Sacral Nerve Stimulation Coverage Guidance

Sacral nerve stimulation is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder function. This treatment is one of several alternative modalities for patients with urge urinary incontinence whose incontinence has been refractory to behavioral and pharmacologic treatment.

This treatment involves electrical stimulation of the sacral nerves in the lower region of the spine via a totally implantable system. System components include a lead, an implantable pulse generator and an extension that connects the lead to the pulse generator. It is expected that the physician performing this service has completed a training course in the use and implantation of the device.

Sacral nerve stimulation is covered for the following indications and limitations under CMS National Coverage Determination 230.18:

•    Urinary urge incontinence.
•    Urgency-frequency syndrome.
•    Urinary retention.
Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable stimulator would be effective and if a permanent implantation is appropriate for candidates. Both the test and the permanent implantation are covered.

•    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 or specific neurologic disease (e.g., diabetes with peripheral nerve involvement) with associated secondary manifestations of the above indications are excluded from coverage for test stimulation and permanent implantation of sacral nerve stimulation.
•    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:

Sacral nerve neuromodulation may be considered medically necessary for the treatment of fecal incontinence when ALL of the following criteria are met:
•    chronic fecal incontinence of greater than two incontinent episodes on average per week with duration greater than six months; 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% improvement in symptoms, was performed; AND
•    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
•    incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.
Sacral nerve neuromodulation is considered experimental, investigational and unproven in the treatment of chronic constipation or chronic pelvic pain.

Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

As published in CMS IOM 100-08, Chapter 13, Section 13.5.1, in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
•    Safe and effective.
•    Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the CLinical Trials NCD are considered reasonable and necessary).
•    Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
o    Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.
o    Furnished in a setting appropriate to the patient's medical needs and condition.
o    Ordered and furnished by qualified personnel.
o    One that meets, but does not exceed, the patient's medical needs.
o    At least as beneficial as an existing and available medically appropriate alternative.

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