Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Pelvic Floor Stimulation as a Treatment of Incontinence

Policy #:07.12.01e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

NON-IMPLANTABLE PELVIC FLOOR ELECTRICAL STIMULATION

Pelvic floor electrical stimulation with a non-implantable stimulator is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

MAGNETIC PELVIC FLOOR STIMULATION

Magnetic pelvic floor stimulation is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to, records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS

Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY

Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES

The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, magnetic pelvic floor stimulation for incontinence is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA)

The NeoControl® Pelvic Floor Therapy System (formerly known as the Netonus Model 1000 Magnetic Stimulator) was approved by the FDA in June 2000 for the treatment of urinary incontinence in women.

The MyoTrac Infiniti non-implantable electrical stimulator was cleared for marketing by the FDA in March 2006 for the treatment of urinary incontinence.

The itouch Sure Pelvic Floor Exerciser (marketed as EmbaGYN® in the U.S.) non-implantable electrical stimulator was cleared for marketing by the FDA in April 2011 for the treatment of urinary incontinence in women.

The InTone® MV non-implantable electrical stimulator was cleared for marketing by the FDA in February 2012 for urinary and fecal incontinence.

Description

Pelvic floor stimulation has been proposed as a nonsurgical treatment option for the treatment of urinary and fecal incontinence. This approach involves either non-implantable electrical stimulation (NIES) of the pelvic floor musculature or extracorporeal magnetic pelvic floor stimulation (MPFS). The intent of these interventions is to stimulate the pudendal nerve to activate the pelvic floor musculature, which may lead to improved urethral closure. It is also believed that through the process of reinnervation, pelvic floor stimulation may improve partially denervated urethral and pelvic floor muscles.

NON-IMPLANTABLE ELECTRICAL STIMULATION (NIES)

Depending on the etiology of incontinence (i.e., detrusor instability, stress incontinence), NIES utilizes variations in electrical pulse amplitude and frequency to mimic and stimulate different physiologic mechanisms of the voiding response. Methods of NIES have been varied in location (e.g., vaginal, rectal), stimulus frequency, intensity, or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. Initial training occurs in a physician's office, followed by home treatment with a rented or purchased pelvic floor stimulator. There are currently several FDA-approved NIES devices for the treatment of urinary and/or fecal incontinence.

PEER-REVIEWED LITERATURE
Urinary Incontinence

In a prospective randomized controlled trial, Goode et al. (2003) evaluated the potential for NIES to improve the effectiveness of behavioral training for women with stress incontinence. Two hundred women with primary stress incontinence were scheduled to undergo either 8 weeks of behavioral training, behavioral training and home pelvic floor stimulation, or self-administered behavioral training alone using a self-help booklet. The primary outcome measurements included self-reported bladder diaries and changes in quality of life (QOL). Though individuals in all groups reported statistically significant improvements in incontinence, there was no statistically significant difference between the treatment groups. The authors concluded that treatment with NIES did not increase the effectiveness of a comprehensive behavioral program for women with stress incontinence.

In a single-blind, randomized comparative study, Wang et al. (2004) evaluated the safety and effectiveness of NIES (n=35) when compared to either pelvic floor muscle training (n=34) or biofeedback-assisted pelvic floor muscle training (n=34) in the management of overactive bladder (OAB). Biofeedback consisted of an intravaginal electromyographic probe, while an intravaginal electrode provided electrical stimulation. Individuals were followed during the 12-week treatment period. Outcome measurements included self-reported voiding diaries, QOL, and urodynamic measures. Both biofeedback and electrical stimulation groups reported an increased incidence of symptom resolution, though the authors did not describe how these outcomes were assessed. Improvement in overall QOL scores was significantly better in the NIES group when compared to the pelvic floor muscle training group. There were no statistically significant differences in voiding diary scores. The authors concluded that NIES had the greatest reduction rate of OAB. The study is limited in its heterogeneous design and lack of long-term follow-up.

