Sacral nerve modulation/stimulation (SNS), e.g., InterStim Continence Control Therapy System, is recognized as safe and effective for treatment of urinary urge incontinence, urgency-frequency, or non-obstructive urinary retention not resulting from a neurologic condition.

Other applications of sacral nerve modulation/stimulation are considered experimental/investigational, including but not limited to treatment of the following:

• urinary urge incontinence due to a neurologic condition (340, 436) (e.g., detrusor hyperreflexia - 344.61),
• stress incontinence (625.6, 788.32), 
• other types of chronic voiding dysfunction (788.30, 788.33-788.39, 788.42-788.43, 788.5, 788.61-788.69),
• fecal incontinence (787.6),
• chronic constipation (564.00-564.09), or
• chronic pelvic pain (625.9) 

Scientific evidence does not demonstrate the efficacy of SNS when used for the applications noted above. A participating, preferred, or network provider can bill the member for the denied service.

Sacral nerve modulation/stimulation is considered eligible when documentation is submitted indicating the patient meets all the following criteria:

• The patient has a diagnosis of urinary urge incontinence (788.31), urgency-frequency (788.41), or non-obstructive urinary retention (788.20-788.29) that is not due to a neurologic condition.
• Symptoms of urinary urge incontinence, urgency-frequency, or non-obstructive urinary retention have been present for at least one year's duration and have resulted in significant disability (e.g., the urgency-frequency and/or severity of leakages, or urinary retention are limiting the patient's ability to work or participate in activities outside the home).
• The patient has tried and failed the following conservative treatments:

  Pharmacological - e.g., two different anticholinergic drugs (such as oxybutynin and hyoscyamine) or a combination of an anticholinergic and a tricyclic antidepressant (such as imipramine).

  Behavioral - e.g., pelvic muscle exercises, biofeedback, timed voids, fluid management.

• The patient has had a successful screening peripheral nerve evaluation test.
• A test stimulation of the device has provided at least a 50% reduction in incontinence symptoms.

1. An implantable pulse generator (IPG) and an extension that connects the lead to the IPG.
2. Two external components:
   • a control magnet used by the patient to turn the device on or off
   • a console programmer used by the physician to adjust the settings of the pulse generator.
     

The permanent device is implanted under general anesthesia. An incision is made over the lower back and the electrical leads are placed in contact with the sacral nerve root(s)(64581). Wire leads are extended through a second incision underneath the skin across the flank to the lower abdomen. A third incision is made in the lower abdomen where the pulse generator is inserted (64590) and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that patient. Surgical revision/removal (64585 and 64595) may be required for adverse affects, such as pain at the operative sites or migration of the leads.

NOTE:

When the device is provided by the hospital, the charge should be billed as a facility expense. When the physician incurs the cost of the device (L8680, L8681, L8682, L8684, L8686), the charge should be billed as a professional expense.

Refer to Medical Policy Bulletin Z-7 for additional information on electrical nerve stimulation for other conditions.

Description

Urinary urge incontinence is a sudden uncontrollable loss of urine caused by involuntary bladder wall contractions. Urgency-frequency is defined as an uncontrollable urge to urinate, resulting in very frequent, small volumes. Urinary retention is the inability to completely empty the bladder of urine. Treatment of these conditions can include therapies such as bladder retraining, pelvic muscle/Kegel exercises, and medication. Information concerning these treatments can be found on Medical Policy Bulletin Y-12, Urinary Incontinence Therapy.

An alternative therapy, SNS therapy involves electrical stimulation of the sacral nerves that control voiding function and is performed in two phases: test stimulation and permanent implantation. SNS modulates the neural pathways controlling bladder function/contractions. There has also been research interest in using the device as a treatment of fecal incontinence, constipation and chronic pelvic pain.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

PRN References

06/1999, Sacral Nerve Stimulation for Urinary Urge Incontinence
06/2001, Sacral Nerve Stimulation

Sacral Root Neuromodulation in Idiopathic Nonobstructive Chronic Urinary Retention, Journal of Urology, Vol. 159, No. 5, 05/1998

Long-term Results of a Multicenter Study on Sacral Nerve for Treatment of Urinary Urge Incontinence, Urgency-Frequency, and Retention, Urology, Vol. 56, No. 6, 12/2000

Efficacy of Sacral Nerve Stimulation for Urinary Retention: Results 18 Months After Implantation, Journal of Urology, Vol. 165, No. 1, 01/2001

Sacral Nerve Modulation/Stimulation for Pelvic Floor Dysfunction, National Blue Cross Blue Shield Association Medical Policy Reference Manual, Policy No. 7.01.69, 3/2004

Surgical Treatment Options for Fecal Incontinence, Gastroenterology, Vol. 126, No. 1, 01/2004