Coverage Policy Manual
Policy #: 2005004
Category: Medicine
Initiated: January 2005
Last Review: May 2024
  Sacral Nerve Stimulation for the Treatment of Fecal Incontinence

Description:
Sacral nerve neuromodulation, also known as sacral nerve stimulation, involves the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function.
 
Fecal incontinence is personally and socially incapacitating. It can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways, central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery. The evidence base consists of 2 RCTs, observational studies including several with long-term follow-up, and systematic reviews of RCTs and uncontrolled studies. Collectively, findings from these studies have suggested that sacral nerve neuromodulation and sacral nerve stimulation improve outcomes when used to treat chronic fecal incontinence in well-selected patients who have failed conservative therapy such as dietary modification, bulking, and pharmacologic treatment.
 
Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for individuals with incontinence who have failed behavioral and/or pharmacologic therapies.
 
The sacral nerve neuromodulation device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet, kept by the individuals, is used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.
 
Before implantation of the permanent device, individuals undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation. This procedure is done with the patient under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for 4 to 7 days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. The results of this test phase are used to determine whether individuals are appropriate candidates for the permanent device. If individuals show a 50% or greater reduction in symptom frequency, they are deemed eligible for the permanent device.
 
The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if individuals show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The 2-stage surgical procedure has been used in various ways. They include its use instead of percutaneous nerve evaluation, for individuals who failed percutaneous nerve evaluation, for with an inconclusive percutaneous nerve evaluation, or for individuals who had a successful percutaneous nerve evaluation to refine individual selection further.
 
The permanent device is implanted with the individuals under general anesthesia. The electrical leads are placed in contact with the sacral nerve root(s) via an incision in the lower back, and the wire leads are extended through a second incision underneath the skin, across the flank to the lower abdomen. Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that individual. The individual can switch the pulse generator on and off by placing the control magnet over the area of the pulse generator for 1 to 2 seconds.
 
Regulatory Status
In 2011, the InterStim® System was approved by the FDA through the premarket approval process for the indication of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.
 
In 2020, the InterStim X™ device was approved by the FDA. This latest generation of the InterStim device does not require recharging and has a battery life of at least 10 years and up to 15 years if used at a low-energy setting.
 
In 2019, the Axonics® Sacral Neuromodulation System (Axonics) received premarket approval from the FDA for fecal incontinence. This system has a rechargeable battery that has a device life of 15 years after implantation.
 
Sacral nerve neuromodulation involves several steps that are identified by the following codes:
 
1. In the first step, the patient undergoes a peripheral nerve stimulation test to determine candidacy for permanent implantation. A temporary test needle is placed percutaneously onto the sacral nerve. The following HCPCS/CPT codes may be used to describe the stimulation tests:
HCPCS codes
    • A4290 Sacral nerve stimulation test lead, each
    • E1399 Bulk leads, needles, and cables
    • E0745 Stimulator electronic shock unit
CPT code
    • 64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
 
2. Open implantation of the electrode array whether as the first stage of the 2-stage implantation procedure, or as the final implantation of the electrode array after a positive percutaneous test, would be reported using the following codes:
HCPCS codes
    • L8680 Implantable neurostimulator electrode each
CPT code
    • 64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
 
3. Open implantation of the neurostimulator pulse generator would be reported using the following codes:
HCPCS codes
    • L8685 Implantable neurostimulator pulse generator, single array, rechargeable
    • L8686 Implantable neurostimulator pulse generator, single array, non-rechargeable
    • L8687 Implantable neurostimulator pulse generator, dual array, rechargeable
    • L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable
CPT code
    • 64590 Incision and subcutaneous placement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
 
4. Some patients will require analysis and reprogramming of the device once implanted. The following CPT codes may be used. A site of service differential may apply.
CPT codes
    • 95970 Electronic analysis of implanted neurostimulator pulse generator system:   Without reprogramming
    • 95972 With intraoperative or subsequent programming, first hour
    • 95973 As above, but each additional 30 minutes after first hour
 
5. Some patients may require revision or removal of the implanted electrodes or pulse stimulator. The following CPT codes may be used.
CPT codes
    • 64585 Revision or removal or peripheral neurostimulator electrode array
    • 64595 Revision or removal of implanted peripheral neurostimulator pulse generator or receiver
Note: HCPCS code L8680 is reported with one unit for each contact point on the implanted lead.

