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Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Policy Number: MP-455

Latest Review Date: October 2024

Category: Surgery                                                                  

POLICY:

The use of carbon-coated spheres (e.g., Durasphere), calcium hydroxylapatite (e.g., Coaptite), polyacrylamide hydrogel (e.g., Bulkamid), or polydimethylsiloxane (e.g., Silicone, Macroplastique), may be considered medically necessary to treat stress urinary incontinence in men and women.

The use of other periurethral bulking agents not addressed above, including, but not limited to Teflon®, to treat stress urinary incontinence is considered investigational.

The use of autologous cellular therapy (e.g., myoblasts, fibroblasts, muscle-derived stem cells, or adipose-derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered investigational.

The use of periurethral bulking agents to treat urge urinary incontinence is considered investigational.

The use of perianal bulking agents to treat fecal incontinence is considered investigational.

*Cross linked collagen no longer commercially available.

DESCRIPTION OF PROCEDURE OR SERVICE:

Bulking agents are injectable substances used to increase tissue bulk. They can be injected periurethrally to treat urinary incontinence and perianally to treat fecal incontinence. The U.S. Food and Drug Administration (FDA) has approved several bulking agent products for treating urinary incontinence and 1 for treating fecal incontinence.

Incontinence

Incontinence, especially urinary, is a common condition and can have a substantial impact on quality of life. Estimates from the National Center for Health Statistics have suggested that, among noninstitutionalized persons 65 years of age and older, 44% have reported issues with urinary incontinence and 17% issues with fecal incontinence.

Treatment

Urinary Incontinence

Injectable bulking agents are space-filling substances used to increase tissue bulk. When used to treat stress urinary incontinence (SUI), bulking agents are injected periurethrally to increase the tissue bulk and thereby increase resistance to the outflow of urine. The bulking agent is injected into the periurethral tissue as a liquid that then solidifies into a spongy material to bulk the urethral wall. Bulking agents may be injected over a course of several treatments until the desired effect is achieved. Periurethral bulking agents have been widely used for incontinence in women. Men have also been treated, typically those with post-prostatectomy incontinence.

After the success of periurethral bulking agents for treating SUI, bulking agents injected into the anal canal have been proposed for treating fecal incontinence. In particular, bulking agents are a potential treatment for passive fecal incontinence associated with internal anal sphincter (IAS) dysfunction. The bulking agent is injected into the submucosa of the anal canal to increase tissue bulk in the area, which narrows the opening of the anus. Current treatment options for fecal incontinence include conservative measures e.g., dietary changes, pharmacotherapy and pelvic floor muscle exercises, sacral nerve stimulation, and surgical interventions to correct an underlying problem.

Key factors in determining the optimal product are biocompatibility, durability, and absence of migration. A number of periurethral bulking agents to treat urinary incontinence have been cleared for marketing by the U.S. Food and Drug Administration (FDA); however, products developed to date have not necessarily met all criteria of the ideal bulking agents. The first FDA approved product was cross-linked collagen (e.g. Contigen). The agent was found be absorbed over time and symptoms could recur, requiring additional injections.  Contigen production was discontinued in 2011. Other periurethral bulking agents cleared by the FDA for urinary incontinence include carbon-coated beads (e.g., Durasphere®), spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite®), polydimethylsiloxane (silicone, Macroplastique®), cross-linked polyacrylamide hydrogel (Bulkamid®), and ethylene vinyl alcohol copolymer implants (e.g., Tegress, formerly Uryx). Tegress was voluntarily removed from the market due to safety concerns.

Fecal Incontinence

After the success of periurethral bulking agents for treating SUI, bulking agents injected into the anal canal have been proposed to treat fecal incontinence. In particular, bulking agents are a potential treatment for passive fecal incontinence associated with internal anal sphincter dysfunction. The bulking agent is injected into the submucosa of the anal canal to increase tissue bulk in the area, which narrows the opening of the anus. Current treatment options for fecal incontinence include conservative measures (eg, dietary changes, pharmacotherapy, pelvic floor muscle exercises), sacral nerve stimulation, and surgical interventions to correct an underlying problem.

