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Percutaneous and Subcutaneous Tibial Nerve Stimulation

Policy Number: MP-286

 Latest Review Date: August 2024

Category:  Medical                                                     

POLICY:

Percutaneous tibial nerve stimulation for an initial 12-week course may be considered medically necessary for individuals with non-neurogenic urinary dysfunction including overactive bladder who have both:

  • Failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals; and

  • Failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals.

Maintenance therapy using monthly percutaneous tibial nerve stimulation may be considered medically necessary for individuals following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.

Percutaneous tibial nerve stimulation is considered investigational for all other indications, including but not limited to the following:

  • Neurogenic bladder dysfunction

  • Fecal incontinence.

Posterior tibial nerve stimulation by any other means (e.g. transcutaneous, subcutaneous, implantable) is non-covered and considered investigational.

*See policy #159 for Sacral Nerve Modulation/Stimulation for Pelvic Floor Dysfunction

DESCRIPTION OF PROCEDURE OR SERVICE:

Percutaneous tibial nerve stimulation (PTNS, also known as posterior tibial nerve stimulation) is a technique of electrical neuromodulation primarily used for treating voiding dysfunction.Subcutaneous tibial nerve stimulation via an implantable peripheral neurostimulator is an alternate technique for treating urgency urinary incontinence associated with overactive bladder syndrome.

Voiding Dysfunction

Common causes of non-neurogenic voiding dysfunction are pelvic floor neuromuscular changes (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics, anticholinergics), obesity, and psychogenic factors. Overactive bladder is a non-neurogenic voiding dysfunction characterized by urinary frequency, urgency, urge incontinence, and non-obstructive retention.

Neurogenic bladder dysfunction is caused by neurologic damage in patients with multiple sclerosis, spinal cord injury, detrusor hyperreflexia, diabetes with peripheral nerve involvement. Symptoms include overflow incontinence, frequency, urgency, urge incontinence, and retention.

Treatment

Approaches to the treatment of incontinence differentiate between urge incontinence and stress incontinence. Conservative behavioral management such as lifestyle modification (e.g., dietary changes, weight reduction, fluid management, and smoking cessation) along with pelvic floor exercises and bladder training are part of the initial treatment of overactive bladder symptoms and both types of incontinence. Pharmacotherapy is another option, and different medications target different symptoms. Some individuals experience mixed incontinence.

If behavioral therapies and pharmacotherapy are unsuccessful, percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation, or botulinum toxin may be recommended.

Percutaneous Tibial Nerve Stimulation

The current indication cleared by the U.S. Food and Drug Administration (FDA) for PTNS is overactive bladder and associated symptoms of urinary frequency, urinary urgency, and urge incontinence.

Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. The mechanism of action is believed to be retrograde stimulation of the lumbosacral nerves (L4- S3) via the posterior tibial nerve located near the ankle. The lumbosacral nerves control the bladder detrusor and perineal floor.

Administration of PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low-voltage (10 mA, 1–10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes. The recommended course of treatment is an initial series of 12 weekly office-based treatments followed by an individualized maintenance treatment schedule.

PTNS is less invasive than traditional sacral nerve neuromodulation*, which has been successfully used in the treatment of urinary dysfunction but requires implantation of a permanent device. In sacral root neuromodulation, an implantable pulse generator that delivers controlled electrical impulses is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root that modulates the neural pathways controlling bladder function.

PTNS has also been proposed as a treatment for non-neurogenic and neurogenic bladder syndromes and fecal incontinence.

Subcutaneous Tibial Nerve Stimulation

The current indication approved by the FDA for subcutaneous tibial nerve stimulation (STNS) is urgency urinary incontinence in individuals who are intolerant or who have had an inadequate response to more conservative treatments or who have undergone a successful trial of PTNS. STNS is administered through a coin-sized leadless battery-powered implant (see Governing Bodies section). STNS offers a less invasive alternative to traditional sacral nerve neuromodulation and offers a convenient delivery system for automated treatments without the need for chronic outpatient PTNS treatment sessions.

KEY POINTS:

This evidence review was created and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through June 19, 2024.

