Sacral Nerve Stimulation/Neuromodulation

 

Medical Policy: 08.01.21 

Original Effective Date: September 2013 

Reviewed: June 2016 

Revised: July 2015 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Sacral nerve neuromodulation (SNM), also known as sacral nerve stimulation (SNS), is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. The SNM/SNS 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.

 

Treatment using sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS), is one of several alternative modalities for patients with fecal or urinary incontinence (urge incontinence, urgency-frequency syndrome,  nonobstructive urinary retention or overactive bladder) who have a documented failure or intolerance to conventional conservative therapies.

 

Urinary voiding dysfunction is usually defined as the inability to control urination and are divided into different types:

  • Urinary urge incontinence is defined as the involuntary leakage of urine when there is a strong urge to void due to bladder spasms or contractions with enough force to override the sphincter muscles of the urethra.
  • Urinary urgency-frequency incontinence is defined as strong and abnormal urge to urinate, resulting in frequent urination without a loss of the feeling of the fullness of the bladder.
  • Non-obstructed urinary retention is usually caused by weak pelvic floor muscles or dysfunction in the neural pathway between the brain and bladder and results in the inability to completely empty the bladder of urine.
  • Overactive bladder (OAB) – defined as urinary urgency, usually with urinary frequency and nocturia with or without urgency urinary incontinence

Treatment options for urinary voiding disorders may include behavioral strategies, pharmacological interventions, electrical stimulation or reconstructive surgery.

 

Fecal incontinence is the inability to control bowl movements leading to feces leaking from the rectum. The reported prevalence in the general population is 2% to 3%. Severe fecal incontinence can be socially isolating, an individual with the condition may alter his/her lifestyle to accommodate the likelihood of bowel leakage.

 

Fecal incontinence may be caused by several factors including muscle damage, such as that experienced by childbirth, or after rectal surgery, or from damage to the nerves that control the anal muscle or regulate rectal sensation. Additionally, it may be caused by a reduction in the elasticity of the rectum, which shortens the time between the sensation of the stool and the urgent need to have a bowel movement. Surgery or radation injury can scar and stiffen the rectum. Inflammatory bowel disease can also make the rectum less elastic.

  

Treatment depends on the cause of the incontinence and may include dietary changes, drug therapy, bowel training, sacral nerve stimulation or surgery.

 

Before implantation of the permanent device, patients undergo an initial trial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). This procedure is done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary lead wire is inserted through the test needle and the wire is attached to an external stimulator, which is carried in the pocket or on a belt loop for a trial period of three to seven 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 trial stimulation must demonstrate at least 50 percent reduction in symptoms in order for the permanent placement of the stimulator to be medically indicated.

 

A staged implant 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 U.S. 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 implantable pulse generator (IPG).

 

The implantable pulse generator (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 physician utilizes a console programmer to adjust the device settings and to check the 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 physician. A control magnet is kept by the patient and can be used to the turn the device on and off.

 

Summary

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

 

All other uses of sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS) for incontinence control including but not limited to the treatment of stress or urge incontinence due to neurological condition (e.g. diabetic neuropathy, detrusor hyperreflexia, multiple sclerosis, spinal cord injury), other types of chronic urinary dysfunction, and the treatment of chronic constipation or chronic pelvic pain are considered investigational because safety and/or effectiveness cannot be established based on the peer reviewed medical literature.

 

Practice Guidelines and Position Statements

American Society of Colon and Rectal Surgeons (ASCRS)

2015 practice parameter, The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence states sacral neuromodulation may be considered as first line surgical option for incontinent patients with and without sphincter defects. Grade of Recommendation: Strong recommendation based on moderate quality of evidence, 1B.

  

American Urological Association (AUA)/Society of Urodynamic, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)

In 2014, the American Urological Association (AUA) and the Scoeity of Urodynamic, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) issued an updated guideline on diagnosis and treatment of overactive bladder. The guideline states that sacral neuromodulation may be offered as a third-line treatment in carefully selected patients with severe refractory symptoms or in those who are not candidates for second line therapy (e.g. oral anti-muscarinics, oral B3 – adrenoceptor agnoists or transdermal oxybutynin) and are willing to undergo surgery.

