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DESCRIPTIONSacral 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. This policy addresses use of SNS in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, or chronic pelvic pain.
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 behavioral (e.g., prompted voiding) and/or pharmacologic therapies. Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgency-frequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes and is a prominent symptom of interstitial cystitis. Urinary retention is the inability to completely empty the bladder of urine. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways, central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery.
The SNS device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet is kept by the patient and can be used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.
Prior to implantation of the permanent device, patients undergo a peripheral nerve stimulation test to estimate potential response to SNS. This procedure is done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for several days. This lead is connected to an external stimulator, which is carried by patients in their pocket or belt. Patients then keep track of voiding symptoms while the temporary device is functioning. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device. If patients show a 50 percent or greater reduction in incontinence frequency, they are deemed eligible for the permanent device. According to data from the manufacturer, approximately 63 percent of patients have a successful peripheral nerve evaluation and are thus candidates for the permanent SNS.
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). The wire leads are extended through a second incision underneath the skin across the flank to the lower abdomen. Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that patient. The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for 1-2 seconds.
In 1997, the Medtronic InterStim® Sacral Nerve Stimulation (SNS) system received U.S. Food and Drug Administration (FDA) approval for marketing for the indication of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. In 1999, the device received FDA approval for the additional indications of urgency frequency and urinary retention in patients without mechanical obstruction.
In 2006, the Medtronic Insterstim® II System received U.S. Food and Drug Administration (FDA) approval for treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original system and is reported to be suited for those with lower energy requirements or small stature. The device also includes updated software and programming options.
In 2011, the Medtronic InterStim System received FDA approval for the indication of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.
POLICYUrinary Incontinence and Non-obstructive Retention
A. A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet all of the following criteria:
1. There is a diagnosis of at least one of the following:
2. There is documented failure or intolerance to at least two conventional therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy)
3. Incontinence is not related to a neurologic condition;
B. Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet all of the following criteria:
1. All of the criteria in I. A (1-3) above are met.
2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 2 weeks
Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition, e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction.
Sacral nerve neuromodulation may be considered medically necessary for the treatment of fecal incontinence when all of the following criteria are met:
1. chronic fecal incontinence of greater than 2 incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; AND
2. documented failure or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously); AND
3. the patient is an appropriate surgical candidate; AND
4. a successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND
5. 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; AND
6. incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.
Sacral nerve neuromodulation is considered investigational in the treatment of chronic constipation or chronic pelvic pain.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESSacral nerve stimulation involves several steps. Some patients will require analysis and reprogramming of the device once implanted. Some patients may require revision or removal of the implanted electrodes or pulse stimulator.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1998: Approved by the Medical Policy Advisory Committee (MPAC), HCPCS E0751, E0753 added
5/21/2001: Code Reference section revised; E0751 deleted, typo 64586 should be 64585, ICD-9 diagnosis codes added, CPT code 95972, 95973 added
2/15/2002: Investigational definition added
2/21/2002: CPT codes updated in the policy section, HCPCS E0751 added
5/2/2002: Type of Service and Place of Service deleted
5/30/2002: ICD-9 procedure code 04.93 added
6/21/2004: Sources updated, Code Reference section updated, HCPCS E0751, E0753 deleted, HCPCS E0752, E0754, E0759 added, CPT codes 95970, 95971 description revised,CPT 95972, 95973 deleted, ICD diagnosis code range 788.20-788.29 listed separately
2/21/2005: CPT code 64561, 64555, 64581, 64590 description revised, ICD-9 procedure code 04.92, 04.93 description revised, HCPCS E0745 description revised
10/18/2005: Policy Guidelines updated
11/15/2005: ICD9 procedure codes 86.97, 86.98 added
3/21/2006: Coding updated. HCPCS 2006 revisions added to policy
3/23/2006: Policy reviewed, no changes
9/22/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
1/3/2007: Policy section re-written for clarification
9/18/2007: Policy reviewed, no changes. Title of policy changed to "Sacral Nerve Neuromodulation/Stimulation for Pelvic Floor Dysfunction", formerly titled "Sacral Nerve Stimulation (SNS) for Urinary Incontinence"
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
7/23/2009: Policy Statement Section updated to include criteria for medically necessary treatments of urge incontinence, urgency-frequency, and non-obstructive urinary retention, Code Reference Section updated with ICD-9 Procedure codes 04.92 and 86.94 added to Covered Codes Table for second step, CPT codes 95972 and 95973 added to Covered Codes Table for third step, Deleted HCPCS codes E0754, E0756, E0757, and E0758 removed from Covered Codes table second step
06/24/2010: Policy description updated to include information regarding sacral nerve neuromodulation for fecal incontinence. Policy statement regarding fecal incontinence changed from investigational to medically necessary under specified conditions. FEP verbiage added to the Policy Exceptions section. Added ICD-9 code 787.6 to the Covered Codes table.
10/19/2010: Annual ICD-9 code update: 787.6 deleted/expanded to the fifth digit. Added 787.60 and 787.63 to the Covered Codes table.
07/29/2011: Policy description updated regarding available devices. Policy statement unchanged.
07/12/2012: Policy statement regarding Urinary Incontinence and Non-obstructive Retention divided into two parts for trial and permanent implantation. Deleted outdated references from the Sources section.
SOURCE(S)Blue Cross Blue Shield Association policy #7.01.69
CODE REFERENCEThis is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.
The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.