Latest Review Date: April 2024

Category: Surgery                                                                 

POLICY:

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals with urinary incontinence and nonobstructive retention who meet all 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
2. There is documented failure or intolerance to conventional conservative therapies (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).
   •  The individual is an appropriate surgical candidate.
   • Incontinence is not related to a neurologic condition.

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals with urinary incontinence and nonobstructive retention who meet all the following criteria:

• All the criteria above (trial period 1-2) are met.
• A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition, (e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction).

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals with fecal incontinence who meets all the following criteria:

• 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.
• There is 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.
• The individual is an appropriate surgical candidate.
• 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.
• Incontinence is not related to a neurologic condition.
• The individual 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.

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals with fecal incontinence who meets all the following criteria:

• All the criteria above (trial period 1-6) are met.
• A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is considered investigational for the treatment of chronic constipation or chronic pelvic pain.

DESCRIPTION OF PROCEDURE OR SERVICE:

Sacral nerve stimulation (SNS), also referred to as sacral nerve neuromodulation (SNM), is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. This evidence review addresses the use of SNS in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, or chronic pelvic pain in individuals with intact neural innervation of the bladder and/or rectum.

Treatment

Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for individuals with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) 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 is kept by the patient and can be 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.

Prior to implantation of the permanent device, patients undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). 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 several days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. Patients then keep track of voiding symptoms while the temporary device is functioning. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device. If patients show a 50% or greater reduction in incontinence 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 patients 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. These include its use instead of PNE, for patients who failed PNE, for patients with an inconclusive PNE, or for patients who had a successful PNE to further refine patient selection.

The permanent device is implanted with the patient under general anesthesia. An incision is made over the lower back, and the electrical leads are placed in contact with the sacral nerve root(s). 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 patient. The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for 1–2 seconds.

This evidence review does not address pelvic floor stimulation, which refers to electrical stimulation of the pudendal nerve. Pelvic floor stimulation is addressed separately (see Medical Policy #201 Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence).

KEY POINTS:

The most recent literature review was performed through February 13, 2024.

Summary of Evidence

For individuals with urinary incontinence who have failed conservative treatment who receive sacral nerve neuromodulation, the evidence includes RCTs and case series. Relevant outcomes are symptoms, morbid events, and treatment, related morbidity. Results from the RCTs and case series with long-term follow-up have suggested that sacral nerve neuromodulation reduces symptoms of urge incontinence, urgency-frequency syndrome, nonobstructive urinary retention, and overactive bladder in selected patients. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with fecal incontinence who have failed conservative treatment who receive sacral nerve neuromodulation, the evidence includes RCTs, systematic reviews, and observational studies including several with long-term follow-up. Relevant outcomes are symptoms, morbid events, and treatment, related morbidity. Although relatively small, the available trials had a low risk of bias and demonstrated improvements in incontinence relative to alternatives in selected patients. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with constipation who have failed conservative treatment who receive sacral nerve neuromodulation, the evidence includes RCTs, systematic reviews, and case series including several with long-term follow-up. Relevant outcomes are symptoms, morbid events, and treatment, related morbidity. The available trials have not consistently reported improvements in outcomes with sacral nerve neuromodulation. Additional studies are needed to demonstrate the health benefits of this technology. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic pelvic pain who receive sacral nerve neuromodulation, the evidence is limited to systemic reviews of case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Urinary Disorders

American Urological Association

In 2019, the American Urological Association 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 β3-adrenoceptor agonists or transdermal oxybutynin) and are willing to undergo surgery.

American College of Obstetricians and Gynecologists (ACOG)

A 2015 practice bulletin on urinary incontinence (replaced practice bulletin number 63, 2005; reaffirmed in 2019) from the College stated, “sacral neuromodulation may be considered for patients with recalcitrant urinary urge incontinence who have failed other conservative measures, including bladder training, pelvic floor physical therapy with biofeedback, and pharmacologic treatment.”

International Continence Society

In 2018, the International Continence Society published a best practice statement on the use of sacral neuromodulation. 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.

National Institute for Health and Care Excellence

In 2020, NICE issued guidance on the Axonics sacral neuromodulation system for treating refractory overactive bladder. The guidance states that the Axonics system should be considered an option for people with refractory overactive bladder. Similarly, 2004 guidance states that use of sacral nerve stimulation for urge incontinence and symptoms of urgency/frequency is supported by evidence of efficacy and safety.

