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Bladder and Sacral Nerve Stimulation

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Bladder and Sacral Nerve Stimulation POLICY AND PROCEDURE MANUAL Policy Title: Bladder and Sacral Nerve Stimulation Policy Number: G.08 Primary Department: Medical Management NCQA Standard: N/A Affiliated Department(s): N/A URAC Standard: N/A Last Revision Date: 05/2018 Next Review Date: 07/2020 Revision Dates: 06/2014; 02/2015; 04/2015; 06/2016; 06/2017; Review Dates: 09/27/2013; 06/27/2014; 05/2018 03/27/2015; 06/26/2015; 06/24/2016; 06/28/2017; 06/27/2018; 6/26/2019 Effective Date: 11/01/2013 Applicable Lines of Business:☒MeridianCare ☒MeridianHealth ☒MeridianComplete ☒MeridianChoice Applicable States: ☐All ☒MI ☒IL ☐OH ☐_______ ☐________ Applicable Programs: ☒All ☐Other ________________________ Policy is to be published: Internally Only ☐ Internally & Externally ☒ Definitions: Overactive Bladder A term used to describe urinary urgency, usually with urinary frequency and nocturia, with Syndrome (OAB) or without urgency urinary incontinence. Percutaneous Tibial These stimulators deliver retrograde access to the sacral nerve through percutaneous Nerve Stimulator (PTNS) stimulation of the tibial nerve Policy: There are a number of devices available to induce emptying of the urinary bladder by using electrical current which forces the muscles of the bladder to contract. These devices (commonly known as bladder stimulators or pacemakers) are characterized by the implantation of electrodes in the wall of the bladder, the rectal cones, or the spinal cord. While these treatments may effectively empty the bladder, the safety issues involving the initiation of infection, erosion, placement, and material selection have not been resolved. Further, some facilities previously using electronic emptying have stopped using this method due to the pain experienced by patients. Procedure: Specific Diagnoses: A. Sacral Nerve Stimulation: Meridian Health Plan (MHP) considers implantation of the Sacral Neuromodulator (SNM) (e.g. InterStim), a device for unilateral stimulation of the sacral nerve, potentially medically necessary for the treatment of the following diagnosis; Urinary urge incontinence or Urinary urge frequency AND: Medical Management Policy: G.08 Page 1 of 5 The member has experienced urge UI or symptoms of urge-frequency for at least 6 months and the condition has resulted in significant disability (the frequency and/or severity of symptoms are limiting the member's ability to participate in ADL) AND: Active urinary tract infections and anatomical abnormalities of the lower urinary tract have been excluded as a source of urinary dysfunction AND: These aforementioned diagnoses must be made by urodynamic testing with or without EMG evaluation of the bladder. General Information Required: Criteria/Algorithm: SNM for treatment for Overactive Bladder (OAB) and associated conditions (urge incontinence or urinary urge frequency/urgency): SNM is considered a third and final line of therapy for these conditions. Therefore, SNM will only be considered when First and Second-line therapies have failed. These lines of therapy are defined as follows; 1. First-Line Therapy, also known as Pelvic floor rehabilitation, consists of; a. Lifestyle modifications-dietary changes-avoidance of alcohol, caffeine intake, carbonated beverage. b. Bladder training- timed voiding with voiding diary for at least 6 weeks. c. Pelvic floor muscle exercises for at least 6 weeks. d. Fluid management - If patient was drinking excessive fluid intake, decrease fluid intake to < 64 oz/day and before bed if has nocturia. 2. Second-Line Therapy consists of trial and failure of at least two FDA APPROVED oral pharmacological anti- muscarinic agents ON Meridian’s FORMULARY OR Any other medication that has been FDA approved for this use on Meridian’s formulary. **Pharmacologic trials must consist of attempts of dose and delivery modulation (e.g. 5 vs. 10mg, pill vs. patch, immediate vs. extended release preparations). Pharmacologic trials must have been attempted for at least 6 weeks per medicine tried. A second pharmacologic agent can be tried after 6 weeks of no improvement with dose adjusting after every 2 weeks. If some improvement is noted, it can take up to 12 weeks to get maximum efficacy. Constipation and dry mouth should be addressed/treated before abandoning anti-muscarinic treatments. 