Summary of Evidence

For individuals who have non-neurogenic urinary dysfunction including OAB who have failed behavioral and pharmacologic therapy who receive an initial course of PTNS, the evidence includes randomized sham-controlled trials, RCTs with an active comparator, and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The SUmiT and the OrBIT trials are two key industry-sponsored RCTs. Systematic reviews that include these trials and other published trials have found short-term improvements with PTNS. The largest, highest quality study was the double-blinded, sham-controlled SUmiT trial, which reported a statistically significant benefit of PTNS vs sham at 12 weeks. In an additional small sham-controlled trial, a 50% reduction in urge incontinent episodes was attained in 71% of PTNS group compared with 0% in the sham group. The non-blinded OrBIT trial found that PTNS was noninferior to medication treatment at 12 weeks. Adverse events were limited to local irritation effects. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OAB syndrome that have failed behavioral and pharmacologic therapy who respond to an initial course of PTNS who receive maintenance PTNS, the evidence includes observational studies and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The SUmiT and the OrBIT trials each included extension studies that followed individuals who responded to the initial course of PTNS and continued to receive periodic maintenance therapy. There is variability in the interval between and frequency of maintenance treatments and an optimal maintenance regimen remains unclear. There are up to 36 months of observational data available, reporting that there is a durable effect for some of these patients. While comparative data are not available after the initial 12-week treatment period, the observational data support a clinically meaningful benefit for use in individuals who have already failed behavioral and pharmacologic therapy and who respond to the initial course of PTNS. PTNS may allow such individuals to avoid more invasive interventions. Adverse events appear to be limited to local irritation for both short and long-term PTNS use. Typical regimens schedule maintenance treatments every 4-6 weeks. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have non-neurogenic urinary dysfunction including overactive bladder and who have failed behavioral and pharmacologic therapy or who have responded to an initial course of PTNS and then receive subcutaneous tibial nerve stimulation (STNS), the evidence includes single-arm studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The pivotal open-label, single-arm study leading to FDA-approval of the subcutaneously-implanted, wireless eCoin tibial nerve stimulation system demonstrated a 68% response rate at 48 weeks of follow-up which surpassed a performance goal of 40%. However, the certainty of the evidence is limited by the lack of comparator group and a lower response rate observed during the COVID-19 pandemic. Additionally, the FDA noted that the performance goal was identified after patients had already been implanted. An ongoing post-approval study may elucidate the certainty of benefit, including safety of reimplantation given battery lifespan concerns. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have neurogenic bladder dysfunction who receive PTNS, the evidence includes several RCTs and a systematic review of RCTs and observational data. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Only a few RCTs evaluating tibial nerve stimulation for treating neurogenic bladder have been published to date, and all but one performed transcutaneous stimulation rather than PTNS. Studies varied widely in factors, such as the study populations and comparison interventions. Study findings have not reported that tibial nerve stimulation significantly improved incontinence symptoms and other outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fecal incontinence who receive PTNS, the evidence includes several RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The available RCTs have not found a clear benefit of PTNS. None of the sham-controlled trials found that active stimulation was superior to sham for achieving a reduction in mean weekly fecal incontinence episodes. The larger sham-controlled randomized trial did find a significantly greater decrease in the absolute number of weekly incontinence episodes in the active treatment group, but the overall trial findings did not suggest the superiority of PTNS over sham treatment. A meta-analysis of a single RCT and several observational studies reported that patients receiving sacral nerve simulation experienced significant benefits compared with patients receiving PTNS. A post hoc analysis of the larger trial suggested a subset of patients with fecal incontinence (those without concomitant obstructive defecation) may benefit from PTNS. The evidence is insufficient to determine the effects of the technology on health outcomes. A meta-analysis of a single RCT and several observational studies reported that patients receiving sacral nerve simulation experienced significant benefits compared with patients receiving PTNS. A post hoc analysis of the larger trial suggested a subset of patients with fecal incontinence (those without concomitant obstructive defecation) may benefit from PTNS. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Urological Association et al.

In 2019, the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) published updated guidelines on the diagnosis and treatment of non-neurogenic overactive bladder in adults. The guidelines included a statement that clinicians may offer PTNS as a third-line treatment option in carefully selected patients. The statement carried a grade C rating, indicating that the balance of benefits and risks/burdens are uncertain. In 2024,the AUA/SUFU published a guideline on the diagnosis and treatment of idiopathic overactive bladder. In the unabridged version of the guideline, PTNS is mentioned as a minimally invasive therapy option. The guideline states that "Clinicians may offer minimally invasive procedures to patients who are unable or unwilling to undergo behavioral, non-invasive, or pharmacologic therapies (Clinical Principle)" and " Clinicians may offer patients with OAB, in the context of shared decision making, minimally invasive therapies without requiring trials of behavioral, non-invasive, or pharmacologic management (Expert Opinion)".