Several agents identical to or similar to those used for urinary incontinence e.g., Durasphere, silicone biomaterial, etc. have been studied for the treatment of fecal incontinence. To date, only one bulking agent has been approved by the FDA for treating fecal incontinence. This is a formulation of non-animal stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) and is marketed by Palette Life Sciences as Solesta. A hyaluronic acid/dextranomer formulation (Deflux®) from the same company has been commercially available for a number of years for the treatment of vesicoureteral reflux in children (see medical policy #454 - Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux).

Autologous fat and autologous ear chondrocytes have also been used as periurethral bulking agents; autologous substances do not require FDA approval. Polytetrafluoroethylene (Teflon®) has been investigated as an implant material but has not received FDA approval. A more recently explored alternative is cellular therapy with myoblasts, fibroblasts, or stem cells (muscle-derived or adipose-derived). In addition to their use as periurethral bulking agents, it is hoped that transplanted stem cells will undergo self-renewal and multipotent differentiation, which could result in the regeneration of the sphincter and its neural connections.

KEY POINTS:

The most recent literature review searched PubMed database through August 20, 2024.

Summary of Evidence

For individuals who have stress urinary incontinence (SUI) who receive injectable bulking agents, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The trials vary by bulking agents used and comparator interventions (eg, placebo, conservative therapy, surgical procedure, another bulking agent). Due to this heterogeneity across studies, and the small number of studies in each category, Cochrane reviewers were unable to draw specific conclusions about the efficacy of specific bulking agents compared with alternative treatments. Additionally, authors of another recent systematic review concluded that bulking agents were less effective than surgical procedures regarding subjective improvement after treatment, with no difference between the interventions with regard to complications. Studies have shown that cross-linked collagen improves the net health outcome (ie, it is effective in some patients who have failed conservative treatment with fewer adverse events than surgery), although products that cross-link in such a way are no longer commercially available. There is evidence that FDA approved carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, and polydimethylsiloxane have efficacy for treating incontinence, and further that they produce outcomes with a safety profile similar to cross-linked collagen. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fecal incontinence who receive injectable bulking agents, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A comparative effectiveness review from the Agency for Healthcare Research and Quality (AHRQ) evaluated 2 RCTs with the FDA-approved product NASHA Dx (Solesta) and 2 RCTs with Durasphere (off-label in the United States). One RCT using NASHA Dx found that compared with sham, NASHA Dx improved some outcome measures but not others. The other RCT did not find a significant difference in efficacy between NASHA Dx (Solesta) and biofeedback. Two additional RCTs with Durasphere found only short-term improvements in fecal incontinence severity. Controlled trials with longer follow-up are important to determine the durability of any treatment effect. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Urinary Incontinence

American College of Obstetricians and Gynecologists

In 2015 (reaffirmed in 2022), the American College of Obstetricians and Gynecologists (ACOG) 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 sling placement and are rarely used as primary treatment for stress urinary incontinence." There was insufficient evidence to recommend any specific bulking agent.

American Urogynecologic Society 

In 2024, the American Urogynecologic Society published a clinical practice statement on urethral bulking. They recommended that urethral bulking agents are indicated in cases of stress urinary incontinence (SUI), and that intrinsic sphincter deficiency is not predictive of patient outcomes (Grade B evidence; strength of recommendation[SOR]: strong recommendation). They also stated that urethral bulking agents may be considered for initial management of SUI, however the grade of evidence and strength of the recommendation were weaker (Grade C evidence; SOR: recommendation).

The 2017 joint guidelines on the surgical treatment of female SUI 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 SUI. The guidelines also stated that there are few long-term data on the efficacy of bulking agents and that retreatment is common. These recommendations are consistent in the 2023 update to the guidelines.

National Institute for Health and Care Excellence

In 2019, NICE updated its guidance on urinary incontinence in women. The updated guidance recommends "intramural bulking agents to manage stress urinary incontinence if alternative surgical procedures are not suitable for or acceptable to the woman." The patient should be educated that these are permanent injectable materials, repeat injections may be needed, and there is limited evidence on long-term effectiveness and adverse events.

