Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Urinary incontinence (leaking of urine) is a distressing problem for which a large number of treatments have been developed. Many treatments for this problem are covered.

2)    Some specific treatments require preauthorization such as:

a)    Periurethral Injections of Bulking Agents;

b)    Artificial Urinary Sphincter (AUS);

c)    Sacral Nerve Stimulation (InterStim device);

d)    Percutaneous Tibial Nerve Stimulation (PTNS);

e)    Tension-Free Vaginal Tape Procedures;

f)     Colposuspension and Sling Procedures.

3)    Several medications are covered. Please refer to your formulary for verification of their status. If there are questions regarding covered supplies, please consult your plan documents.

4)    For use of Botox (botulinum toxin) for incontinence, see BI079.

5)    Some treatments are not covered, such as:

a)    The Neocontrol System;

b)    Kegelmaster;

c)    Electrical Stimulation of the bladder;

d)    Permanent adjustable balloon continence devices.

e)    Temporary intraurethral valve-pumps

6)    Diapers, Depends, Chux, and other convenience items are not covered. 

Medications

For medications covered under the pharmacy benefit for urinary incontinence, please refer to the MagellanRx formulary on the QualChoice website. Treatments

QualChoice covers the following treatments for urinary incontinence when the clinical indications for the treatment are met.

The following treatments require pre-authorization:

1)    Artificial Urinary Sphincter (AUS) 

a)    Appropriate candidates must have adequate motivation and sufficient manual dexterity to operate the device, AND

b)    One of the following applies:

                                      i.  There has been no improvement in urinary incontinence in a post-prostatectomy (at least 6 months or more post-op) patient despite behavioral and pharmacological therapies; OR

                                    ii.  Failed bladder neck reconstruction in patients with epispadias–exstrophy; OR

                                   iii.  Women with intractable urinary incontinence who have failed behavioral, pharmacological, and other surgical treatments; OR

                                   iv.  Children with true intractable urinary incontinence who have failed treatment with behavioral or pharmacological therapies and who are not candidates for other surgical correction of urinary incontinence.

2)    Periurethral Injections of Bulking Agents (Injection of agents such as collagen and Durasphere)

a)    When the clinical situation meets the following criteria:

                                      i.  There has been no improvement in urinary incontinence for at least six (6) months of Kegel exercises, biofeedback, electrical stimulation, and/or pharmacotherapies; AND

                                    ii.  The patient does not have an unstable or noncompliant bladder; AND

                                   iii.  The patient does not have acute cystitis, urethritis, or infection; AND

                                   iv.  A pre-treatment skin test for the bulking agent shows no evidence of local hypersensitivity.

b)    LIMITS: An initial three (3) treatments will be authorized. If there is no improvement after three sessions no additional treatments will be authorized. Patients whose incontinence does not improve after three therapies are considered treatment failures and are not likely to respond to this therapy. A total of five (5) treatments may be authorized per lifetime when clinical information is provided indicating an improvement.

Treatment with Macroplastique is not covered. Its effectiveness has not been established.

3)    Sacral Nerve Stimulation

a)    For the treatment of urge urinary or symptoms of urge frequency when ALL the following are met (Hayes B):

                                      i.  The prescribing physician is experienced in the diagnosis and treatment of lower urinary tract disorders and trained in the InterStim Continence Control System (to comply with FDA requirements); AND

                                    ii.  The patient has experienced urge incontinence for at least twelve (12) months; AND

                                   iii.  The condition has resulted in significant disability (e.g., the frequency and/or severity of leakages is limiting the patient’s ability to work or participate in activities outside of the home);

                                   iv.  The patient has failed to improve with behavioral treatments (e.g., pelvic floor exercise, biofeedback, timed voids, fluid management, and avoiding caffeine, carbonated beverages, alcohol, and smoking). This is considered first-line treatment in the American Urologic Association (AUA) guideline for treatment of non-neurogenic overactive bladder (OAB). The AUA guideline recommends offering this treatment. An adequate trial of each step in the guideline is required when a third-line procedural intervention like InterStim is being requested. To meet this criteria, there needs to have been at least a three month trial of a behavioral intervention without success; AND

                                    v.  The patient has failed therapy with at least two (2) different muscarinic antagonist drugs (unless there is a clinical contraindication).  If intolerable side effects are experienced with one muscarinic antagonist it is appropriate to try a different muscarinic antagonist. There are a variety of different anti-muscarinic agents with very different metabolic pathways, pharmacokinetics, and side effect profiles.  It is often possible to respond well to a different anti-muscarinic despite not tolerating another agent in the same broad medication class. This approach is recommended as a second-line treatment in the AUA guideline for OAB; AND

                                   vi.  The patient has also failed therapy with mirabegron, a beta-3 adrenergic agonist. This is also considered a second-line treatment per the AUA guideline for OAB; AND

                                  vii.  A test stimulation of the device (which must be pre-authorized) has provided at least a 50% decrease in incontinence symptoms. 

b)    LIMITS: According to product labeling, InterStim is contraindicated and not covered:

                                      i.  For patients who have not demonstrated an appropriate response to test stimulation, OR

                                    ii.  For patients who are unable to operate the Neurostimulator.

c)    InterStim is also covered for the treatment of non-obstructive urinary retention when ALL of the following are met (Hayes B):

                                      i.  The prescribing physician is experienced in the diagnosis and treatment of lower urinary tract disorders and trained in the InterStim Continence Control System (to comply with FDA requirements); AND

                                    ii.  The patient has experienced urinary retention for at least twelve (12) months; AND

                                   iii.  The condition has resulted in significant disability; AND

                                   iv.  Patient has failed or has been unable to tolerate other forms of therapy such as alpha blockers, anticholinergics, antibiotics for UTI, and intermittent catheterization; AND

                                    v.  A test stimulation of the device (which must also be pre-authorized) has provided at least a 50% decrease in the residual urine volume.

4)    Percutaneous Tibial Nerve Stimulation (Urgent PC Neuromodulation System, Uroplasty, Inc., Minneapolis, MN)

a)    For the treatment of members with non-neurogenic urinary voiding dysfunctions (e.g., overactive bladder/urge incontinence)

b)    The patient has experienced urge incontinence for at least twelve (12) months; AND

c)    The condition has resulted in significant disability (e.g., the frequency and/or severity of leakages is limiting the patient’s ability to work or participate in activities outside of the home); AND

d)    The patient has failed therapy with at least two (2) different anticholinergic drugs or a combination of an anticholinergic and a tricyclic antidepressant;

e)    Limits:

                                      i.  Programming is not associated with this procedure.

                                    ii.  In general, 12 treatments (once weekly) with PTNS are needed for symptom relief.  If the member fails to improve after 12 PTNS treatments, continued treatment is considered not medically necessary.

5)    Tension-Free Vaginal Tape Procedures or Colposuspension and Sling Procedures

a)  For persons with stress urinary incontinence that is refractory to conservative management.

The following treatments DO NOT require pre-authorization:

1)    Vaginal Cones: For the treatment of simple urinary incontinence when they are used in combination with a structured pelvic floor muscle exercise program.

2)    Pessary (Bladder Neck Support Prosthesis): A pessary (a plastic device that fits into the vagina to help support the uterus and bladder) for the treatment of stress and mixed urinary incontinence.

3)    Biofeedback: See Biofeedback policy (BI237).

Codes Used In This BI:

1)    The Neocontrol system: The Neocontrol system uses extracorporeal magnetic intervention (ExMI) for the treatment of urinary incontinence related to pelvic floor muscle weakness in women. Longer follow-up is needed to determine the durability of treatment results. It is considered Experimental/Investigational and is not covered.

2)    Kegelmaster:  The Kegelmaster and similar devices are not covered. They are considered exercise machines and do not meet the definition of covered DME.They are not covered.

3)    Electrical Stimulation of the Bladder: There is insufficient evidence to support a determination of effectiveness. Hayes D. This is considered Experimental/ Investigational and is not covered.

4)    Diapers, Depends and Chux: These items are considered convenience items and are not covered

5)    Radiofrequency Electrothermal Energy: Radiofrequency Electrothermal energy for the treatment of stress urinary incontinence experimental and investigational because its effectiveness for this indication has not been established.

6)    Permanent adjustable balloon continence devices: Transperineal implantation of permanent adjustable balloon continent devices is considered experimental/investigational and is not covered.

7)    Temporary female intraurethral valve-pump (voiding prosthesis).

Overactive Bladder (OAB)

1.    Mansfield, K. J. (2010). Muscarinic receptor antagonists, the overactive bladder, and efficacy against urinary urgency. Clinical Medicine Insights: Therapeutics, 2 471-480.

2.    Gromley, E A, et al. Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: AUA/SUFU Guideline 2014. Accessed at: https://www.auanet.org/guidelines/overactive-bladder-(oab)-(aua/sufu-guideline-2012-amended-2014)

 

Artificial Urinary Sphincter

1.    Agency for Healthcare Quality and Research. Urinary Incontinence in Adults. Clinical Practice Guideline, AHCPR Pub. No. 92-0038. Rockville, MD: AHRQ; March 1992.

2.    Kreder KJ, Webster GD. Evaluation and management of incontinence after implantation of the artificial urinary sphincter. Urol Clin North Am. 1991; 18(2):375-381.

3.    Leo ME, Barrett DM. Success of the narrow-backed cuff design of the AMS800 artificial urinary sphincter: Analysis of 144 patients. J Urol. 1993; 150:1412-1414.

4.    Singh G, Thomas DG. Artificial urinary sphincter for post-prostatectomy incontinence. Br J Urol. 1996; 77(2):248-251.

5.    Levesque PE, et al. Ten-year experience with artificial urinary sphincter in children. J Urol. 1996; 156:625-628.

6.    Fulford SC, et al. The fate of the `modern` artificial urinary sphincter with a follow-up of more than 10 years. Br J Urol. 1997; 79(5):713-716.

7.    Haab F, et al. Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of follow-up. J Urol. 1997; 158(2):435-439.

Periurethral Injections of Bulking Agents

1.    Eckford SD, Abrams P. Para-urethral collagen implantation for female stress incontinence. Br J Urol. 1991; 68:586-589.

2.    Kieswetter H, et al. Endoscopic implantation of collagen (GAX) for the treatment of urinary incontinence. Br J Urol. 1992; 69:22-25.

3.    Stricker P, Haylen B. Injectable collagen for type 3 female stress incontinence: The first 50 Australian patients. Med J Aust. 1993; 158(2):89-91.

4.    Winters JC, Appell R. Periurethral injection of collagen in the treatment of intrinsic sphincter deficiency in the female patient. Urol Clin North Am. 1995; 22(3):673-678.

5.    Herschorn S, et al. Follow up of intraurethral collagen for female stress urinary incontinence. J Urol. 1996; 156:1305-1309.

6.    Sanchez-Ortiz RF, et al. Collagen injection therapy for post-radical retro pubic prostatectomy incontinence: Role of Valsalva leak point pressure. J Urol. 1997; 158:2132-2136.

7.    Smith DN, et al. Collagen injection therapy for female intrinsic sphincter deficiency. J Urol. 1997; 157:1275-1278.

8.    McGuire EJ, English SF. Periurethral collagen injection for male and female sphincter incontinence: Indications, techniques, and results. World J Urol. 1997; 15(5):306-309.

9. Dmochowski RR, Appell RA. Injectable agents in the treatment of stress urinary incontinence in women: Where are we now? Urology. 200; 56(6 Suppl 1):32-40.

