CurrentUnitedHealthcarePolicy CS358.E

Sacral Nerve Stimulation for Urinary and Fecal Indications – Community Plan Medical Policyopen_in_new

Defines medical necessity criteria, indications, exclusions, and applicable procedure/diagnosis codes for sacral nerve stimulation (SNS/SNM) screening trials, permanent implantation, replacement/revision, and noncovered indications for adults (≥18 years). Applies to UnitedHealthcare Community Plan except listed states with state-specific policies.

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation for Urinary and Fecal Indications – Community Plan Medical Policyopen_in_new

Policy CodePolicy CS358.E

Change TypeCoverage rationale & definitions updated; template edits

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument prior conservative treatments attempted and that symptoms are refractory to them; document test-phase >=50% improvement during screening trial to support permanent implantation.

SourceLink

POLICY UPDATE CHANGES

Coverage rationale and definitions updated to replace 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)' and added definition.

Template update removed content/language pertaining to the state of Louisiana and updated a related policy link.

2Primary Covered Indications (Urinary, Fecal)

2Unproven/Not Covered Indications

>=50%Required Trial Improvement Threshold

35%Aggregate revision rate (fecal review)

19.7%Aggregate explant rate (fecal review)

3Primary device PMA references

Coverage Summary

Subject: Sacral Nerve Stimulation (SNS/SNM) for Urinary and Fecal Indications. Status: COVERED WITH CRITERIA. Effective date: December 1, 2025.

Short overview: SNS (also called sacral neuromodulation or urologic nerve stimulation) is a minimally invasive implantable neurostimulation therapy that is covered for select urinary and fecal indications for adults aged ≥ 18 years when specified medical necessity criteria are met. Primary covered indications include refractory overactive bladder (urgency-frequency syndrome), urge urinary incontinence, nonobstructive urinary retention (NOUR), and fecal incontinence. Coverage requires documentation of meeting the policy criteria (including required conservative therapy attempts), and permanent implantation is allowed only after a successful screening trial showing the policy's response threshold. The policy applies to UnitedHealthcare Community Plan members except in states with listed state-specific policies; see exclusions for specific states.

Key thresholds and quick facts

Bladder capacity threshold>= 100 mL

Screening/permanent implant responder threshold>= 50% improvement in reported symptoms during screening trial

Chronic Urinary Retention definitionPVR >= 300 mL persisting >= 6 months, documented on >= 2 occasions

PNE (test) duration — bladderTypically 7 days

PNE (test) duration — bowelTypically 10–21 days

Stage 1 test durationTypically 2–3 weeks

Reported pooled test-phase success (nLUTD meta-analysis)Approx. 66.2% test success

Reported pooled permanent success (nLUTD meta-analysis)Approx. 84.2% permanent success

Fecal incontinence long-term success range (per-protocol)59.4%–87.5% (per-protocol)

Fecal incontinence revision & explant rates (aggregate)Revision rate ~35.2%; Explant rate ~19.7%

EAU surgical revision rate (3–4 years)Surgical revision rates commonly 30–40% at 3–4 years

Test-phase success characterization>=50% improvement in one or more troublesome urinary or bowel parameters during PNE or Stage 1 to be offered implantation

Medical-Necessity Criteria and Contraindications

SNS Screening Trial for Urinary Voiding Dysfunction - Medically Necessary

Proven and medically necessary when ALL of the following are met:

ALL of the following

Individual is ≥ 18 years of age
ONE OF
- Overactive bladder symptoms (urgency frequency syndrome)
- Urge Incontinence
- Nonobstructive urinary retention (NOUR)

Procedure, Supply, and Diagnosis Codes (Reference)

CPT / Temporary and Permanent SNS Procedure Codes (reference)CPT

0784T	Insertion or replacement of percutaneous electrode array, spinal, with integrated neurostimulator, including imaging guidance, when performed.
0785T	Revision or removal of neurostimulator electrode array, spinal, with integrated neurostimulator.
0786T	Insertion or replacement of percutaneous electrode array, sacral, with integrated neurostimulator, including imaging guidance, when performed.
0787T	Revision or removal of neurostimulator electrode array, sacral, with integrated neurostimulator.
64561	Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed.
64581	Open implantation of neurostimulator electrode array; sacral nerve (transforaminal placement).
64585	Revision or removal of peripheral neurostimulator electrode array.
64590	Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver.
64595	Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array.

HCPCS / Implantable Device Supply CodesHCPCS

L8679	Implantable neurostimulator, pulse generator, any type.
L8680	Implantable neurostimulator electrode, each.
L8682	Implantable neurostimulator radiofrequency receiver.
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension.

