Incontinence Treatments Form

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Incontinence Treatments

Indications

(1) Biofeedback is not a covered benefit under many Baylor Scott & White Health Plan (BSWHP) policies, however, if the contract does provide coverage, prior authorization is NOT required. Biofeedback for urinary incontinence is not a treatment; it is a tool to help patients learn how to perform pelvic muscle exercises (Kegel exercises). BSWHP may cover physical therapy which includes instruction in performance of pelvic muscle exercise when medically appropriate. Once proficiency is achieved further biofeedback therapy would not be covered. 2. Sacral nerve stimulation (SNS) - Use InterQual® as directed above. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 2 of 10 3. BSWHP considers Transurethral Radiofrequency (RF) Therapy (Renessa® System) experimental, investigational and/or unproven 4. Posterior Tibial Nerve Stimulation (PTNS) PTNS consists of insertion of a percutaneous needle above the medial malleolus into a superficial branch of the posterior tibial nerve. An adjustable low voltage electrical impulse (10mA, 1-10 Hz frequency) travels via the posterior tibial nerve to the sacral nerve plexus to alter pelvic floor function by neuromodulation. PTNS may be considered medically necessary for the treatment of medically diagnosed overactive bladder which has failed standard pharmacotherapy. a. BSWHP considers an initial treatment plan of up to 12 weekly, 30-minute sessions, medically necessary. b. Patients must report an improvement in symptoms within 12 weeks (i.e., 12 sessions) of initiation of PTNS for continued coverage. c. Treatment beyond the initial 12 sessions will be allowed at a frequency of 1 every 1 to 2 months for up to 12 months IF there is documentation of 50% decrease in symptoms as evidenced by a daily uro-log (i.e., record of bladder events, voiding diary) and an improvement in quality of life d. Treatments after 12 months are considered experimental/investigational 5. Bedwetting Alarms are commercially available without a prescription and therefore are not covered by the health plan. Fecal Incontinence 1. Sacral Nerve Stimulator for Fecal Incontinence A trial period of sacral nerve stimulation device may be considered medically necessary when ALL the following criteria is met: a. Chronic fecal incontinence with greater than two incontinent episodes on average per week and duration of incontinence greater than six months or for more than twelve months after vaginal childbirth; AND b. Documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment); AND c. Condition is not related to anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) and/or chronic inflammatory bowel disease; AND d. Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 3 of 10 Permanent placement of sacral nerve stimulation device may be considered medically necessary when ALL the following criteria is met: a. All of the above criteria were met for temporary placement AND b. A successful percutaneous test stimulation, defined as at least 50% sustained (more than one week) improvement in symptoms. Sacral nerve modulation/stimulation is considered experimental, investigational and unproven for the treatment of chronic constipation or chronic pelvic pain. 2. Interventions that are NOT considered medically necessary include: a. Solesta - an injectable gel, is considered experimental and investigational. b. Botox - is considered experimental and investigational. BACKGROUND: Urinary Incontinence Urinary incontinence, defined as the involuntary loss of urine, is common, particularly in women. There are four prevalent types of UI in adults: a) stress incontinence (urine loss that occurs with an increase in abdominal pressure, and is often due to urethral hypermobility.), b) urge incontinence (which is thought to be related to detrusor over activity.), c) overflow incontinence (dribbling or leaking associated with incomplete bladder emptying), and d) mixed stress and urge incontinence. Treatments for UI pelvic muscle exercises (Kegel exercise), behavioral therapies such as bladder training and/or biofeedback, pharmacotherapies (e.g., anticholinergic agents, musculotropic relaxants, calcium channel blockers, tricyclic antidepressants, or a combination of anticholinergic, antispasmodic medications and tricyclic antidepressants), and a variety of surgical procedures including intraurethral injection of Coaptite, and implantation of an artificial urinary sphincter. Specifically, urge incontinence is more effectively managed with peripherally