In a randomized controlled trial, Castro et al. (2008) compared the effectiveness of NIES to pelvic floor exercises, vaginal cones, and no active treatment in women with urodynamic stress urinary incontinence. All of the active interventions consisted of 3 sessions per week under the supervision of a trained physical therapist. A total of 116 women were randomized and treated for 6 months, at which time they were assessed for reductions in stress urinary episodes and QOL. A statistically significant reduction in the number of stress urinary episodes and a significant improvement in QOL were found for individuals who used the active treatments when compared to no active treatment. However, no statistically significant difference was found between groups in urodynamic parameters. The authors concluded that active treatment was more effective than no active treatment in women with urinary stress incontinence. The study is limited in its loss to follow-up (14%) and heterogeneous treatment design.

In a Cochrane systematic review, Berghmans et al. (2013) evaluated the safety and effectiveness of NIES for the treatment of post-prostatectomy urinary incontinence in men. The authors identified 6 randomized controlled trials, noting that there was considerable variation in the interventions, study protocols, populations, and outcome measures. A total of 544 men were included, of whom 305 received some form of NIES, with 239 acting as a control or comparative treatment. In a pooled analysis of 4 randomized controlled trials comparing a combination of NIES and pelvic floor muscle exercises to pelvic floor muscle exercises alone, there was no statistically significant difference between groups at 3-month follow-up. The authors concluded that there was some short-term evidence of NIES enhancing the effect of pelvic floor muscle exercises, though not after 6 months. They also reported more adverse effects with electrical stimulation, including pain and discomfort. The study is limited in its heterogeneous design.

In a systematic review, Imamura et al. (2010) evaluated the clinical effectiveness of non-surgical treatments for women with stress urinary incontinence. Specific to NIES, the authors identified 8 randomized controlled trials comparing electrical stimulation to no active treatment, with a sham control being used in 6 of the studies. A pooled analysis of the studies did not find a statistically significant difference between groups in symptom relief. When stratified by studies which compared NIES to pelvic floor muscle training (n=5), there was no statistically significant difference between groups. The authors concluded that there was insufficient evidence to recommend NIES on a routine basis for treatment of stress urinary incontinence.

In a 2012 comparative effectiveness review, the Agency for Healthcare Research and Quality (AHRQ) identified 9 randomized controlled trials evaluating electrical intravaginal stimulation in women with urgency, stress, or mixed incontinence, with one study published after 2000. A pooled analysis of continence rate improvements comparing NIES to no active treatment yielded a relative risk of 2.01. AHRQ concluded that NIES was associated with increased continence rates and improvement in urinary incontinence. The review is limited in its heterogeneity as electrical stimulation was conducted under variable stimulation parameters, including length of treatment, depending on the type of urinary incontinence being treated.

Fecal Incontinence

In a randomized controlled trial, Norton et al. (2006) evaluated the effectiveness of NIES for the treatment of fecal incontinence in 90 adults. Study participants used a home electrical stimulation device for 8 weeks. Those allocated to active treatment had stimulation set at 35 Hz with a 0.5 second ramped pulse. The sham stimulator looked identical, but stimulation was set at 1 Hz. The primary outcome measurement was self-reported improvement. There was no statistically significant difference between groups in self-reported improvement. The study is limited in its high loss to follow-up (22%), short-term follow-up, and design.

In a Cochrane systematic review, Hosker et al. (2007) evaluated the effectiveness of NIES for the treatment of fecal incontinence in adults. Four eligible trials, representing 260 individuals, were identified. One trial was sham-controlled, 2 used NIES as an adjunct treatment, and 1 compared NIES to levatorplasty, a surgical procedure which combines the posterior liberation of the levator with the levator plication. The authors did not pool study findings due to the heterogeneous design of the included studies. Although all included studies reported general symptom improvement, it was noted that it was not clear whether symptom resolution was clearly due to NIES. The authors concluded that there was insufficient evidence to draw conclusions on the effectiveness of NIES for treating fecal incontinence.

