Background
Sacral Nerve Stimulation for urinary incontinence is covered for the treatment of urinary urge incontinence, urge-frequency syndrome, and urinary retention by the CMS National Coverage Determination (NCD) 230.18, http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf. Direct stimulation of the sacral nerve(s) via an electrode array implanted at the level of the sacrum is the only treatment modality covered by the NCD. In addition, Noridian will cover sacral nerve stimulation by the same modality for the treatment of fecal incontinence, effective March 1, 2012.
Indications and Limitations
Urinary Incontinence
Sacral nerve stimulation is covered for the treatment of urinary urge incontinence, urgency-frequency syndrome, and urinary retention. Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable stimulator would be effective and a permanent implantation in appropriate candidates. Both the test and the permanent implantation are covered.
The NCD describes the following limitations for coverage to all three conditions:
• Patient must be refractory to conventional therapy (documented behavioral, pharmacologic and/or surgical corrective therapy) and be an appropriate surgical candidate such that implantation with anesthesia can occur.
• Patients 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 are excluded.
• Patient must have had a successful test stimulation in order to support subsequent implantation. Before a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation. Improvement is measured through voiding diaries.
Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.
Fecal Incontinence
Noridian will cover sacral nerve modulation/stimulation for fecal incontinence effective March 1, 2012, when all of the following criteria are met:
• Chronic fecal incontinence with greater than two incontinent episodes on average per week and duration of incontinence greater than six months or for more than twelve months after vaginal childbirth; AND
• Documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment); AND
• A successful percutaneous test stimulation, defined as at least 50% sustained (more than one week) improvement in symptoms; AND
• Condition is not related to anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) and/or chronic inflammatory bowel disease; AND
• Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.
Sacral nerve modulation/stimulation is considered experimental, investigational and unproven for the treatment of chronic constipation or chronic pelvic pain.
Sources:
•Internet Only Manual (IOM) Medicare National Coverage Determination Manual, Publication 100-03, Section 230.18 Sacral Nerve Stimulation for Urinary Incontinence;
•Abrams P et al. Fourth International Consultation on Incontinence recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence;
• Neurourol Urodyn. 2010; 29(1):213-40;
• Annals of Surgery, March 2010, Vol 251, Number 3. Sacral Nerve Stimulation for Fecal Incontinence, Results of a 120-Patient Prospective Multicenter Study;
•Michelsen H, Thompson-Fawcett M, Lundy L, Krogh K, Laurberg S, Buntzen S;
•Six Year Experience with Sacral Nerve Stimulation for Fecal Incontinence;
• Dis Colon Rectum. 2010; 53(4)414-421; Mowatt G, Glazener CMA, Jarrett M. Sacral nerve stimulation for fecal incontinence and constipation in adults (Review);
• The Cochrane Library. 2009, Issue 1; National Institute for Health and Clinical Excellence. Fecal incontinence: the management of fecal incontinence in adults. NICE Clinical Guideline 49, June 2007;
•Trailblazer Health Enterprises, Local Coverage Determination for Sacral Nerve Stimulation – 4S-154AB-R9, Effective March 01, 2008