acting receptor agonists or antagonists while stress incontinence is better controlled by pelvic muscle exercises, behavioral therapies, or corrective surgery. Fecal Incontinence Fecal incontinence (FI) is loss of control of the bowels resulting in involuntary excretion of liquid or solid feces. The prevalence of FI ranges from 1% to 8% in healthy individuals and approaches 30% in institutionalized patients. FI affects 20 million non-institutionalized adults in the United States. FI has a negative impact on activities of daily living and quality of life. Current treatments for FI range from conservative measures aimed at reducing symptoms to surgical interventions intended to correct anal sphincter or pelvic floor abnormalities. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 4 of 10 Sacral nerve stimulation, also called sacral nerve modulation, involves the application of a mild electrical pulse to the sacral nerves through a surgically implanted neuromodulation system to treat fecal incontinence. The electrical pulses modulate the sacral nerves that influence the functioning of the bladder, bowel, urinary, and anal sphincters, and the pelvic floor muscles. The InterStim Therapy System is manufactured by Medtronic. MANDATES: None CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. PT Codes 53444 - Insertion of tandem cuff (dual cuff) 53445 - Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff 64561 - Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, 64566 – Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming, 64581 – Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement), 64585 - Revision or removal of peripheral neurostimulator electrode array 64590 –Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, director or inductive coupling, 64595 – Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver, 95970 – Electronic analysis of implanted neurostimulator pulse generator system; simple or complex brain, spinal cord, or peripheral neurostimulator pulse generator/transmitter, without reprogramming 95971 - Electronic analysis of implanted neurostimulator pulse generator system; simple spinal cord, or peripheral neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, 95972 - Electronic analysis of implanted neurostimulator pulse generator system; complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 5 of 10 CPT Codes NOT Covered 53860 - Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence HCPCS Codes A4290 - Sacral nerve stimulation test lead, each C1767 - Generator, neurostimulator (implantable), nonrechargeable E0745 - Neuromuscular stimulator, electronic shock unit L8679 - Implantable neurostimulator, pulse generator, any type L8681 - Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only L8682 - Implantable neurostimulator radiofrequency receiver L8683 - Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver L8684 - Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement L8689 - External recharging system for battery (internal) for use with implantable neurostimulator, replacement only MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 6 of 10 ICD-10 Codes N31.0 - N31.9 - Bladder atony N39.4 – N39.498 – Other specified urinary incontinence N36.44 - Muscular disorders of urethraN39.4 – N39.498 – Other specified urinary incontinence N36.44 - Muscular disorders of urethra N39.3 - Stress incontinence (female) (male) N39.41 - Urge incontinence N39.46 - Mixed incontinence R15.x - Incontinence of feces R30.1 - Vesical tenesmus R32 - Unspecified urinary incontinence R33.0 - R33.9 - Urinary retention R35.0 - Frequency of micturition R39.11 - Hesitancy of micturition R39.14 - Feeling of incomplete bladder emptying R39.2 - Extrarenal uremia R39.81 - Functional urinary incontinence R39.89 - Other symptoms and signs involving the genitourinary system R39.9 - Unspecified symptoms and signs involving the genitourinary system MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 7 of 10 POLICY HISTORY: Status Date Action New 12/6/2010 New policy Reviewed 12/6/2011 Reviewed. Reviewed 11/15/2012 Reviewed. Reviewed 11/14/2013 ICD10 codes added. Reviewed 09/25/2014 Updated LCD information and SNS and PTNS criteria accordingly Reviewed 10/22/2015 New LCD. Coverage for fecal incontinence added. Reviewed 12/02/2015 Reviewed with pelvic surgery team and made mild modifications. Reviewed 10/27/2016 Minor format changes Reviewed 09/19/2017 Policy language clarification Reviewed 03/13/2017 Corrected indications to include retention. Updated 10/01/2018 Added one HCPCS code C1767 Reviewed 06/27/2019 No significant changes