THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 06/16/2025.
THIS IS NO LONGER AN ACTIVE POLICY. POLICY WAS ARCHIVED ON 06/16/2025.
Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
This medical policy outlines Highmark Health Options services for Posterior Tibial Nerve Stimulation.
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Posterior or Percutaneous Tibial Nerve Stimulation (PTNS) – An indirect external technique for stimulating the sacral plexus. PTNS was developed as a less-invasive treatment alternative to traditional sacral neuromodulation, which has been successfully used in the treatment of urinary dysfunction but requires the implantation of a permanent device. PTNS, rather, is an office-based type of electrical neuromodulation that is used for treating voiding dysfunction in individuals who have failed behavioral and/or pharmacologic therapies. The principle behind PTNS is that stimulation of specific nerves of the pelvic floor through gentle electrical impulses can alter the activity of the bladder, disrupt the signals that lead to symptoms of urinary dysfunction and improve voiding function and control.
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup
Procedures
PTNS may be considered medically necessary in individuals who meet the following criteria:
This policy covers an initial treatment regimen of 30-minute weekly sessions for 12 weeks of PTNS for the treatment of overactive bladder (OAB) symptoms when there is documented failure, contraindication, or an intolerance to first and second line urological, medical management for the above covered conditions as stated in the policy.
More than 12 PTNS treatments are considered not medically necessary when there is no documentation of improvement of symptoms (50% reduction or greater) of urinary frequency, nocturia, and/or urinary urgency.
PTNS maintenance therapy that goes beyond the initial 12 sessions may be considered medically necessary for the treatment of urinary urgency, urinary frequency, and urge incontinence at a frequency of up to one (1) session every month for up to a maximum of three (3) when ALL the following criteria are met:
The maximum lifetime number of PTNS treatments will be 48 total. PTNS treatments that exceed the frequency guidelines listed on the policy are considered not medically necessary.
PTNS not meeting the criteria as indicated in this policy is considered not medically necessary, including but not limited to fecal incontinence.
IMPLANTABLE TIBIAL NERVE STIMULATION
Implantable tibial nerve stimulation is considered not medically necessary.
POST-PAYMENT AUDIT STATEMENT
The medical record must include documentation that reflects the medical necessity criteria and is
subject to audit by Highmark Health Options at any time pursuant to the terms of your provider
agreement.
PLACE OF SERVICE: INPATIENT/OUTPATIENT
Experimental/investigational (E/I) services are not covered regardless of place of service.
PTNS is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Participating facilities will be reimbursed per their Highmark Health Options contract.
Vecchioli-Scaldazza C, Morosetti C, Giampieretti R, et al. Percutaneous tibial nerve stimulation versus electrical stimulation with pelvic floor muscle training for overactive bladder syndrome in women: Reults of a randomized controlled study. Int Braz J Urol. 2017;43(1):121-126.
Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: A systematic review and meta-analysis. International J Colorectal Dis. 2018;33(5):645-8.
Sanagapalli S, Neilan L, Lo JYT, et al. Efficacy of percutaneous posterior tibial nerve stimulation for the management of fecal incontinence in multiple sclerosis: A pilot study. Neuromodulation. 2018;21(7):682-7.
Hayes, Inc. Comparative Effectiveness Review. Comparative Effectiveness Review of Percutaneous Tibial Nerve Stimulation for the Treatment of Symptomatic Non-Neurogenic Overactive Bladder. Lansdale, PA: Hayes, Inc.; 02/04/2020.
Hayes, Inc. Medical Technology Directory. Percutaneous Tibial Nerve Stimulation for the Treatment of Symptomatic Neurogenic Lower Urinary Tract Dysfunction. Lansdale, Pa: Hayes, Inc.; 04/15/2019.
Tutolo M, Ammirati E, Heesakkers J, et al. Efficacy and safety of sacral and percutaneous tibial neuromodulation in non-neurogenic lower urinary tract dysfunction and chronic pelvic pain: A systematic review of the literature. Eur Urol. 2018;73(3):406-418.
Tutolo M, Ammirati E, Van der Aa F. What is new in neuromodulation for overactive bladder? Eur Urol Focus. 2018;4(1):49-53.