Policy/
Coverage:
Effective June 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Sacral nerve neuromodulation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment of fecal incontinence when all of the following criteria are met:
 
        • chronic fecal incontinence of greater than 2 incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; AND
        • documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously); AND
        • the patient is an appropriate surgical candidate; AND
        • a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND
        • 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; AND
        • incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Sacral nerve neuromodulation for the treatment of fecal incontinence for any circumstance other than those described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, sacral nerve neuromodulation for the treatment of fecal incontinence for any circumstance other than those described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to June 2021
 
Sacral nerve neuromodulation meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of fecal incontinence when all of the following criteria are met:
 
    • chronic fecal incontinence of greater than 2 incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; AND
    • documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously); AND
    • the patient is an appropriate surgical candidate; AND
    • a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND
    • 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; AND
    • incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.
 
Effective January 2005 through April 2010
Sacral nerve stimulation for treatment of fecal incontinence does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.  This treatment is under study in a clinical trial to determine effectiveness.
 
For contracts without primary coverage criteria, sacral nerve stimulation for treatment of fecal incontinence is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
The device is recommended for those patients with fecal incontinence who have an intact or repaired anal sphincter, who have failed conservative treatment or for whom conventional treatment is inappropriate.  Sacral nerve neurostimulation for fecal incontinence has shown improvement in multiple outcome measures (e.g., patient satisfaction, physical functioning, social functioning, coping & behavior, depression and self-perception, and embarrassment) at 24 & 36 months post implantation. Patients undergo a staged procedure with placement of a temporary, percutaneously placed test stimulation lead, followed by operative placement of a permanent quadripolar lead and pacer.  The device is approved by the appropriate regulatory agencies in Europe; it is not yet approved for marketing in the United States, but is under study to determine effectiveness and safety.
 
2009 Update
A small randomized trial of SNS reported decreased episodes of fecal incontinence and improved quality of life (Leroi, 2005).  Following the crossover period, the blinded participants chose the period of stimulation (on or off) that they had preferred. For the 19 who preferred the “on” period, episodes of incontinence fell from 1.7 to 0.7 per week.  However, for the other 5 subjects incontinence episodes increased from 1.7 per week during the “off” period to 3.7 during the “on” period. Four of the 27 participants experienced an adverse event requiring removal. These results suggest that temporary percutaneous stimulation for a 2- to 3-week period does not always successfully identify those for whom a permanent implant will be beneficial. A 2007 Cochrane review identified only 2 controlled trials (2 subjects each) in addition to the study of 27 patients described (Mowatt, 2008).  The authors concluded that SNS can improve continence in selected individuals, but additional studies are needed to confirm these results and also to better define patient selection criteria.
 
