Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 2|05|2013 POLICY LAST REVIEWED: 11/05/2025 OVERVIEW 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 one for treating fecal incontinence.
This policy is applicable to Commercial Products only. For Medicare Advantage Plans, see Related Policies section.
MEDICAL CRITERIA Not applicable
PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Commercial Products Urinary Incontinence The use of carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy.
The use of autologous cellular therapy (eg, myoblasts, fibroblasts, muscle-derived stem cells, adipose-derived stem cells), autologous fat, and autologous ear chondrocytes, to treat stress urinary incontinence is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. The use of any other periurethral bulking agent, including, but not limited to Teflon, to treat stress urinary incontinence is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. The use of periurethral bulking agents to treat urge urinary incontinence is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Fecal Incontinence
The use of perianal bulking agents to treat fecal incontinence is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND Incontinence Medical Coverage Policy | Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence d

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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.

Definition of Failed Appropriate Conservative Therapy for Stress Urinary Incontinence (SUI)  Treatments used for at least 3 months.
 Includes pelvic floor muscle exercises and behavioral changes, such as fluid management and moderation of physical activities that provoke incontinence.
 Additional options include intravaginal estrogen therapy, use of a pessary, and treatment of other underlying causes of incontinence in individuals amenable to these treatments.

Treatment of Urinary Incontinence Injectable bulking agents are space-filling substances used to increase tissue bulk. When used to treat SUI, bulking agents are injected periurethrally to increase tissue bulk and thereby increase resistance to the outflow of urine. The bulking agent is injected into the periurethral tissue as a liquid that 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 postprostatectomy incontinence.

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 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 (eg, Contigen). The agent was found to be absorbed over time and symptoms could recur, requiring additional injections. Contigen production was discontinued in 2011. Other periurethral bulking agents cleared by FDA for urinary incontinence include carbon-coated beads (eg, 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 (eg, Tegress®, formerly Uryx). Tegress was voluntarily removed from the market due to safety concerns.

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 does not have 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 hypothesized that transplanted stem cells would undergo self-renewal and multipotent differentiation, which could result in regeneration of the sphincter and its neural connections.

For individuals who have stress urinary incontinence 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.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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 (eg, Durasphere, silicone biomaterial) have been studied for the treatment of fecal incontinence. To date, only 1 bulking agent has been approved by FDA for fecal incontinence. This formulation is a non-animal-stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) and is marketed by Q-Med 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

For individuals who have fecal incontinence 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. A comparative effectiveness review from the Agency for Healthcare Research and Quality evaluated 2 RCTs with the FDA-approved product NASHA Dx (Solesta) and 2 RCTs with Durasphere (off-label in the United States). One RCT comparing NASHA Dx with sham found that NASHA Dx improved some outcomes but not others. The other RCT did not find a significant difference in efficacy between NASHA Dx and biofeedback. Two additional RCTs evaluating Durasphere found only short-term improvements in fecal incontinence severity. Controlled trials with longer follow-up are needed 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.

CODING Commercial Products

Urinary Incontinence The following HCPCS codes are medically necessary when filed with ICD-10 code:
N39.3 Stress incontinence (female) (male)

L8603 Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and
necessary supplies L8606 Injectable bulking agent, synthetic implant, urinary tract, 1ml syringe, includes shipping and necessary supplies

There are no specific HCPCS codes for bulking agents or therapies that are identified in the Policy Statement as not medically necessary. Claims for these services should be filed with an unlisted HCPCS code.

Fecal Incontinence The following CPT/HCPCS code(s) are not medically necessary: 0963T Anoscopy with directed submucosal injection of bulking agent into anal canal (New Code Effective 7/1/2025) L8605 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies

RELATED POLICIES Medicare Advantage Plans National and Local Coverage Determinations Unlisted Procedures

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

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REFERENCES: Gorina Y, Schappert S, Bercovitz A, et al. Prevalence of incontinence among older americans. Vital Health Stat