In a systematic review, Vonthein et al. (2013) evaluated the effectiveness of biofeedback and/or NIES for the treatment of fecal incontinence. Thirteen studies evaluating biofeedback and/or NIES were included and reported symptom resolution and response rates using validated scales. A pooled analysis did not find a statistically significantly higher rate of symptom resolution with NIES when compared to controls. However, when comparing the combination of NIES and biofeedback with NIES alone, there was a significantly higher rate of symptom resolution with combination intervention. The authors concluded that individuals may benefit from combination biofeedback and NIES treatment when compared to biofeedback alone. The study is limited in its heterogeneous design. Additionally, the systematic review was primarily focused on biofeedback and does not allow conclusions to be drawn about NIES alone for the treatment of fecal incontinence.

MAGNETIC PELVIC FLOOR STIMULATION (MPFS)

MPFS or pulsed magnetic neuromodulation utilizes extracorporeal magnetic innervation (ExMI™) technology to deliver nerve impulses to the pelvic floor area to increase muscular contractions in an attempt to improve bladder control. The NeoControl® Pelvic Floor Therapy System is FDA-approved for the treatment of urinary incontinence in women. The system consists of a control unit and treatment chair. Pulsed magnetic fields generated by the chair's therapeutic head stimulate the perineal tissues, nerves, and muscles, reportedly increasing contractions and improving circulation. The treatment is typically performed twice a week, with each session lasting approximately 20 minutes. A complete course of treatment may take 8 weeks or more depending on the condition of the pelvic floor muscles when therapy is started.

PEER-REVIEWED LITERATURE
In a randomized controlled trial, Yokoyama et al. (2004) evaluated the safety and effectiveness of MPFS, utilizing a NeoControl® Pelvic Floor Therapy System, for the treatment of urinary incontinence when compared to functional electrical stimulation (FES). Thirty-six male individuals with urinary incontinence after retropubic radical prostatectomy were randomly assigned to three groups (12 each in FES, MPFS, and control groups). Outcome measurements included bladder diaries, 24-hour pad weight testing, and a QOL survey at 1, 2, and 4 weeks, and 2, 3, 4, 5, and 6 months, after catheter removal. At one month after catheter removal, pad weight was statistically significantly lower in the FES group than in the control group; at 2 months, pad weight was statistically significantly lower in the MPFS group; and at 3 months, there were no statistically significant differences in pad weight between the groups. QOL measures decreased after surgery, but gradually improved over time in all three groups. However, there were no statistically significant differences between the groups. There were no complications noted in any of the groups, as well. The authors concluded that both MPFS and FES were recommended for patients who seek quick improvement of postoperative urinary incontinence. The study is limited in its small sample size and indicates that at mid-term follow-up, there is no evidenced statistically significant difference between the control and MPFS groups.

In a double-blind randomized controlled trial, Gilling et al. (2009) evaluated the safety and effectiveness of MPFS for treating stress urinary incontinence (SUI) when compared to sham electromagnetic stimulation (SES). Seventy women with urodynamically confirmed SUI were randomized in a 1:1 ratio to receive MPFS or SES. Outcome measurements included a 20-minute pad-test, a 24-hour pad test, a 3-day bladder diary, and a QOL survey. Patients were evaluated 8 weeks after treatment, and the bladder diary, QOL survey, and pad-test were repeated at 6 months. At 8-week follow-up, there were statistically significant improvements from pre-treatment scores in the 20-min pad-test, the 24-hour pad-test, and the QOL survey. However, these improvements were not statistically significantly different when compared with the SES group. The authors did note that among patients who had a poor pelvic floor contraction at initial assessment (defined by circumvaginal muscle rating score and perineometry), there was a statistically significant reduction in the 20-minute pad-test leakage when compared with the SES group. The authors concluded that PMFS was no more effective than SES for the treatment of SUI. The study is limited in its post-hoc sub-group analysis with respect to conclusions about individuals with poor pelvic floor contraction.