3. Third-Line Therapy: If an adequate trial of First and Second line therapies have failed, a trial of SNM will be considered. A test stimulation of the device is considered medically necessary for members who meet selection criteria 1 and 2 above. (Note: Sequential stimulation of the right and left sides (no more than 6 stimulations total) is acceptable) A member may be eligible for permanent SNM placement if all of the following criteria are met; a. The temporary SNM trial was successful as defined by voiding diaries completed by member over at least 2 weeks: i. Urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day. ii. Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void b. The device must be FDA approved and used according to FDA labeling (Interstim is currently the only FDA approved device for this indication; and c. The member is 16 years or older B. SNM for treatment of Non-Obstructive Urinary Retention. MHP considers implantation of SNM medically necessary for treatment of non-obstructive urinary retention when all of the following criteria are met: a. The member has experienced urinary retention for at least 12 months as defined as PVR > 30% of total bladder capacity and the condition has resulted in significant disability (the frequency and/or severity of symptoms are limiting the member's ability to participate in daily activities) AND there is concern for adverse outcomes without treatment including risk of infection and increased bladder pressures which are felt to cause risks of upper tract injury and impairment of renal function and b. Pharmacotherapies (e.g., alpha blockers and cholinergics when deemed appropriate, and antibiotics for urinary tract infections) as well as intermittent catheterization have failed or are not well-tolerated; and Medical Management Policy: G.08 Page 2 of 5 c. All other causes of urinary retention have been ruled out (see non-covered conditions) including side effects of medicines, constipation, etc. d. A test stimulation of the device is considered medically necessary for members who meet selection criteria a, b, and c. above. (Note: Sequential stimulation of the right and left sides (no more than 6 stimulations total) is acceptable) A member may be eligible for permanent SNM placement if all of the following criteria are met; a. A test stimulation of the device has provided at least 50 % decrease in residual urine volume/catheterization frequencies documented by member’s voiding diary over at least 2 weeks. b. The device must be FDA approved and used according to FDA labeling (interstim is currently the only FDA approved device for this indication c. The member is 16 years or older. Meridian Health Plan considers removal of an Interstim medically necessary even where the initial implantation of the Interstim was not indicated. C. Percutaneous Tibial Nerve Stimulator (PTNS): Covered for the treatment of overactive bladder and associated symptoms of urinary frequency, urge incontinence, and urinary urgency, when all of the following are present: 1. Symptoms have been present at least 12 months and have resulted in a significant limitation of activities of daily living. 2. Active urinary tract infections and anatomical abnormalities of the lower urinary tract have been excluded as a source of urinary dysfunction. 3. These aforementioned diagnoses must be made by urodynamic testing with or without EMG evaluation of the bladder. 4. First-line therapies have failed as outlined above for SNM. 5. Second-line therapies have failed as outlined above for SNM Continued coverage for monthly maintenance beyond the initial 12 weekly treatments (up to 36 months total) will be considered on a case by case basis depending on documentation of individual member’s response to the treatment as documented by voiding diary for first 2 weeks including: a. Urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day. b. Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void. Absolute Contraindications: MHP considers the SNM device experimental and investigational for members with the following diagnoses: Members with stress incontinence, urinary obstruction, and specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications. Neurogenic urinary retention Pregnancy Diabetes Interstitial cystitis Chronic Pelvic pain Fowler’s syndrome Multiple sclerosis Patients with mechanical obstructions/strictures or cancer Indications that are not covered: PTNS for the treatment of all other indications, including stress incontinence and other non-covered conditions as above, is not covered. Medical Management Policy: G.08 Page 3 of 5 Of Note: The American Urologic Society considers botulism Toxin injections a third-line treatment for urge incontinence, urgency/frequency. Members may possibly be approved for these q 3
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