 

American College of Gastroenterolgy (ACG)

In 2014, ACG issued a clinical guideline management of benign anorectal disorders which includes fecal incontinence. Recommendations for surgical treatment include sacral nerve stimulation and states: “sacral nerve stimulation should be considered in patients with fecal incontinence who do not respond to conservative therapy (strong recommendation, moderate quality of evidence).  

 

American College of Obstetricians and Gynecologists (ACOG)

A 2005 position statement considered sacral nerve stimulation to be beneficial for treating chronic voiding dysfunction.

 

National Institute for Clinical Evidence (NICE)

2007 guidance on management of fecal incontinence recommended: A trial of temporary sacral nerve stimulation should be considered for people with fecal incontinence in whom sphincter surgery is deemed inappropriate. These may be patients with intact anal sphincters, or those with sphincter disruption. In those with a defect, contraindications to direct repair may include atrophy, denervation, a small defect, absence of voluntary contraction, fragmentation of the sphincter or a poor-quality muscle.

 

All individuals should be informed of the potential benefits and limitations of this procedure and should undergo a trial stimulation period of at least 2 weeks to determine if they are likely to benefit. People with fecal incontinence should be offered sacral nerve stimulation on the basis of their response to percutaneous nerve evaluation during specialist assessment, which is predictive of therapy success. People being considered for sacral nerve stimulation should be assessed and managed at a specialist center that has experience of performing this procedure.

 

2013 guidance on the management of urinary incontinence in women recommended: Offer percutaneous sacral nerve stimulation to women if: their overactive bladder (OAB) has not responded to conservative management including drugs and botulinum toxin A.

 

Regulatory Status

In 1997, the Medtronic® InterStim® Therapy System received FDA approval for marketing for the indication of urinary incontinence in patients who have failed or could not tolerate more conservative treatments. In 1999, the device received FDA approval for the additional indications of urgency-frequency and urinary retention in patients without mechanical obstruction. In 2006, the Medtronic InterStim II System received FDA approval for treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original system and is reported to be suited for those with lower energy requirements or small stature. The device also includes updated software and programming options. In 2011, Medtronic InterStim System received FDA approval for the indication of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments. The InterStim device has not been specifically approved by the FDA for treatment of chronic pelvic pain. FDA product code: EZW.

 

Prior Approval:

 

Not applicable.

 

Policy:

See Related Medical Polcies

  • Anorectal Biofeedback 02.01.04
  • Fecal Incontinence Management 02.01.51
  • Urinary Incontinence/Voiding Dysfunction Treatments and Devices 02.01.27

Urinary Incontinence

  1. A trial period of sacral nerve neuromodulation (SNM)/sacral nerve stimulator (SNS) with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet all of the following criteria:
    1. There is a diagnosis of at least one of the following:
      • Urge incontinence
      • Urgency-frequency syndrome
      • Non-obstructive urinary retention
      • Overactive Bladder (OAB)
    2. There is documented failure or intolerance to at least two conventional conservative therapies performed for a minimum of 6 months (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy.
    3. Incontinence is not related to a neurologic condition.
  2. Permanent implantation of a sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS) device may be considered medically necessary in patients who meet all of the following criteria:
    1. All of the criteria in A (1-3) above are met; and
    2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 1 week.

Note: A successful trial of a temporary sacral nerve stimulator/neuromodulator is defined as:

  • Urinary retention: At least a 50% reduction in catheter volume/catheterization
  • Urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day
  • Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void.
  • Overactive bladder (OAB): At least 50% reduction in the number of daily incontinence episodes or pads used.