Updated 05/28/2020 Transitioned to IQ and aligned for FirstCare and SWHP Reviewed 05/27/2021 No major change. Codes updated Reviewed 04/21/2022 No changes Reviewed 04/27/2023 No changes Reviewed 04/08/2024 Formatting changes, added hyperlinks to NCD and TMPPM, beginning and Reviewed 03/10/2025 Ending note section updated to align with business entity changes. Updated 08/11/2025 Removed “Medicare NCD or LCD specific InterQual criteria may be used Reviewed 03/26/2026 Minor reformatting changes; Specified Baylor Scott & White Health Plan where BSWHP is first written; replaced Transurethral RF with Transurethral Radiofrequency; added trademark to Renessa® System; removed “not medically necessary” from the Renessa system; removed the word percutaneous from PTNS; Added criteria for sacral nerve stimulator for fecal incontinence; Added references REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: Scientific review. JAMA. 2004;291(8):986995. 2. Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD001308. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 8 of 10 3. Glazener CMA, Cooper K. Bladder neck needle suspension for urinary incontinence in women. Cochrane Database Syst Rev. 2004;(2):CD003636. 4. Hay-Smith EJC, Bø K, Berghmans LCM, et al. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2007 Jul 18; (1):CD001407 (available at https://www.ncbi.nlm.nih.gov/pubmed/17636671. Accessed on 9/12/2017). 5. Thomas LH, Cross S, Barrett J, et al. Treatment of urinary incontinence after stroke in adults. Cochrane Database Syst Rev. 2008;(1):CD004462. 6. Hunter KF, Moore KN, Glazener CMA, et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007;(2):CD001843. 7. Onwude J. Stress incontinence. In: BMJ Clinical Evidence. London, UK: BMJ Publishing Group; December 2006. 8. Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801. 9. Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802. 10. Cody JD, Richardson K, Moehrer B, et al. Oestrogen therapy for urinary incontinence in post-menopausal women. Cochrane Database Syst Rev. 2009;(4):CD001405..Page 5 of 7 11. Glazener CMA, Cooper K. Anterior vaginal repair for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001755. 12. Eustice S, Roe B, Paterson J. Prompted voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2000;(2):CD002113. 13. Hay-Smith EJC, Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2006;(1):CD005654. 14. National Institute for health and Clinical Excellence (NICE). The care and treatment of women aged 18 years and older with urinary incontinence (stress, urgency or mixed urinary incontinence or overactive bladder). 15. Clinical guideline [CG171]. London, UK: NICE; 2015. (Available at https://www.nice.org.uk/guidance/cg171. Accessed on 9/13/2017). 16. Hay-Smith EJC, Bø K, Berghmans LCM, et al. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2006;(1):CD001407. 17. Hunter K, Glazener C, Moore K. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007;(2):CD001843. 18. Macdonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: A systematic review of effectiveness. BJU Int. 2007;100(1):76-81. 19. Walsh, J. Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder, MEDSCAPE, available at http://www.medscape.com/viewarticle/773418_2. (Accessed on 9/12/2017). 20. Lukacz, E, Treatment of urinary incontinence in women. Up-To-Date available at https://www.uptodate.com/contents/treatment-of-urinary-incontinence-in-women. (accessed on 9/12/2017) 21. Dumoulin C, Hay-Smith EC, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment for urinary incontinence in women. Cochrane Database Syst Rev. 5/14/2014. Available at http://www.cochrane.org/CD005654/INCONT_pelvic-floor-muscle-training-versus-no-treatment-for-urinary- incontinence-in-women. (Accessed on 9/13/2017). 22. http://www.webmd.com/urinary-incontinence-oab/news/20150515/botox-overactive-bladder#1 accessed pm 9/18/2017. InterStim Continence Control Therapy/Sacral Nerve Stimulation 1. Burrows E, Harris A, Gospodarevskaya E. Sacral nerve stimulation for refractory urinary urge incontinence or urinary retention. MSAC Application 1009. Canberra, ACT: Medicare Services Advisory Committee (MSAC); 2000. 2. Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev. 2009;(2):CD004202. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 9 of 10 3. National Institute for Clinical Excellence (NICE). Sacral nerve stimulation for urge incontinence and urgency- frequency. Interventional Procedure Guidance 64. London, UK: NICE; June 2004. 4. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. Health Technology Literature Review. Toronto, ON: MAS; 2005. Solesta References 1. Bernstein MA, Purdy CH, Becker A, Magar R. Three-year cost-effectiveness model for non-animal stabilized hyaluronic acid and dextranomer copolymer compared with sacral nerve stimulation after conservative therapy for the management of fecal incontinence. Clin Ther. 2014;36(6):890-905. Available at: http://www.clinicaltherapeutics.com/article/S0149-2918(14)00208-2/pdf. Accessed October 15, 2014. 2. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network. MLN Matters. MLN Matters® Number: MM8228. April 2013 Update of the Hospital Outpatient Prospective Payment System (OPPS). March 1, 2013. Available at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/ MM8228.pdf. Accessed September 17, 2017. 3. Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009;52(6):1101-1106. 4. 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;17(4):389-395. 5. 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. 2013;48(3):302-310. 6. Dodi G, Jongen J, de la Portilla F, Raval M, Altomare DF, Lehur PA. An open-label, noncomparative, multicenter study to evaluate efficacy and safety of NASHA/Dx gel as a bulking agent for the treatment of fecal incontinence. Gastroenterol Res Pract. 2010;2010:467136. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3017894. Accessed September 17, 2017. 7. Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;377(9770):997-1003. 8. Hoy SM. Dextranomer in stabilized sodium hyaluronate (Solesta®): in adults with faecal incontinence. Drugs. 2012;72(12):1671-1678. Fecal Incontinence References 1. Leroi AM, Lenne X, Dervaux B, et al. Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence. Ann Surg. 2011;253(4):720-732. 2. Leroi AM, Parc Y, Lehur PA, et al. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005;242(5):662-669. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1409867. Accessed September 17, 2017. 3. Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011;98(1):140-147. 4. Medtronic Inc. InterStim® Therapy: InterStim® Model 3023 Neurostimulator, InterStim® II Model 3058 Neurostimulator [implant manual]. 2006. Available at: http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/sns-is3058-23- impmanl.pdf. Accessed September 17, 2017. MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 10 of 10 5. Medtronic Inc. Indications, Safety, and Warnings. Revised April 2009. Available at: http://professional.medtronic.com/pt/uro/snm/ind/index.htm. Accessed September 17, 2017. 6. Mellgren A, Wexner SD, Coller JA, et al.; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011;54(9):1065-1075. 7. Michelsen HB, Krogh K, Buntzen S, Laurberg S. A prospective, randomized study: switch off the sacral nerve stimulator during the night? Dis Colon Rectum. 2008;51(5):538-540.? 

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MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 1 of 10 Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy. SERVICE: Urinary and Fecal Incontinence: Biofeedback, Sacral Nerve Stimulation, Posterior Tibial Nerve Stimulation PRIOR AUTHORIZATION: Required for Sacral Nerve Stimulator POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for coverage details. Note: Unless otherwise indicated (see below), this policy will apply to all lines of business. For Medicare plans, please refer to appropriate Medicare NCD (National Coverage Determination) NCD 230.18 Sacral Nerve Stimulation For Urinary Incontinence or LCD (Local Coverage Determination). If there are no applicable NCD or LCD criteria, use the criteria set forth below. For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures
Manual | TMHP (TMPPM). If there are no applicable criteria to guide medical necessity decision making in the TMPPM, use the criteria set forth below. For all other lines of business use the criteria set forth in InterQual®. When the InterQual® criteria-set only includes Medicare sources (i.e., National or Local Coverage Determinations), those sources will be used to review requests for all lines of business. Urinary Incontinence/Retention

  1. Biofeedback is not a covered benefit under many Baylor Scott & White Health Plan (BSWHP) policies, however, if the contract does provide coverage, prior authorization is NOT required. Biofeedback for urinary incontinence is not a treatment; it is a tool to help patients learn how to perform pelvic muscle exercises (Kegel exercises). BSWHP may cover physical therapy which includes instruction in performance of pelvic muscle exercise when medically appropriate. Once proficiency is achieved further biofeedback therapy would not be covered.
