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Medical Policy: 02.01.27
Original Effective Date: November 1995
Reviewed: October 2011
Revised: September 2009
Benefit Application
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.
Description:
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.
- 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 ( FemSoft®), 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.
- Sacral Nerve Stimulation (SNS): It involves electrical stimulation of the sacral nerve via a totally implantable system.
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Prior Approval:
Not applicable
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Policy:
The following urinary incontinence treatments and devices may be considered medically necessary when the following conditions have been met:
- Sacral nerve stimulation may be considered medically necessary when the following criteria are met;
- A diagnosis of urge incontinence, urgency-frequency, or non-obstructive urinary retention, AND
- Incontinence is not due to neurologic condition, AND
- Previous behavioral and pharmacological therapy has been unsuccessful, AND
- A successful peripheral nerve evaluation test has been done to determine candidacy for a permanent implantation.
- Periurethral bulking agents using cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane marketed under the trade names Contigen®, 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
- If collagen implants are used, a skin test is performed about a month prior to the implant to ensure that no hypersensitivity exists, AND
- The patient has shown no improvement from at least 12 months of conservative measures such as behavioral or pharmacological treatments.
- 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.
- The patient who has a reoccurrence of incontinence following a successful treatment series (i.e. 6-12 months previously) series may benefit from additional treatments.
- Urethral Insert Device: FemSoft® , a self-inserted intra-urethral product may be considered medically necessary for the diagnosis of stress incontinence when the device is prescribed by a physician.
- Surgical Treatments: Procedures such as bladder diversion, bladder neck suspension, including tension free vaginal tape procedure, artificial sphincter, and cystectomy may be considered medically necessary for patients who fail to respond to conservative treatments.
The following treatments and devices are considered investigational for the treatment of urinary incontinence;
- Computerized or electric biofeedback is considered investigational, since there is no evidence that this method 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
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Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- Sacral Nerve Stimulation for the treatment of urge incontinence, to report a peripheral nerve stimulation test to determine candidacy for the permanent implant;
- 64561, percutaneous implantation of neurostimulator electrodes; sacral nerve (transforaminal placement)
- For patients with a positive result of the peripheral nerve stimulation test who undergo permanent implantation of the electrode and pulse generator, use the following codes:
- 64581, incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal approach)
- 64585, revision and removal of peripheral neurostimulator electrodes
- 64590, incision and subcutaneous placement of peripheral neurostimulator pulse generator or receiver
- 64595, revision or removal of peripheral neurostimulator pulse generator or receiver
- 95970, electronic analysis of implanted neurostimulator pulse generator system simple or complex neurostimulator pulse generator without programming
- 95971, With programming
- Collagen Implant: The following codes may be used to report the collagen implant for urinary incontinence;
- Q3031, for collagen skin test
- 51715, for endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder
- L8603, injectable bulking agent, collagen implant, urinary tract, per 2.5 ml syringe, including shipping supplies and necessary supplies
- L8606, injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies
- Pelvic Floor Stimulation is considered investigational.
- 97014, Physical medicine and rehabilitation; electric stimulation, unattended
- 97032, electric stimulation, attended
- 97039, may be used to describe pelvic floor stimulation by magnetic chair.
- E0740, incontinence treatment system, pelvic floor stimulator
- Biofeedback as a treatment of urinary incontinence is considered investigational
- 90911, biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and /or manometry
- E0746, EMG biofeedback device will be denied for all diagnosis codes.
- Periurethral Teflon® injection: CPT codes 11950-11954
- FemSoft®: No specific HCPCS code is available, to report this service use HCPCS code A4335, incontinence supply, miscellaneous.
- 57287 Removal or revision of sling for stress incontinence (eg, fascia or synthetic)
- 57288 Sling operation for stress incontinence (eg, fascia or synthetic)
- 0193T Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
- 53860 Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
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Selected References:
- 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) Also available: http://www.ecri.org.
- 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) Also available: http://www.ecri.org.
- ECRI. Sling Systems for Female Urinary Stress Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 October 25. 13p. (ECRI Hotline Response) Also available: http://www.ecri.org.
- 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) Also available: http://www.ecri.org.
- 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. Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for Female Stress Urinary Incontinence. Plymouth Meeting (PA):ECRI Health Technology Information Service;2010 Aug 24. (ECRI Hotline Service) Also available: http://www.ecri.org.
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Policy History:
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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