Urinary Incontinence — Trial Stimulation
Covered when ALL of the following criteria are met:
ALL of the following
At least ONE diagnosis
Overactive bladder with urinary urgency, frequency, nocturia, and/or urinary incontinence
Urgency urinary incontinence
Non-obstructive urinary retention
Symptoms have been present for at least 6 months and result in clinically significant impairment of daily functioning and/or quality of life
Conservative treatment
Symptoms are refractory to, the member has a contraindication to, or the member is intolerant of conservative treatment of sufficient duration to fully assess treatment effect
Behavioral therapy, such as bladder training, fluid management, pelvic floor muscle training, or pelvic floor physical therapy with or without biofeedback, has been attempted when appropriate
Pharmacologic therapy has been attempted when clinically appropriate
For non-obstructive urinary retention, urinary retention is not due to a mechanical obstruction, such as urethral stricture, obstructing malignancy, or significant benign prostatic obstruction
The member is an appropriate surgical candidate and is capable of participating in device operation, management, and required follow-up
Symptoms are not primarily due to a spinal cord injury, neurogenic bladder, or progressive neurologic disease
Urinary Incontinence — Permanent Implantation
Covered when ALL of the following criteria are met:
ALL of the following
All criteria for urinary incontinence trial stimulation have been met
A successful trial stimulation has been documented, demonstrated by at least a 50% improvement in baseline symptoms≥ 50% improvement
At least ONE documented measure of improvement
Reduction in urinary incontinence episodes
Reduction in pad utilization
Fecal Incontinence — Trial Stimulation
Covered when ALL of the following criteria are met:
ALL of the following
Chronic refractory fecal incontinence
The member has chronic refractory fecal incontinence with an average of at least 2 incontinent episodes per week≥ 2 episodes per week
Symptoms have been present for at least 6 months, or for at least 12 months following vaginal childbirth
The member has failed, is intolerant of, or has a contraindication to conservative treatment of sufficient duration to assess treatment effect, including dietary modification, pharmacologic therapy when appropriate, bowel training programs, and/or pelvic floor rehabilitation or biofeedback
The member is an appropriate surgical candidate and capable of participating in device management and required follow-up
Fecal Incontinence — Permanent Implantation
Covered when BOTH of the following criteria are met:
BOTH of the following
All criteria for fecal incontinence trial stimulation have been met
Trial stimulation demonstrates at least a 50% improvement in baseline symptoms≥ 50% improvement
Replacement, Revision, or Removal
Covered when ANY of the following criteria are met:
ANY of the following
The device is no longer functioning appropriately
Battery depletion has occurred, and the member has previously demonstrated clinical benefit
Lead migration or lead malfunction has occurred
Infection, erosion, pain, or another device-related complication is present
Removal is necessary because the device is no longer effective or no longer tolerated
For non-obstructive urinary retention, coverage requires that the retention is not due to a mechanical urinary outlet obstruction, such as urethral stricture, obstructing malignancy, or significant benign prostatic obstruction. Mechanical urinary outlet obstruction is not a covered indication.
Fecal incontinence coverage excludes conditions related to anorectal malformation or other specified anorectal conditions, including congenital anorectal malformation, external anal sphincter defects greater than 60 degrees, visible sequelae of pelvic radiation, active anal abscesses, or fistula. Active inflammatory bowel disease and recent rectal surgery are also exclusionary under the applicable coverage criteria.
Symptoms or incontinence primarily due to spinal cord injury, neurogenic bladder, or progressive neurologic disease are excluded from the applicable urinary and fecal incontinence coverage criteria. Urinary incontinence due to neurologic conditions, including multiple sclerosis, spinal cord injury, detrusor hyperreflexia, or other neurogenic bladder disorders, is investigational.
Sacral nerve neuromodulation is investigational for all other urinary, bowel, pelvic floor, or voiding indications, including stress urinary incontinence, urinary incontinence due to neurologic conditions, mechanical urinary outlet obstruction, chronic constipation, and chronic pelvic pain.