  2. Sacral nerve stimulation (SNS) - Use InterQual® as directed above.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 2 of 10

  1. BSWHP considers Transurethral Radiofrequency (RF) Therapy (Renessa® System) experimental, investigational and/or unproven
  2. Posterior Tibial Nerve Stimulation (PTNS) PTNS consists of insertion of a percutaneous needle above the medial malleolus into a superficial branch of the posterior tibial nerve. An adjustable low voltage electrical impulse (10mA, 1-10 Hz frequency) travels via the posterior tibial nerve to the sacral nerve plexus to alter pelvic floor function by neuromodulation. PTNS may be considered medically necessary for the treatment of medically diagnosed overactive bladder which has failed standard pharmacotherapy. a. BSWHP considers an initial treatment plan of up to 12 weekly, 30-minute
    sessions, medically necessary. b. Patients must report an improvement in symptoms within 12 weeks (i.e., 12 sessions) of initiation of PTNS for continued coverage. c. Treatment beyond the initial 12 sessions will be allowed at a frequency of 1 every 1 to 2 months for up to 12 months IF there is documentation of 50% decrease in symptoms as evidenced by a daily uro-log (i.e., record of bladder events, voiding diary) and an improvement in quality of life d. Treatments after 12 months are considered experimental/investigational
  3. Bedwetting Alarms are commercially available without a prescription and therefore are not covered by the health plan. Fecal Incontinence
  4. Sacral Nerve Stimulator for Fecal Incontinence A trial period of sacral nerve stimulation device may be considered medically necessary when ALL the following criteria is met: a. Chronic fecal incontinence with greater than two incontinent episodes on average per week and duration of incontinence greater than six months or for more than twelve months after vaginal childbirth; AND b. Documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment); AND c. Condition is not related to anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) and/or chronic inflammatory bowel disease; AND d. Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 3 of 10 Permanent placement of sacral nerve stimulation device may be considered medically necessary when ALL the following criteria is met: a. All of the above criteria were met for temporary placement AND b. A successful percutaneous test stimulation, defined as at least 50% sustained (more than one week) improvement in symptoms.
Sacral nerve modulation/stimulation is considered experimental, investigational and unproven for the treatment of chronic constipation or chronic pelvic pain.

  1. Interventions that are NOT considered medically necessary include: a. Solesta - an injectable gel, is considered experimental and investigational. b. Botox - is considered experimental and investigational. BACKGROUND: Urinary Incontinence Urinary incontinence, defined as the involuntary loss of urine, is common, particularly in women. There are four prevalent types of UI in adults: a) stress incontinence (urine loss that occurs with an increase in abdominal pressure, and is often due to urethral hypermobility.), b) urge incontinence (which is thought to be related to detrusor over activity.), c) overflow incontinence (dribbling or leaking associated with incomplete bladder emptying), and d) mixed stress and urge incontinence. Treatments for UI pelvic muscle exercises (Kegel exercise), behavioral therapies such as bladder training and/or biofeedback, pharmacotherapies (e.g., anticholinergic agents, musculotropic relaxants, calcium channel blockers, tricyclic antidepressants, or a combination of anticholinergic, antispasmodic medications and tricyclic antidepressants), and a variety of surgical procedures including intraurethral injection of Coaptite, and implantation of an artificial urinary sphincter. Specifically, urge incontinence is more effectively managed with peripherally acting receptor agonists or antagonists while stress incontinence is better controlled by pelvic muscle exercises, behavioral therapies, or corrective surgery. Fecal Incontinence Fecal incontinence (FI) is loss of control of the bowels resulting in involuntary excretion of liquid or solid feces. The prevalence of FI ranges from 1% to 8% in healthy individuals and approaches 30% in institutionalized patients. FI affects 20 million non-institutionalized adults in the United States. FI has a negative impact on activities of daily living and quality of life. Current treatments for FI range from conservative measures aimed at reducing symptoms to surgical interventions intended to correct anal sphincter or pelvic floor abnormalities.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 4 of 10 Sacral nerve stimulation, also called sacral nerve modulation, involves the application of a mild electrical pulse to the sacral nerves through a surgically implanted neuromodulation system to treat fecal incontinence. The electrical pulses modulate the sacral nerves that influence the functioning of the bladder, bowel, urinary, and anal sphincters, and the pelvic floor muscles. The InterStim Therapy System is manufactured by Medtronic. MANDATES: None CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. PT Codes 53444 - Insertion of tandem cuff (dual cuff) 53445 - Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff 64561 - Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, 64566 – Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming, 64581 – Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement), 64585 - Revision or removal of peripheral neurostimulator electrode array 64590 –Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, director or inductive coupling, 64595 – Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver, 95970 – Electronic analysis of implanted neurostimulator pulse generator system; simple or complex brain, spinal cord, or peripheral neurostimulator pulse generator/transmitter, without reprogramming 95971 - Electronic analysis of implanted neurostimulator pulse generator system; simple spinal cord, or peripheral neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, 95972 - Electronic analysis of implanted neurostimulator pulse generator system; complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 5 of 10 CPT Codes NOT Covered 53860 - Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence HCPCS Codes A4290 - Sacral nerve stimulation test lead, each C1767 - Generator, neurostimulator (implantable), nonrechargeable E0745 - Neuromuscular stimulator, electronic shock unit L8679 - Implantable neurostimulator, pulse generator, any type L8681 - Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only L8682 - Implantable neurostimulator radiofrequency receiver L8683 - Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver L8684 - Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement L8689 - External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 6 of 10 ICD-10 Codes N31.0 - N31.9 - Bladder atony N39.4 – N39.498 – Other specified urinary incontinence N36.44 - Muscular disorders of urethraN39.4 – N39.498 – Other specified urinary incontinence N36.44 - Muscular disorders of urethra N39.3 - Stress incontinence (female) (male) N39.41 - Urge incontinence N39.46 - Mixed incontinence R15.x - Incontinence of feces R30.1 - Vesical tenesmus R32 - Unspecified urinary incontinence R33.0 - R33.9 - Urinary retention R35.0 - Frequency of micturition R39.11 - Hesitancy of micturition R39.14 - Feeling of incomplete bladder emptying R39.2 - Extrarenal uremia R39.81 - Functional urinary incontinence R39.89 - Other symptoms and signs involving the genitourinary system R39.9 - Unspecified symptoms and signs involving the genitourinary system

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 7 of 10 POLICY HISTORY: Status Date Action New 12/6/2010 New policy Reviewed 12/6/2011 Reviewed. Reviewed 11/15/2012 Reviewed. Reviewed 11/14/2013 ICD10 codes added. Reviewed 09/25/2014 Updated LCD information and SNS and PTNS criteria accordingly Reviewed 10/22/2015 New LCD. Coverage for fecal incontinence added. Reviewed 12/02/2015 Reviewed with pelvic surgery team and made mild modifications. Reviewed 10/27/2016 Minor format changes Reviewed 09/19/2017 Policy language clarification Reviewed 03/13/2017 Corrected indications to include retention. Updated 10/01/2018 Added one HCPCS code C1767 Reviewed 06/27/2019 No significant changes Updated 05/28/2020 Transitioned to IQ and aligned for FirstCare and SWHP Reviewed 05/27/2021 No major change. Codes updated Reviewed 04/21/2022 No changes Reviewed 04/27/2023 No changes Reviewed 04/08/2024 Formatting changes, added hyperlinks to NCD and TMPPM, beginning and Reviewed 03/10/2025 Ending note section updated to align with business entity changes. Updated 08/11/2025 Removed “Medicare NCD or LCD specific InterQual criteria may be used Reviewed 03/26/2026 Minor reformatting changes; Specified Baylor Scott & White Health Plan where BSWHP is first written; replaced Transurethral RF with Transurethral Radiofrequency; added trademark to Renessa® System; removed “not medically necessary” from the Renessa system; removed the word percutaneous from PTNS; Added criteria for sacral nerve stimulator for fecal incontinence; Added references REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

  1. Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: Scientific review. JAMA. 2004;291(8):986995.