In a randomized controlled trial, Wallis et al. (2012) evaluated the safety and effectiveness of MPFS for the treatment of women aged 60 years and older who have had urinary incontinence for 6 months or more. Patients were randomly assigned to the MPFS group (n=50) or the placebo group (n=51). Outcome measurements included a 24-hour pad test, an incontinence severity index, a 24-hour bladder diary, and a Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF; measures the frequency and severity of symptoms). The authors found no statistically significant differences between the groups in any of the outcome measurements from baseline to 12-week follow-up. They concluded that any initial evidence of subjective improvement in the treatment group compared to the placebo group was not sustained with sensitivity analysis.

In an industry-sponsored, randomized sham-controlled study, Yamanishi et al. (2013) evaluated MPFS in women with urinary urgency. Individuals received either sham stimulation (n=50) or SMN-X (n=101), a non-FDA approved MPFS device manufactured in Japan, 2 times a week for 6 weeks. The primary outcome measurement was the self-reported change in the number of urinary incontinence episodes per week. The decrease in the weekly number of incontinence episodes was 13 in the MPFS group compared to 9 in the sham control group, representing a statistically significant difference (p = 0.038). Individuals in the MPFS group also had better results on secondary outcome measurements including number of urgency episodes per day, though the results were not statistically significant for the number of voids per day. The authors concluded that MPFS was effective for the treatment of urgency incontinence in female individuals with OAB. The study is limited in its lack of long-term follow-up.

SUMMARY

Various professional societies and expert groups have issued position statements regarding NIES and MPFS for the treatment of urinary and fecal incontinence. In 2006, the National Institute for Health and Clinical Excellence (NICE) issued a guideline on the management of urinary incontinence in women. NICE noted that perineometry or pelvic floor electromyography as biofeedback should not be used as a routine part of pelvic floor muscle training, but that electrical stimulation and/or biofeedback should be considered in individuals who cannot actively contract pelvic floor muscles to aid motivation. However, NICE noted that further research into optimal electrical stimulation parameters was required to inform clinical practice. In an updated 2013 guideline, NICE noted that electrical stimulation should not be routinely used in the treatment of women with OAB or in combination with pelvic floor muscle training.

In 2007, NICE issued a guideline on the management of fecal incontinence in adults. The guidelines noted that the evidence on electrical stimulation for the treatment of fecal incontinence was inconclusive. In 2012, the European Association of Urology (EAU) published clinical guidelines on the non-surgical management of urinary incontinence. The guidelines indicated that existing randomized controlled trials were of poor quality with short follow-up and inconclusive effects. The EAU determined that there was no consistent evidence regarding the effectiveness of NIES and MPFS for the cure or improvement of urinary incontinence and did not recommend treatment. In an updated 2014 guideline on urinary incontinence, the EAU determined that there was inconsistent evidence on whether NIES was effective in improving urinary incontinence compared to sham treatment or that it added benefit to pelvic floor muscle training. The EAU concluded that MPFS does not cure or improve urinary incontinence. In 2014, the American College of Physicians issued guidelines on the nonsurgical management of urinary incontinence and NIES and MPFS were not discussed.

The current state of evidence indicates that there is a paucity of peer-reviewed literature documenting the safety and effectiveness of pelvic floor stimulation for the treatment of urinary and fecal incontinence. There exist some randomized controlled trials which indicate that there may be no sustained statistically significant differences between pelvic floor stimulation and placebo for the treatment of incontinence. Additionally, there are several guidelines which suggest that the current available studies are inconsistent and of poor quality. There are few, if any, studies evaluating the safety and effectiveness of MPFS for the treatment of fecal incontinence. Therefore, questions remain regarding the safety and effectiveness of NIES and MPFS for the treatment of urinary and fecal incontinence.
References


Amaro JL, Gameiro MO, Kawano PR, Padovani CR. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand.2006;85(5):619-22.

