Tibial Nerve Stimulation

POLICY NUMBER

A.7.01.106

DESCRIPTION

Percutaneous tibial nerve stimulation (PTNS, also known as posterior tibial nerve stimulation) is an electrical neuromodulation technique used primarily 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 (eg, 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 nonobstructive retention.

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

TreatmentApproaches to the treatment of incontinence differentiate between urge incontinence and stress incontinence. Conservative behavioral management such as lifestyle modification (eg, dietary changes, weight reduction, fluid management, 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 StimulationThe 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 simulation 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 inserting 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 as evidenced by a tickling sensation and plantarflexion or fanning of all toes. Noninvasive PTNS has also been delivered with transcutaneous or surface electrodes. The recommended course of treatment is an initial series of 12 weekly office-based treatments followed by an individualized maintenance treatment schedule.

Percutaneous tibial nerve stimulation is less invasive than traditional sacral nerve neuromodulation (see Sacral Nerve Neuromodulation/Stimulation medical policy), which has been successfully used to treat 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.

Percutaneous tibial nerve stimulation 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. 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.

Transcutaneous Tibial Nerve Stimulation

The current indication approved by the FDA for transcutaneous tibial nerve stimulation (TTNS) (Vivally System) is for the treatment of individuals with the bladder conditions of urge urinary incontinence and urinary urgency. The device consists of a stimulator that is worn on the ankle and delivers electrical signals to the tibial nerve. This is typically an at-home treatment.

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

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).

FDA-Cleared Percutaneous Tibial Nerve Stimulators (FDA Product Code: NAM)

Related medical policies -

• Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

• Biofeedback as a Treatment of Urinary Incontinence in Adults

• Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

• Percutaneous Electrical Nerve Stimulation, Percutaneous Neuromodulation Therapy, and Restorative Neurostimulation Therapy

• Sacral Nerve Neuromodulation/Stimulation

POLICY

Percutaneous tibial nerve stimulation for an initial 12-week course is 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 is 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.

Subcutaneous tibial nerve stimulation delivered by an implantable peripheral neurostimulator system (e.g., eCoin®) is considered investigational for all indications, including individuals with non-neurogenic urinary dysfunction including overactive bladder.

Transcutaneous tibial nerve stimulation (e.g., Vivally System) is considered investigational for individuals with urge urinary incontinence and urinary urgency.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Individuals may be considered to have failed behavioral therapies following an appropriate duration of 8 to 12 weeks without meeting treatment goals.

Individuals may be considered to have failed pharmacologic therapies following 4 to 8 weeks of treatment without meeting treatment goals.

Annual evaluation by a physician may be performed to ensure efficacy is continuing for maintenance percutaneous tibial nerve stimulation treatments.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

9/29/2006: Policy updated.

10/7/2008: Policy reviewed, no changes.

04/13/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.

12/30/2010: Policy statement updated to add "overactive bladder syndrome" to the list of investigational indications. 

04/18/2011: Policy reviewed; no changes.

07/12/2012: Policy reviewed; no changes.

10/15/2013: Policy reviewed; no changes to policy statement. Code Reference section updated to add CPT code 64566, to add ICD-9 procedure code 04.92, and to delete ICD-9 procedure code 86.09.

03/21/2014: Policy reviewed; policy statement updated to add "neurogenic bladder" to the list of investigational indications.

02/09/2015: Policy title changed from "Posterior Tibial Nerve Stimulation for Voiding Dysfunction" to "Percutaneous Tibial Nerve Stimulation." Policy description updated to add information regarding overactive bladder and fecal incontinence. Policy statement revised to change "posterior" to "percutaneous" and to add fecal incontinence as an investigational indication. It previously stated: Posterior tibial nerve stimulation for urinary dysfunction, including but not limited to overactive bladder syndrome, neurogenic bladder, urinary frequency, urgency, incontinence and retention, is considered investigational.

08/17/2015: Medical policy revised to add ICD-10 codes.

03/09/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.106 added.

09/30/2016: Code Reference section updated to add new ICD-10 procedure codes 05H03MZ, 05H33MZ, and 05H43MZ.

05/31/2018: Medical policy links updated in policy description.

08/15/2018: Policy description updated regarding voiding dysfunction, treatment approaches, and devices. Added medically necessary statement regarding percutaneous tibial nerve stimulation (PTNS) for an initial 12-week course of therapy for individuals with non-neurogenic urinary dysfunction who have met certain criteria. Added statement that maintenance therapy using monthly PTNS is considered medically necessary for individuals following a 12-week initial course of PTNS that resulted in improved urinary dysfunction meeting treatment goals. Investigational statement updated to state that PTNS is investigational for all other indications. Code Reference section updated to add the following ICD-10 diagnosis codes as medically necessary: N32.81, N39.41 - N39.498, R33.0 - R33.9, R35.0, and R39.15.

08/23/2018: Policy description updated regarding neurogenic bladder dysfunction. Policy statements unchanged.

09/11/2019: Policy reviewed; no changes.

12/20/2019: Code Reference section updated to add new CPT codes 0587T, 0588T, 0589T, and 0590T effective 01/01/2020.

09/10/2020: Policy reviewed; no changes.

12/09/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

09/30/2022: Code Reference section updated to add new ICD-10 procedure code X0HK3Q8, effective 10/01/2022.

10/17/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated regarding failed behavioral therapies, failed pharmacologic therapies, and annual evaluations.

12/21/2023: Code Reference section updated to add new 2024 CPT codes 0816T and 0818T. Revised the code descriptions for CPT codes 0587T, 0588T, 0589T, and 0590T, effective 01/01/2024.

03/15/2024: Policy title changed from "Percutaneous Tibial Nerve Stimulation" to "Percutaneous and Subcutaneous Tibial Nerve Stimulation." Policy description updated regarding subcutaneous tibial nerve stimulation and devices. Added links to related medical policies. Policy section updated to add that subcutaneous tibial nerve stimulation delivered by an implantable peripheral neurostimulator system (e.g., eCoin®) is considered investigational for all indications, including individuals with non-neurogenic urinary dysfunction including overactive bladder.

11/01/2024: Policy description updated regarding devices. Policy statements unchanged.

09/15/2025: Policy title changed from "Percutaneous and Subcutaneous Tibial Nerve Stimulation" to "Tibial Nerve Stimulation." Policy description updated regarding transcutaneous tibial nerve stimulation. Added policy statement that transcutaneous tibial nerve stimulation (e.g., Vivally System) is considered investigational for individuals with urge urinary incontinence and urinary urgency. Code Reference section updated to add HCPCS codes A4545, E0736, and E0737 to the Investigational Codes table.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.106

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Investigational Codes

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