In 2008, Tjandra and colleagues randomized 120 patients with severe fecal incontinence to SNS or best supportive therapy, consisting of pelvic floor exercises with biofeedback, bulking agents, and dietary management with a team of dieticians (Tjandra, 2008).  Due to the differences in treatments, this study was not blinded. Exclusion criteria included neurologic disorders and external anal sphincter defects of more than 120 degrees of the circumference, although a “high proportion” of the patients had pudendal neuropathy. Of the 60 patients randomized to SNS, 54 (90%) had successful test stimulation and 53 decided to proceed with implant of the pulse generator. At baseline, the SNS group had an average of 9.5 incontinent episodes per week, and the controls had 9.2. Both groups had an average of 3.3 days per week with incontinence. At 12-month follow-up, episodes had decreased to 1 day per week with 3.1 episodes in the SNS group, but had not changed in the control group (mean 3.1 days per week with 9.4 episodes). Complete continence was achieved in 22 of the 53 SNS patients (42%) and 13 patients (24%) improved by 75% to 99%. None of the patients had worsening of fecal continence. Adverse events included pain at implant site (6%), seroma (2%), and excessive tingling in the vaginal region (9%). Matzel and colleagues reported long-term outcomes from 12 patients with severe incontinence (average of 54% incontinent episodes per week) who underwent SNS between 1994 and 1999 (Matzel, 2008).  In 3 patients the device was removed because of pain or neurologic disease; the remaining 9 patients showed continued efficacy over an average 10-year follow-up (range 7–14 years). Complete continence was achieved in 5 patients (42% of 12), and 3 patients (25%) had less than 10% incontinent episodes. Pulse generator exchange was required in 8 of the 9 patients after a mean of 7 years for battery fatigue. Although promising, additional studies with longer-term results are needed.
 
Practice Guidelines from the American College of Gastroenterology (ACG) in 2004 on the diagnosis and management of fecal incontinence found limited evidence in favor of SNS (Rao, 2004).  The ACG concluded that the precise indication for SNS, its comorbidity, its long-term outcome, and efficacy remain to be defined.
 
Summary
Recent literature indicates increasing study of SNS for the treatment of fecal incontinence and constipation, particularly from outside of the United States. Identification of patients who will respond to SNS remains problematic, and the evidence remains insufficient to determine the effect of this technology on net health outcomes.
 
2010 Update
In 2010, Wexner et al. reported results from a 16-site multicenter FDA investigational device exemption (IDE) trial of sacral nerve stimulation in 120 patients with fecal incontinence (Wexner, 2010). To be included in the study, patients had to complain of chronic fecal incontinence with duration greater than 6 months or for more than 12 months after vaginal childbirth, defined as greater than 2 incontinent episodes on average per week. All patients had failed or were not candidates for more conservative treatments such as dietary modification, the addition of bulking and antidiarrheal agents, and biofeedback therapy. Exclusion criteria included congenital anorectal malformation; previous rectal surgery, if performed within the last 12 months (or 24 months in case of cancer); defects of the external anal sphincter over 60 degrees; chronic inflammatory bowel disease; visible sequelae of pelvic radiation; active anal abscesses and fistulae; neurologic diseases such as clinically significant peripheral neuropathy or complete spinal-cord injury; and anatomic limitations preventing the successful placement of an electrode. A total of 285 patients were evaluated for potential enrollment between 2002 and 2008; 133 were enrolled and underwent acute test stimulation, 129 of the 133 patients progressed to the 2-week subchronic test stimulation, and 120 showed > 50% improvement during the test phase. Of the 120 patients who received a permanent stimulator, 34 exited the study for a variety of reasons both related (i.e., lack of efficacy in 6 and implant site infection or skin irritation in 5) and unrelated to the implant (i.e., death of a local principal investigator). At the time of data cut-off for the manuscript, 111 patients had completed 12 months follow-up, 76 patients completed 2 years, and 34 patients completed 3 years. Conservative analysis based on the initial 133 patients showed a 66% success rate (> 50% improvement), while analysis based on 106 patients who were considered completed cases at 12 months showed an 83% success rate. The success rate based on the 120 patients who received a permanently implanted stimulator would fall between these two figures. Out of 106 completed cases (88% of 120) included in the 12-month results, perfect continence (100% improvement) was reported in about 40%, while an additional 30% of patients achieved 75% or greater improvement in incontinent episodes. Success was lower in patients with an internal anal sphincter defect (65%, n = 20) compared with patients without a defect (87%, n = 86). There were 307 adverse events reported in 96 patients related to the device or therapy, including infection, implant site pain, hematomas, lead fractures or migrations, extremity pain or skin irritation; 26 were considered serious adverse events that were life threatening, required hospitalization, or resulted in persistent or significant disability.
 