  2. Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD001308.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 8 of 10

  1. Glazener CMA, Cooper K. Bladder neck needle suspension for urinary incontinence in women. Cochrane Database Syst Rev. 2004;(2):CD003636.
  2. Hay-Smith EJC, Bø K, Berghmans LCM, et al. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2007 Jul 18; (1):CD001407 (available at https://www.ncbi.nlm.nih.gov/pubmed/17636671. Accessed on 9/12/2017).
  3. Thomas LH, Cross S, Barrett J, et al. Treatment of urinary incontinence after stroke in adults. Cochrane Database Syst Rev. 2008;(1):CD004462.
  4. Hunter KF, Moore KN, Glazener CMA, et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007;(2):CD001843.
  5. Onwude J. Stress incontinence. In: BMJ Clinical Evidence. London, UK: BMJ Publishing Group; December 2006.
  6. Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801.
  7. Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802.
  8. Cody JD, Richardson K, Moehrer B, et al. Oestrogen therapy for urinary incontinence in post-menopausal women. Cochrane Database Syst Rev. 2009;(4):CD001405..Page 5 of 7
  9. Glazener CMA, Cooper K. Anterior vaginal repair for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001755.
  10. Eustice S, Roe B, Paterson J. Prompted voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2000;(2):CD002113.
  11. Hay-Smith EJC, Dumoulin C. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2006;(1):CD005654.
  12. National Institute for health and Clinical Excellence (NICE). The care and treatment of women aged 18 years and older with urinary incontinence (stress, urgency or mixed urinary incontinence or overactive bladder).
  13. Clinical guideline [CG171]. London, UK: NICE; 2015. (Available at https://www.nice.org.uk/guidance/cg171. Accessed on 9/13/2017).
  14. Hay-Smith EJC, Bø K, Berghmans LCM, et al. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2006;(1):CD001407.
  15. Hunter K, Glazener C, Moore K. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007;(2):CD001843.
  16. Macdonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: A systematic review of effectiveness. BJU Int. 2007;100(1):76-81.
  17. Walsh, J. Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder, MEDSCAPE, available at http://www.medscape.com/viewarticle/773418_2. (Accessed on 9/12/2017).
  18. Lukacz, E, Treatment of urinary incontinence in women. Up-To-Date available at https://www.uptodate.com/contents/treatment-of-urinary-incontinence-in-women. (accessed on 9/12/2017)
  19. Dumoulin C, Hay-Smith EC, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment for urinary incontinence in women. Cochrane Database Syst Rev. 5/14/2014. Available at http://www.cochrane.org/CD005654/INCONT_pelvic-floor-muscle-training-versus-no-treatment-for-urinary- incontinence-in-women. (Accessed on 9/13/2017).
  20. http://www.webmd.com/urinary-incontinence-oab/news/20150515/botox-overactive-bladder#1 accessed pm 9/18/2017. InterStim Continence Control Therapy/Sacral Nerve Stimulation
  21. Burrows E, Harris A, Gospodarevskaya E. Sacral nerve stimulation for refractory urinary urge incontinence or urinary retention. MSAC Application 1009. Canberra, ACT: Medicare Services Advisory Committee (MSAC); 2000.
  22. Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev. 2009;(2):CD004202.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 9 of 10

  1. National Institute for Clinical Excellence (NICE). Sacral nerve stimulation for urge incontinence and urgency- frequency. Interventional Procedure Guidance 64. London, UK: NICE; June 2004.
  2. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. Health Technology Literature Review. Toronto, ON: MAS; 2005. Solesta References
  3. Bernstein MA, Purdy CH, Becker A, Magar R. Three-year cost-effectiveness model for non-animal stabilized hyaluronic acid and dextranomer copolymer compared with sacral nerve stimulation after conservative therapy for the management of fecal incontinence. Clin Ther. 2014;36(6):890-905. Available at: http://www.clinicaltherapeutics.com/article/S0149-2918(14)00208-2/pdf. Accessed October 15, 2014.