ICD-10 Diagnosis Codes - Urinary Indications (reference)ICD-10

N32.81	Overactive bladder.
N32.9	Bladder disorder, unspecified.
N39.3	Stress incontinence (female) (male).
N39.41	Urge incontinence.
N39.42	Incontinence without sensory awareness.
N39.46	Mixed incontinence.
N39.490	Overflow incontinence.
N39.498	Other specified urinary incontinence.
R30.0	Dysuria.
R30.1	Vesical tenesmus.

1–10 of 31

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ICD-10 Diagnosis Codes - Fecal Indications (reference)ICD-10

R15.0	Incomplete defecation.
R15.1	Fecal smearing.
R15.2	Fecal urgency.
R15.9	Full incontinence of feces.

Device approvals / PMA references (informational)mixed

P970004	Medtronic InterStim PMA (Initial 1997) - treatment of overactive bladder; P970004 referenced for InterStim
S004	Medtronic supplement approval for urinary retention (April 1999)
S302	Medtronic InterStim Micro approval (July 2020)
P190006	Axonics r-SNM System PMA (Sept 6, 2019)
P240031	Neuspera Sacral Neuromodulation System PMA (Neuspera Medical Inc.) referenced (accessed 2025)

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Screening trial and permanent implantation preauthorization

Screening trial (PNE or Stage 1) and permanent implantation require preauthorization. Permanent implantation claims will only be authorized when documentation demonstrates a successful therapeutic trial with ≥50% improvement in targeted urinary or bowel symptoms during the trial period. Affected procedure codes for authorization reviews include the CPT/temporary codes listed below; inclusion is for reference and does not guarantee payment.

Affected procedure codes: 64561, 64581, 64590, 0786T, 0784T
Permanent implantation requires documented ≥50% improvement during the trial prior to authorization

Documentation Required

Document conservative therapy failure

Document prior conservative treatments attempted and that symptoms are refractory. Records should show trials of appropriate noninvasive therapies (e.g., bladder/bowel training, pelvic floor rehabilitation, behavioral interventions, pharmacologic therapy, bulking agents when applicable) and reasons for failure or intolerance.

Background and Supporting Evidence

Background: SNS (also known as sacral neuromodulation or SNM) was originally developed and used to treat urinary symptoms such as overactive bladder, urge incontinence, and nonobstructive urinary retention and has been explored for fecal incontinence and other pelvic disorders.

Trial-phase testing: Individuals typically undergo a temporary test stimulation period (PNE or Stage 1) to assess response prior to permanent implantation. Typical trial durations noted are 3–7 days for the initial brief implantation/test to determine eligibility (with PNE commonly 7 days for bladder and 10–21 days for bowel, and Stage 1 test periods typically 2–3 weeks when used).

Response threshold for proceeding to permanent implant: A successful screening trial is generally defined as documented symptomatic improvement of 50% or greater in one or more targeted urinary or bowel parameters during the test period; individuals meeting this threshold may be offered complete system implantation.

Evidence / Finding	Value/Result
Screening trial pooled success rate (meta-analysis)	Approx. 66.2% test success (van Ophoven et al. 2021)
Permanent SNM pooled success rate (meta-analysis)	Approx. 84.2% permanent success (van Ophoven et al. 2021)
Fecal incontinence long-term success range (systematic review)	Per-protocol 59.4%–87.5%; ITT 20.9%–87.5% (Eggers et al. 2025)
LARS trial responder rate (SanLARS randomized crossover)	78% (35 of 46) had ≥50% reduction in LARS score (Marinello et al. 2024)
LARS pooled success (meta-analysis)	83.3% overall success rate (95% CI 71.33–95.26%) (Ram et al. 2020)
Fecal incontinence aggregate device revision/explant rates (systematic review)	Aggregate revision rate 35.2%; explant rate 19.7% (Eggers et al. 2025)
Constipation RCT (Heemskerk 2024)	53.7% success with SNM vs 3.8% with personalized conservative treatment at 6 months (OR 36.4; p=0.003) — but overall evidence for constipation is insufficient/ conflicting (Zerbib 2017)

Definitions

Chronic Urinary RetentionPVR >= 300 mL persisting >= 6 months and documented on >= 2 separate occasions

Fecal Incontinence (FI)Involuntary passage of fecal matter or inability to control discharge of bowel contents; severity ranges from flatus to complete evacuation

Revision History

2025-12-01material

Coverage Rationale and Definitions updates (material): replaced references to 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)'; added SNS definition; supporting information (Clinical Evidence, FDA, References) updated and prior version archived.