3. Jun 2014; (36): 1-33. PMID 24964267 Agency for Health Care Policy and Research. Clinical Practice Guideline. Urinary Incontinence in Adults. Rockville, MD: Department of Health and Human Services; 1996. 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. May 2005; 65(5): 898-904. PMID 15882720 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. PMID 34015151 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. PMID 34351463 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. PMID 28738443 Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. Feb 15 2012; (2): CD003881. PMID 22336797 Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long- term effectiveness and durability. Adv Urol. 2011; 2011: 176498. PMID 21738529 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. Jul 2001; 58(1): 12-5. PMID 11445471 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. PMID 17482925 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): 843-9. PMID 24704117 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. PMID 31479396 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): 428-33. PMID 26855795 Lose G, Sørensen 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. PMID 20645077 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. PMID 23371485 Mouritsen L, Lose G, Møller-Bek K. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence. Acta Obstet Gynecol Scand. Feb 2014; 93(2): 209-12. PMID 24372312 Ghoniem G, Corcos J, Comiter C, et al. Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study. J Urol. Jan 2009; 181(1): 204-
4. PMID 19013613 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. PMID 20171691

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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. Oct 2009; 74(4): 771-5. PMID 19660800 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. Sep 2005; 48(3): 488-94. PMID 15967568 Lone F, Sultan AH, Thakar R. Long-term outcome of transurethral injection of hyaluronic acid/dextranomer (NASHA/Dx gel) for the treatment of stress urinary incontinence (SUI). Int Urogynecol J. Nov 2010; 21(11): 1359-64. PMID 20571764 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. PMID 11125386 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. PMID 11170190 Strasser H, Marksteiner R, Margreiter E, et al. Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial. Lancet. Jun 30 2007; 369(9580): 2179-2186. PMID 17604800 Kleinert S, Horton R. Retraction--autologous myoblasts and fibroblasts versus collagen [corrected] for treatment of stress urinary incontinence in women: a [corrected] randomised controlled trial. Lancet. Sep 06 2008; 372(9641): 789-90. PMID 18774408 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): 469-76. PMID 24582537 Jankowski RJ, Tu LM, Carlson C, et al. A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence. Int Urol Nephrol. Dec 2018; 50(12): 2153-2165. PMID 30324580 Forte ML, Andrade KE, Butler M, et al. Treatments for Fecal Incontinence (Comparative Effectiveness Review No. 165). Rockville, MD: Agency for Healthcare Research and Quality; 2016. 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. PMID 23450581 Graf W, Mellgren A, Matzel KE, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. Mar 19 2011; 377(9770): 997-1003. PMID 21420555 Mellgren A, Matzel KE, Pollack J, et al. Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence. Neurogastroenterol Motil. Aug 2014; 26(8): 1087-94. PMID 24837493 Dehli T, Stordahl A, Vatten LJ, et al. Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial. Scand J Gastroenterol. Mar 2013; 48(3): 302-10. PMID 23298304 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. PMID 23374680 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. PMID 35001051 American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. May 2016;127(5):e66-81. PMID 27548423 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. PMID 28625508 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. PMID 37096580 National Institute for Health and Care Excellence (NICE). Urinary incontinence and pelvic organ prolapse in women: management [NG123]. 2019; https://www.nice.org.uk/guidance/ng123. Accessed September 5, 2023. ACOG Practice Bulletin No. 210: Fecal Incontinence. Obstet Gynecol. Apr 2019; 133(4): e260-e273. PMID 30913197 Bharucha AE, Rao SSC, Shin AS. Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders. Clin Gastroenterol Hepatol. Dec 2017; 15(12): 1844-1854. PMID 28838787 Bordeianou LG, Thorsen AJ, Keller DS, et al. Management of fecal incontinence. Dis Colon Rectum. 2023;66:637-661.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

National Institute for Health and Care Excellence (NICE). Injectable bulking agents for faecal incontinence [IPG210]. 2007; https://www.nice.org.uk/guidance/ipg210/chapter/1-guidance. Accessed September 4,

2023. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Incontinence Control Devices (230.10). 1996; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=241&ncdver=1&DocID=230.10&bc=gAAAAAgAAAAAAA%3D%3D&. Accessed September 5, 2023.

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      This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS