Medical Policy: 02.01.27
Original Effective Date: November 1995
Reviewed: July 2015
Revised: July 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Urinary incontinence is defined as the involuntary loss of urine, or the inability to hold urine. It is a common condition affecting both men and women. There are several types, such as stress and urge incontinence, detrusor instability, etc. Many women experience this after childbirth and with increasing age due to muscle weakness. Many men experience this along with prostate problems. There are various treatment options available, such as conservative, surgical procedures and supportive devices. Examples of these various treatment options are listed below;
- Conservative: Includes medical treatment, pelvic floor rehabilitation, Kegel exercises and chronic catheterization. The American Urogynecologic Society recommends a minimum of three months conservative treatment.
- Surgical Procedures: Include, but are not limited to, periurethral bulking agents, augmentation cystoplasty, bladder denervation or detrusor myomectomy, enterocystoplasty, bladder diversion, artificial urinary sphincter and cystectomy. These may not be considered first line treatments for most patients and other conservative measures may be considered first.
- Other measures and supportive devices for the management of urinary incontinence: Include intermittent catheterization, indwelling urethral catheterization, suprapubic catheters, external collection systems, urethral insert devices, penile compression device, pelvic organ support devices, sling systems (MiniArcTM ) and absorbant garments.
- Pelvic Floor Stimulation (PFS): It involves the electrical stimulation of the pelvic floor muscles using a probe wired to a device controlling the electrical stimulation, or more recently, extracorporeal pulsed magnetic innervation. It is believed that electric or magnetic stimulation leads to PFS, which in turn stimulates the pudendal nerve to improve urethral closure by activating the pelvic musculature by enhancing the process of re-innervation. PFS is an off-label use for electrical stimulation devices.
- Posterior tibial nerve stimulation (PTNS) The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low voltage (10mA, 1-10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes.
Artificial Urinary Sphincter
The artificial urinary sphincter (AUS) is an externally controlled urethral occlusion device. The transfer of fluid within the device is controlled by a pressure-regulating balloon placed extraperitoneally in the individual's pelvis or abdominal cavity and a control pump placed in a subcutaneous pocket in the scrotum. Squeezing of the pump allows fluid within the closed-loop system to be transferred from the cuff to the balloon. It takes a few minutes before the cuff re-inflates automatically to the preset level, allowing the urethra to remain open for voiding. The valve then automatically re-tightens several minutes later which closes the urethra, thereby enabling control of urine flow and continence to be achieved.
The artificial urinary sphincter (AUS) is the gold standard of treatment for male urinary incontinence following prostate surgery. It has withstood the test of time, being unsurpassed by any other device for decades. The AUS is particularly effective for the more severe type of male urinary incontinence, where circumferential compression of the urethra is required.
The following urinary incontinence treatments and devices may be considered medically necessary when the following conditions have been met:
- Periurethral bulking agents using cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane marketed under the trade names Durasphere®, Coaptite®, and Macroplastique® respectively, may be considered medically necessary when the following criteria have been met:
- The patient has been diagnosed with stress incontinence due to intrinsic sphincter weakness, or due to post traumatic or surgical injury, AND
- The patient has shown no improvement from conservative measures.
- If collagen implant (Contigen) is used, a skin test is performed about a month prior to the implant to ensure that no hypersensitivity exists
- The only FDA approved product for the use in men is Contigen
Up to five injection treatments may be considered medically necessary, beyond that, the patient would be considered a treatment failure and further treatment would be considered not medically necessary.
- Artificial Urinary Sphincter
Implantation of an artificial urinary sphincter device is considered medically necessary in male adults following prostate surgery to treat urinary incontinence due to reduced outlet resistance (Intrinsic Sphincter Deficiency [ISD]) when the symptoms of incontinence have been refractory to at least 6 months of conservative medical treatment.
Artificial urinary sphincter implantation is not considered first-line treatment of refractory incontinence in male adults following prostate surgery. Examples of first-line conservative medical treatment may include one or more of the following: behavioral therapy, pharmacologic treatments, and intermittent self-catheterization.
- Implantation of an artificial urinary sphincter device is considered not medically necessary for all other indications including, but not limited to:
Treatment of intrinsic sphincter deficiency in women and children whose incontinence has been refractory to conservative medical treatment or other surgical treatments; and
Treatment of intrinsic sphincter deficiency in men who have not undergone prostate surgery.
Subureteric injection of dextranomer/hyaluronic acid copolymer (Deflux) Deflux® is a gel-like liquid containing complex sugars, packaged in a syringe. It is used to treat children who have vesicoureteral reflux, an abnormal condition in which urine flows backwards from the bladder to the kidneys.
- Indications include treatment of children with vesicoureteral reflux (VUR) grades II-IV. All other indications are considered investigational.
The following treatments and devices are considered investigational for the treatment of urinary incontinence/urinary dysfunction;
- Biofeedback is considered investigational, since there is no evidence that this is more effective than pelvic muscle exercises, i.e. Kegel exercises.
- Vaginal weight training with specially designed weights (cones) is considered investigational.
- Pelvic floor stimulation by any method, electrical or magnetic, is considered investigational.
- Periurethral bulking agents other than those listed in the policy section above, including, but not limited to, Teflon®, autologous ear chondrocytes and autologous fat tissue are all considered investigational.
- Transvaginal and transurethral radiofrequency energy therapies for bladder neck suspension, including, but not limited to, the Renessa® System, and the SURx Radiofrequency Bladder Neck Suspension System are all considered investigational.
Posterior tibial nerve stimulation is considered investigational for all indications, including but not limited to: urinary frequency, urgency, incontinence, and retention in the treatment of urinary dysfunction.
The Neocontrol system, which uses extracorporeal magnetic innervation (ExMI) is considered investigational because its effectiveness has not been established.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- HCPCS L8603 Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies
- HCPCS L8604 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies
- HCPCS L8606 Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies
- HCPCS E0740 Incontinence treatment system, pelvic floor stimulator, monitor, sensor, and/or trainer
- HCPCS E0746 Electromyography (EMG), biofeedback device
- CPT 51715 Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
- CPT 53445 Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff
- CPT 53446 Removal of inflatable urethral/bladder neck sphincter, including pump, reservoir, and cuff
- CPT 53447 Removal and replacement of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff at the same operative session
- CPT 53449 Repair of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff
- CPT 53860 Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
- CPT 64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
- CPT 90911 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry
- CPT 97039 Unlisted modality (specify type and time if constant attendance)
- CPT 53899 Unlisted procedure, urinary system (specifically for ExMi)
- HCPCS C1815 Prosthesis, urinary sphincter (implantable)
- Galloway. N, El-Galley R, Appell R et al. Extracorporeal Magnetic Innervation Therapy for Stress Urinary Incontinence. Urology 1999;53:1108-11
- Bo K, Talseth T. Change in Urethral Pressure During Voluntary Pelvic Floor Muscle Contraction and Vaginal Electrical Stimulation. International Urogynecology Journal and Pelvic floor dysfunction 1997; 8:3-7.
- Choe JM, Staskin DDR, Clinical usefulness of urinary control urethral insert devices International Urogynecology Journal and Pelvic floor dysfunction 1997; 8:307-313.
- Gallo ML, Hancock R, Davila W. Clinical experience with a balloon-tipped urethral insert for stress urinary incontinence. Journal of Wound, Ostomy and Continence Nurses Society 1997:24:51-57.
- TEC policy 7.01.19 Periurethral bulking agents for the treatment of urinary incontinence.
- Dmochowski RR. Radiofrequency bladder neck suspension for the treatment of genuine stress urinary incontinence. Curr Urol Rep. 2002 Oct;3(5):378-81. Review.
- Ross JW, Galen DI, et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):493-9.
- ECRI. Implantable Sacral Nerve Stimulator for Urinary Dysfunction. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 August 17. 8p. (ECRI Hotline Response).
- ECRI. Injectable Urethral Bulking Agents for the Treatment of Urinary Stress Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 September 22. 11p. (ECRI Hotline Response).
- ECRI. Sling Systems for Female Urinary Stress Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 October 25. 13p. (ECRI Hotline Response).
- ECRI. Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for Female Stress Urinary Incontinence. Plymouth Meeting (PA):ECRI Health Technology Information Service; 2007 August 10. 6p. (ECRI Hotline Response).
- Elser, DM, Mitchell, GK, Miklos, JR, Nickell, KG, Cline, K, Winkler, H, and Wells, WG. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol. 2009;16(1):56-62.
- Davila, GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol. 2011;2011:176498.
- Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010 Nov;29(8):1424-8.
- ECRI Health Technology Information Service. Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for Female Stress Urinary Incontinence. Plymouth Meeting (PA). 2010 Aug 24. (ECRI Hotline Service)
- Lucas MG, Bosch RJ, Burkhard FC, et al. EAU Guidelines on Surgical Treatment of Urinary Incontinence. Eur Urol. 2012 Sep 17. [Epub ahead of print]
- Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinece in Adult Women: Diagnosis and Comparative Effectiveness. Pub. No. 11(12)-EHC074-EF. Rockville (MD): Agency for Healthcare Research and Quality (US). Comparative Effectiveness Review; April 2012.
- National Institute for Health and Clinical Excellence (NICE). Urinary incontinence in neurological disease. Clinical guideline 148; August 2012.
- Ghoniem GM & Miller CJ. A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence. Int Urogynecol J. 2012 Jun 15. [Epub ahead of print]
- Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2012 Jul;23(7):831-41.
- Monga AK, Tracey MR, Subbaroyan J. A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction. Int Urogynecol J. 2012 Aug;23(8):993-1005.
- Greer JA, Smith AL, Arya LA. Pelvic floor muscle training for urgency urinary incontinence in women: a systematic review. Int Urogynecol J. 2012 Jun;23(6):687-97.
Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. 2012 May. 36 p.
Agency for Healthcare Research and Quality (AHRQ). Nonsurgical Treatments for Urinary Incontinece in Adult Women: Diagnosis and Comparative Effectiveness. Pub. No. 11(12)-EHC074-EF. Prepared by Minnesota Evidence-based Practice Center, Minneapolis MN; April 2012.
ECRI. Posterior Tibial Nerve Stimulation for Treating Urge Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service; 3/20/12.[Hotling Response].
Deflux-product insert, Oceana Therapeutics. Accessed 9/16/13.
Committee on Gynecologic Practice, guideline recommendation Nuber 603. June 2014.
U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). 510(k) Summary of Safety and Effectiveness. AMS Sphincter 800™ Urinary Prosthesis. No. P000053. Rockville, MD: FDA. June 14, 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P000053.
Petero VG Jr, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. J Urol. 2006; 175(2):605-609.
Islah M, Cho SY, Son H. The current role of the artificial urinary sphincter in male and female urinary incontinence. World J Mens Health. 2013; 31(1):21-30. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3640149/.
O'Connor RC, Nanigian DK, Patel BN, et al. Artificial urinary sphincter placement in elderly men. Urology. 2007 Jan; 69(1): 126-8.
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
October 2012 Annual review Policy renewed
September 2013 Annual review Policy renewed
May 2014 Policy review Policy revised
August 2014 Annual review Policy revised
July 2015 Annual review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.