Michelsen et al. published a retrospective analysis of all 177 patients who had been seen at their clinic for a percutaneous nerve evaluation test and sacral nerve stimulation (Michelson, 2010). Of these, 142 (80%) had a positive test and 126 received a permanent stimulator. All data were presented as the median. At a follow-up of 24 months, 15 patients (12%) had undergone explantation for decreased function, pain, or infection. Out of the 107 patients who still had the pulse generator in situ, 87 (81%) had improvement in the Wexner incontinence score (17 at baseline to 9). The Wexner incontinence score improved from 16 to 10 at follow-up; similar changes were observed in subjects followed out to 6 years (n = 86 at 2 years, 51 at 3 years, 28 at 4 years, 16 at 5 years, and 10 at 6 years). For those 49 patients who had collected 3-week diaries (stopped in 2006 due to the research burden), episodes of incontinence decreased from a median of 25 at baseline to 2 at 1-year and days of soiling decreased from a median of 16 to 5.
 
Technology Assessments, Guidelines and Position Statements
French implant centers provided a 2010 position statement on sacral nerve stimulation for the management of patients with fecal incontinence, based on review of the evidence and a formal consensus process, (Leroi, 2009):
 
Indications:
    • Severe fecal incontinence, i.e., at least one or more episodes of fecal incontinence per week and/or a significant change in the patient’s quality of life.
    • Without any significant damage (>30% of the anal circumference) to the external anal sphincter, with or without previous repair
    • Failed conservative therapy (diet, antidiarrheals and bulking agents, treatment of incomplete rectal evacuation by any means, and rehabilitation with biofeedback training
    • Double fecal and urinary incontinence (excluding stress urinary incontinence).
 
Contraindications:
    • Congenital anorectal malformation
    • Flatus incontinence alone
    • Recent rectal surgery
    • Present external rectal prolapse
    • Chronic bowel diseases
    • Chronic diarrhea
    • Altered bowl habit associated with abdominal pain
    • Stoma present
    • Complete bilateral or spinal nerve lesions
    • Inappropriate surgical candidate (i.e., bleeding, pregnancy, anatomical limitations, skin disease risking infection, psychiatric disease)
 
Potential Contraindications:
    • Fecal incontinence associated with constipation
    • Non-active inflammatory bowel disease
    • Progressive incomplete neurological disease
 
Guidance from the United Kingdom’s National Institute for Clinical Excellence (NICE) concluded in 2004 that the safety and efficacy of sacral nerve stimulation for fecal incontinence appears adequate to support the use of this procedure.
 
Summary
With consistent and longer-term results from 2 large trials in 2010 (a prospective multicenter investigational trial with 120 patients and a European cohort of 177 patients), together with a randomized controlled trial with 12-month follow-up from 2008, evidence is considered sufficient for sacral nerve stimulation to be an option for the treatment for chronic fecal incontinence in well-selected patients who have failed conservative therapy.
 
It should be emphasized that not all patients will benefit, and that the adverse event rate for this procedure, including serious adverse events, is high. Patients should therefore be provided with adequate information to make an informed choice regarding the potential risks and benefits of this procedure. As concluded in the 2009 Cochrane review of sacral nerve stimulation for urinary incontinence (Herbison, 2009), while some people benefit, more research is needed to improve patient selection, to carry out the implant, and to find why so many fail.
 
The literature on sacral nerve stimulation for constipation or chronic pelvic pain remains insufficient to evaluate the effect of this technology on health outcomes.
 
2012 Update
A literature search was conducted using the MEDLINE database. There was no new information that would prompt a change in the coverage statement.
 
In 2011, Tan and colleagues published a meta-analysis of randomized trials and observational studies published between 2000 and 2008 on SNS for treating fecal incontinence (Tan, 2011). They identified a total of 34 studies that reported on at least one of their outcomes of interest and clearly documented how many patients underwent temporary and permanent SNS.  In the 34 studies, a total of 944 patients underwent temporary SNS and 665 subsequently underwent permanent SNS implantation. There were 279 patients who did not receive permanent implantation, and 154 of these 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 incontinence episodes per week with SNS compared to maximal conservative therapy (weighted mean difference: -6.83; 95% confidence interval [CI]: -8.05 to -5.60, p<0.001). Fourteen studies reported incontinence scores, and when these results were pooled, there was also a significantly greater improvement in scores with SNS compared to conservative therapy (weighted mean difference: -10.57, 95% CI: -11.89 to -9.24, p<0.001).
 