  4. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network. MLN Matters. MLN Matters® Number: MM8228. April 2013 Update of the Hospital Outpatient Prospective Payment System (OPPS). March 1,
  5. Available at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/ MM8228.pdf. Accessed September 17, 2017.
  6. Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009;52(6):1101-1106.
  7. 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;17(4):389-395.
  8. 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. 2013;48(3):302-310.
  9. Dodi G, Jongen J, de la Portilla F, Raval M, Altomare DF, Lehur PA. An open-label, noncomparative, multicenter study to evaluate efficacy and safety of NASHA/Dx gel as a bulking agent for the treatment of fecal incontinence. Gastroenterol Res Pract. 2010;2010:467136. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3017894. Accessed September 17, 2017.
  10. Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;377(9770):997-1003.
  11. Hoy SM. Dextranomer in stabilized sodium hyaluronate (Solesta®): in adults with faecal incontinence. Drugs. 2012;72(12):1671-1678. Fecal Incontinence References
  12. Leroi AM, Lenne X, Dervaux B, et al. Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence. Ann Surg. 2011;253(4):720-732.
  13. Leroi AM, Parc Y, Lehur PA, et al. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005;242(5):662-669. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1409867. Accessed September 17, 2017.
  14. Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011;98(1):140-147.
  15. Medtronic Inc. InterStim® Therapy: InterStim® Model 3023 Neurostimulator, InterStim® II Model 3058 Neurostimulator [implant manual]. 2006. Available at: http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/sns-is3058-23- impmanl.pdf. Accessed September 17, 2017.

MEDICAL COVERAGE POLICY SERVICE: Incontinence Treatment Policy Number: 052 Effective Date: 05/01/2026 Last Review: 03/26/2026 Next Review: 03/26/2027 Page 10 of 10

  1. Medtronic Inc. Indications, Safety, and Warnings. Revised April 2009. Available at: http://professional.medtronic.com/pt/uro/snm/ind/index.htm. Accessed September 17,
  2. Mellgren A, Wexner SD, Coller JA, et al.; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011;54(9):1065-1075.
  3. Michelsen HB, Krogh K, Buntzen S, Laurberg S. A prospective, randomized study: switch off the sacral nerve stimulator during the night? Dis Colon Rectum. 2008;51(5):538-540.
  4. Michelsen HB, Thompson-Fawcett M, Lundby L, Krogh K, Laurberg S, Buntzen S. Six years of experience with sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2010;53(4):414-421.
  5. Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502.
  6. Wald, Arnold MD, MACG1; Bharucha, Adil E. MBBS, MD2; Limketkai, Berkeley MD, PhD, FACG3; Malcolm, Allison MBBS, FRACP4; Remes-Troche, Jose M. MD, MsC5; Whitehead, William E. PhD6; Zutshi, Massarat MD7,8. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. The American Journal of Gastroenterology 116(10):p 1987-2008, October 2021. | DOI: 10.14309/ajg.0000000000001507
  7. 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. 2017 Dec;15(12):1844-1854. doi: 10.1016/j.cgh.2017.08.023. Epub 2017 Aug 22. PMID: 28838787; PMCID: PMC5693715.
  8. Bordeianou, Liliana G. M.D., M.P.H.1; Thorsen, Amy J. M.D.2; Keller, Deborah S. M.S., M.D.3; Hawkins, Alexander T. M.D., M.P.H.4; Messick, Craig M.D.5; Oliveira, Lucia M.D., Ph.D.6; Feingold, Daniel L. M.D.7; Lightner, Amy L. M.D.8; Paquette, Ian M. M.D.9. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. Diseases of the Colon & Rectum 66(5):p 647-661, May 2023. | DOI: 10.1097/DCR.0000000000002776 Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan. RightCare STAR Medicaid is offered through Scott and White Health Plan in the Central Texas Medicaid Rural Service Area (MRSA); FirstCare STAR is offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs;and FirstCare, CHIP is offered through FirstCare in the Lubbock Service Area.
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