Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence

Policy #:11.17.04s

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.

SACRAL NERVE STIMULATION

MEDICALLY NECESSARY
Temporary Test Stimulation for the Treatment of Urinary Urge Incontinence, Urinary Urgency/Frequency, Nonobstructive Urinary Retention

Sacral nerve stimulation (SNS) with either percutaneous nerve stimulation or a temporary implanted lead for temporary test stimulation is considered medically necessary and, therefore, covered for the treatment of urinary urge incontinence, urinary urgency-frequency, and nonobstructive urinary retention when all of the following criteria are met:
  • The individual is an appropriate surgical candidate such that implantation with anesthesia can occur.
  • There is documented failure of or intolerance to at least two conventional therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment, and/or surgical corrective therapy).
  • Urinary incontinence is not related to another neurologic condition (e.g., diabetes with peripheral nerve involvement) that is associated with secondary manifestations of urinary urge incontinence, urinary urgency/frequency, or nonobstructive urinary retention.

Permanent Implantation Following a Successful Temporary Test Stimulation for the Treatment of Urinary Urge Incontinence, Urinary Urgency/Frequency, Nonobstructive Urinary Retention

SNS for the permanent placement of the implantable pulse generator (IPG) device is considered medically necessary and, therefore, covered for the treatment of urinary urge incontinence, urinary urgency-frequency, and nonobstructive urinary retention when the following criterion is met:
  • A successful test stimulation was performed, with either percutaneous nerve stimulation or a temporary implanted lead, resulting in at least a 50 percent reduction in symptoms that had occurred over a period of at least one week.

Temporary Test Stimulation for the Treatment of Fecal Incontinence

SNS with percutaneous nerve stimulation for temporary test stimulation is considered medically necessary and, therefore, covered for the treatment of fecal incontinence when all of the following criteria are met:
  • The individual is an appropriate surgical candidate such that implantation with anesthesia can occur.
  • Either of the following is met:
    • There is documentation of chronic fecal incontinence of two or more incontinent episodes on average per week with duration greater than six months.
    • There is documentation of chronic fecal incontinence of two or more incontinent episodes on average per week with duration greater than 12 months after vaginal childbirth.
  • There is documented failure of or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment, and/or surgical corrective therapy performed more than 12 months [or 24 months in the case of cancer] previously).
  • The condition is not related to an 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) or chronic inflammatory bowel disease.
  • The incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.

Permanent Implantation Following a Successful Temporary Test Stimulation for the Treatment of Fecal Incontinence.

SNS for the permanent placement of the IPG device is considered medically necessary and, therefore, covered for the treatment of fecal incontinence when the following criterion is met:
  • A successful percutaneous test stimulation was performed, resulting in at least a 50 percent reduction in symptoms had occurred over a period of at least one week.

EXPERIMENTAL/INVESTIGATIONAL
All other uses of SNS for incontinence control including, but not limited to the treatment of stress or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury, diabetes with peripheral nerve involvement), other types of chronic urinary dysfunction, and the treatment of chronic constipation or chronic pelvic pain) are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

POSTERIOR TIBIAL NERVE STIMULATION

MEDICALLY NECESSARY
Initial Therapy

Posterior tibial nerve stimulation (PTNS) delivered in 30-minute sessions once a week for 12 weeks, is considered medically necessary for the treatment of urinary urgency, urinary frequency, and urge incontinence when both of the following criteria are met:
  • There is documented failure of or intolerance to behavioral training (e.g., bladder training, prompted voiding, pelvic muscle exercise training).
  • There is documented failure of or intolerance to at least two anticholinergic drugs, each taken for at least 4 weeks duration, prior to the PTNS therapy initiation.

Maintenance Therapy

PTNS maintenance therapy, beyond the initial 12 sessions, is considered medically necessary for the treatment of urinary urgency, urinary frequency, and urge incontinence at a frequency of up to one session every month for up to two years when both of the following criteria are met:
  • There is documented completion and tolerance during the initial PTNS therapy (i.e., first 12 sessions of PTNS)
  • There is documented improvement (i.e., 50 percent reduction) in symptoms of urinary frequency, nocturia, and/or urinary urgency during the initial PTNS therapy

EXPERIMENTAL/INVESTIGATIONAL
All other uses of PTNS including, but not limited to subsequent PTNS maintenance therapy beyond two years, are 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 peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care 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.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

SACRAL NERVE STIMULATION AND POSTERIOR TIBIAL NERVE STIMULATION
Subject to the terms and conditions of the applicable benefit contract, sacral nerve stimulation for the control of urinary and fecal incontinence is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the US Food and Drug Administration (FDA) for sacral nerve stimulation for the control of urinary and fecal incontinence.

The Urgent® PC Neuromodulation System from Uroplasty INC revised US Food and Drug Administration (FDA) 510K approval in October 2005 for the treatment of urinary urgency, urinary frequency, and urge incontinence. The indications were expanded to include overactive bladder (OAB) in October 2010.