Long-term follow-up of data on the 120 patients who received a permanently implanted stimulator were reported in 2011 by Mellgren and colleagues (Mellgren, 2011). Mean length of follow-up among the 120 patients was 3.1 years, and 83 (69%) completed at least part of the 3-year follow-up assessment. In an intention-to-treat analysis using the last observation carried forward, 79% of patients experienced at least a 50% reduction in the number of incontinent episodes per week compared to baseline, and 74% experienced at least a 50% reduction in the number of incontinent days per week. In a per-protocol analysis at 3 years, 86% of patients experienced at least a 50% reduction in the number of incontinent episodes per week, and 78% experienced at least a 50% reduction in the number of incontinent days per week. By the 3-year follow-up, a total of 334 adverse events that were potentially device-related had been reported in 99 patients; 67% of these occurred within the first year. The most frequently reported adverse events among the 120 patients were implant site pain (28%), paresthesia (15%), implant site infection (10%), diarrhea (6%), and extremity pain (6%). Six infections required surgical intervention (5 device removals and 1 device replacement).
 
In 2011, Maeda and colleagues published a systematic review of studies on complications following permanent implantation of a SNS device for fecal incontinence and constipation (Maeda, 2011). The authors identified 94 articles. The vast majority of studies addressed fecal incontinence. A combined analysis of data from 31 studies on SNS for fecal incontinence reported a 12% suboptimal response to therapy (149 of 1,232 patients). A review of complications reported in the studies found that the most commonly reported complication was pain around the site of implantation, with a pooled rate of13% (81/621 patients). The most common response to this complication was repositioning the stimulator, followed by explantation of the device and reprogramming. The second most common adverse event was infection, with a pooled rate of 4% (40/1025 patients). Twenty-five of the 40 infections (63%) led to explantation of the device.
 
2013 Update
A literature search was conducted using the MEDLINE database through May 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
In 2012, Hull and colleagues reported outcomes in 72 patients (60% of the 120 implanted patients) who had completed a 5-year follow-up visit (Hull, 2013). Sixty-four (89%) of the patients who contributed bowel diary data at 5 years had at least a 50% improvement from baseline in weekly incontinent episodes and 26 of the 72 patients (36%) had achieved total continence. It is uncertain whether outcomes differed in the 40% of patients who were missing from the 5-year analysis.
 
Several small case series have reported long-term follow-up. For example, in 2012, George and colleagues reported on 23 patients who underwent SNS for fecal incontinence after a successful trial of temporary stimulation (George, 2012). Over a median follow-up of 9.5 years, 12 of the 23 patients (48%) maintained full continence. Two patients lost efficacy at 4 years and 5 years, respectively and had the device removed. Nine patients required a change of battery after a mean of 7 years. Three patients died of unrelated causes.
    
 
2014 Update
A literature search conducted through May 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
 
A 2014 study by Altomare et al reported long-term outcome (minimum of 60-month follow-up, median of 84-month follow-up) in patients implanted with an sacral nerve stimulator for fecal incontinence.16 Patients were identified in a European registry and surveyed. Long-term success was defined as maintaining the temporary stimulation success criteria, ie, at least 50% improvement in the number of fecal incontinence episodes (or fecal incontinence symptom score) at last follow-up, compared with baseline. A total of 272 patients underwent permanent implantation of an SNS device and 228 were available for follow-up. A total of 194 of the 272 (71.3%) implanted patients maintained improvement in the long term.
 