InterStim Continence Control Therapy/Sacral Nerve Stimulation

1.    Thon W, et al. Neuromodulation of voiding dysfunction and pelvic pain. World J Urol. 1991; 9:138-141.

2.    Dijkema H, et al. Neuromodulation of sacral nerve for incontinence and voiding dysfunction. Eur Urol. 1993; 24:72-77.

3.    Bosch J, Groen J. Sacral (S3) segmental nerve stimulation as a treatment for urge incontinence in patients with detrusor instability: Results of chronic electrical stimulation using an implantable neural prosthesis. J Urol. 1995; 154:504-507.

4.    Shaker HS, Hassouna M. Sacral nerve root neuromodulation: An effective treatment for refractory urge incontinence. J Urol. 1998; 159:1516-1519.

5.    Elabbady AA, et al. Neural stimulation for chronic voiding dysfunction. J Urol. 1994; 152:2076-2080.

6.    Janknegt RA, et al. improving neuromodulation techniques for refractory voiding dysfunctions: Two-stage implant. Urology. 1997; 49:358-362.

7.    Schmidt RA, et al. Sacral nerve stimulation for the treatment of refractory urinary urge incontinence. J Urol. 1999; 162(2); 352-357.

8.    Hayes: Implantable Sacral Nerve Stimulation for Urinary voiding Dysfunction; April 2003

9.    Dallosso, H.M., McGrother, C.W., Matthews, R.J., Donaldson, M.M.K., and the Leicestershire MRC Incontinence Study Group (2003), the association of diet and other lifestyle factors with overactive bladder and stress incontinence: a longitudinal study in women. BJU International, 92: 69–77.

10. Hashim, H., and Abrams, P. (2008), how should patients with an overactive bladder manipulate their fluid intake? BJU International, 102: 62–66.

11. Hampel C, et al. Definition of overactive bladder and epidemiology of urinary incontinence. Urology. 1997; 50(6)-Supplement 1: 4-14.

12. Bump, Richard C. et al. Cigarette smoking and urinary incontinence in women. AJOG, 1992 167(5):1213 - 1218

13. Tampakoudis P et al. Cigarette smoking and urinary incontinence in women—a calculative method of estimating the exposure to smoke. EJOG, 1995; 63:27-30

Percutaneous Tibial Nerve Stimulation

1.    Govier FE, Litwiller S, Nitti V, et al. Percutaneous afferent neuromodulation for the refractory overactive bladder: Results of a multicenter study. J Urol. 2001; 165(4):1193-1198.

2.    Hoebeke P, Renson C, Petillon L, et al. Percutaneous electrical nerve stimulation in children with therapy resistant non-neuropathic bladder sphincter dysfunction: A pilot study. J Urol. 2002; 168(6):2605-2607; discussion 2607-2608.

3.    Krivoborodov GG, Mazo EB, Shvarts PG. Afferent stimulation of the tibial nerve in patients with hyperactive bladder. Urologiia. 2002 ;( 5):36-39.

4.    Vandoninck V, van Balken MR, Finazzi Agro E, et al. Percutaneous tibial nerve stimulation in the treatment of overactive bladder: Urodynamic data. Neurourol Urodyn. 2003; 22(3):227-232.

5.    De Gennaro M, Capitanucci ML, Mastracci P, et al. Percutaneous tibial nerve neuromodulation is well tolerated in children and effective for treating refractory vesical dysfunction. J Urol. 2004; 171(5):1911-1913.

6.    Van der Pal F, van Balken MR, Heesakkers JP, et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int. 2006a; 97(1):113-116.

The Neocontrol™ System

1.    Galloway N, et al. Multi-center trial: Extracorporeal magnetic innervation (ExMI) for the treatment of stress urinary incontinence. Proceedings of the 1st International Continence Society Meeting, hosted by the World Health Organization, Monaco, June 1998.

Vaginal Cones

1.    Olah KS, et al. The conservative management of patients with symptoms of stress incontinence: A randomized, prospective study comparing weighed vaginal cones and interferential therapy. Am J Obstet Gynecol. 1990; 162:87-92?

2.    Agency for Healthcare Quality and Research. Urinary Incontinence in Adults. Clinical Practice Guideline. AHCPR Pub. No. 92-0038. Rockville, MD: AHRQ; March 1992:27.

3.    Kato K, Kondo A. Clinical value of vaginal cones for the management of female stress incontinence. Int Uro Gynecol J Pelvic Floor Dysfunct. 1997; 8(5):314-317.

4.    Fischer W, Linde A. Pelvic floor findings in urinary incontinence -- results of conditioning using vaginal cones. Acta Obstet Gynecol Scand. 1997; 76(5):455-460.

Peccaries

1.    Davila GW, Ostermann KV. The bladder neck support prosthesis: A non-surgical approach to stress incontinence in adult women. Am J Obstet Gynecol. 1994; 171(1):206-211.

2.    Kondo A, Yokoyama E, Koshiba K, et al. Bladder neck support prosthesis: A non-operative treatment for stress or mixed urinary incontinence. J Urol. 1997; 157(3):824-827.

3.    Davila GW, Neal D, Horbach N, et al. A bladder-neck support prosthesis for women with stress and mixed incontinence. Obstet Gynecol. 1999; 93(6):938-942.

4.    Bash KL. Review of vaginal peccaries. Obstet Gynecol Surv. 2000; 55(7):455-460.

5.    Viera AJ, Larkins-Pettigrew M. Practical use of the pessary. Am FAM Physician. 2000; 61(9):2719-2726, 2729.

6.    Mouritsen L. Effect of vaginal devices on bladder neck mobility in stress incontinent women. Acta Obstet Gynecol Scand. 2001; 80(5):428-431.

Tension-Free Vaginal Tape Procedure

1.    Ward KL, Hilton P; UK and Ireland TVT Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and Colposuspension for primary urodynamic stress incontinence: Two-year follow-up. Am J Obstet Gynecol. 2004; 190(2):324-331.

2.    Meschia M, Pifarotti P, Spennacchio M, et al. A randomized comparison of tension-free vaginal tape and endo-pelvic fascia plication in women with genital prolapse and occult stress urinary incontinence. Am J Obstet Gynecol. 2004; 190(3):609-613.

3.    DeTayrac R, Deffieux X, Droupy S, et al. A prospective randomized trial comparing tension-free vaginal tape and Tran’s obturator sub urethral tape for surgical treatment of stress urinary incontinence. Am J Obstet Gynecol. 2004; 190(3):602-608.

4.    Valpas A, Kivela A, Penttinen J, et al. Tension-free vaginal tape, and laparoscopic mesh Colposuspension for stress urinary incontinence. Obstet Gynecol. 2004; 104(1):42-49.

5.    Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch Colposuspension versus tension-free vaginal tape: A randomized trial. Obstet Gynecol. 2004; 104(6):1249-1258.

6.    Abdel-Fattah M, Barrington JW, Arunkalaivanan AS. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence: A prospective randomized three-year follow-up study. Eur Urol. 2004; 46(5):629-635.

7.    Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol. 2004; 104(6):1259-1262.

8.    Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004; 104(3):607-620.

9.    Cody J, Wyness L, Wallace S, et al. Systematic review of the clinical effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence. Health Technol Assess. 2003; 7(21):1-202.

Colposuspension and Sling Procedures

1.    Moehrer B, Ellis G, Carey M, Wilson PD. Laparoscopic Colposuspension for urinary incontinence in women. Cochrane Database Syst Rev. 2000 ;( 3):CD002239.

2.    Lapitan MC, Cody DJ, Grant AM. Open retro pubic Colposuspension for urinary incontinence in women. Cochrane Database Syst Rev. 2005 ;( 3):CD002912.

3.    Bezerra CA, Bruschini H, Cody DJ. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2005 ;( 3):CD001754.