2026-04-01template updateLatest

Template update: removed Louisiana-specific content and updated related policy link for Gastrointestinal Disorders Diagnostic Procedures; non-material template language/format changes.

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation for Urinary and Fecal Indications – Community Plan Medical Policyopen_in_new

Policy CodePolicy CS358.E

Change TypeCoverage rationale & definitions updated; template edits

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument prior conservative treatments attempted and that symptoms are refractory to them; document test-phase >=50% improvement during screening trial to support permanent implantation.

SourceLink

On This Page

Bladder capacity of 100 ml or greater>= 100 mL

Urinary voiding dysfunction is not secondary to a neurologic disease origin (e.g., Parkinson's disease, stroke, spinal cord injury, multiple sclerosis)

No bladder outlet or mechanical obstruction (e.g., BPH, tumor/radiation-caused obstruction, urethral stricture)

Symptoms refractory to conservative care (e.g., bladder training, pelvic floor rehabilitation, pharmacological therapy)

Individual capable of operating sacral nerve stimulating device

SNS Permanent Implantation for Urinary Voiding Dysfunction - Medically Necessary

Proven and medically necessary when ALL of the following are met:

ALL of the following

All criteria for SNS screening trial have been met
Improvement in reported symptoms of 50% or greater in response to a screening trial of SNS>= 50% improvement

SNS Screening Trial for Fecal Incontinence - Medically Necessary

Proven and medically necessary when ALL of the following are met:

ALL of the following

Symptoms refractory to conservative care (e.g., bowel training, bulking agents, pelvic floor rehabilitation, pharmacological therapy)
Individual capable of operating sacral nerve stimulating device
Fecal Incontinence is not secondary to a neurologic disease origin (e.g., Parkinson's disease, stroke, spinal cord injury, multiple sclerosis)
Fecal Incontinence is not secondary to Constipation
Lack of distorted anatomy (e.g., anorectal malformation, abscess or fistula, rectal surgery)

SNS Permanent Implantation for Fecal Incontinence - Medically Necessary

Proven and medically necessary when ALL of the following are met:

ALL of the following

All criteria for SNS screening trial have been met
Improvement in reported symptoms of 50% or greater in response to a screening trial of SNS>= 50% improvement

SNS Replacement or Revision - Medically Necessary

Considered medically necessary when ALL of the following are met:

ALL of the following

Individual has met all applicable indication criteria above (urinary or fecal)
Existing device is nonfunctional and either cannot be repaired or is no longer under warranty

Not Medically Necessary / Unproven Indications

Considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy:

ANY of the following

Treatment of Constipation
Treatment of Chronic Pelvic Pain

Screening for success during the test period

Criteria used to determine candidacy for permanent implantation after test stimulation:

ALL of the following

Individuals who achieve 50% improvement in one or more of their troublesome urinary or bowel parameters during the PNE or Stage 1 test period may be offered complete system implantation.>= 50% improvement
Typical test durations
- PNE test stimulation period is typically seven days for the bladderPNE bladder = 7 days
- PNE test stimulation period is typically 10-21 days for bowel indicationsPNE bowel = 10-21 days
- Stage 1 test period duration is typically 2-3 weeksStage 1 = 2-3 weeks

Absolute contraindications

ALL of the following

Insufficient clinical response to a therapeutic trial
Absolute contraindication to permanent implantation if less than 50% improvement
Incapability to operate the device with an absence of supportive caregivers who could otherwise offer assistance
Pregnancy

Relative contraindications

ANY of the following

Severe or rapidly progressive neurologic disease
Established complete spinal cord injury (SCI)
Known expected need for magnetic resonance imaging (MRI) of body parts below the head
Abnormal sacral anatomy

Absolute contraindications for SNM

Definitions of successful outcome:

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List prior conservative therapies, duration, response, and reasons for discontinuation
State that symptoms are refractory to conservative management before trial authorization

Documentation Required

Document test-phase improvement

Provide objective evidence of test-phase improvement. For percutaneous nerve evaluation (PNE) or Stage 1 (temporary lead) testing, document measurable improvement of ≥50% in one or more targeted urinary or bowel parameters (for example: frequency, urgency episodes, incontinence episodes, number of pads, post-void residual, bowel leakage episodes). Progress notes, bladder/bowel diaries, and validated symptom scores should be included.