Description

Urinary urge incontinence is defined as the involuntary leakage of urine with a sudden strong urge to void due to bladder spasms or contractions with enough force to override the sphincter muscles of the urethra. Nonobstructed urinary retention is defined as the inability to empty the bladder completely without structural obstruction. Nonobstructed urinary retention is usually caused by weak pelvic floor muscles or dysfunction in the neural pathway between the brain and bladder. Urinary urgency/frequency incontinence is defined as a strong and abnormal urge to urinate, resulting in frequent urination without a loss of the feeling of fullness of the bladder.

Fecal incontinence is the unexpected leakage of feces or gas (i.e., flatus) from the rectum. Fecal incontinence can be caused by loss of rectal wall compliance, dysfunction of efferent and afferent neural pathways, dysfunction of central and peripheral nerve systems for the anal sphincter or rectum, and damage to voluntary and involuntary anal sphincter muscles.

SACRAL NERVE STIMULATION (SNS) FOR THE CONTROL OF URINARY AND FECAL INCONTINENCE

A sacral nerve stimulator (SNS), also referred to as a sacral nerve neuromodulation (SNM) device, is a surgically implanted device (e.g., InterStim® or InterStim II®, Medtronic, Inc; Minneapolis, MN) that is used to manage bladder or rectal function via neural pathways that control bladder or rectal function. SNS consists of an implantable pulse generator (IPG) that transmits electrical impulses to the sacral nerves through an implanted wire that modulates bladder and rectal function by increasing capacity or improving emptying ability. SNS therapy is indicated for use after conservative treatments such as pharmacologic treatments (e.g., anticholinergics, tricyclic antidepressants), behavioral therapy (e.g., timed voiding, controlled fluid intake, pelvic floor muscle training, biofeedback), and/or surgery are ineffective and/or not well tolerated.

SNS consists of both a temporary test stimulation and a permanent implantation. A test stimulation is performed prior to permanent placement to establish if a permanent implantation will be effective. Individuals must keep a diary to record voiding patterns so that the clinical effectiveness of the device can be properly evaluated.

The test stimulation may be implanted in an outpatient setting under local anesthesia. The appropriate sacral nerve(s) are identified by using a test needle and an attached temporary lead wire. The wire is attached to an external stimulator, which is carried in a pocket or on a belt loop for a trial period of three to five days. The individual records voiding patterns during the trial period and for one week after the wire is removed. Data from the voiding diaries are used to compare the symptoms that are experienced at baseline, during the test phase, and after removal of the wire. The test stimulation must demonstrate at least a 50 percent reduction in symptoms in order for the permanent placement of the stimulator to be medically indicated.

A staged implant test procedure may be required in some individuals if the initial temporary test yields a false-negative finding secondary to migration of the temporary lead. The US Food and Drug Administration (FDA) approved an accurate screening tool, a chronic lead test, for use when the initial temporary test offers inconclusive results. In a staged implant, the permanent lead is surgically inserted and connected to an external pulse generator. The individual returns home for a trial period of one to four weeks. If the staged implant test is successful (i.e., at least a 50 percent reduction in symptoms), the permanent stage of the procedure is completed with the implantation of the IPG.

The IPG is surgically implanted subcutaneously in the individual's lower abdomen or upper buttock under general anesthesia. A lead is placed next to the identified sacral nerve and is then connected to the neurostimulator by an extension. The professional provider utilizes a console programmer to adjust the device settings and to check neurostimulator information. A hand-held programmer is used to turn the neurostimulator on and off and to adjust the level of stimulation, as prescribed by the professional provider. A control magnet turns the neurostimulator on and off.

PEER-REVIEWED LITERATURE
In 1997, a multicenter, randomized, controlled trial (RCT), conducted as part of the FDA approval process, enrolled individuals with severe urinary urge incontinence who had failed prior treatments such as drugs or behavioral therapy. The clinical trial concluded that SNS reduced urinary urge incontinence compared to control individuals. Furthermore, in 1999, the FDA approved the SNS device for the additional indications of urgency/frequency and urinary retention in individuals without mechanical obstruction.

In a long-term follow-up study, van Kerrebroek et al. (2007) reported on a 5-year prospective, multicenter FDA-regulated trial that evaluated the long-term safety and efficacy of SNS in individuals with refractory urinary urge incontinence, urinary urgency/frequency, and urinary retention. The study enrolled 163 individuals, and after undergoing test stimulation, 152 of them underwent SNS implantation. Clinical success was defined as at least a 50 percent improvement of baseline symptoms. At 5-year follow-up after implantation, 68 percent of patients with urge incontinence, 56 percent with urgency frequency, and 71 percent with retention had successful outcomes. In 102 patients, 279 device- or therapy-related adverse events were observed. The authors concluded that SNS was a safe and effective modality for providing relief for appropriately selected individuals with urinary urge incontinence, urinary urgency/frequency, and urinary retention cases refractory to other forms of treatment. The study is limited in its lack of a comparative control group.

