorous is 3-4.5 mg).

Gastric electrical stimulation is considered experimental/investigational and, therefore, non-covered for all other indications including, but not limited to, initial treatment of gastroparesis and treatment of obesity because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

Procedure Codes

43647

43648

43881

43882

64590

64595

95980

95981

95982

Outpatient HCPCS (C Codes)

C1767

C1778

Diagnosis Codes

Covered Diagnosis Code for Procedure Codes 43647, 43881, C1767 and C1778

E08.43

E09.43

E10.43

E11.43

E13.43

K31.84

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2020 Adding Diagnosis codes

Internal Medical Policy Committee 7-22-2021 Annual Review

Links

References (PDF)

Disclaimer

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