Fecal Incontinence

American College of Obstetricians and Gynecologists

In 2019 (reaffirmed in 2023), ACOG published a practice bulletin on the clinical management of fecal incontinence in women. The College stated that "anal sphincter bulking agents may be effective in decreasing fecal incontinence episodes up to 6 months and can be considered as a short-term treatment option for fecal incontinence in women who have failed more conservative treatments." This recommendation is based on limited or inconsistent scientific evidence.

American Gastroenterological Association

In 2017, the American Gastroenterological Association (AGA) published guidance on surgical interventions and the use of device-aided therapy for the treatment of fecal incontinence and defecatory disorders. The AGA recommends, "Perianal bulking agents such as intra-anal injection of dextranomer may be considered when conservative measures and biofeedback therapy fail."

American Society of Colon and Rectal Surgeons

In 2023, the American Society of Colon and Rectal Surgeons (ASCRS) published practice parameters for the treatment of fecal incontinence. ASCRS states, "Injection of biocompatible bulking agents into the anal canal is not routinely recommended for the treatment of FI [fecal incontinence]" based on low quality evidence showing limited improvement over placebo, diminishing long-term results, and cost.

National Institute for Health and Care Excellence

The Institute (2007) published guidance on injectable bulking agents for treating fecal incontinence. The guidance stated that there is insufficient evidence to support the safety and efficacy of injectable bulking agents for fecal incontinence.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Collagen, Treatment of Urinary Incontinence; Durasphere; Incontinence, Treatment with Bulking Agents; Teflon, Periurethral Injection for Urinary Incontinence, Uryx, Treatment of Urinary Incontinence, Tegress, Treatment of Urinary Incontinence, Ethylene Vinyl Alcohol Copolymer, Treatment of Urinary Incontinence, Coaptite,  CalciumH, Treatment of Urinary Incontinence; Macroplastique, Polydimethylsiloxane, Treatment of Urinary Incontinence Dextranomer/ Hyaluronic Copolymer, Treatment of Urinary Incontinence, Zuidex, Implacer, Solesta

APPROVED BY GOVERNING BODIES:

Several periurethral bulking agents have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency; other than Contigen, approval is only for use in adult women. Products include:

  • In 1993, Contigen (Allergan), a cross-linked collagen, was approved. A supplemental approval in 2009 limited the device’s indication to treatment of urinary incontinence due to intrinsic sphincter deficiency in patients (men or women) who have shown no improvement in incontinence for at least 12 months. The manufacturer of the product ceased production in 2011; no reason for discontinuation was provided to the public.
  • In 1999, Durasphere (Advanced UroScience), pyrolytic carbon-coated zirconium oxide spheres, was approved.
  • In 2004, Uryx (CR Bard), vinyl alcohol copolymer implants, was approved. In 2005, approval was given to market the device under the trade name Tegress®. In 2007, Tegress was voluntarily removed from the market due to safety concerns.
  • In 2005, Coaptite (Boston Scientific, previously Bioform Medical), spherical particles of calcium hydroxylapatite, suspended in a gel carrier, was approved.
  • In 2006, Macroplastique (Laborie, previously Cogentix Medical), polydimethylsiloxane, was approved.
  • In 2020, Bulkamid Urethral Bulking System (Axonics Modulation Technologies, Inc.), a soft hydrogel that consists of 97.5% water and 2.5% polyacrylamide, was approved.

In 2011, non-animal stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) marketed as Solesta (Q-Med now Palette Life Sciences), was approved by FDA through the premarket approval process as a bulking agent to treat fecal incontinence in patients 18 years and older who have failed conservative therapy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT Codes:

For dates of service 01/01/20 and after there is not a specific diagnosis code for Anoscopy with directed submucosal injection of bulking agent for fecal incontinence. Report using the unlisted code 46999.

