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DESCRIPTIONPercutaneous tibial nerve stimulation (PTNS, also known as posterior tibial nerve stimulation) is a technique of electrical neuromodulation used primarily for treating voiding dysfunction.
Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. Although the posterior tibial nerve is located near the ankle, it is derived from the lumbar-sacral nerves (L4-S3), which control the bladder detrusor and perineal floor. Voiding dysfunction includes urinary frequency, urgency, incontinence, and nonobstructive retention. Common causes of voiding dysfunction are pelvic floor dysfunction (eg, from pregnancy, childbirth, surgery, etc), inflammation, medication (e.g., diuretics, anticholinergics), obesity, psychogenic factors, and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyperreflexia, diabetes with peripheral nerve involvement). The current FDA-cleared indication for PTNS is overactive bladder (OAB), which is defined as the presence of urinary urgency, with or without urgency urinary incontinence, that is usually accompanied by frequency and nocturia and is not associated with urinary tract infections or other known pathology.
The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low-voltage (10mA, 1-10 Hz frequency) electrical stimulation which 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 is not cleared by FDA for treating fecal incontinence; however, the treatment has been proposed for this purpose. The manufacturer recommends a course of treatment for fecal incontinence similar to the one used to treat OAB; an initial course of 12 weekly sessions of tibial nerve stimulation followed by a personalized schedule of follow-up treatments.
In July 2005, the Urgent® PC Neuromodulation System (Uroplasty, Inc) received 510(k) marketing clearance for percutaneous tibial nerve stimulation to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. In 2010, the cleared indication was changed to “overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.” The Urgent PC Neuromodulation System is not FDA-cleared for other indications, such as the treatment of fecal incontinence.
Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed in a separate policy. See Sacral Nerve Stimulation.
Pelvic floor stimulation as a treatment of urinary incontinence refers to electrical stimulation of the pudendal nerve and is addressed in a separate policy. See Incontinence Therapy.
Percutaneous tibial nerve stimulation is considered investigational for all indications, including but not limited to the following:
POLICY EXCEPTIONSFederal 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 GUIDELINESInvestigative 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.106
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.