For the treatment of fecal incontinence, Tjandra et al. (2008) published an RCT with 120 individuals with severe fecal incontinence and SNS. Individuals were randomly assigned to receive SNS or best supportive therapy, consisting of pelvic floor exercises with biofeedback, bulking agents, and dietary management with a team of dieticians. Exclusion criteria included neurologic disorders and external anal sphincter defects of more than 120 degrees of the circumference, although a large proportion of the individuals had pudendal neuropathy. Sixty individuals were randomized to SNS, and of these individuals, 90 percent had successful test stimulation. Fifty-three individuals decided to proceed with implant of the pulse generator. At baseline, the SNS group had an average of 9.5 fecal incontinent episodes per week, and the controls had 9.2. Both groups had an average of 3.3 days per week with fecal incontinence. At 12-month follow-up, fecal incontinent episodes had decreased to 1 day per week with 3.1 fecal incontinent episodes in the SNS group, but had not changed in the control group. Complete continence was achieved in 42 percent of the SNS individuals and 24 percent improved by 75 percent to 99 percent. None of the individuals had worsening of fecal continence.

In a clinical study conducted as part of the FDA approval process, Wexner et al. (2010) evaluated 120 individuals who had an average of 9.4 episodes of fecal incontinence a week. After SNS for a period of 12 months, 88 out of 120 individuals had a 50 percent reduction in the number of fecal incontinence episodes, and 43 out of 120 individuals achieved full continence of bowel movements. The primary effectiveness endpoint of at least a 50 percent reduction in fecal incontinent episodes at 12 months post-implant in at least 50 percent of the individuals was met. There were no device- or procedure-related deaths or permanent injuries reported in this study. The adverse events seen in the study were consistent with the events seen in the clinical studies for the urinary incontinence indications. The authors concluded that SNS using InterStim® therapy was safe and effective in treating individuals with fecal incontinence. The study is limited in its lack of a comparative control group and short-term follow-up period.

In a meta-analysis, Tan et al. (2011) evaluated randomized trials and observational studies published between 2000 and 2008 on SNS for treating fecal incontinence. They identified a total of 34 studies that reported on at least one of their outcomes of interest and clearly documented how many individuals underwent temporary and permanent SNS. In these 34 studies, a total of 944 individuals underwent temporary SNS and 665 subsequently underwent permanent SNS implantation. There were 279 individuals who did not receive permanent implantation, and of these individuals, 154 were lost to follow-up. Follow-up in the studies ranged from 2 weeks to 35 weeks. In a pooled analysis of findings of 28 studies, there was a statistically significant decrease in fecal incontinence episodes per week with SNS compared to maximal conservative therapy. Fourteen studies reported fecal incontinence scores, and when these results were pooled, there was also a statistically significantly greater improvement in scores with SNS compared to conservative therapy.

For the treatment of fecal incontinence, Thin et al (2013) published a systematic review of randomized trials for treating fecal incontinence. A total of 61 studies met eligibility criteria; including at least 10 patients, having a clear follow-up interval and reporting the success rate of therapy based on a 50% or greater improvement in fecal incontinence episodes. Only 2 of the studies were RCTs (Tjandra et al and Leroi et al studies, described next) and 50 were prospective case series. Data from 2 studies with long-term follow-up could be pooled to calculate median success rates using an intention-to-treat analysis. These median success rates were 63% in the short term (no more than 12 months of follow-up), 58% in the medium term (12-36 months), and 54% in the long term (>36 months). The per-protocol short-, medium-, and long-term success rates were 79%, 80%, and 84%, respectively.

In a multi-center prospective study, Hull et al. (2013) evaluated the long-term results of SNS for severe fecal incontinence. A total of 120 patients underwent implantation and were followed at 3, 6, and 12 months, and annually after device implantation. Patients were assessed with a 14 day diary and fecal incontinence quality-of-life and severity index questionnaires. Therapeutic success was defined as at least a 50 percent improvement over baseline in fecal incontinence episodes per week. Ultimately, 63 percent of the patients (n=76) completed the minimum follow-up of 5 years. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89 percent (n=64) having therapeutic success and 36 percent (n=26) having complete continence. Fecal incontinence quality of life scores statistically significantly improved between baseline and 5 year follow-up (p < 0.0001). Thirty-five percent of patients (n=27) required device revision, replacement, or explant. The authors concluded that the therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after SNS implantation. The study is limited in its lack of a comparative control group.