46999 Unlisted procedure, anus
51715 Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck

HCPCS:

L8603 Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies
L8604 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies
L8605 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies
L8606 Injectable bulking agent synthetic implant, urinary tract, 1ml syringe, includes shipping and necessary supplies


REFERENCES:

  1. ACOG Practice Bulletin No. 210: Fecal Incontinence. Obstet Gynecol. Apr 2019; 133(4): e260-e273.
  2. Agency for Health Care Policy and Research. Clinical Practice Guideline. Urinary Incontinence in Adults. Department of Health and Human Services, Rockville, Md., 1996.
  3. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No.155: Urinary Incontinence in Women. Obstet Gynecol May 2016; 126:e66–81. 
  4. Bent AE, Tutrone RT, McLennan MT et al. Treatment of intrinsic sphincter deficiency using autologous ear chondrocytes as a bulking agent. Neurourol Urodyn 2001; 20(2):157-65.
  5. Bharucha AE, Rao SSC, Shin AS. Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of FecalIncontinence and Defecatory Disorders. Clin Gastroenterol Hepatol. Dec 2017; 15(12): 1844-1854.
  6. Bordeianou LG, Thorsen AJ, Keller DS, et al. Management of fecal incontinence. Dis Colon Rectum. 2023;66:637-661.
  7. Chapple CR, Cruz F, Deffieux X, et al. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. Sep 2017;72(3):424-431.
  8. Chapple CR, Haab F, Cervigni M et al. An open, multicentre study of NASHA/Dx Gel (Zuidex) for the treatment of stress urinary incontinence. Eur Urol May 2005; 48(3):488-94.
  9. Corcos J, Collet JP, Shapiro S et al. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology 2005; 65(5):898-904.
  10. Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol 2013 Aug; 17 (4):389-95.
  11. Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol 2011; 176498.
  12. Dehli T, Stordahl A, Vatten LJ.  Sphincter training or anal injections of dextranomer for treatment of anal incontinence:  a randomized trial.  Scand J Gastroenterol 2013. Scand J Gastroenterol. 2013 Mar; 48(3):302-10.
  13. Durasphere package insert, Advanced UroSciences, St. Paul, Minn.
  14. Fleischmann N, Chughtai B, Plair A, et al. Urethral Bulking. Urogynecology (Phila). Aug 01 2024; 30(8): 667-682.
  15. Food and Drug Administration. Summary of Safety and Effectiveness: URYX Urethral Bulking Agent. 2004;www.accessdata.fda.gov/cdrh_docs/pdf3/P030030b.pdf. 
  16. Forte ML, Andrade KE, Butler M, et al. Treatments for Fecal Incontinence. Rockville, MD; Agency for Healthcare Research and Quality: March 2016. Report No.: 15(16)-EHC037-EF.  
  17. Ghoniem G, Corcos J, Comiter C et al. Cross-linked polydimethylsiloxane injection for female stress incontinence: results from a multicenter, randomized, controlled single-blind study. J Urol Jan 2009; 181(1): 204-10.
  18. Ghoniem G, Corcos J, Comiter C et al.  Durability of urethral bulking agent injection for female stress urinary incontinence:  2-year multicenter study results.  J Urol Apr 2010; 183(4):1444-9. 
  19. Gorina Y, Schappert S, Bercovitz A, et al. Prevalence of incontinence among older Americans. Vital Health Stat 3. Jun 2014(36):1-33.
  20. Graf W, Mellgren A, Matzel KE et al.  Efficacy of dextranomer in stabilized hyaluronic acid for treatment of faecal incontinence:  a randomised, sham-controlled trial.  Lancet Mar 19 2011; 377(9770):997-1003. 
  21. Hoe V, Haller B, Yao HH, et al. Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review. Neurourol Urodyn. Aug 2021; 40(6): 1349-1388.
  22. Hussain ZI, Lim M, Stojkovic SG.  Systematic review of perianal implants in the treatment of faecal incontinence.  Br J Surg Nov 2011; 98(11):1526-36.
  23. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  24. Itkonen Freitas AM, Mentula M, Rahkola-Soisalo P, et al. Tension-Free Vaginal Tape Surgery versus Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial. J Urol. Feb 2020; 203(2): 372-378.
  25. Jankowski RJ, Tu LM, Carlson C, et al. A double-blind, randomized, placebo-controlled clinical trial evaluating the safetyand efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence. Int Urol Nephrol. Dec2018; 50(12): 2153-2165.
  26. Kirchin V, Page T, Keegan PE et al.  Urethral injection therapy for urinary incontinence in women.  Cochrane Database Syst Rev Jul 25 2017; 7(7): CD003881.
  27. Kleinert S, Horton R. Retraction--autologous myoblasts and fibroblasts versus collagen corrected for treatment of stress urinary incontinence in women: a [corrected] randomized controlled trial. Lancet Sept 06 2008; 372(9641):789-90.
