ModifiedUnitedHealthcarePolicy CS358TN.E

Sacral Nerve Stimulation for urinary and fecal indications (Tennessee Medicaid/CoverKids)

Defines medical necessity, coverage criteria, and coding for sacral nerve stimulation (SNS/SNM) for urinary and fecal indications for Medicaid and CoverKids members in Tennessee aged 18 and older.

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation for urinary and fecal indications (Tennessee Only) — coverage criteria for Medicaid/CoverKids

Policy CodePolicy CS358TN.E

Change TypeModified — documentation clarification and terminology updates (material change included)

Effective DateDecember 1, 2025

Next Review DateN/A

Key ActionDocument trial-phase response (≥50% improvement) and include legible medical history, physical exam, and diagnostic test results in the medical record prior to permanent implantation authorization.

SourceLink

POLICY UPDATE CHANGES

Replaced references to 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)'.

Added language clarifying that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and listing examples of necessary documentation.

Added definition of 'Sacral Nerve Stimulation (SNS) [Also Known as Sacral Neuromodulation (SNM) or Urologic Nerve Stimulation]'.

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

Updated related policy link/title for Gastrointestinal Disorders Diagnostic Procedures (for Tennessee Only).

≥18Min age

≥100 mLMin bladder capacity

Trial response threshold

~7 daysPNE duration (bladder)

66% / 84%Pooled SNM success

Coverage Criteria for Sacral Nerve Stimulation

inv-01: SNS screening trial — Urinary indications

Covered when ALL of the following are met:

Urinary SNS screening trial criteria: Lower urinary tract symptoms (overactive bladder/urgency-frequency, urge incontinence, or nonobstructive urinary retention); bladder capacity ≥ 100 mL; urinary condition not secondary to neurologic disease (e.g., Parkinson's, stroke, spinal cord injury, multiple sclerosis); no bladder outlet or mechanical obstruction (e.g., BPH, tumor/radiation, urethral stricture); symptoms refractory to conservative care (e.g., bladder training, pelvic floor rehabilitation, pharmacologic therapy); individual capable of operating sacral nerve stimulating device.

Applies to individuals ≥ 18 years

inv-02: SNS permanent implantation — Urinary indications

Covered when ALL of the following are met:

Urinary SNS permanent implantation criteria: All criteria for Sacral Nerve Stimulation screening trial have been met AND improvement in reported symptoms of ≥ 50% in response to a screening trial of Sacral Nerve Stimulation.50%

Permanent implantation after successful trial

inv-03: SNS screening trial — Fecal incontinence

Covered when ALL of the following are met:

Fecal SNS screening trial criteria: Fecal incontinence 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 not secondary to neurologic disease; fecal incontinence not secondary to constipation; absence of distorted anorectal anatomy (e.g., anorectal malformation, abscess/fistula, prior rectal surgery).

Applies to individuals ≥ 18 years

inv-04: SNS permanent implantation — Fecal incontinence

Covered when ALL of the following are met:

Fecal SNS permanent implantation criteria: All criteria for Sacral Nerve Stimulation screening trial for fecal incontinence have been met AND improvement in reported symptoms of ≥ 50% in response to a screening trial of Sacral Nerve Stimulation.50%

Permanent implantation after successful trial

inv-05: Replacement or revision

Replacement or revision of sacral nerve stimulator is medically necessary when the individual has met prior coverage criteria and the existing device is nonfunctional and either cannot be repaired or is no longer under warranty.

inv-06: Not medically necessary / Unproven

Unproven indications: Sacral Nerve Stimulation (neurostimulation) for the treatment of Constipation and Chronic Pelvic Pain is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

inv-07: Coverage — general (evidence-derived)

Covered when evidence-based criteria are met (as described in cited trials and assessments):

General preconditions: Patient has refractory symptoms after behavioral and pharmacologic therapy and demonstrates clinically meaningful improvement during a test stimulation (commonly ≥50% improvement or return to <8 voids/day).≥50% improvement

Derived from multiple trials and health technology assessments

inv-08: General covered indications (OAB/UUI, select retention, FI)

Covered when ALL of the following are met (guideline-aligned indications):

General coverage conditions: 1) Documented failure or intolerance of appropriate conservative therapies and pharmacologic management for the target condition; 2) Patient is an appropriate surgical candidate and consents to device implantation and long-term management; 3) A successful trial phase (PNE/test stimulation) demonstrating clinically meaningful improvement is documented prior to permanent implantation.

Based on AUA/SUFU, EAU, ICS guidance

inv-09: Insufficient evidence / restricted

Not routinely covered / considered experimental or insufficient evidence when ANY of the following are present:

Constipation: Use of SNM for chronic functional constipation or refractory idiopathic slow transit constipation is considered to have insufficient and inconclusive evidence; routine permanent implantation is not supported without high-quality RCT evidence and demonstration of durable benefit.