In 2014, an RCT was published by Siegel et al; this was an industry-sponsored FDA-mandated postapproval study and is known as the Insite trial. This study compared SNM using a 2-stage surgical procedure with standard medical therapy.5 Study inclusion criteria included a diagnosis of overactive bladder (at least 8 voids per day and/or at least 2 involuntary leaking episodes in 72 hours) and a failed trial of at least 1 anticholinergic or antimuscarinic medication. In addition, there needed to be at least 1 such medication that had not yet been attempted. Patients with neurologic diseases and with primary stress incontinence were excluded. A total of 70 patients were allocated to SNM and 77 to standard medical therapy. Of the 70 patients in the SNM group, 11 elected not to receive test stimulation with the tined lead and 8 received the lead but did not receive a full system implant due to lack of response to a 14-day test stimulation period (response was defined as at least a 50% reduction in average leaks and/or voids). Patients in the medical treatment group tried the next recommended medication or restarted a discontinued medication. Therapeutic success was defined as at least a 50% improvement in average leaks/day or at least a 50% improvement in the number of voids per day or a return to fewer than 8 voids per day. In an intention-to-treat analysis, the therapeutic success rate at 6 months was 61% in the SNM group and 42% in the standard medical treatment group; the difference between groups was statistically significant (p=0.02). QOL at 6 months was a secondary outcome. Several validated QOL scales were used, and all favored the SNM group compared with the standard medical treatment group (p<0.002 for all comparisons).

POSTERIOR TIBIAL NERVE STIMULATION FOR THE CONTROL OF URINARY INCONTINENCE

Posterior tibial nerve stimulation (PTNS), also referred to as percutaneous tibial nerve stimulation, is an indirect form of neuromodulation used for the treatment of voiding dysfunction. The posterior tibial nerve is derived from the lumbar-sacral nerves (L4-S3), which innervate the bladder detrusor and pelvic floor. While the mechanism of action in neuromodulation of the bladder (PTNS) is not fully understood, it is believed that improvements in coordination of the bladder detrusor and sphincter muscles can be achieved through retrograde stimulation of the sacral nerve plexus and restoration of the balance between bladder inhibitory and excitatory control systems.

The procedure involves the placement of a fine-needle electrode above the ankle, near or into the tibial nerve, followed by low-voltage electrical-stimulation-producing sensory and/or motor responses. Non-invasive PTNS therapy has also been administered using surface electrodes. PTNS treatment is generally composed of weekly 30 minute sessions for 12 weeks. Successful PTNS treatment is typically defined as the resolution or at least a 50 percent reduction in urinary urge incontinence or urinary urgency/frequency episodes. Regimens including additional PTNS treatments are not well defined and are often tailored to the individual based upon symptoms.

PEER-REVIEWED LITERATURE
In an industry-sponsored RCT, Peters et al. (2009) compared the effectiveness of PTNS to extended-release tolterodine in 100 adults (50 per group) diagnosed with overactive bladder syndrome (the OrBIT Trial). Of the enrolled individuals, 90 percent were females with symptoms of overactive bladder (OAB), with at least eight voids per day. The primary outcome of the 12 week trial was the noninferiority of PTNS compared to extended-release tolterodine in the mean reduction in the number of voids per 24 hours after 12 weeks of treatment. Non-inferiority was defined as no more than a 20 percent difference in the mean decrease in voiding episodes. Individuals completed 2 day voiding diaries at baseline and at 12 weeks. Of the 84 individuals that completed final follow-up, the authors reported decreases in the number of voids per day in both the PTNS and tolterodine groups (2.5 ± 3.9 vs. 2.4 ± 4.0, respectively). The decrease in voiding episodes between groups was not statistically significant (p=0.44). The authors concluded that the data supported noninferiority of PTNS when compared to extended-release tolterodine. The authors' conclusions are limited in that no statistically significant difference between PTNS and tolterodine groups was observed in other voiding diary parameters, including mean change in nocturia, moderate to severe urgency episodes per day, and urge incontinence episodes per day. Additional limitations include the lack of individual and provider blinding, lack of sham or placebo group, lack of longer-term follow-up, and inconsistent data collection methods, which may hinder any conclusions that can be drawn from the OrBIT trial.

MacDiarmid et al. (2010) reported on the 1-year follow-up data for individuals assigned to the PTNS arm of the OrBIT trial and had responded to the initial 12-week course of treatment. During the additional 9 months of follow-up, 33 of the original 35 responders received a mean of 12.1 ± 4.9 treatments, with a mean of 21 days (median of 17 days) between treatments. Voiding diary data were available for 32 of 35 participants at 6 months, and 25 of 35 of participants at 12 months. The authors observed a reduction in the average number of voids per day from baseline (original primary outcome of the OrBIT trial) of 3.2 ± 3.7 at 6 months, and 2.8 ± 3.7 at 12 months. Secondary outcomes at 12 months, based on n=25 voiding diaries, included mean improvements from baseline urge incontinence of -1.6 episodes per day, nocturia episodes of -0.8, and in episodes of moderate to severe urgency per day of -3.7. Symptom severity scores for OAB were also statistically significantly improved from 12 weeks to 12 months. The authors concluded that the statistically significant effectiveness of PTNS achieved after 12 weekly treatments to improve frequency, nocturia, urgency, voided volume, and urge incontinence episodes was durable through 12 months of prolonged therapy offered at individualized tapering intervals. The study is limited in its high potential for selection bias because the follow-up analysis was restricted to individuals classified as responders to the original course of PTNS. Additionally, the lack of a comparative control group or longer-term follow-up results in an inability to determine any generalizable conclusions regarding the long-term effectiveness of PTNS in the treatment of OAB.