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
FECAL INCONTINENCE
Thaha and colleagues published a Cochrane review on sacral nerve stimulation for fecal incontinence and constipation in adults, which included randomized, quasi-randomized, and crossover trials (Thaha, 2015). For fecal incontinence, the review included 6 trials of SNM (n=219), 2 of which used a parallel group design (Thin et al [2015], Tjandra et al [2008]) and the remaining of which used a crossover design. The primary methodological quality issue noted was related to lack of clarity around randomization techniques and allocation concealment. The review concluded, “The limited evidence from the included trials suggests that SNS can improve continence in a proportion of patients with fecal incontinence.”
 
CONSTIPATION
Systematic Reviews
In the 2015 Cochrane review by Thaha and colleagues on sacral nerve stimulation for fecal incontinence and constipation in adults, 2 trials on SNM for constipation were included (Dinning et al [2015], along with an additional crossover trial) (Thaha, 2015). In one trial, the time with abdominal pain and bloating decreased during the “on” period from 79% to 33%. However, in the larger Dinning et al study, there was no improvement with SNM during the “on” period. The review concluded, “SNS did not improve symptoms in patients with constipation.”
 
Randomized Controlled Trials
Zerbib and colleagues reported on a double-blind crossover RCT of SNS in 36 women with refractory constipation (Zerbib, 2016). Subjects were eligible if they had chronic constipation (>1 year), with 2 or fewer bowel movements per week, straining to evacuate with more than 25% of attempts, or sensation of incomplete evacuation with more than 25% of attempts, with lack of response to standard therapies. Thirty-six subjects meeting inclusion criteria underwent an initial peripheral nerve evaluation; those who had adequate symptom improvement to a predefined level were offered permanent SNS implant. After a 2 week washout, subjects were randomized to “on” or “off” for 8 weeks, followed by a 2-week washout, when the groups crossed over. Of the 36 patients enrolled, 20 responded and underwent randomization. Four were excluded; 2 due to wound infection, and 1 each to withdrawal of consent and lack of compliance. At 1-year follow-up, a positive response was observed in 12/20 and 11/20 patients after active and sham stimulation periods, respectively (P=0.746).
 
2018 Update
A literature search conducted using the MEDLINE database through May 2018 did not reveal any new information that would prompt a change in the coverage statement.
 
2019 Update
A literature search was conducted through May 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through May 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A study by Leo et al prospectively evaluated long-term function with sacral nerve stimulation for fecal incontinence (N=256) (Leo, 2020). The median incontinence score improved from 19/24 at baseline to 7/24 at the 6-month follow-up. Of the total cohort, 235 patients were followed for a median of 110 months (range 12-270) with a median continence score of 10/24; this score was confirmed at longer-term follow-up (132 months, range 60-276) of 185 patients.
 
A French study by Desprez et al that retrospectively analyzed prospectively collected data found that long-term efficacy with sacral nerve stimulation was maintained for at least 10 years post-implantation in approximately half of the patients treated for fecal incontinence (Desprez, 2020). A similarly designed study by De Meyere et al in a single-center in Belgium demonstrated that the efficacy of sacral nerve stimulation in patients with fecal incontinence or low anterior resection syndrome was maintained for at least 5 years (De Meyere, 2020).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A study by Picciariello et al identified patients who had a sacral nerve modulation implantation procedure more than 10 years earlier for fecal incontinence to assess long-term functional outcomes and quality of life (Picciariello, 2022). They found that only 17 (27%) of 58 patients originally identified are still experiencing efficacy with sacral nerve modulation, after a median follow-up of 13 years.
 
A systematic review by Pauwels et al assessed the role of neuromodulation for treatment in chronic constipation (Pauwels, 2021). Seventeen studies on sacral nerve modulation were included. Although multiple uncontrolled retrospective and prospective studies included in the analysis demonstrated positive results on the effect of sacral nerve modulation in constipation, 3 RCTs demonstrated no significant improvements in outcomes.
 