Fecal Disorders

National Institute for Health and Care Evidence

In 2007, NICE issued guidance on management of fecal incontinence. The guidance was reviewed in 2014 and 2018, and no changes were made. The guidance has recommended:  

“A trial of temporary sacral nerve stimulation should be considered for people with faecal incontinence in which sphincter surgery is deemed inappropriate…. 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 faecal 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.”

American College of Gastroenterology

In its 2014 clinical guideline on the management of benign anorectal disorders, including fecal incontinence, the American College of Gastroenterology (ACG) found that "sacral nerve stimulation should be considered in [fecal incontinence] who do not respond to conservative therapy (strong recommendation, moderate quality of evidence)." The 2021 update of these guidelines keep the recommendation for sacral nerve stimulation in patients with fecal incontinence refractory to medical therapy the same as in the 2014 version. 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."

American College of Obstetricians and Gynecologists

A 2019 practice bulletin (reaffirmed 2021) on fecal incontinence from the American College of Obstetricians and Gynecologists (ACOG) stated, "Sacral nerve stimulation can be considered as a surgical treatment option for women with fecal incontinence with or without anal sphincter disruption who have failed conservative treatments."

American Society of Colon and Rectal Surgeons

In 2023, the American Society of Colon and Rectal Surgeons released an updated clinical practice guideline for the treatment of fecal incontinence. 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)."

In 2016, the Society released a clinical practice guideline for the management of constipation. 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)."

Chronic Pelvic Pain

American College of Obstetricians and Gynecologists

A 2020 practice bulletin (reaffirmed 2023) on chronic pelvic pain from ACOG does not mention sacral nerve stimulation or modulation.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Interstim, incontinence, sacral nerve stimulation, sacral neuromodulation, InterStim® II, InterStim iCon™ Patient Programmer, fecal incontinence, urinary incontinence,InterStim X, Virtis, Axonics

APPROVED BY GOVERNING BODIES:

In 1997, the InterStim® Sacral Nerve Stimulation system (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the indication of urinary urge 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 InterStim II System (Medtronic) was approved by the FDA through the premarket approval process for the treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original 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, the FDA approved the use of InterStim® for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for 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.

The InterStim® device has not been specifically approved by the FDA for the treatment of chronic pelvic pain.

In 2019, the Axonics® Sacral Neuromodulation System (Axonics) received premarket approval from the FDA for both fecal incontinence and treatment of urinary retention and symptoms of overactive bladder. This system has a rechargeable battery that has a device life of 15 years after implantation.

In 2023, the Virtis™ Sacral Neuromodulation System (Nuvectra) was approved by the FDA for treatment of urinary retention and symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed more conservative treatments.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

CPT codes:    

64561	Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed
64581	Open implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
64585	Revision or removal of peripheral neurostimulator electrodes array
64590	Insertion or replacement of peripheral, sacral or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver
64595	Revision or removal of peripheral, sacral or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array
95970	Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without programming, first hour
95971	Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
95972	Electronic analysis of implanted neurostimulator pulse generator system (e.g. 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 (i.e. peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

HCPCS:

A4290	Sacral nerve stimulation test lead, each
E0745	Neuromuscular stimulator, electrical shock unit
E1399	Durable medical equipment, miscellaneous
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, non-rechargeable, includes extension
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

REFERENCES:

1. ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. Nov 2015; 126(5):e66-81.
2. 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.
3. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin List of Titles- March 2014. Available online at: www.acog.org/~/media/List%20of%20Titles/PBListOfTitles.pdf?dmc=1&ts=20140311T1415320475.
4. American Urological Association (AUA). Guideline on Diagnosis and Treatment of Overactive Bladder. 2014; //www.auanet.org/education/guidelines/overactive-bladder.cfm.
5. Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. Oct 04 2016; 316(13):1366-1374.
6. Baxter C, Kim JH. Contrasting the percutaneous nerve evaluation versus staged implantation in sacral neuromodulation. Curr Urol 2010; 11(5):310-4.
7. Blok B, Van Kerrebroeck P, de Wachter S, et al. Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol Urodyn. Apr 2020; 39(4): 1108-1114.
8. Bordeianou, L. G., Thorsen, A. J., Keller, D. S., et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. 2023. Diseases of the colon and rectum, 66(5), 647-661. https://doi.org/10.1097/DCR.0000000000002776
9. Chartier-Kastler E, Normand LL, Ruffion A, et al. Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study. Eur Urol Focus. Sep 2022; 8(5): 1399-1407. 
10. Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. Mar 2020; 135(3): e98-e109.
11. De Meyere C, Nuytens F, Parmentier I, et al. Five-year single center experience of sacral neuromodulation for isolated fecal incontinence or fecal incontinence combined with low anterior resection syndrome. Tech Coloproctol. Sep 2020; 24(9): 947-958.
12. Desprez C, Damon H, Meurette G, et al. Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study. Ann Surg. Apr 01 2022; 275(4): 735-742.
13. Diagnosis and treatment of non-neurogenic overactive bladder (OAB) in adults: an AUA/SUFU Guideline (2019). https://www.auanet.org/guidelines/overactive-bladder-(oab)-guideline.
14. 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.
15. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: Medtronic Interstim System for Urinary Control. http://www.accessdata.fda.gov/cdrh_docs/pdf/P970004S004b.pdf.
16. George AT, Kalmar K, Panarese A et al. Long-term outcomes of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum 2012; 55(3):302-6.
17. Goldman HB, Lloyd JC, Noblett KL, et al. International Continence Society best practice statement for use of sacral neuromodulation. Neurourol Urodyn. Jun 2018; 37(5): 1823-1848.
18. Gormley EA, Lightner DJ, Faraday M, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment. J Urol. May 2015; 193(5):1572-1580.
19. Greig J, Mak Q, Furrer MA, et al. Sacral neuromodulation in the management of chronic pelvic pain: A systematic review and meta-analysis. Neurourol Urodyn. Apr 2023; 42(4): 822-836.
20. 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):954-9.
21. 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.
22. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
23. Jottard K, Van den Broeck S, Komen N, et al. Treatment of Fecal Incontinence With a Rechargeable Sacral Neuromodulation System: Efficacy, Clinical Outcome, and Ease of Use-Six-Month Follow-Up. Neuromodulation. Oct 2021; 24(7): 1284-1288.
24. Kamm MA, Dudding TC, Melenhorst J, et al. Sacral nerve stimulation for intractable constipation. Gut. Mar 2010; 59(3):333-340.
25. 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 2012; 255(4):643-9.
26. Leo CA, Thomas GP, Bradshaw E, et al. Long-term outcome of sacral nerve stimulation for faecal incontinence. Colorectal Dis. Dec 2020; 22(12): 2191-2198.
27. 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):1249-52.
28. 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):1443-60.
29. Maeda Y, Lundby L, Buntzen S, et al. Sacral nerve stimulation for constipation: suboptimal outcome and adverse events. Dis Colon Rectum. Jul 2010; 53(7):995-999.
30. 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.
31. Martellucci J, Naldini G, Carriero A. Sacral nerve modulation in the treatment of chronic pelvic pain. Int J Colorectal Dis 2012; 27(7):921-6.
32. 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):1065-75.
33. 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):414-21.
34. National Institute for Health and Care Excellence (NICE). Axonics sacral neuromodulation system for treating refractory overactive bladder [MTG50]. 2020; https://www.nice.org.uk/guidance/mtg50.
35. National Institute for Health and Care Excellence (NICE). Sacral nerve stimulation for urge incontinence and urgency-frequency. IPG64. https://www.nice.org.uk/guidance/ipg64. June 23, 2004. 
36. 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. Feb 2016; 35(2):246-251.
37. Paquette IM, Varma M, Ternent C, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum. Jun 2016; 59(6): 479-92.
38. Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. Jul 2015; 58(7): 623-36.
39. Picciariello A, Rinaldi M, Dibra R, et al. Ageing with sacral nerve modulation for fecal incontinence: how many patients get benefit after more than 10 years?. Updates Surg. Feb 2022; 74(1): 185-191.
40. Pilkington SA, Emmett C, Knowles CH et al. Surgery for constipation; systematic reviews and practice recommendations: Results V: Sacral Nerve Stimulation. Colorectal Dis. Sep 2017; 19 (Suppl 3): 92-100.
41. Siegel S, Noblett K, Mangel J et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared with standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn 2014.
42. 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. Mar 2015; 34(3):224-230.
43. Tan E, Ngo NT, Darzi A et al. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis 2011; 26(3):275-94.
44. 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 2013; 92(8):881-7.
45. Thaha MA, Abukar AA, Thin NN, et al. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. Aug 24 2015; (8):CD004464.
46. Thomas GP, Dudding TC, Rahbour G et al. Sacral nerve stimulation for constipation. Br J Surg 2013; 100(2):174-81.
47. 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 2013; 100(11):1430-47.
48. Wald A, Bharucha AE, Cosman BC, et al. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014 Aug; 109(8):1141-57; (Quiz) 1058. 
49. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am J Gastroenterol. Oct 01 2021; 116(10): 1987-2008.
50. Wexner SD, coller JA, Devroede G et al. Sacral nerve stimulation for fecal incontinence:  results of a 120-patient prospective multicenter study. Ann Surg 2010; 25(3):441-9.
51. Zerbib F, Siproudhis L, Lehur PA, et al. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. Feb 2017; 104(3):205-213.

