PERCUTANEOUS TIBIAL NERVE STIMULATION Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O757.7.docx Page 1 of 6
Description: Percutaneous Tibial Nerve Stimulation (PTNS): The current indication cleared by the U.S. Food and Drug Administration for PTNS is overactive bladder and associated symptoms of urinary frequency, urinary urgency, and urge incontinence. These symptoms can all be classified as non-neurogenic urinary dysfunctions. PTNS has been investigated as a treatment for fecal incontinence and for use in neurogenic bladder syndromes. A needle is inserted above the medial malleolus into the posterior tibial nerve followed by application of low voltage electrical stimulation. Noninvasive PTNS has been delivered with surface electrodes. The Urgent PC Neuromodulation System and the NURO Neuromodulation System are FDA-approved for treatment of non-neurogenic urinary dysfunction including overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. They are not FDA-approved for other indications, such as the treatment of fecal incontinence or neurogenic bladder. Conservative behavioral therapy management could include lifestyle modification (e.g., dietary changes, weight reduction, fluid management, smoking cessation, and kegel exercises). Criteria: Percutaneous tibial nerve stimulation (PTNS) for an initial 12-week course for the treatment of nonneurogenic urinary dysfunction is considered medically necessary with documentation of BOTH of the following: 1. Failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals. 2. Failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals. Following a 12-week initial course of percutaneous tibial nerve stimulation (PTNS) that resulted in improved non-neurogenic urinary dysfunction meeting treatment goals, maintenance therapy using monthly PTNS is considered medically necessary. O757.7.docx Page 2 of 6
Criteria: (cont.) Percutaneous tibial nerve stimulation for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Fecal Incontinence Neurogenic bladder dysfunction Resources: Literature reviewed 05/15/18. We do not include marketing materials, poster boards and nonpublished literature in our review. The BCBS Association Medical Policy Reference Manual (MPRM) policy is included in our guideline review. References cited in the MPRM policy are not duplicated on this guideline. 1. 7.01.106 BCBS Association Medical Policy Reference Manual. Percutaneous Tibial Nerve Stimulation. Re-issue date 04/12/2018, issue date 07/20/2006. 2. Asari SA, Meurette G, Mantoo S, Kubis C, Wyart V, Lehur PA. Percutaneous tibial nerve versus sacral nerve stimulation for faecal incontinence: a comparative case-matched study. Colorectal Dis. Jun 9 2014. 3. Booth J, Hagen S, McClurg D, et al. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. Apr 2013;14(4):270-274. 4. California Technology Assessment Forum. Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder. 06/20/2012. O757.7.docx Page 3 of 6
Resources: (cont.) 5. George AT, Maitra RK, Maxwell-Armstrong C. Posterior tibial nerve stimulation for fecal incontinence: where are we? World J Gastroenterol. Dec 28 2013;19(48):9139-9145. 6. Hotouras A, Murphy J, Allison M, et al. Prospective clinical audit of two neuromodulatory treatments for fecal incontinence: sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS). Surg Today. May 5 2014. 7. Hotouras A, Murphy J, Walsh U, et al. Outcome of percutaneous tibial nerve stimulation (PTNS) for fecal incontinence: a prospective cohort study. Ann Surg. May 2014;259(5):939-943. 8. Lopez-Delgado A, Arroyo A, Ruiz-Tovar J, et al. Effect on anal pressure of percutaneous posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. Jul 2014;16(7):533-537. 9. MacDiarmid S, Martinson M, Black E. Neurostimulation Treatment for Overactive Bladder: An Evaluation of Cost Effectiveness Data,. Presented at the 2012 AUA Annual Meeting. 10. Martinson M, MacDiarmid S, Black E. Cost of neuromodulation therapies for overactive bladder: percutaneous tibial nerve stimulation versus sacral nerve stimulation. J Urol. Jan 2013;189(1):210-216. 11. Staskin DR, Peters KM, MacDiarmid S, Shore N, de Groat WC. Percutaneous tibial nerve stimulation: a clinically and cost effective addition to the overactive bladder algorithm of care. Curr Urol Rep. Oct 2012;13(5):327-334. 12. Thomas GP, Dudding TC, Nicholls RJ, Vaizey CJ. Bilateral transcutaneous posterior tibial nerve stimulation for the treatment of fecal incontinence. Dis Colon Rectum. Sep 2013;56(9):1075-1079. 13. Thomas GP, Dudding TC, Rahbour G, Nicholls RJ, Vaizey CJ. A review of posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. May 2013;15(5):519-526. O757.7.docx Page 4 of 6
Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O757.7.docx Page 5 of 6
Multi-Language Interpreter Services: (cont.) O757.7.docx Page 6 of 6