HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 

Medical Policy:
S-155-010
Topic:
Gastric Electrical Stimulation, Gastric Pacing
Section:
Surgery
Effective Date:
April 9, 2018
Issued Date:
June 24, 2019
Last Revision Date:
May 2019
Annual Review:
May 2019
 
 

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.

Policy Position

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. The safety and/or effectiveness of this service cannot be established by review of the available published literature.

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 for total parenteral nutrition are met: 

o    Adequate trials of dietary adjustment, oral supplements, or tube enteral nutrition have been demonstrated that the individual can receive less than or equal to 30% of his/her caloric needs orally and/or tube; and

o    The individual must be in a stage of wasting as indicated by:

§  Weight loss greater than 10% within six (6) months; and

§  Serum albumin is less than 3.4 grams; and

§  Blood urea nitrogen (BUN) level is less than ten (10) mg; and

§  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. The safety and/or effectiveness of this service cannot be established by review of the available published literature.

43647

 43648

 43881

 43882

 64590

 64595

 95980

95981

 95982

 

 

 

 

 



C1767

C1778

 

 

 

 

 




Related Policies

Refer to medical policy G-24 Obesity for additional information.


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

 

Diagnosis Codes

K31.84



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Gastric Electrical Stimulation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.