Fecal Incontinence

  1. A trial period of sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS) with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet all of the following criteria:
    1. There is a diagnosis of 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.
    2. There is documented failure or intolerance to conventional conservative therapy (e.g., dietary modification and pharmacologic treatment) for at least a sufficient duration to fully assess its efficacy.
    3. The patient has not had rectal surgery in the previous 12 months, or in the case of cancer, the patient has not had rectal surgery in the past 24 months
    4. 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.
    5. Incontinence is not related to a neurologic condition, including but not limited to peripheral neuropathy or spinal cord injury.
  2. Permanent implantation of a sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS) device may be considered medically necessary in patients who meet all of the following criteria:
    1. All of the criteria in A (1-5) above are met; and
    2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 1 week.

Sacral nerve neuromodulation (SNM)/sacral nerve stimulation (SNS) is considered investigational for all other indications, including but not limited to the following, because safety and/or effectiveness cannot be established based on the peer reviewed medical literature:

  • The treatment of chronic constipation
  • The treatment of chronic pelvic pain
  • Stress incontinence
  • Urge incontinence due to a neurological condition (diabetic neuropathy, detrusor hyperreflexia, multiple sclerosis, spinal cord injury)
  • Other types of chronic voiding dysfunction

 

Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
  • 64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
  • 64585 Revision or removal of peripheral neurostimulator electrode array
  • 64590 Incision and subcutaneous placement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
  • 64595 Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
  • 95970 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming
  • 95971 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
  • 95972 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
  • A4290 Sacral nerve stimulation test lead, each
  • L8679 Implantable neurostimulator, pulse generator, any type
  • L8680 Implantable neurostimulator electrode, each
  • L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
  • L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement
  • 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
  • C1767 Generator, neurostimulator (implantable), nonrechargeable
  • C1778 Lead, neurostimulator (implantable)
  • C1787 Patient programmer, neurostimulator
  • C1816 Receiver and/or transmitter, neurostimulator (implantable)
  • C1820 Generator, neurostimulator (implantable), non high-frequency with rechargeable battery and charging system
  • C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
  • C1897 Lead, neurostimulator test kit (implantable)

 

Selected References:

  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Sacral nerve stimulation for the treatment of urge incontinence. TEC Assessments 1998; Volume 13, Tab 18.
  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Sacral nerve stimulation for the treatment of refractory urinary urgency/frequency in adults. TEC Assessments 2000; Volume 15, Tab 7.
  • Food and Drug Administration (FDA). Summary of Safety and Effectiveness: Medtronic Interstim System for Urinary Control Last accessed Sept, 2013.
  • National Institute for Clinical Evidence (NICE). Faecal incontinence the management of faecal incontinence in adults. NICE clinical guideline 49. 2007.
  • Rao SS, American College of Gastroenterology Practice Parameters C. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol 2004; 99(8):1585-604.
  • American College of Obstetricians and Gynecologists (ACOG). Chronic pelvic pain: ACOG practice bulletin no. 51 2004 (reaffirmed 2008). Last accessed Sept, 2013
  • Medicare National Coverage Decision Sacral Nerve Stimulation for Urinary Incontinence. January 1, 2002. Last accessed Sept, 2013
  • National Institute for Clinical Evidence (NICE) Urinary incontinence: The management of urinary incontinence in women. NICE guideline CG171. 2013.
  • American College of Obstetricians and Gynecologists (ACOG). Urinary Incontinence in Women. Obstet Gynecol. June 2005;105(6):1533-1545. PIMD 15932869
  • American College of Obstetricians and Gynecologists (ACOG). Urinary Incontinence in Women, Practice Bulletin #63, 2005.
  • Anne-Marie Leroi, PhD, Uann Parc, PhD, et. al. Efficacy of Sacral Nerve Stimulation for Fecal Incontinence, Results of a Multicenter Double Blind Crossover Study, Annals of Surgery Volume 242, Number 5, November 2005
  • ECRI Institute Product Brief: InterStim Implantable Sacral Nerve Stimulator (Medtronic, Inc.) for Treating Urinary Incontinence, Published April 2014.
  • Food and Drug Administration (FDA) Premarket Approval Application for Medtronic InterStim Therapy System for the Treatment of Fecal Incontinence March 2011.
  • E. Ann Gormley, Deborah J. Lightner, et. al. American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Guideline – Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults, May 2014.
  • American College of Gastroenterology Patient Education and Resouce Center, Fecal Incontinence Updated July 2013.
  • Paquette Ian M, Varma G. Madhulika. et. al, The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence, Dis Colon Rectum 2015; 58: 623-636
  • UpToDate . Treatment of Urinary Incontinence in Women, Emily S. Lukacz, M.D., MAS. Topic last updated May 13, 2015.
  • UpToDate . Fecal Incontinence in Adults: Management, Kristen M. Robson, M.D., MBA, FACG, Anthony J. Lembo, M.D., Topic last updated November 17, 2014.
  • National Guideline Clearinghouse, Surgical Treatment In: Guidelines on Urinary Incontinence, European Association of Urology (EAU); 2013 Mar. p. 65-100
  • Siegel S, Noblett K, Mangel J, et. al. Results of Prospective, Multicenter Study Evaluating Quality of Life, Safety, and Efficacy of Sacral Neuromodulation at Twelve Months in Subjects with Symptoms of Overactive Bladder, Neurourol Urodyn Dec 24, 2014.
  • Altomare DF, Giuratrabocchetta S, Knowels CH, et. al. Long Term Outcomes of Sacral Nerve Stimulation for Fecal Incontinence. Br J Surg. March 2015; 102(4):407-415. PMID 25644687
  • Dinning PG, Hunt L, Patton V, et. al. Treatment Efficacy of Sacral Nerve Stimulation in Slow Transit Constipation: A Two Phase, Double Blind Randomized Controlled Crossover Study. Am J Gastroenterol. May 2015; 110(5):733-740. PMID 25895520
  • Wald A, Bharucha A, Cosman B, et. al. ACG Clinical Guideline: Management of Benign Anorectal Disorders. AM J Gastroenterol 15 July 2014
  • Siegel S, Noblett K, Mangel J, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. Jan 10 2014. PMID 24415559
  • Noblett K, Siegel S, Mangel J, et al. Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder. Neurourol Urodyn. Dec 24 2014. PMID 25546568
  • Thin NN, Horrocks EJ, Hotouras A, et al. Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg. Oct 2013;100(11):1430-1447. PMID 24037562
  • Hull T, Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. Feb 2013;56(2):234-245. PMID 23303153
  • Altomare DF, Giuratrabocchetta S, Knowles CH, et al. Long-term outcomes of sacral nerve stimulation for faecal incontinence. Br J Surg. Mar 2015;102(4):407-415. PMID 25644687
  • 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.
  • Thomas GP, Dudding TC, Rahbour G, et al. Sacral nerve stimulation for constipation. Br J Surg. Jan 2013;100(2):174-181. PMID 23124687
  • Knowles CH, Thin N, Gill K, et al. Prospective randomized double-blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity. Ann Surg. Apr 2012;255(4):643-649. PMID 22418005
  • Dinning PG, Hunt L, Patton V, et al. Treatment efficacy of sacral nerve stimulation in slow transit constipation: a two-phase, double-blind randomized controlled crossover study. Am J Gastroenterol. May 2015;110(5):733-740. PMID 25895520
  • Tirlapur SA, Vlismas A, Ball E, et al. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. Aug 2013;92(8):881-887. PMID 23710833
  • Martellucci J, Naldini G, Carriero A. Sacral nerve modulation in the treatment of chronic pelvic pain. Int J Colorectal Dis. Jul 2012;27(7):921-926. PMID 22203519

 

Policy History:

  • June 2016 - Annual review, Policy revised
  • July 2015 - Annual review, Policy revised
  • February 2015 - Policy revised
  • August 2014 - Annual review, Policy revised
  • September 2013 - Literature review, New policy

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