In a second randomized trial, Peters et al. (2010) assessed the effectiveness of PTNS compared to sham in the treatment of OAB symptoms (the SUmiT trial). The multicenter trial enrolled 220 adults with overactive bladder symptoms. Study eligibility criteria included self-reported bladder symptoms lasting at least three months, failure of conservative therapy, and a score of at least 4 on the OAB questionnaire for urgency. Following enrollment, participants were randomized 1:1 to 12 weekly 30-minute PTNS or sham therapy sessions. The sham procedure utilized a blunt instrument to stimulate the location and sensation of electrode placement in active treatment, and was previously validated in a separate pilot study conducted by the Peters et al. workgroup. The primary endpoint was to assess the effectiveness of PTNS compared to an inactive sham intervention based on a single-item global response assessment (GRA) variable at 13 weeks. Possible responses to the single-item GRA were that symptoms were markedly worse, moderately worse, mildly worse, the same, slightly improved, moderately improved, or markedly improved. Responders to treatment were defined as individuals reporting moderated or marked improvement in symptoms. The authors reported that the proportion of responders, based on the GRA, was 54.5 percent of individuals in the PTNS group (n=60) and 20.9 percent of individuals in the sham group (n=23), representing a statistically significant difference (p < 0.001). No serious device-related adverse events or malfunctions were reported. The authors concluded that this multicenter, double-blinded, randomized, sham-controlled trial provided level I evidence that PTNS was safe and effective in treating OAB symptoms. However, the subjective nature of the single-item primary outcome (GRA), reporting of comparative data immediately following the treatment phase, and the lack of long-term follow-up, limit any generalizable conclusions regarding the effectiveness of PTNS.

In a prospective RCT, Finazzi-Agrò et al. (2010) evaluated the effectiveness of PTNS compared to placebo in patients with detrusor overactivity (DO) incontinence. The investigators randomized 35 female individuals, refractory to antimuscarinic therapy, to receive twelve 30 minute PTNS or placebo sessions. The primary outcome, assessed through completion of a 3-day voiding diary at baseline and following treatment, was percent responders (defined as greater than 50 percent reduction in incontinent episodes). Within the PTNS group, 71 percent of patients (n=12) were considered responders compared with no responders in the placebo group. Improvements in secondary outcomes, including number of incontinence episodes, number of voids, voided volume and incontinence quality of life, were also reported. The investigators concluded that PTNS can be considered an effective treatment for DO with a negligible placebo effect in this specific patient population. The study is limited in its small sample size, loss to follow-up of 8.6 percent, and lack of clinician blinding. Additionally, the authors did not perform intent-to-treat analysis (designed to avoid effects of cross-over and loss to follow-up), which may hinder the validity of the study. These limitations may inhibit the establishment of any generalizable conclusions.

In a systematic review, Burton et al. (2012) evaluated the effectiveness of PTNS in treating OAB symptoms. Relevant RCTs and prospective studies were included in the review, with studies reporting variable initial success rates from 37 to 82 percent for treating OAB symptoms. The authors identified four RCTs comparing PTNS with sham treatment, which showed a statistically significant difference favoring PTNS. Two RCTs compared PTNS with antimuscarinic medication, which showed no statistically significant difference in the change in bladder diary parameters between the treatments. Ten prospective non-randomized studies were included with varying definitions of success. The authors concluded that there was evidence of significant improvement in OAB symptoms using PTNS, which was comparable to the effect of antimuscarinics. The authors noted that the included studies only considered short-term outcomes after initial treatment. As such, they called for longer-term follow-up data. The study is limited in its heterogeneity of the included studies and lack of long-term follow-up.

In a prospective study, Peters et al. (2013) evaluated the effectiveness of PTNS for OAB symptoms after 3 years of therapy. Fifty participants from the SUmiT trial who met the primary effectiveness endpoint after 12 weeks of PTNS treatments were enrolled in this prospective study to assess the long-term outcomes (the STEP trial). Study patients were prescribed a fixed 14-week tapering protocol followed by a personal treatment plan aimed at sustaining OAB symptom improvement. OAB and quality-of-life questionnaires were completed every 3 months, and 3 day-voiding diaries were completed every 6 months. A total of 29 patients completed the 36-month protocol and received a median of 1.1 treatments per month after a 14 week treatment-tapering protocol. Seventy-seven percent of patients maintained moderate or marked improvement in OAB at 3 year follow-up. Compared to baseline, median voids per day decreased from 12.0 to 8.7, nighttime voids decreased from 2.7 to 1.7, and urge incontinence episodes decreased from 3.3 to 0.3 (p < 0.0001). One patient experienced two mild treatment-related adverse events of bleeding at the needle site during follow-up. The authors concluded that most STEP participants safely sustained OAB symptom improvement to 3 years, with an average of 1 treatment per month. The study is limited in its lack of a comparative control group and the high loss to follow-up (42 percent). This may impact the internal validity of the study results as there is a high potential for bias. Additionally, the study population in the STEP trial included participants from the SUmiT trial who met the primary effectiveness endpoints, which may introduce study selection bias.