The 2021 update of the American College of Gastroenterology clinical guidelines kept the recommendation for sacral nerve stimulation in patients with fecal incontinence refractory to medical therapy the same as in the 2014 version (Wald, 2021). Additionally, due to a lack of evidence supporting efficacy and the risk of adverse events and complications, the 2021 ACG Panel makes a statement stating that sacral nerve stimulation "cannot be recommended in patients with constipation of any type."
 
In 2015, the American Society of Colon and Rectal Surgeons released a clinical practice guideline for the treatment of fecal incontinence (Paquette, 2015). They stated that "sacral neuromodulation may be considered as a first-line surgical option for incontinent patients with and without sphincter defects (Grade of Recommendation: Strong, based on moderate-quality evidence, 1B)."
 
In 2016, the Society released a clinical practice guideline for the management of constipation (Paquette, 2016). In this guideline, they stated "sacral neuromodulation may be an effective treatment for patients with chronic constipation and successful peripheral nerve evaluation test when conservative measures have failed; however, it is not currently approved by the US Food and Drug Administration for this condition in the United States (Grade of Recommendation: Weak, based on moderate quality evidence, 2B)."
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Jottard et al prospectively studied the Axonics system in 15 patients with fecal incontinence (Jottard, 2021). The primary outcome was fecal incontinence episodes at 4 weeks according to self-recorded stool diaries. Response (defined as 50% improvement in fecal incontinence episodes) occurred in 87% of patients. The median number of incontinence episodes decreased from 8 at baseline to 1.5 at both 4 weeks and 6 months (both p=.001).
 
In 2018, the International Continence Society published a best practice statement on the use of sacral neuromodulation (Goldman, 2018). The authors specified that the guideline recommendations applied primarily to the Interstim device and may or may not be applicable to future devices that have become available since that time. For both urinary and bowel disorders, first-line interventions include behavioral therapy, physical therapy, and medical management. Sacral neuromodulation can be offered to patients who fail or have an intolerance to first-line interventions. The guideline also states that sacral neuromodulation is appropriate for interstitial cystitis, bladder pain syndrome, Fowler's syndrome, voiding dysfunction, and nonobstructive urinary retention. However, there was a lack of evidence supporting the use of sacral neuromodulation for chronic pelvic pain unrelated to any of the aforementioned etiologies. For constipation, sacral neuromodulation should only be considered for patients who have had symptoms for at least 1 year, whose symptoms cannot be attributed to a mechanically correctable cause, and when conservative treatment has failed. Contraindications to sacral neuromodulation include lack of response during a therapeutic trial and pregnancy. Relative contraindications may include severe or rapidly progressive neurologic disease, abnormal sacral anatomy, anticipated need for magnetic resonance imaging below the head, and spinal cord injury.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2023, the American Society of Colon and Rectal Surgeons released an updated clinical practice guideline for the treatment of fecal incontinence (Bordeianou, 2023). They stated that "sacral neuromodulation may be considered as a first-line surgical option for incontinent patients with and without sphincter defects (strength of recommendation, conditional; GRADE quality of evidence, low).

CPT/HCPCS:
0786TInsertion or replacement of percutaneous electrode array, sacral, with integrated neurostimulator, including imaging guidance, when performed
0787TRevision or removal of neurostimulator electrode array, sacral, with integrated neurostimulator
0788TElectronic analysis with simple programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters, when performed by physician or other qualified health care professional, spinal cord or sacral nerve, 1 3 parameters
64561Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed
64581Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
64585Revision or removal of peripheral neurostimulator electrode array
64590Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
64595Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
95970Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming
95971Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95972Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex spinal cord or peripheral nerve (eg, sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
A4290Sacral nerve stimulation test lead, each
E0745Neuromuscular stimulator, electronic shock unit
E1399Durable medical equipment, miscellaneous
L8678Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
L8679Implantable neurostimulator, pulse generator, any type
L8680Implantable neurostimulator electrode, each
L8685Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686Implantable neurostimulator pulse generator, single array, non rechargeable, includes extension
L8687Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688Implantable neurostimulator pulse generator, dual array, non rechargeable, includes extension

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