HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 

Medical Policy:
S-106-010
Topic:
Bulking agents for the Treatment of Urinary Stress Incontinence and Vesicoureteral Reflux
Section:
Surgery
Effective Date:
September 27, 2021
Issued Date:
September 27, 2021
Last Revision Date:
September 2021
Annual Review:
September 2021
 
 

Stress urinary incontinence can result from intrinsic sphincter deficiency (ISD). Periurethral bulking agent is a material that is injected around the urethra that can assist in narrowing the urethra so leakage is less likely to occur.

Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney. Bulking agents can be injected into tissue around the ureteral orifices to minimize reflux.

Policy Position

Urinary Stress Incontinence

The use of United States Food and Drug Administration (U.S. FDA) approved bulking agents for the treatment of urinary stress incontinence may be considered medically necessary  in individuals who have failed appropriate conservative therapy for at least three (3) months.

  • Note: Conservative therapy for stress urinary incontinence may include:
    • Pelvic floor muscle exercises (Kegel exercises); or
    • Behavioral changes, such as:
      • Fluid management; or
      • Smoking cessation; or
      • Weight loss; or
      • Moderation of physical activities that provoke stress urinary incontinence; or
    • Additional options may include:
      • Intravaginal estrogen therapy; or
      • Use of a pessary; or
      • Treatment of other underlying causes of stress incontinence in individuals amenable to these treatments.

Additional treatments for reoccurrence of stress urinary incontinence with a periurethral bulking agent may be considered medically necessary following successful treatment in the past six (6) to 12 months.

Further treatment of stress urinary incontinence with a bulking agent is considered not medically necessary when there is failure to improve after five (5) separate treatment sessions.

The use of bulking agents to treat stress urinary incontinence 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 the published peer-reviewed literature including but not limited to the following:

  • Teflon; and
  • Autologous fat; and
  • Autlogous ear chondrocytes; and
  • Autologous cellular therapy, including but not limited to:
    • Myloblasts; and
    • Fibroblasts; and
    • Muscle derived stem cells; and
    • Adipose derived stem cells.

51715

L8606

 

 

 

 

 




Urge Urinary Incontinence

The use of U.S. FDA approved periurethral bulking agents to treat urge urinary incontinence is considered not medically necessary.

 

L8604

 

 

 

 

 

 




Vesicoureteral Reflux

The use of U.S. FDA approved periureteral bulking agents for the treatment of pediatric individuals with VUR grades II, III, or IV may be considered medically necessary  when medical therapy has failed, and surgical intervention is otherwise indicated.

The use of periurethral bulking agents for VUR not meeting the criteria as indicated in this policy is considered not medically necessary.

52327

L8604

 

 

 

 

 




The use of bulking agents is contraindicated in individuals with:

  • Non-functioning kidney(s); or
  • Hutch diverticuli; or
  • Active voiding dysfunction; or
  • Ongoing urinary tract infection.

Professional Statements and Societal Positions Guidelines

American Urological Association et al - 2017

The 2017 joint guidelines on surgical treatment of female stress urinary incontinence from the American Urological Association and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction stated that bulking agents are an option for patients considering surgery for stress urinary incontinence (SUI). The guidelines also stated that there are few long-term data on the efficacy of bulking agents and that retreatment is common.

In 2017, the American Urological Association reviewed and confirmed the validity of its 2010 published guideline on the management of primary VUR in children. The Association recommended that [individuals] older than one (1) year of age who have a febrile breakthrough urinary tract infection while receiving continuous antibiotic prophylaxis be considered for open surgery or endoscopic injection of bulking agents.


Covered Diagnosis Codes for 51715, L8606

N36.42

N36.43

N39.3

 

 

Covered Diagnosis Codes for 52327, L8604

N11.0

N13.70

N13.71

N13.72

N13.721

N13.722

N13.729

N13.73

N13.731

N13.732

N13.739

 

 

 





Place of Service: Inpatient/Outpatient

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

The treatment of urinary stress incontinence and/or vesicoureteral reflux 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.