Objective evidence may include bladder diary, bowel diary, validated questionnaires, pad counts, PVR measurements, or clinician-measured symptom logs
Threshold for permanent implantation: ≥50% improvement in one or more targeted parameters during the therapeutic trial

Documentation Required

Document device-operability and contraindications

Document that the individual (or caregiver) can operate the device and document any contraindications. Record assessment of cognitive and functional ability to manage stimulation, charging (if rechargeable), and follow-up, and note exclusions such as neurologic disease causing symptoms, mechanical bladder outlet obstruction, primary constipation (for FI), or distorted anorectal anatomy.

Assess and document the individual's ability to understand device use, or that a responsible caregiver is available and willing to manage the device
List contraindications identified (e.g., neurologic disease, mechanical obstruction, constipation as primary diagnosis, distorted anatomy)

Documentation Required

Preoperative counseling

Obtain and document preoperative counseling that covers procedure risks, expected benefits, the requirement for lifelong follow-up, potential need for battery replacement or generator revision, likelihood of reprogramming or revision procedures, and the possibility that a successful trial is required before a permanent system will be implanted.

Discuss and document risks (infection, lead migration, pain, device malfunction), and likelihood of additional procedures
Explain need for ongoing follow-up, possible battery replacements, and reprogramming or revision
Document that the patient understands that permanent implantation is offered only after a successful ≥50% response to the trial

Denial Risk

Nonresponse to trial risks noncoverage

Insufficient clinical response during the trial (defined as <50% improvement in targeted urinary or bowel parameters) is a basis for denial of authorization or payment for permanent complete system implantation claims. Claims for full system implantation without documented successful trial response risk denial.

Insufficient trial response (<50% improvement) is grounds for denial of complete system implantation claims
Ensure trial documentation clearly meets the ≥50% improvement requirement prior to submitting for permanent implantation

Billing Rule

Reference procedure and device codes

Use the listed CPT and HCPCS codes when submitting claims related to sacral nerve stimulation procedures and devices. Code lists are provided for reference and do not guarantee coverage or payment; preauthorization and clinical criteria must be met.

Reference procedure/device codes include CPT: 64561, 64581, 64590, 0784T, 0786T and HCPCS: L8679, L8680, L8682, L8685, L8686, L8687, L8688
Listing of a code does not imply coverage or payment — preauthorization and medical necessity criteria apply

Documentation Required

Assess patient capability

Assess and document the patient's cognitive ability and manual dexterity to operate the stimulator; if the patient cannot reliably operate the device and no responsible caregiver is available to manage it, this is an absolute contraindication to implantation.

Document cognitive assessment and demonstration (or caregiver plan) for device operation and follow-up
Inability to operate the device with no caregiver support is an absolute contraindication

Denial Risk

Absolute contraindication - pregnancy or failed trial

Pregnancy at the time of implantation or a failed/unsuccessful therapeutic trial are absolute contraindications for permanent implantation and are grounds for denial. Refer to the Medical Necessity criteria for detailed exclusion language.

Absolute contraindications include pregnancy and failed therapeutic trial (insufficient documented response)
See Medical-Necessity section for full criteria and exclusions

Documentation Required

Offer permanent implantation after successful trial; therapeutic trial and MRI/anatomy considerations

Offer permanent implantation only after a documented successful therapeutic trial demonstrating objective ≥50% improvement. Therapeutic trial response documentation should include baseline and post-trial symptom measures, duration of trial, type of test (PNE vs Stage 1), and any device settings used. Consider and document MRI needs and relevant pelvic/sacral anatomy that may affect lead placement or future imaging when planning permanent implantation.

Provider must offer permanent implantation only after documented successful trial (≥50% improvement)
Therapeutic trial documentation must include baseline vs post-trial measures, trial duration, test type (PNE or Stage 1), and device parameters used
Document consideration of MRI compatibility and patient anatomy (pelvic/sacral anatomy, prior surgeries, scar tissue) that could affect lead placement or future imaging

Chronic Pelvic Pain (CPP)Persistent or recurrent episodic pelvic pain with associated urinary, sexual, bowel, or gynecologic dysfunction without proven infection or other obvious pathology

PNEPercutaneous nerve evaluation — temporary test stimulation prior to permanent implant

Stage 1 testSurgical test lead implantation period typically lasting 2–3 weeks to assess response prior to full system implantation

LARSLow Anterior Resection Syndrome

Sacral Nerve Stimulation (SNS)Also known as Sacral Neuromodulation (SNM) or Urologic Nerve Stimulation; implantable neurostimulation therapy delivering sacral nerve stimulation