In a randomized controlled crossover study, Vecchioli-Scaldazza et al. (2013) compared the effectiveness of solifenacin succinate (SS) with PTNS in women with OAB symptoms. Forty women were randomized into 2 groups: 1 SS control group (5 mg for 40 days) and a separate PTNS group (twice weekly for 6 weeks), which included women who subsequently received SS. Voiding diaries, quality-of-life surveys, and patient perception of intensity of urgency questionnaire were performed before and after each treatment. A reduction in the number of daily episodes of urinary urgency, nocturia, and urge incontinence were found with both SS and PTNS group, though the authors noted a greater effectiveness in the PTNS group. There was an increase in voided volume in all groups, though individuals in the PTNS group had a greater increase. The authors concluded the study demonstrated the effectiveness of both SS and PTNS in women with OAB symptoms, with greater improvements found in women who received PTNS. The study is limited in its short-term follow-up, small sample size, and cross-over design. Patient crossover typically limits the internal validity of the study as it may introduce study bias. Additionally, this limits the authors' ability to directly compare the effectiveness of medication to PTNS.

In a prospective RCT, Gungor Ugurlucan et al. (2013) evaluated the effectiveness of transvaginal electrical stimulation (ES) and PTNS in the treatment of OAB symptoms. A total of 59 women with symptoms of urgency, frequency, and nocturia with or without incontinence were included in the study. Ultimately, 35 patients received ES (20-minute treatments 3 times a week for 6 to 8 weeks), while 17 received PTNS (12 30 minute weekly sessions). The authors assessed numerous outcome variables including quality of life parameters, but did not specify primary outcomes or adjust p-values for multiple comparisons. From baseline to the end of the treatment period, there were no statistically significant differences in mean change in urgency episodes, nocturia, or incontinence episodes, though there was a statistically significant difference in daytime frequency. The authors concluded that PTNS and ES were both effective in the treatment of OAB, though the proportion of patients describing themselves as cured was significantly higher in the ES group. The study is limited in its small sample size and lack of an appropriate comparative control group (e.g., medical therapy). Additionally, the study did not provide proportions or p-values on which to validate the authors' conclusions.

SUMMARY

SACRAL NERVE STIMULATION (SNS) FOR THE CONTROL OF URINARY AND FECAL INCONTINENCE
Various professional societies and expert groups have issued guidelines regarding SNS. In 2004, the National Institute for Health and Clinical Excellence (NICE) published separate guidelines on SNS for the treatment of fecal incontinence and urge incontinence/frequency, respectively. NICE determined that the current evidence on the safety and efficacy of SNS for these indications was adequate to support its use. In 2007, NICE published additional guidelines for the management of fecal incontinence in adults which support the use of SNS. In 2007, the Agency for Health Care Research and Quality (AHRQ) published results of a systematic review of several small RCTs to determine the benefit of SNS for urinary incontinence. The evidence from these studies suggested that SNS can improve predominantly urinary urge incontinence in adults, but curative results are not as consistent. In 2014, the American Urological Association (AUA) issued updated guidelines on the diagnosis and treatment of OAB which state that SNS is considered appropriate as a third-line treatment in carefully selected population characterized by severe refractory OAB symptoms or individuals who are not candidates for second-line therapy and are willing to undergo a surgical procedure.

The current evidence suggests that SNS may be considered a safe and effective treatment for select individuals with urinary and fecal incontinence who have failed conservative therapies (e.g., pharmacologic and behavioral therapies). There remain concerns about adverse events including device replacement. However, the available published peer-reviewed literature consists of prospective RCTs and meta-analyses which indicate that SNS may result in a reduction in urinary and fecal incontinence episodes. Additionally, at long-term follow-up (e.g., up to 5 years), the therapeutic effects and improvements in quality of life appear to be maintained.

POSTERIOR TIBIAL NERVE STIMULATION FOR THE CONTROL OF URINARY INCONTINENCE
Various professional societies and expert groups have issued position statements regarding PTNS. In 2010, NICE published guidelines on PTNS for OAB symptoms. They determined that the current evidence indicated that PTNS was effective in reducing symptoms in the short and medium term. A 2012 comparative effectiveness review evaluated nonsurgical treatments for urinary incontinence in adult women and identified 4 RCTs comparing PTNS with no active treatment in patients with OAB. The AHRQ report included a pooled analysis of data from 3 of these RCTs, representing 405 patients who had a statistically significantly greater improvement in urinary incontinence in the PTNS group compared to the control group. A limitation of the analysis was that the 150 patients in the SUmiT sub-analysis were included twice. Additionally, the AHRQ report did not discuss the evidence on the effectiveness of PTNS beyond 12 weeks.