American Urological Association. Diagnosis and Management of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. 2014. Available at:https://www.auanet.org/guidelines/overactive-bladder-(oab)-(aua/sufu-guideline-2012-amended-2014). Accessed April 13, 2018.

Berghmans B, Hendriks E, Bernards A, et al. Electrical stimulation with non-implanted electrodes for urinary incontinence in men. Cochrane Database Syst Rev. 2013; 6:CD001202.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Magnetic stimulation in the treatment of urinary incontinence in adults. TEC Assessments 2000; Volume 15, Tab 8.

Castro RA, Arruda RM, Zanetti MR, et al. Single-blind randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones and no active treatment in the management of stress urinary incontinence. Clinics (Sao Paulo).2008; 63(4):465-72.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Non-Implantable Pelvic Floor Electrical Stimulator (230.8). 6/19/2006. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=231&ncdver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=pelvic&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d&. Accessed April 13, 2018.

Fujishiro T, Enomoto H, Ugawa Y, et al. Magnetic stimulation of the sacral roots for the treatment of stress incontinence: an investigational study and placebo controlled trial. J Urol.2000;164(4):1277-9.

Galloway NT, El-Galley RE, Sand PK, et al. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology.1999;53(6):1108-11.

Galloway NT, El-Galley RE, Sand PK, et al. Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. Urology.2000;56(6 Supp 1):82-6.

Gilling PJ, Wilson LC, Westenberg AM, et al. A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence. BJU Int.2009;103(10):1386-90.

Hosker G, Cody JD, Norton CC. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. 2007; (3):CD001310.

Imamura M, Abrams P, Bain C et al. Systematic review and economic modeling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technology Assessment.2010; Volume 14, No. 40.

Lim R, Lee SW, Tan PY, et al. Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn.2015; 34(8):713-722.

Lucas MG, Bosch RJ, Burkhard FC, et al. EAU guidelines of assessment and nonsurgical management of urinary incontinence. Eur Urol.2012;62(6):1130-42.

McClurg D, Ashe RG, Lowe-Strong AS. Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis-a double blind, placebo controlled, randomized clinical trial. Neurourol Urodyn. 2008;27(3):231-7.

Moroni RM, Magnani PS, Haddad JM, et al. Conservative treatment of stress urinary incontinence: a systematic review with meta-analysis of randomized controlled trials. Rev Bras Ginecol Obstet. 2016; 38(2):97-111.

National Institute for Health and Clinical Excellence (NICE). Faecal incontinence: the management of faecal incontinence in adults. 2007. Available online at: http://www.nice.org.uk/CG49. Accessed April 13, 2018.

National Institute of Health and Clinical Excellence (NICE). Clinical Guideline 40. Urinary incontinence: the management of urinary incontinence in women. [NICE Web site]. October 2006. Available at: http://www.nice.org.uk/CG40. Accessed April 13, 2018.

National Institute of Health and Clinical Excellence (NICE). Clinical Guideline 40. Urinary incontinence: the management of urinary incontinence in women. [NICE Web site]. September 2013. Available at: http://guidance.nice.org.uk/CG171. Accessed April 13, 2018.

Norton C, Gibbs A, Kamm MA. Randomized, controlled trial of anal electrical stimulation for fecal incontinence. Dis Colon Rectum. 2006; 49(2):190-6.

Novitas Solutions, Inc. Local Coverage Determination (LCD). LCD L35390: Magnetic pelvic floor stimulation (MPFS). [Novitas Solutions, Inc. Web site]. Original: 07/11/08. (Revised: 12/11/15). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35390&ver=4&Date=12%2f31%2f2015&DocID=L35390&bc=iAAAAAgAAAAAAA%3d%3d& Accessed April 13, 2018.

