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Date Printed: October 17, 2017: 04:23 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-64000-01

Original Effective Date: 05/15/08

Reviewed: 02/26/15

Revised: 11/01/15

Subject: Percutaneous Tibial Nerve Stimulation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Update    

DESCRIPTION:

Percutaneous tibial nerve stimulation (PTNS, also known as posterior tibial nerve stimulation) is said 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. 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).

The procedure for PTNS consists of the insertion of a needle adjacent to the posterior tibial nerve followed by the application of low-voltage electrical stimulation that produces sensory and motor responses. Noninvasive PTNS has also been delivered with surface electrodes. 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.

The current FDA (U.S. Food and Drug Administration) 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. PTNS has been proposed for the treatment of fecal incontinence but it is not cleared by the FDA for this indication.

POSITION STATEMENT:

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

• Urinary dysfunction, including but not limited to overactive bladder syndrome, neurogenic bladder, urinary frequency, urgency, incontinence, and retention

• Fecal incontinence.

There is insufficient evidence regarding the long-term safety, efficacy, clinical utility, and a standardized maintenance regimen to permit conclusions on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

64566

Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT and PROGRAM EXCEPTIONS.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Posterior Tibial Nerve Stimulation (PTNS) (L32304) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Pelvic Floor Stimulation as a Treatment of Urinary Incontinence, 01-97000-06
Sacral Nerve Neuromodulation/Stimulation, 02-61000-23

Transvaginal Radiofrequency Bladder Neck Suspension for Urinary Stress Incontinence, 02-50000-16

OTHER:

Other names used to report PTNS:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Incontinence, Posterior Tibial Nerve Stimulation
Percutaneous Stoller Afferent Nerve System
PerQ SANS System
UrgentĀ® PC Neuromodulation System

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ), Prevention of Fecal and Urinary Incontinence in Adults, December 2007, accessed at ahrq.gov 02/12/10.
  2. American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline. accessed at auanet.org 01/29/15.
  3. American Urological Association. Position statement on specific therapies for treatment of urinary incontinence. April 2000, accessed at auanet.org 01/26/11.
  4. Blue Cross and Blue Shield Association. Medical Policy Reference Manual. 7.01.106 Percutaneous Tibial Nerve Stimulation, 01/15.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous tibial nerve stimulation for the treatment of voiding dysfunction. TEC Assessments 2013; Volume 28.
  6. Boyle DJ, et al, Percutaneous Tibial Nerve Stimulation for the Treatment of Urge Fecal Incontinence, Diseases of the Colon & Rectum, April 2010, Vol 53, Issue 4, pp 432 – 437.
  7. California Technology Assessment Forum (CTAF), Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder, 2012.
  8. ClinicalTrials.gov, Sustained Therapeutic Effects on Percutaneous Tibial Nerve Stimulation, sponsored by Uroplasty, Inc. accessed 04/23/12.
  9. Finazzi-Agro E, et al, Percutaneous Tibial Nerve Stimulation Effects on Detrusor Overactivity Incontinence are Not Due to a Placebo Effect: A Randomized, Double-Blind, Placebo Controlled Trial, The Journal of Urology, Vol. 184, 2001 – 2006, November 2010.
  10. First Coast Service Options, Inc. (FCSO), Article for Percutaneous Tibial Nerve Stimulation (PTNS) for Voiding Dysfunction (A48472), 02/02/09.
  11. First Coast Service Options, Inc. (FCSO), Local Coverage Determination (LCD) for Posterior Tibial Nerve Stimulation (PTNS) (L32304), 04/23/13, accessed at fcso.com 01/29/15.
  12. Gaziev G, Topazio L, Iacovelli V et al. Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urol 2013; 13:61.
  13. Hayes, Inc. Hayes Search & Summary. Percutaneous Electrical Stimulation of the Tibial Nerve for the Treatment of Urinary Incontinence. Lansdale, PA: Hayes, Inc.; February 2007.
  14. MacDiarmid S, et al, Long-Term Durability of Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder, J Urol. 2010 Jan; 183(1):234-40.
  15. National Guideline Clearinghouse (NGC), Guideline Summary: Urinary incontinence: The Management of Urinary Incontinence in Women, accessed at guideline.gov 03/25/14.
  16. National Institute for Health and Clinical Excellence (NICE), NICE interventional procedure guidance [IPG362] Percutaneous Posterior Tibial Nerve Stimulation for Overactive Bladder Syndrome, 10/10; accessed aat nice.org.uk/guidance 01/31/15.
  17. National Institute for Health and Clinical Excellence (NICE), NICE interventional procedure guidance [IPG395]-Percutaneous Tibial Nerve Stimulation for Faecal Incontinence, 05/11; accessed at nice.org.uk/guidance 01/30/15.
  18. Nuhoğlu B, Fidan V, Ayyildiz A, Ersoy E, Germiyanoğlu C. Stoller afferent nerve stimulation in woman with therapy resistant over active bladder; a 1-year follow up. Int Urogynecol J Pelvic Floor Dysfunct. 2006 May; 17(3): 204-7.
  19. Peters K, Carrico D, Burks F, Validation of a Sham for Percutaneous Tibial Nerve Stimulation (PTNS), Neurourology and Urodynamics 28: 58-61, 2009.
  20. Peters KM, Carrico DJ, MacDiarmid SA, et al, Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation: 24-Month Results of the STEP Study, Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
  21. Peters KM, Carrico DJ, Wooldridge LS et al. Percutaneous Tibial Nerve Stimulation for the Long-Term Treatment of Overactive Bladder: 3-Year Results of the STEP Study. J Urol 2013; 189(6):2194-201.
  22. Peters KM, et al, Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial, The Journal of Urology, Vol 183, Issue 4, pages 1438-1443, 04/10.
  23. Peters KM, 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, The Journal of Urology, Vol 182, Issue 3 pages 1055-1061, 09/09.
  24. Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic Review: Randomized, Controlled Trials of Nonsurgical Treatments for Urinary Incontinence in Women. Ann Intern Med. 2008 Feb 11.
  25. Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Agency for Healthcare Research and Quality;Rockville (MD), 2012, accessed at effectivehealthcare.ahrq.gov 03/19/14.
  26. Van Balken MR, Vergunst H, Bemelmans BL. Prognostic factors for successful percutaneous tibial nerve stimulation. Eur Urol. 2006 Feb; 49(2): 360-5.
  27. Van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int. 2006 Mar; 97(3): 547-50.
  28. Van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Kiemeney LA, Bemelmans BL. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int. 2006 Jan; 97(1): 113-6.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/26/15.

GUIDELINE UPDATE INFORMATION:

05/15/08

New Medical Coverage Guideline.

05/15/09

Annual review: position statement maintained and references updated.

04/15/10

Annual review: position statement maintained; Medicare Advantage program exception and references updated.

01/01/11

Annual HCPCS coding update. Added 64566.

03/15/11

Annual review; position statement maintained and references updated.

06/15/12

Annual review; position statement maintained, Program Exceptions section and references updated.

07/15/13

Annual review; position statement maintained, description section and references updated.

05/15/14

Annual review; position statement maintained and references updated.

03/15/15

Annual review; description section, position statement, title, and references updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 17, 2017: 04:23 PM