  28. Kobashi KC, Albo ME, Dmochowski RR, et al. Surgical treatment of female stress urinary incontinence: AUA/SUFU Guideline. J Urol. Oct 2017;198(4):875-883.
  29. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to Surgical Treatment of Female Stress Urinary Incontinence(SUI): AUA/SUFU Guideline (2023). J Urol. Jun 2023; 209(6): 1091-1098.
  30. La Torre F, de la Portilla F. Long-term efficacy of dextranomer in stabilized hyaluronic acid (NASHA/Dx) for treatment of faecal incontinence. Colorectal Dis May 2013; 15(5):569-74.
  31. Lee PE, Kung RC, Drutz HP. Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial. J Urol Jan 2001; 165(1):153-8.
  32. Leone Roberti Maggiore U, Alessandri F, Medica M et al. Outpatient periurethral injections of polyacrylamide hydrogel for the treatment of female stress urinary incontinence: effectiveness and safety. Arch Gynecol Obstet Jul 2013; 288(1):131-7.
  33. Leung FW. Treatment of fecal incontinence-review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue.  J Interv Gastroenterol Oct 2011; 1(4):202-6.
  34. Lightner D, Calvosa C, Andersen R et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled double-blind study of Durasphere. Urology July 2001; 58(1):12-5.
  35. Lightner D, Rovner E, Corcos J et al. Randomized controlled multisite trial of injected bulking agents for women with intrinsic sphincter deficiency: mid-urethral injection of Zuidex via the Implacer versus proximal urethral injection of Contigen cystoscopically. Urology 2009 Oct; 74(4):771-5.
  36. Lone F, Sultan AH, thakar R.  Long-term outcome of transurethral injectio of hyaluronic acid/dextranomer (NASHA/Dxgel) for the treatment of stress urinary incontinence (SUI). Int Urogynecol J Nov 2010; 21(11):1359-64.
  37. Lose G, Sorensen HC, Axelsen SM et al. An open multicenter study of polyacrylamide hydrogel (Bulkamid) for female stress and mixed urinary incontinence. Int Urogynecol J Dec 2010; 21(12):1471-7.
  38. Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. Feb 28 2013; (2):CD007959.
  39. Mayer RD, Dmochowski RR, Appell RA et al. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology May 2007; 69(5):876-80.
  40. Mellgren, A, Matzel, KE, Pollack J, Hull T, Bernstein M, Graf W. Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence. Neurogastroenterology & Motility Aug 2014; 26(8): 1087-94.
  41. Morris OJ, Smith S, Draganic B. Comparison of bulking agents in the treatment of fecal incontinence: a prospective randomized clinical trial. Tech Coloproctol Oct 2013; 17(5):517-23.
  42. Mouritsen L, Lose G, Moller-Bek K. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence. Acta Obstet Gynecol Scand. Feb 2014; 93(2):209-212.  
  43. National Institute for Health and Care Excellence (NICE). Injectable bulking agents for faecal incontinence [IPG210]. 2007; www.nice.org.uk/guidance/ipg210/chapter/1-guidance. 
  44. National Institute for Health and Care Excellence (NICE). Urinary incontinence and pelvic organ prolapse in women: management [NG123]. 2019; www.nice.org.uk/guidance/ng123. 
  45. National Institute for Health and Clinical Excellence (NICE). Urinary incontinence: The management of urinary incontinence in women 2013; //publications.nice.org.uk/urinary-incontinence-cg171/recommendations.
  46. National Institute for Health and Clinical Excellence (NICE).  Injectable bulking agents for faecal incontinence [IPG210]:  February 2007.  www.nice.org.uk/guidance/ipg210/chapter/1-guidance. 
  47. Pai A, Al-Singary W. Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid(®)) in the management of stress and mixed urinary incontinence: three year follow up outcomes. Cent European J Urol. 2015; 68(4):428-433.
  48. Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' clinical practice guideline for the treatment of fecal incontinence. Dis Colon Rectum. Jul 2015;58(7):623-636.
  49. Peters KM, Dmochowski RR, Carr LK, et al. Autologous muscle derived cells for treatment of stress urinary incontinence in women. J Urol. Aug 2014; 192(2):469-476.
  50. Pivazyan L, Kasyan G, Grigoryan B, et al. Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. Apr 2022; 33(4): 777-787. 
  51. Quiroz LH, Galliano DE, da Silva G, et al. Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up. Dis Colon Rectum. Feb 01 2023; 66(2): 278-287.
  52. Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol. Sep 2014; 192(3):843-849.
  53. Strasser H, Marksteiner R, Margreiter E et al. Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomized controlled trial. Lancet June 30 2007; 369(9580):2179-86.