Sarveazad A, Babahajian A, Amini N, et al. Posterior tibial nerve stimulation in fecal incontinence: A systematic review and meta-analysis. Basic Clin Neurosci. 2019;10(5):419-431.
Tan K, Wells CI, Dinning P, et al. Placebo response rates in electrical nerve stimulation trials for fecal incontinence and constipation: A systematic review and meta-analysis. Neuromodulation. 2020;23(8):1108-1116.
Bharucha AE, Rao SSC, Shin AS. Surgical interventions and the use of device-aided therapy forthe treatment of fecal incontinence and defecatory disorders. Clin Gastroenterol Hepatol. 2017;15(12):1844-1854.
Kavanagh A, Baverstock R, Campeau L, et al. Canadian Urological Association guideline: Diagnosis, management, and surveillance of neurogenic lower urinary tract dysfunction. Can Urol Assoc J. 2019;13(6): E157-E176.
Rahnama'i MS. Neuromodulation for functional bladder disorders in patients with multiple sclerosis. Mult Scler. 2020;26(11):1274-1280.
Lane GI, Mao-Draayer Y, Barboglio-Romo P, et al. A prospective observational cohort study of posterior tibial nerve stimulation in patients with multiple sclerosis: Design and methods. BMC Urol. 2020;20(1):58.
Canbaz Kabay S, Kabay S, Mestan E, et al. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017;36(1):104-110.
Tudor KI, Seth JH, Liechti MD, et al. Outcomes following percutaneous tibial nerve stimulation (PTNS) treatment for neurogenic and idiopathic overactive bladder. Clin Auton Res. 2020;30(1):61-67.
Andersen K, Kobberø H, Pedersen TB, Poulsen MH. Percutaneous tibial nerve stimulation for idiopathic and neurogenic overactive bladder dysfunction: A four-year follow-up single centre experience. Scand J Urol. 2021;55(2):169-176.
Wang M, Jian Z, Ma Y, Jin X, Li H, Wang K. Percutaneous tibial nerve stimulation for overactive bladder syndrome: A systematic review and meta-analysis. Int Urogynecol J. 2020;31(12):2457- 2471.
Xiong SC, Peng L, Hu X, Shao YX, Wu K, Li X. Effectiveness and safety of tibial nerve stimulation versus anticholinergic drugs for the treatment of overactive bladder syndrome: A meta-analysis. Ann Palliat Med. 2021;10(6):6287-6296.
Horrocks EJ, Chadi SA, Stevens NJ, Wexner SD, Knowles CH. Factors associated with efficacy of percutaneous tibial nerve stimulation for fecal incontinence, based on post-hoc analysis of data from a randomized trial. Clin Gastroenterol Hepatol. 2017;15(12):1915-1921.e2.
Lo CW, Wu MY, Yang SS, Jaw FS, Chang SJ. Comparing the efficacy of OnabotulinumtoxinA, sacral neuromodulation, and peripheral tibial nerve stimulation as third line treatment for the management of overactive bladder symptoms in adults: Systematic review and network metaanalysis. Toxins (Basel). 2020 Feb 18;12(2):128.
Lashin AM, Eltabey NA, Wadie BS. Percutaneous tibial nerve stimulation versus sham efficacy in the treatment of refractory overactive bladder: Outcomes following a shortened 6-week protocol, a prospective randomized controlled trial. Int Urol Nephrol. 2021;53(12):2459-2467.
Vollstedt A, Gilleran J. Update on implantable PTNS devices. Curr Urol Rep. 2020;21(7):28.
Yamashiro J, de Riese W, de Riese C. New implantable tibial nerve stimulation devices: Review of published clinical results in comparison to established neuromodulation devices. Res Rep Urol. 2019; 11:351-357.
Rahnama'i MS. Neuromodulation for functional bladder disorders in patients with multiple sclerosis. Mult Scler. 2020;26(11):1274-1280.
Janssen DA, Martens FM, de Wall LL, van Breda HM, Heesakkers JP. Clinical utility of neurostimulation devices in the treatment of overactive bladder: Current perspectives. Med Devices (Auckl). 2017; 10:109-122.
Te Dorsthorst M, Digesu A, van Kerrebroeck P, et al. Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms. Neurourol
Urodyn. 2022.