POLICY HISTORY:

Medical Policy Group, October 2003

Medical Review Committee, December 2003

Medical Policy Administration Committee, December 2003

Medical Policy Group, May 2004 (3)

Medical Policy Administration Committee, May 2004

Available for comment May 17-June 30, 2004

Medical Policy Group, August 2004 (3)

Medical Policy Administration Committee, August 2004

Available for comment August 12-September 25, 2004

Medical Policy Group, August 2006 (3)

Medical Policy Administration Committee, September 2006

Medical Policy Group, August 2009 (1)

Medical Policy Panel, May 2010

Medical Policy Group, June 2010 (3)

Medical Policy Group, November 2010 (3)

Medical Policy Administration Committee, December 2010

Available for comment December 10, 2010 through January 24, 2010

Medical Policy Group, April 2011: (3) Added statement to Approved by Govern. Bodies

Medical Policy Group, December 2011 (3): 2012 Code Updates – verbiage change to 64561, 64581, 64585, 95970, 95972, and 95973.

Medical Policy Group, June 2012 (3): 2012 Updates-Description, Policy, Key Points, & References

Medical Policy Group, December 2012 (3): 2013 Coding Update: Verbiage change to 64561

Medical Policy Panel, April 2013

Medical Policy Group, April 2013 (3):  2013 Updates to Key points and References; minor clarification to policy statement

Medical Policy Group, May 2014 (5):  2014 Coding Update: Deleted code L8680 effective July 1, 2014.

Medical Policy Group, June 2014 (5):  2014 Quarterly Coding Update: Code L8680 did not delete; removed delete date.

Medical Policy Panel, April 2014

Medical Policy Group, July 2014 (4): Added indication of overactive bladder to policy statement. Updated Approved Governing Bodies, Key Points and References.

Medical Policy Administration Committee, August 2014

Available for comment July 28 through September 8, 2014

Medical Policy Group, November 2014: 2015 Coding Update – Code 95972-removed ‘simple’ and ‘brain’ and all references to cranial. Changed from ‘first hour’ to ‘up to one hour’.

Medical Policy Group, March 2015 (6):  Rearranged policy statement; no change to policy intent.

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (6): Added/clarified statement on fecal incontinence policy statement and changed trial stimulation period to 48 hours on both urinary and fecal policy statements; updates to Key Points, Coding and References.

Medical Policy Administration Committee, July 2015

Available for comment July 21 through September 3, 2015

Medical Policy Group, November 2015: 2016 Annual Coding Update. Created a previous coding section and moved cpt code 95973 from current coding to previous coding section. Revised CPT code 95972.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (6): Updates to Key Points, Practice Guidelines and References. No change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (6): Updates to Description, Key Points, Practice Guidelines, Key Words and References; Removed old policy statement from 2013.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, April, 2020

Medical Policy Group, May 2020 (3): 2020 Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, April, 2021

Medical Policy Group, May 2021 (3): 2021 Updates to Key Points. Policy statement updated to remove “not medically necessary,” no other changes to policy statement or intent.

Medical Policy Group, December, 2021: 2022 Annual Coding Update.  Revised CPT code 64581 to state: “Open implantation of neurostimulator electrode array; sacral nerve (transforaminal placement).”

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words, Current Coding and References.

Medical Policy Group, November 2023: 2024 Annual CPT Coding Update: Revised 64590, 64595.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (6): Updates to Key Points, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.