Stress urinary incontinence can result from intrinsic sphincter deficiency (ISD). Periurethral bulking agent is a material that is injected around the urethra; this narrows the urethra so leakage is less likely to occur.
Most commonly seen in children, 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.
Urinary Stress Incontinence
The use of carbon-coated spheres, calcium hydroxylapatite, polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in individuals who have failed appropriate conservative therapy for at least three (3)months.
Conservative therapy for stress urinary incontinence may include:
Individuals who have a reoccurrence of stress-urinary incontinence following successful treatment with FDA approved periurethral bulking agent implants in the past (e.g., 6-12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be considered medically necessary when supported by medical record documentation.
Individuals whose stress urinary incontinence does not improve with five (5) injection procedures (five (5) separate treatment sessions) are considered treatment failures. Therefore, any further treatment of stress urinary incontinence with a periurethral bulking agent is considered not medically necessary.
The use of any other periurethral bulking agent, including, but not limited to Teflon, autologous cellular therapy (e.g., myloblasts, muscle derived stem cells, adipose derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered experimental/investigational and is therefore non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
51715 |
L8606 |
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Urge Urinary Incontinence
The use of periurethral bulking agents to treat urge urinary incontinence is considered not medically necessary.
L8604 |
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Vesicoureteral Reflux
Periureteral bulking agents such as dextranomer/hyaluronic acid (Deflux) may be considered medically necessary as a treatment of children with VUR grades II, III, or IV when medical therapy has failed and surgical intervention is otherwise indicated.
The use of bulking agents is contraindicated in individuals with:
The use of periurethral bulking agents for VUR in other clinical situations is considered not medically necessary.
52327 |
L8604 |
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Society of Obstetricians and Gynecologists of Canada - 2010
In 2010, the Society of Obstetricians and Gynecologists of Canada Urogynaecology Committee published a guideline on the evaluation and treatment of recurrent urinary incontinence after pelvic floor surgery. The guideline recommends that conservative management be used as first-line therapy. It also stated that patients with significantly decreased urethral mobility may be managed with periurethral bulking agents as one of several treatment options.
National Institute for Health and Care Excellence - 2015
In 2013, the National Institute for Health and Care Excellence (NICE) amended its 2006 clinical guideline on urinary incontinence in women. The guideline now recommends considering intramural bulking agents (silicone, carbon-coated zirconium beads or hyaluronic acid/dextran copolymer) for the management of SUI if conservative management has failed. Women should be made aware that repeat injections may be needed to achieve efficacy and that efficacy diminishes with time and is inferior to that of synthetic tapes or autologous rectus fascial slings.
American College of Obstetricians and Gynecologists - 2016
In 2016, the American College of Obstetricians and Gynecologists updated its practice bulletin on urinary incontinence in women. The practice bulletin stated that urethral bulking injections are a relatively noninvasive treatment for stress urinary incontinence that may be appropriate if surgery has failed to achieve adequate symptom reduction, if symptoms recur after surgery, in women with symptoms who do not have urethral mobility, or in older women with comorbidities who cannot tolerate anesthesia or more invasive surgery. However, urethral bulking agents are less effective than surgical procedures such as as sling placement and are rarely used as primary treatment for stress urinary incontinence. There was insufficient evidence to recommend any specific bulking agent.
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 their guidelines and confirmed that endoscopic injection therapy for VUR is an option in the treatment of VUR. Success rates for open surgery are 98%, with few complications, compared to rates of 83% for endoscopic surgery; however, the higher success rates for open surgery are offset by the greater expense and the need for in-patient hospitalization. Postoperative urinary tract infections (UTIs) can occur with either treatment, but are more likely to occur in patients with a prior history of frequent UTIs. Following surgery, an ultrasound to confirm absence of obstruction is a standard of care. While an infrequent occurrence, urinary obstruction may be "clinically silent" and have severe consequences that could be readily corrected. Cystography is a recommendation after endoscopic surgery and an option after open surgery. Following reflux resolution (surgically or spontaneously) it is recommended that a planned follow-up, including assessment for infection, renal abnormalities, and overall health, be continued through adolescence.
Infants under one year of age may not show clinical evidence of pyelonephritis as clearly as older children and they may have a greater risk of infection-related morbidity. It is therefore recommended that continuous antibiotic prophylaxis (CAP) be used in these children until more definitive studies suggest otherwise. Reflux resolution occurs in about 50% of these children within 24 months
Covered Diagnosis Codes for 51715, L8606
N36.42 |
N36.43 |
N39.3 |
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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 |
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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.
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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:
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Room 509F, HHH Building
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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:
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.