POLICY HISTORY:

Medical Policy Group, November 2010

Medical Policy Administration Committee, November 2010 (2)

Available for comment November 4 – December 20, 2010

Medical Policy Group, July 2012 (4): Updated Key Points, Coding, and References.

Medical Policy Panel, March 2013

Medical Policy Group, July 2013 (2): Policy updated with literature review through February 12, 2013.  Policy expanded to include fecal incontinence.  Statement added that perianal bulking agents to treat fecal incontinence is investigational.  Title changed to Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence.  Key Points, Approved by Governing Bodies, Key Words, Coding, and Reference updated to support Policy statement.

Medical Policy Administration Committee, July 2012

Available for comment July 18 through September 6, 2013

Medical Policy Panel, March 2014

Medical Policy Group, July 2014 (4): No changes to the policy at this time.  Updated the Description, Approved Governing Bodies, Key Points and References.

Medical Policy Group, October 2014(4): No changes to the policy.  Updated References.

Medical Policy Group, November 2014:  2015 Annual Coding update.  Added code 0377T to current coding and removed HCPC code C9735 from current coding and added new previous coding section to include C9735.

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (4):  Updates to Key Points and References.  Added new policy statement section for effective dates 03/01/2015 which removed “cross linked collagen” from policy statement (no longer commercially available) and added “to treat stress urinary incontinence” to policy statements. No change to intent of policy statements.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (4): Updates to Description, Key Points and References. Removed policy statements for effective dates of service prior to September 1, 2013.  No change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, August 2018

Medical Panel Group, August 2018 (4): Updates to Key Points, Practice Guidelines, Coding (added L8604 to Current Coding) and References.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (5): Updates to Key Points. No changes to Policy Statement.

Medical Policy Group, December 2019 (5): 2020 Annual Coding Update. Moved CPT 0377T from Current coding section. Created Previous Coding section to include CPT code 0377T. No change in Policy Statement.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (5): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Group, October 2021 (5): CPT Q3031 removed from policy. No change to Policy Statement. 

Medical Policy Panel, October 2021

Medical Policy Group, October 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to included polyacrylamide hydrogel. Policy statement updated to remove “not medically necessary,” no change to policy intent. Available for comment November 1, 2021 through December 14, 2021.

Medical Policy Panel, October 2022

Medical Policy Group, October 2022 (5): Updates to Description, Key Points, and References. No change to Policy Statement.

Medical Policy Panel, October 2023

Medical Policy Group, October 2023 (11): Updates to Description, Key Points, Approved by Governing Bodies, Benefit Application and References. No change to Policy Statement.

Medical Policy Group, July 2024 (11): Updated Policy Statement to include Manufacturer examples to product types for clarification. No change to policy intent.

Medical Policy Panel, October 2024

Medical Policy Group, October 2024 (11): Updates to Key Points and References. Removed policy statements effective for dates of service prior to December 16, 2021. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.