In 2014, the AUA issued updated guidelines on the diagnosis and treatment of OAB. The guidelines state that PTNS is considered appropriate as a third-line treatment in carefully selected patients. Overall, the evidence supporting this recommendation was considered to be grade C (i.e., recommendations are based primarily on consensus and expert opinion) due to the predominance of observational designs, short follow-up periods, and varying patient populations within the body of literature evaluating the safety and effectiveness of this technology.

Questions remain regarding the safety and effectiveness of PTNS for the treatment of urinary incontinence. The available published peer-reviewed literature primarily consists of retrospective case series with varying rates of success. The data available within RCTs for PTNS demonstrate short-term improvements on measures of urinary incontinence. However, there are numerous methodological flaws (e.g., inconsistent data collection, lack of blinding, lack of comparative data, use of subjective outcome measures) which collectively bias the observed results and conclusions that are obtained from these investigations. Additionally, due to the quality and design of the available studies, a placebo response to the original and additional PTNS treatments cannot be ruled out. There are concerns about the magnitude of treatment effect, durability of treatment response, and maintenance regimen requirements that may require longer-term comparative data to appropriately establish the long-term safety and effectiveness of PTNS for the treatment of urinary incontinence. However, based on clinical input and guidance from relevant medical societies, in a select population of symptomatic individuals who are refractory to bladder training and drug therapy, PTNS may be appropriate as a third-line treatment during 12 week initiation therapy and maintenance therapy for up to 2 years.
References


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Finazzi-Argo E, Filomena P, Sciobica F, et al. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: A randomized, double-blind, placebo controlled trial. J Urol. 2010;184:2001-2006.

Ganio E, Luc AR, Clerioco G, et al. Sacral nerve stimulation for treatment of fecal incontinence. Dis Colon Rectum. 2001;44(5):619-631.

Ganio E, Ratto C, Masin A, et al. Neuromodulation for fecal incontinence: outcome in 16 patients with definitive implant. Dis Colon Rectum. 2001;44(7):965-970.

Groen J, Blok BF, Bosch JL. Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol. 2011;186(3):954-959.

Gungor Ugurlucan F, Onal M, Aslan E, et al. Comparison of the effects of electrical stimulation and posterior tibial nerve stimulation in the treatment of overactive bladder syndrome. Gynecol Obstet Invest. 2013;75(1):46-52.

Hassouna MM, Siegel SW, Nyeholt AA, et al. Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol. 2000;163(6):1849-1854.

Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev. 2009;(2):CD004202.

Holzer B, Rosen HR, Novi G, et al. Sacral nerve stimulation in patients with severe constipation. Dis Colon Rectum. 2008;51(5):524-529.

Hull T, Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56(2):234-45.

Jones CA, Nyberg L. Epidemiology of interstitial cystitis. Urology.1997;49(5A Suppl):2-9.

Kamm MA, Dudding TC, Melenhorst J, et al. Sacral nerve stimulation for intractable constipation. Gut.2010;59:333-340.

Leong RK, De Wachter SG, Nieman FH, et al. PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. Neurourol Urodyn. 2011;30(7):1249-1252.

Levin PJ, Wu JM, Kawasaki A, et al. The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review. Int Urogynecol J. 2012;23(11):1591-7.

MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term Durability of Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder. J Urol. 2010;183: 234-240.

Maeda Y, Lundby L, Buntzen S et al. Sacral nerve stimulation for constipation: suboptimal outcomes and adverse events. Dis Colon Rectum. 2010;53:995-999.

Maeda Y, Matzel K, Lundby L, et al. Postoperative issues of sacral nerve stimulation for fecal incontinence and constipation: a systematic literature review and treatment guideline. Dis Colon Rectum. 2011;54(11):1443-1460.

Marcelissen TA, Leong RK, de Bie RA, et al. Long-term results of sacral neuromodulation with the tined lead procedure. J Urol.2010;184(5):1997-2000.

Matzel KE, Lux P, Heuer S, Besendörfer M, Zhang W. Sacral nerve stimulation for faecal incontinence: Long-term outcome. Colorectal Dis. 2008;11(6):636-641.

Medtronic. News Release: Medtronic initiates long-term, post-market study with Interstim Therapy for overactive bladder. [Medtronic Web site]. 11/01/07. Available at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1193922073226&lang=nl_NL. Accessed August 25, 2017.

Medtronic. Sacral nerve stimulation. InterStim® therapy. [Medtronic Web site]. Available at: http://professional.medtronic.com/pt/uro/snm/prod/interstim/#.VWc2RnL77cs. Accessed August 25, 2017.

Medtronic. Summary of Multi-Center Clinical Study. Medtronic Neurological, Minneapolis, MN. Available at: www.interstim.com. Accessed August 25, 2017.