American College of Obstetricians and Gynecologists

The 2015 American College of Obstetricians and Gynecologists practice bulletin on treatment of urinary incontinence in women did not address PTNS or other types of nerve stimulation.

American Gastroenterological Association

In 2017, the American Gastroenterological Association issued an expert review and clinical practice update on surgical interventions and device-aided therapy for the treatment of fecal incontinence. The update stated that "until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing FI [fecal incontinence] in clinical practice."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Incontinence, Posterior Tibial Nerve Stimulation, Percutaneous Stoller Afferent Nerve System, PerQ SANS System, Urgent® PC Neuromodulation System, Uroplasty, Renova iStim, ZIDA, eCoin, leadless tibial nerve Stimulator, Vivally system

APPROVED BY GOVERNING BODIES:

In 2005, the Urgent® PC Neuromodulation System was the initial device cleared for marketing by FDA through the 510(k) process for PTNS to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. Additional percutaneous tibial nerve stimulators have been cleared for marketing through the 510(k) process. They are listed in Table 1.

The devices are not FDA cleared for other indications, such as the treatment of fecal incontinence.

Wireless technology is evolving for the treatment of overactive bladder. In March 2022, the eCoin® Peripheral Neurostimulator System (Valencia Technologies Corporation) became the first subcutaneous tibial nerve stimulation implant approved by the FDA through the premarket authorization (PMA) process for individuals with urgency urinary incontinence (P200036; FDA Product Code: QPT).

Table 1. FDA-Cleared Percutaneous Tibial Nerve Stimulators

Device Name

Manufacturer

Cleared

510(k)

Indications

Urgent® PC Neuromodulation System

Uroplasty, now Cogentix Medical

Oct 2005

K052025

Indicated for treatment of urinary urgency, urinary frequency, and urge incontinence

Urgent® PC Neuromodulation System

Uroplasty, now Cogentix Medical

Jul 2006

K061333

FDA determined the 70% isopropyl alcohol prep pad contained in the kit is subject to regulation as a drug

Urgent® PC Neuromodulation System

Uroplasty, now Cogentix Medical

Aug 2007

K071822

Labeling update, intended use is unchanged

Urgent® PC Neuromodulation System

Uroplasty, now Cogentix Medical

Oct 2010

K101847

Intended use statement adds the diagnosis of overactive bladder

NURO™ Neuromodulation System

Advanced Uro-Solutions, now Medtronic

Nov 2013

K132561

Intended to treat patients with overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence
ZIDA Wearable Neuromodulation System Exodus Innovations Mar 2021 K192273 Treatment of patients with an overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence
Vivally System, Wearable Non-Invasive Neuromodulation System and Mobile Application Aviation Medical Inc. April 2023 K220454 Treatment of patients with bladder conditions of urinary incontinence and urinary urgency.

FDA: Food and Drug Administration

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:

64566

Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming

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

0587T

Percutaneous implantation or replacement of integrated neurostimulation system for bladder dysfunction including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

0588T

Revision or removal of percutaneously placed integrated neurostimulation system for bladder dysfunction including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

0589T

Electronic analysis with simple programming of implanted integrated neurostimulation system for bladder dysfunction (e.g., 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, posterior tibial nerve, 1-3 parameters  

0590T

Electronic analysis with simple programming of implanted integrated neurostimulation system for bladder dysfunction (e.g., 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, posterior tibial nerve, 4 or more parameters

0816T

Open insertion or replacement of integrated neurostimulation system for bladder dysfunction including electrode(s) (eg, array or leadless), and pulse generator or receiver, including analysis, programming, and imaging guidance, when performed, posterior tibial nerve; subcutaneous (Effective 1/1/24)

0817T

Open insertion or replacement of integrated neurostimulation system for bladder dysfunction including electrode(s) (eg, array or leadless), and pulse generator or receiver, including analysis, programming, and imaging guidance, when performed, posterior tibial nerve; fascial(Effective 1/1/24)

0818T

Revision or removal of integrated neurostimulation system for bladder dysfunction, including analysis, programming, and imaging, when performed, posterior tibial nerve; subcutaneous(Effective 1/1/24)

0819T

Revision or removal of integrated neurostimulation system for bladder dysfunction, including analysis, programming, and imaging, when performed, posterior tibial nerve; subfascial(Effective 1/1/24)

