Sunflower Health Plan Posterior Tibial Nerve Stimulation for Voiding Dysfunction (PDF) Form

Posterior tibial nerve stimulation (PTNS), also known as peripheral tibial nerve stimulation, is a minimally invasive form of electrical neuromodulation used to treat overactive bladder (OAB) syndrome and associated symptoms of urinary urgency, urinary frequency, and urge urinary incontinence.1 This policy describes the medical necessity requirements for posterior tibial nerve stimulation. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that posterior tibial nerve stimulation (PTNS) is medically necessary for the treatment of moderate to severe urinary dysfunction and overactive bladder (OAB) symptoms when all of the following criteria are met: A. Urinary dysfunction has persisted for at least 12 months and the condition has resulted in significant disability (i.e., the urinary urgency, frequency, and/or severity of symptoms are limiting the member/enrollee's ability to participate in activities of daily living); B. There has been a failure of, contraindications to, or intolerance to conservative medical management (e.g. behavioral therapies such as bladder training or pelvic floor muscle training and pharmacotherapy with oral anti-muscarinics or β3-adrenoceptor agonists and/or antibiotics for urinary tract infections); C. Service is provided in accordance with the standard treatment regimen of 30-minute weekly sessions for 12 weeks. II. It is the policy of health plans affiliated with Centene Corporation that once-a-month maintenance treatments with PTNS are medically necessary for patients who experience significant improvement in their OAB symptoms after the 12 initial treatments. Treatment frequency may vary depending on return of symptoms. III.It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the use of PTNS beyond 12 months or when there is no improvement in urinary dysfunction. IV. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the use of implantable tibial nerve stimulation for the treatment of urinary voiding dysfunction. Background The term “voiding dysfunction" has been used to refer to urinary incontinence, urinary retention, and symptoms of frequency and urgency. Overactive bladder (OAB) is a specific type of voiding dysfunction that includes any of the following symptoms: urinary frequency, urinary urgency, urge incontinence, and nocturia.2 OAB can significantly impact quality of life including physical Page 1 of 7 CLINICAL POLICY Posterior Tibial Nerve Stimulation for Voiding Dysfunction CEN"l'.'ENE" ~·orporatwn function, sexual function, and social interactions. Treatments for OAB include lifestyle changes, bladder training, pelvic floor muscle training and anticholinergic (anti-muscarinic) drugs.3-4 Posterior tibial nerve stimulation (PTNS) involves indirect modulation of the specific nerve that controls bladder function (i.e., the sacral nerve plexus) via stimulation of the posterior tibial nerve accessed just above the ankle. This minimally invasive form of neuromodulation consists of insertion of a 34-gauge needle electrode approximately 5 centimeters (cm) cephalad to the medial malleolus and 2 cm posterior to the tibia near the tibial nerve. A surface electrode is placed on the medial aspect of the foot. The needle electrode is connected via a lead wire to a low-voltage electrical stimulator. Stimulation is administered at a current level of 0.5 to 9 milliamperes (mA) at 20 hertz (Hz) and continues for 30 minutes. Initial treatment regimens typically consist of 12 weekly sessions, with responders exhibiting some symptom improvement after 6 to 8 sessions. Maintenance treatment sessions may be required to sustain the response to treatment.5 Several implantable tibial nerve neuromodulation systems, including a battery-less leadless, miniature implantable device, are currently under investigation for the management of OAB, however, evidence is still limited on their benefits and efficacy at this time. National Institute for Health and Care Excellence (NICE) According to NICE, current evidence demonstrates that PTNS for OAB syndrome is effective in reducing symptoms in the short term and medium term. Per NICE guidance, PTNS for OAB syndrome does not have major safety concerns, and the use of this procedure should with standard protocols for consent, audit, and clinical governance.3 A NICE guidance on urinary incontinence in women does not recommend the “routine” use of PTNS to treat OAB. Rather, they recommend PTNS for OAB for following: • There has been a multidisciplinary team (MDT) review, and • Conservative management including OAB drug treatment has not worked adequately, and • The woman does not want botulinum toxin A or percutaneous sacral nerve stimulation.11 American Urological Association Clinicians may offer PTNS as third-line treatment in a carefully selected patient population, characterized by moderately severe baseline incontinence and frequency and willingness to comply with the PTNS protocol. Patients must also have the resources to make frequent office visits both during the initial treatment phase and to obtain maintenance treatments in order to achieve and maintain treatment effects. The most common protocol is the application of 30 minutes of stimulation once a week for 12 weeks (the trial duration; for continued benefit, weekly stimulation would have to continue).1 Studies to date evaluating PTNS for the treatment of OAB conclude there is evidence of benefit, although most studies have been small and report short-term outcomes after 12 weeks of treatment. A small study of 33 PTNS responders who continued therapy for 6-12 months reported excellent durability through 12 months.6 Another small study reported sustained safety and efficacy of PTNS for the treatment of OAB symptom control over 24 months with initial Page 2 of 7 CLINICAL POLICY Posterior Tibial Nerve Stimulation for Voiding Dysfunction CEN"l'.'ENE" ~·orporatwn success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a personalized treatment plan with an average of 1.3 treatments per month.7 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT codes that support medical necessity CPT® Codes 64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming CPT codes that do not support medical necessity CPT® Codes 0587T 0588T 0589T 0590T Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming and imaging guidance when performed, posterior tibial nerve Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve Electronic analysis with simple programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 1-3 parameters Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 4 or more parameters HCPCS Codes N/A Page 3 of 7 CLINICAL POLICY Posterior Tibial Nerve Stimulation for Voiding Dysfunction CEN"l'.'ENE" ~·orporatwn - ICD-10-CM Diagnosis Codes that Support Coverage Criteria - ICD 10 CM Code N32.81 N39.41 N39.45 N39.46 R32 R35.0 through R35.8 R39.15 R39.81 Overactive bladder Urge incontinence Continuous leakage Mixed incontinence Unspecified urinary incontinence Polyuria Urgency of urination Functional urinary incontinence Reviews, Revisions, and Approvals Policy adopted from Health Net NMP368 Posterior Tibial Nerve Stimulation for Voiding Dysfunction References reviewed and updated. Background updated. References reviewed and updated. Revised I.B, examples of pharmacotherapy, to include oral anti- muscarinics or β3-adrenoceptor agonists. References reviewed and updated. Specialist review. Added to the policy criteria that implantable tibial nerve stimulation is investigational. Added the following CPT codes as investigational: 0587T, 0588T,0589T and 0590T References reviewed and updated. Annual review. Replaced “investigational” language with “insufficient evidence to support.” References reviewed, reformatted and updated. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date." Replaced member with member/enrollee. Specialist review. Annual review. Revised Criteria I.B. to include examples of behavioral therapies such as bladder training or pelvic floor muscle training. Background updated to with no impact on criteria. Dashes removed from code ranges. References reviewed and updated. Revision Date 10/16 Approval Date 10/16 09/17 07/18 07/19 10/17 08/18 08/19 01/20 02/20 07/20 08/21 08/20 08/21 08/22 08/22