CMS WISeR documentation checklist · §6.2.7
Operational Guide v7.0, last updated July 24, 2026 · retrieved 2026-09-14
Sacral Nerve Stimulation for Urinary Incontinence (NCD 230.18)
CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”
Prior authorization and pre-payment review are being implemented for the permanent implantation procedure. A trial procedure should be done, and documentation should be submitted for permanent implantation of a stimulator device.17 Please note that lead replacement billed under CPT code 64561 does not require prior authorization or pre-payment review under WISeR, as NCD 230.18 does not explicitly address replacements. General documentation requirements for a permanently implanted sacral nerve stimulator for the treatment of urinary urge incontinence, urgency-frequency syndrome, or urinary retention are as follows:
- Documentation of the relevant diagnosis (e.g., urge incontinence, urgency-frequency syndrome, or urinary retention) a) Of note, urinary voiding dysfunction should not be a secondary manifestation of specific neurologic diseases (e.g., diabetes with peripheral nerve involvement), stress incontinence, or urinary (e.g., bladder outlet) obstruction.
- Documentation of treatments tried and failed (or contraindications), such as but not limited to: a) Behavioral therapy (e.g., bladder training, pelvic floor rehabilitation) b) Pharmacologic therapy c) Surgical corrective therapy (e.g., augmentation cystoplasty)
- Documentation that the patient is capable of demonstrating adequate ability to record voiding diary data such that the clinical results of the implant procedure can be properly evaluated
- Documentation that the patient had a successful test stimulation, as demonstrated by 50% or greater improvement (as measured through voiding diaries)
- [16] Prior authorization and pre-payment medical review for Sacral Nerve Stimulation for Urinary Incontinence will only be implemented for the indications specified in Appendix B.
- [17] During pre-payment review, the billing of a generator implantation code (CPT code 64590) will be used to differentiate between a trial and permanent implantation (billed using CPT code 64561).