 

HCPCS Codes:

A4545 Supplies and accessories for external tibial nerve stimulator (e.g., socks, gel pads, electrodes, etc.), needed for one month (Eff. 10/1/24)
E0736 Transcutaneous tibial nerve stimulator (Effective 4/1/24) 
E0737 Transcutaneous tibial nerve stimulator, controlled by phone application (Eff. 10/1/24)

L8679            

Implantable neurostimulator pulse generator, any type

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  65. Yoong W, Shah P, Dadswell R Et al. Sustained effectiveness of percutaneous tibial nerve stimulation for overactive bladder syndrome: 2-year follow-up of positive responders. Int Urogynecol J 2012. [Epub ahead of print]
  66. Zonic-Imamovic M, Imamovic S, Cickusic A, et al. Effects of Treating an Overactive Urinary Bladder in Patients with Multiple Sclerosis. Acta Med Acad. Dec 2019; 48(3): 271-277.
  67. Zyczynski HM, Richter HE, Sung VW, et al. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial. Am JGastroenterol. Apr 01 2022; 117(4): 654-667.

POLICY HISTORY:

Medical Policy Group, July 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 17-October 2, 2006

Medical Policy Group, January 2007 (2)

Medical Policy Administration Committee, January 2007

Available for comment January 30-March 8, 2007

Medical Policy Group, July 2008

Medical Policy Administration Committee, July 2008 (2)

Medical Policy Group, July 2010 (1) Description, Key points updated

Medical Policy Group, December 2010, 2011 Code update

Medical Policy Panel, October 2010

Medical Policy Group, December 2010) (2)

Medical Policy Panel, January 2011

Medical Policy Administration Committee, January 2011

Available for comment January 25 – March 7, 2011

Medical Policy Panel May 2012

Medical Policy Group, October 2012 (2): 2012 Updates to Key Points and References

Medical Policy Panel, May 2013

Medical Policy Group, June 2013 (2): 2013 Updates to Description, Key Points and References

Medical Policy Group, July 2013 (2): Update to References

Medical Policy Panel, January 2014

Medical Policy Group, July 2014 (4): Updated Key Points and References.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (6):  2015 Updates – Policy Name, Description, Key Points and References; Policy statement updated to reflect title update and clarified fecal incontinence as a voiding dysfunction example - no change in intent of policy statement.

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (6): Updates to Key Points and References, removed ‘for Voiding and Sexual Dysfunction’ from policy title; clarification of policy statement with no change to policy intent.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Description, Policy statement, Key Points, Governing Bodies and References; Policy coverage change to allow PTNS with coverage criteria.

Available for comment June 2 through July 16, 2018

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (9): Updates to Description, Key Points, Position Statements, References; no change to Policy Statement.

Medical Policy Group, May 2019 (6): Removed 97032, 97014, 64999 from coding section. No change to policy intent.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements, and References. Title changed from Percutaneous Tibial Nerve Stimulation to Posterior Tibial Nerve Stimulation for Voiding Dysfunction.

No changes to policy statement or intent.

Medical Policy Group, November 2019: 2020 Annual Coding Update.  Added CPT codes 0587T, 0588T, 0589T, 0590T to the Current Coding section.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words and References. Policy statement clarified to include non-covered modalities: Posterior tibial nerve stimulation by any other means (e.g., transcutaneous, implantable) is non-covered and considered investigational. Implantable and transcutaneous previously investigational for dates of service prior to August 31, 2021 per MP 495 Investigational Criteria.

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (6): Updates to Description, Key Points, Governing Bodies and References. Title changed to: Percutaneous Tibial Nerve Stimulation.

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (6): Updates to Description, Key Points, Governing Bodies, Current Coding (+64590, +L8679), Key Words, Benefit Application and References. Policy title updated: Percutaneous and Subcutaneous Tibial Nerve Stimulation.

Medical Policy Group, November 2023: 2024 Annual Coding Update.  Added CPT codes 0816T-0819T to the Current Coding section. Codes revised: 64590, 0587T-0590T.

Medical Policy Group, March 2024: April 2024 HCPCS Coding Update. Added HCPCS code E0736 to the Current Coding section.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (6): Updates to Key Points, Key Words, Practice Guidelines, Governing Bodies and References.

Medical Policy Group, September 2024 (6): 2024 Quarterly Coding Update, added new HCPCS code A4545, E0737 to the Current Coding section.

 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.