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JOHNS HOPKINS HEALTHCARE Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS21.01 Page 1 of 6 ACTION: ☐ New Policy Number: ☒ Revising Policy Number: CMS21.01 ☐ Superseding Policy Number: ☐ Archiving Policy Number: ☐ Retiring Policy Number: Effective Date: 08/20/2002 Review Dates: 10/22/03, 10/22/04, 10/21/05, 10/19/06, 6/25/08, 6/4/09, 4/2/10, 8/23/11, 9/6/13, 12/4/2015 Johns Hopkins HealthCare (JHHC) provides a full spectrum of health care products and services for Employer Health Programs, Priority Partners, and US Family Health Plan. Each line of business possesses its own unique contract and guidelines which, for benefit and payment purposes, should be consulted to know what benefits are available for reimbursement. Specific contract benefits, guidelines or policies supersede the information outlined in this policy. POLICY: For US Family Health Plan see TRICARE Policy Manual 6010.57-M, February 1, 2008, Urinary System: Chapter 4, Section 14.1. I. When benefits are provided under the member’s contract, JHHC considers the use of sacral nerve stimulation medically necessary for the treatment of urge incontinence, urinary urgency-frequency syndrome and urinary retention not caused by anatomical urethral obstruction when the following criteria are met: A. The patient has experienced urge incontinence, urinary urgency/frequency or idiopathic urinary retention for at least 12 months and the condition has resulted in significant disability (e.g., the frequency and/or severity of leakages are limiting the patient’s ability to work or participate in activities outside the home); AND B. Pharmacotherapy (e.g., anticholinergics and/or tricyclic antidepressants for urge incontinence or urge-frequency symptoms, alpha blockers and/or anticholinergics for functional outflow obstruction and/or urinary retention, and/or antibiotics for urinary infection if present) as well as behavioral treatments (e.g., pelvic floor exercise, biofeedback, timed voids, and fluid management for urge incontinence or urgefrequency symptoms) or other therapies (self-catheterization for retention patients) have failed; AND C. A test stimulation of the device has provided at least 50% decrease in incontinence symptoms or need for intermittent catheterization in the case of urinary retention. II. Unless specific benefits apply, JHHC considers the use of sacral nerve stimulation for all other conditions investigational, as it does not meet TEC (Technology Evaluation Criteria) #2-5. JOHNS HOPKINS HEALTHCARE Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS21.01 Page 2 of 6 BACKGROUND: Sacral nerve stimulation (SNS) is a procedure often used in patients with severe urinary and bladder issues. If conservative treatment options such as diet modifications, behavioral therapies, and certain medications prove to be ineffective, the patient is then recommended for sacral nerve stimulation. The procedure targets nerves that control the bladder and involves a neurotransmitter device which electrically stimulates nerves in the bladder area. Patients that undergo SNS often experience a decrease in bladder control issues such as urinary urge incontinence. CODING INFORMATION: CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Note: The following CPT/HCPCS codes are included below for informational purposes. Inclusion or exclusion of a CPT/HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. The member's specific benefit plan determines coverage and referral requirements. All inpatient admissions require preauthorization. PRE-AUTHORIZATION REQUIRED Compliance with the provision in this policy may be monitored and addressed through post-payment data analysis and/or medical review audits Employer Health Programs (EHP) **See Specific Summary Plan Description (SPD) CPT ® CODES 64561 64581 64590 Priority Partners (PPMCO) refer to COMAR guidelines and PPMCO SPD then apply policy criteria US Family Health Plan (USFHP), TRICARE Medical Policy supersedes JHHC Medical Policy. If there is no Policy in TRICARE, apply the Medical Policy Criteria DESCRIPTION Percutaneous implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) Incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling JOHNS HOPKINS HEALTHCARE Policy Number CMS21.01 Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Page 3 of 6 64595 Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver HCPCS CODE C1767 Generator, neurostimulator (implantable), nonrechargeable C1778 Lead, neurostimulator (implantable) C1816 Receiver and/or