|
Medical Policy: 07.01.47
Original Effective Date: February 2009
Reviewed: October 2011
Revised:
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:
Posterior tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation for the treatment of voiding dysfunction in patients who have failed behavioral and/or pharmacologic therapies. Voiding dysfunction includes urinary frequency, urgency, incontinence, and nonobstructive retention. Common causes of voiding dysfunction are pelvic floor dysfunction (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics and anticholinergics), obesity, psychogenic factors, and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyperreflexia, diabetes with peripheral nerve involvement). Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. While 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.
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 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. PTNS studies have reported on 30-minute sessions given weekly for 10–12 weeks. Recently, consideration has been given to increasing the frequency of treatments to 3 times per week to speed achievement of desired outcomes. However, an optimal treatment approach has not been identified, and the durability of PTNS is uncertain.
PTNS must be distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. Thus in PTNS, the location of stimulation is directly in the posterior tibial nerve rather than using the theories of energy flow that guide placement of stimulation for acupuncture.
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. This device was cleared as a class II "nonimplanted, peripheral nerve stimulator for pelvic floor dysfunction" because it was considered to be substantially equivalent to the previously cleared percutaneous Stoller afferent nerve system (PerQ SANS System) in 2001 (K992069, UroSurge, Inc.).
PTNS was developed as a less-invasive treatment alternative to traditional sacral root 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 proposed as an office-based treatment that requires an initial series of 12 treatments followed by a maintenance treatment schedule as determined by the treating physician.
 Top
Prior Approval:
Not applicable
Top
Policy:
Posterior tibial nerve stimulation is considered investigational for all indications, including but not limited to urinary frequency, urgency, incontinence, and retention in the treatment of urinary dysfunction.
The published evidence is insufficient to permit conclusions concerning the effect of this technology on net health outcome. Until the durability of percutaneous tibial nerve stimulation has been demonstrated in well-designed long-term comparative studies and its clinical impact more clearly shown, its efficacy for treating voiding dysfunction remains uncertain.
Top
Procedure Codes and Billing Guidelines:
-
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
-
64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
Top
Selected References:
-
van der Pal F, van Balken MR, Heesakkers JP et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int 2006 Mar; 97(3):547-50.
-
Finazzi Agro E, Campagna A, Sciobica F et al. Posterior tibial nerve stimulation: is the once-a-week protocol the best option? Minerva Urol Nefrol 2005 Jun; 57(2):119-23.
-
van der Pal F, van Balken MR, Heesakkers JP et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int 2006 Jan; 97(1):113-6.
-
Kim SW, Paick JS, Ku JH. Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. Urol Int 2007; 78(1):58-62.
-
-
Peters K, MacDiarmid SA, Wooldridge LS et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol 2009; 182(3):1055-61.
-
Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn 2009; 28(1): 58-61.
-
Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous tibial nerve stimulation for the treatment of voiding dysfunction. TEC Assessments 2010; Volume 25, Tab 8.
-
National Institute for Health and Clinical Excellence (NICE). Percutaneous posterior tibial nerve stimulation for overactive bladder syndrome. London, UK: NICE; October 2010.
-
ECRI. Posterior Tibial Nerve Stimulation For Urge Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2010 August 02. (ECRI Hotline Response). Also available: http://www.ecri.org.
Top
Policy History:
Date Reason Action
October 2011 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
