Sacral Nerve Neuromodulation / Stimulation for Pelvic Floor Dysfunction
DESCRIPTION
Sacral nerve stimulation (SNS), also referred to as sacral nerve neuromodulation (SNM), is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. There has been research interest in using this technology as a treatment of urinary incontinence, fecal incontinence, constipation and chronic pelvic pain. Before implantation of the permanent device, a nerve stimulation test is necessary to estimate the potential response to the SNS.
This treatment requires the implantation of electrical leads into the lower back, which are in contact with the sacral nerve root(s), most commonly the S3 nerve root. The wire leads are extended through a second incision underneath the skin and across the flank to the lower abdomen. A third incision in the lower abdomen allows for insertion of the pulse generator to deliver controlled electrical impulses through the lead wires. The physician programs the pulse generator to the optimal settings. The individual is able to switch the pulse generator on and off by placing a magnet over the area of the pulse generator for one to two seconds.
Treatment using SNS is one of several alternative modalities for patients with fecal or urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, or nonobstructive urinary retention) who have failed conservative therapies.
POLICY
Sacral nerve stimulation for the treatment of urinary incontinence that includes urge incontinence, non-obstructive urinary retention and/or symptoms of urgency/frequency is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Sacral nerve stimulation for the treatment of fecal incontinence is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Sacral nerve stimulation for the treatment of other conditions/diseases, including, but not limited to, the following is considered investigational:
Urinary incontinence due to neurologic conditions such as detrusor hyperreflexia, multiple sclerosis, cerebrovascular accident or spinal cord injury
Stress incontinence or any other chronic voiding dysfunction
Mechanical obstructions such as benign prostatic hyperplasia, cancer or urethral strictures
Chronic constipation
Chronic pelvic pain
MEDICAL APPROPRIATENESS
Sacral nerve stimulation is considered medically appropriate if ANY ONE of the following are met:
Documented urinary incontinence that includes urge incontinence, nonobstructive urinary retention, and/or symptoms of urgency/frequency and ALL of the following criteria:
There has been a failure of all conservative treatments such as medications, Kegel exercises and behavior modification
A successful nerve stimulation test (success = 50% or greater reduction in incontinence frequency) has been completed with a 1-2 week trial
The individual is at least 16 years of age
The individual is not pregnant
The individual has an adequate bladder capacity and normal urinary tract
The individual has the ability to operate the implantable pulse generator
The individual has the ability to tolerate the surgery
Documented fecal incontinence and ALL of the following criteria:
There has been a failure of, or intolerance to, all conventional therapy (i.e. medications, dietary modification, the addition of bulking and pharmacologic treatment for at least a minimum of 4 months to fully assess its efficacy, and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously)
A successful nerve stimulation test (success = 50% or greater reduction in frequency of incontinence) has been achieved with a 1-2 week trial
The condition is not related to an 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) or chronic inflammatory bowel disease.
Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.
The individual is at least 16 years of age
The individual is not pregnant
The individual has the ability to operate the implantable pulse generator
The individual has the ability to tolerate the surgery
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Sacral nerve stimulation may be affected by or may adversely affect the following:
Automatic internal defibrillator
Cardiac demand pacemakers
Diathermy
Electrocautery
External defibrillators
Ultrasonic equipment
Radiation Therapy
Magnetic resonance imaging
Theft detectors
Safety and effectiveness have not been established for pregnancy and for the pediatric use under the age of 16.
No randomized, controlled, multicenter studies are available in the published literature documenting the safety and efficacy of sacral nerve stimulation/modulation for treatment of other conditions such as:
Urinary incontinence due to neurologic conditions including detrusor hyperreflexia, multiple sclerosis, cerebrovascular accident or spinal cord injury
Stress incontinence or any other chronic voiding dysfunction
Mechanical obstructions such as benign prostatic hyperplasia, cancer or urethral strictures
Chronic constipation
Chronic pelvic pain
SOURCES
Agency for Healthcare Research and Quality. (2007, December). Prevention of urinary and fecal incontinence in adults. Retrieved on July 8, 2010 from www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=erta161.
American Society of Colon and Rectal Surgeons. (August 2007). Practice parameters for the treatment of fecal incontinence. Retrieved July 29, 2010 from http://www.fascrs.org/physicians/practice_parameters/.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2010). Sacral nerve neuromodulation/stimulation for pelvic floor dysfunction (7.01.69). Retrieved July 8, 2010 from BlueWeb. (31 article and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues. [Computer software]. (2010, April). Sacral nerve stimulation for urinary incontinence (NCD 230.8, p. 2-182). Ingenix.
Leroi, A., Parc, Y., Lehur, P., Mion, F., Barth, X., Rullier, E., et al. (2005). Efficacy of sacral nerve stimulation for fecal incontinence. Annals of Surgery. 242 (5) 662-669. (Level 2 Evidence – Industry Sponsored)
Lin, K., Sarosiek, I., & McCallum, R. (2007). Gastrointestinal electrical stimulation for gastrointestinal disorders: Gastroparesis, obesity, fecal incontinence, and constipation. Gastroenterology Clinics of North America, 36 (3), 713-734.
National Guideline Clearing House. (2004, June). Sacral nerve stimulation for urge incontinence and urgency-frequency. Retrieved July 12, 2010 from http://www.nice.org.uk/nicemedia/live/11063/30828/30828.pdf.
National Institute for Health and Clinical Excellence. (2007). Faecal incontinence: The management of faecal incontinence in adults. Retrieved July 28, 2010 from http://www.nice.org.uk/nicemedia/live/11012/30548/30548.pdf.
U. S. Food and Drug Administration. (2001, August). Center for Devices and Radiological Health. Interstim® therapy for urinary control - P970004. Retrieved August 12, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=7515.
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, March) Pelvic floor electrical stimulation for the treatment of urinary incontinence. Retrieved September 10, 2008 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1/2000
MOST RECENT REVIEW DATE: 12/11/2010
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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