transmitter, neurostimulator (implantable) C1883 Adapter/extension, pacing lead or neurostimulator lead (implantable) C1897 Lead, neurostimulator test kit (implantable) E0745 Neuromuscular stimulator, electronic shock unit L8680 Implantable neurostimulator electrode, each L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Implantable neurostimulator radiofrequency receiver L8682 L8683 L8684 L8685 L8686 L8687 L8688 L8689 L8695 REVENUE CODES 0275 0278 0360 0361 DESCRIPTION Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension External recharging system for battery (internal) for use with implantable neurostimulator, replacement only External recharging system for battery (external) for use with implantable neurostimulator, replacement only DESCRIPTION Medical/Surgical Supplies and Devices- Pacemaker Medical/Surgical Supplies and Devices- Other Implants Operating Room Services-General Operating Room Services- Minor Surgery JOHNS HOPKINS HEALTHCARE Policy Number CMS21.01 Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Page 4 of 6 Ambulatory Surgical Care- General 0490 NO PRE-AUTHORIZATION REQUIRED Compliance with the provision in this policy may be monitored and addressed through post-payment data analysis and/or medical review audits CPT ® CODES 95970 95971 95972 HCPCS CODE A4290 DESCRIPTION Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral(i.e., peripheral nerve, sacral nerve, (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour DESCRIPTION Sacral nerve stimulation test lead, each ICD10 CODES ARE FOR INFORMATIONAL PUPOSES ONLY ICD10 Codes N32.0 – N32.9 N39.0 – N39.9 R32 DESCRIPTION Disorders of bladder Disorders of urinary system Unspecified urinary incontinence JOHNS HOPKINS HEALTHCARE Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS21.01 Page 5 of 6 REFERENCES STATEMENT: Analyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCare (JHHC) Medical Policy Team during the development and implementation of this medical policy. Per NCQA standards, the Medical Policy Team will continue to monitor and review any newly published clinical evidence and adjust the references below accordingly if deemed necessary. CLINICAL: 1. 2. 3. 4. 5. Liu, Y., Xu, G., Luo, M., et al. (2015). Effects of Transcutaneous Electrical Nerve Stimulation at Two Frequencies on Urinary Incontinence in Poststroke Patients: A Randomized Controlled Trial. American Journal of Physical Medicine and Rehabilitation, Epub. Joussain, C., Denys, P. (2015). Electrical Management of Neurogenic Lower Urinary Tract Disorders. Annals of Physical and Rehabilitation Medicine, Vol. 58, Issue 4, p. 245-50. Hood, F.J. (2002). Coverage of Urinary Incontinence Treatment. Southern Medical Journal, Vol. 95, Issue 2, p. 198-201. Amarenco, G., Ismael, S.S., Even-Schneider, A., et al. (2003). Urodynamic Effect of Acute Transcutaneous Posterior Tibial Nerve Stimulation in Overactive Bladder. The Journal of Urology, Vol. 169, Issue 6, p. 2210-2215. Hayes, Inc. (2010). Medical Technology Directory: Implantable Sacral Nerve Stimulation for Urinary Voiding Dysfunction. Retrieved: www.hayesinc.com HEALTHPLAN: 6. 7. 8. Aetna. (2015). Coverage Policy Bulletin: Urinary Incontinence Treatments. Medical Policy Number 0223. Retrieved: http://www.aetna.com/cpb/medical/data/200_299/0223.html United Healthcare. (2011). Coverage Summary: Incontinence- Urinary and Fecal Incontinence, Diagnosis and Treatments. Medical Policy Number: I-SHO-001. Retrieved: https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/enUS/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Pol icies%20and%20Protocols/UnitedHealthcare%20Medicare%20Coverage/Incontinence _Urinary_Fecal_SH_Ovations.pdf Cigna. (2015). Medical Coverage Policy: Extracorporeal Electromagnetic Stimulation for Urinary Incontinence. Medical Policy Number: 0041. Retrieved: https://www.supercoder.com/webroot/upload/general_pages_docs/document/mm_0041 _coveragepositioncriteria_ees_for_ui.pdf JOHNS HOPKINS HEALTHCARE Medical Policy: Sacral Nerve Stimulation for Urge Urinary Incontinence Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS21.01 Page 6 of 6 REGULATORY: 9. 10. Centers for Medicare & Medicaid Services (CMS). (2011). Medicare National Coverage Determinations Manual: Chapter 1, Part 4 (Sections 200-310.1), Coverage Determinations, 230.18, - Sacral Nerve Stimulation for Urinary Incontinence. Retrieved: http://cms.gov/manuals TRICARE. (2008). Urinary System. Policy Manual 6010.57-M, Surgery: Chapter 4, Section 14.1. Authority 32 CFR 199.4(c)(2) and (c)(3). Retrieved: www.tricare.mil