Mellgren A, Wexner SD, Coller JA, et al. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011;54(9):1065-1075.

Michelsen HB, Thompson-Fawcett M, Lundby L, et al. Six years of experience with sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2010;53(4):414-421.

Moossdorff-Steinhauser HF, Berghmans B. Effects of percutaneous tibial nerve stimulation on adult patients with overactive bladder syndrome: a systematic review. Neurourol Urodyn. 2013;32(3):206-14.

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Novitas Solutions Inc. Local Coverage Determination (LCD). L35011: Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control. Original 10/01/2015. Revised 01/12/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35011&ver=10&Date=08%2f25%2f2017&SearchType=Advanced&DocID=L35011&bc=KAAAABgAAAAAAA%3d%3d&. Accessed August 25, 2017.

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Peters KM, Carrico DJ, MacDiarmid SA, et al. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013;32(1):24-9.

Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183:1438-1443.

Peters KM, Carrico DJ, Wooldridge LS, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2012. [Epub ahead of print].

Peters KM, Carrico DJ, Wooldridge LS, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study.
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Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended release tolterodine: results from the Overactive Bladder Innovative Therapy trial. J Urol. 2009:182:1055-1061.

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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)

64561, 64566, 64581, 64585, 64590, 64595, 95970, 95971, 95972


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)

PROCEDURE CODES 64561 OR 64581 ARE CONSIDERED MEDICALLY NECESSARY WHEN REPORTED WITH ANY OF THE FOLLOWING DIAGNOSIS CODES:

N31.8 Other neuromuscular dysfunction of bladder

N31.9 Neuromuscular dysfunction of bladder, unspecified

N32.81 Overactive bladder

N36.44 Muscular disorders of urethra

N39.41 Urge incontinence

N39.42 Incontinence without sensory awareness

N39.43 Post-void dribbling

N39.44 Nocturnal enuresis

N39.45 Continuous leakage

N39.46 Mixed incontinence

N39.490 Overflow incontinence

N39.498 Other specified urinary incontinence

R15.0 Incomplete defecation

R15.1 Fecal smearing

R15.2 Fecal urgency

R15.9 Full incontinence of feces

R30.1 Vesical tenesmus

R32 Unspecified urinary incontinence

R33.0 Drug induced retention of urine

R33.8 Other retention of urine

R33.9 Retention of urine, unspecified

R35.0 Frequency of micturition

R39.11 Hesitancy of micturition

R39.14 Feeling of incomplete bladder emptying

R39.15 Urgency of urination

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


PROCEDURE CODE 64566 IS CONSIDERED MEDICALLY NECESSARY WHEN REPORTED WITH ANY OF THE FOLLOWING DIAGNOSIS CODES:

N31.8 Other neuromuscular dysfunction of bladder

N31.9 Neuromuscular dysfunction of bladder, unspecified

N32.81 Overactive bladder

N36.44 Muscular disorders of urethra

N39.41 Urge incontinence

N39.42 Incontinence without sensory awareness

N39.43 Post-void dribbling

N39.44 Nocturnal enuresis

N39.45 Continuous leakage

N39.46 Mixed incontinence

N39.490 Overflow incontinence

N39.498 Other specified urinary incontinence

R30.1 Vesical tenesmus

R32 Unspecified urinary incontinence

R33.0 Drug induced retention of urine

R33.8 Other retention of urine

R33.9 Retention of urine, unspecified

R35.0 Frequency of micturition

R39.11 Hesitancy of micturition

R39.14 Feeling of incomplete bladder emptying

R39.15 Urgency of urination

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




HCPCS Level II Code Number(s)


A4290 Sacral nerve stimulation test lead, each

C1767 Generator, neurostimulator (implantable), nonrechargeable

C1778 Lead, neurostimulator (implantable)

C1787 Patient programmer, neurostimulator

C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)

C1897 Lead, neurostimulator test kit (implantable)

C1894 Introducer/sheath, other than guiding, other than intracardiac electrophysiological, nonlaser

L8679 Implantable neurostimulator, pulse generator, any type

L8680 Implantable neurostimulator electrode, each

L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

L8695 External recharging system for battery (external) for us



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.17.04s:
01/01/2019This policy has been identified for the CPT code update effective 01/01/2019.

The following CPT code narratives have been revised in this policy:
95970, 95971, 95972

11.17.04r
08/15/2018This policy has been reissued in accordance with the Company's annual review process.
12/15/2017This version of the policy will become effective 12/15/2017.

This policy was updated to communicate the Company’s continuing position on Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence.

The intent of the policy remains unchanged however the following policy criteria have been revised for SNS with percutaneous nerve stimulation for temporary test stimulation: documentation of chronic fecal incontinence was changed from three or more incontinent episodes to two or more incontinent episodes.

The following ICD-10 CM code has been removed from this policy:
    N39.3 Stress incontinence (female) (male)

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

Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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