Novitas Solutions Inc. LCD L35094 Services that are not reasonable and necessary. [CMS.gov website]. Original: 10/01/2015. Revised: 07/01/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35094&ver=136&Date=&DocID=L35094&bc=iAAAABAAAAAAAA%3d%3d&
Accessed April 13, 2018.

Qaseem A, Dallas P, Forciea MA, et al. Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians. Ann Intern Med.2014; 161 (6): 429-40. Also available on the National Guideline Clearinghouse Web site at: https://www.guideline.gov. Accessed April 13, 2018.

Schwandner T, Konig IR, Heimerl T, et al. Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study. Dis Colon Rectum. 2010; 53(7):1007-16.

Schwandner T, Hemmelmann C, Heimerl T, et al. Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial. Dtsch Arztebl Int. 2011; 108(39):653-60.

Shamliyan TA, Kane RL, Wyman J, et al. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008;148(6):459-73.

Shamliyan T, Wyman J, Kane R. Agency for Healthcare Research and Quality (AHRQ): Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. 2012. Available at: https://effectivehealthcare.ahrq.gov/topics/urinary-incontinence-treatment/research/. Accessed April 13, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiologic Health. InControl InTone. 510(k) summary and premarket approval letter. [FDA Web site]. 02/22/2012. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110179.pdf. Accessed April 13, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiologic Health. Tenscare itouch Sure Pelvic Floor Exerciser. 510(k) summary and premarket approval letter. [FDA Web site]. 06/21/2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/k103698.pdf. Accessed April 13, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiologic Health. MyoTrac Infiniti. 510(k) summary and premarket approval letter. [FDA Web site]. 12/29/2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k053266.pdf. Accessed April 13, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiologic Health. NeoControl® Pelvic Floor Therapy System. 510(k) summary and premarket approval letter. [FDA Web site]. 08/29/2000. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=1935. Accessed April 13, 2018.

Vonthein R, Heimerl T, Schwandner T, et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis. 2013; 28(11):1567-77.

Voorham- vander Zalm PJ, Pelger RC, Stiggelbout AM , et al. Effects of magnetic stimulation in the treatment of pelvic floor dysfunction. BJU Int. 2006;97(5):1035-8.

Wallis MC, Davies EA, Thalib L, et al. Pelvic static magnetic stimulation to control urinary incontinence in older women: a randomized controlled trial. Clin Med Res. 2012;10(1):7-14.

Wang AC, Wang YY, Chen MC. Single-blind, randomized trial of pelvic floor muscle training, biofeedback-assisted pelvic floor muscle training, and electrical stimulation in the management of overactive bladder. Urology.2004; 63(1):61-6.

Yamanishi T, Homma Y, Nishizawa O, et al. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2013;21(4):395-400.

Yamanishi T, Mizuno T, Watanabe M, et al. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010; 184(5):2007-2012.

Yamanishi T, Yasuda K, Suda S, et al. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol. 2000;163:456-9.

Yokoyama T, Nishiguchi J, Watanabe T, et al. Comparative study of effects of extracorporeal magnetic innervation versus electrical stimulation for urinary incontinence after radical prostatectomy. Urology.2004;63(2):264-7.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

EXPERIMENTAL/INVESTIGATIONAL


THE FOLLOWING CODE REPRESENTS MAGNETIC PELVIC FLOOR STIMULATION: 53899



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MAGNETIC PELVIC FLOOR STIMULATION (MPFS)

Experimental/Investigational for all indications


NON-IMPLANTABLE ELECTRICAL STIMULATION (NIES)

Experimental/Investigational for all indications



HCPCS Level II Code Number(s)



EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT THE DEVICE FOR A NON-IMPLANTABLE ELECTRICAL STIMULATION (NIES):

E0740 Non-implanted pelvic floor electrical stimulator, complete system


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 07.12.01e:
05/23/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Pelvic Floor Stimulation as a Treatment of Incontinence.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 01/01/2017
Version Issued Date: 12/30/2016
Version Reissued Date: 05/23/2018

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