Multiple systematic reviews and RCTs show conflicting results and concerns about complications and cost-effectiveness

Chronic pelvic pain (CPP)/IC/BPS: Evidence for SNM in chronic pelvic pain and interstitial cystitis/bladder pain syndrome is limited and low quality; SNM for these indications is not routinely supported absent stronger randomized evidence.

Based on systematic reviews and guideline statements

inv-10: Neurogenic bladder / fecal incontinence (conditional)

Conditionally covered when ALL of the following are met:

Neurogenic bladder or fecal incontinence due to neurologic disease: Carefully selected individuals with neurogenic bladder/overactive bladder or fecal incontinence refractory to conservative measures who are at low risk for upper tract deterioration may be considered for SNM after a successful trial phase and with informed consent about variable long-term efficacy and risks; selection should consider disease-specific data and patient goals.

Evidence is heterogeneous but shows possible benefit in selected patients

inv-11: Indications, trial success, and contraindications

Guideline-based indications and screening criteria described by expert bodies (ICS, NICE, ASCRS):

Indication for offering SNM: SNM may be offered to individuals with OAB (with or without incontinence), UUI, nonobstructive urinary retention, fecal incontinence, and select bowel/bladder dysfunctions who have failed or are intolerant of conservative and medical therapies.conservative/medical therapy failure

Supported by ICS and other society guidance

Trial requirement: A successful test period (PNE or Stage 1) demonstrating ≥50% improvement in one or more troublesome urinary or bowel parameters is required to offer complete system implantation; PNE is typically ~7 days for bladder and 10–21 days for bowel indications, Stage 1 typically 2–3 weeks.>=50% improvement

Test durations and thresholds per ICS guidance

Contraindications:

Sacral Nerve Stimulation (SNS)/sacral neuromodulation (SNM) for the treatment of constipation and chronic pelvic pain is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

The available literature provides insufficient evidence to support SNS or other neuromodulation techniques as a definitive therapy for chronic pelvic pain (CPP). Systematic reviews and the limited number of randomized trials reported to date are heterogeneous in patient populations and outcomes; additional high-quality, controlled studies are required to demonstrate clinical efficacy, comparative effectiveness, and long-term benefit before routine coverage can be assumed.

Use of SNM for constipation should be restricted. When considered, it should be limited to individuals with symptoms persisting for more than 1 year who have failed comprehensive conservative therapy and in whom a mechanical or anatomic cause has been excluded. Multiple systematic reviews and randomized studies have shown conflicting or negative results and report substantial device-related adverse event and reoperation rates; routine permanent implantation for constipation is not supported without clearer, durable benefit demonstrated in high-quality RCTs.

Absolute contraindications to SNM include pregnancy and the individual's inability to operate the device without caregiver support. Relative contraindications include severe or rapidly progressive neurologic disease, established complete spinal cord injury, an anticipated need for MRI of body parts below the head, and abnormal sacral anatomy; these factors should be considered when selecting candidates for trial or permanent implantation.

This policy is intended to interpret UnitedHealthcare standard benefit plans; providers must reference applicable federal, state, or contractual benefit requirements, which may differ from this policy and govern in the event of conflict.

Use of SNS when the policy criteria are not met—such as for conditions secondary to neurologic disease, presence of bladder outlet or mechanical obstruction, insufficient bladder capacity, failure to demonstrate that conservative therapies were tried, or inability of the patient to operate the device—is not supported by this policy and may be considered not medically necessary.

Maintenance posterior tibial nerve stimulation (PTNS) beyond the initial treatment course lacks well-designed comparative or controlled evidence; the durability of benefit and appropriate patient selection for long-term maintenance remain uncertain, and ongoing maintenance therapy may be considered not medically necessary without stronger evidence.

Permanent implantation after a temporary test for refractory constipation is not supported by high-quality randomized evidence demonstrating benefit over sham or conservative care. Given conflicting RCT results, variable long-term outcomes, and substantial device-related complication and reoperation rates reported in the literature, routine permanent implantation for constipation is not considered medically necessary.

Evidence is limited or lacking for several indications, including interstitial cystitis/bladder pain syndrome (IC/BPS) and many types of chronic pelvic pain; guideline statements note low-quality or limited data for these conditions. Coverage for these indications should not be assumed in the absence of stronger evidence or specific FDA approval and may require case-by-case consideration with supporting documentation.

Applicable Codes and Key Clinical Thresholds

Procedure CPT / Category III codesCPT

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 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.

Diagnosis codes — Urinary indicationsICD-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

1/4

Diagnosis codes — Fecal indicationsICD-10

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

inv-25: Screening trial response threshold — ≥ 50% improvement in reported symptoms

Screening trial response threshold≥ 50% improvement in reported symptoms during screening trial

Permanent implantation requirementImprovement in reported symptoms of 50% or greater in response to a screening trial

Trial duration contextTypical trial period is 3–7 days for initial PNE screening

inv-26: Bladder capacity threshold — ≥ 100 mL

Minimum bladder capacityBladder capacity of 100 mL or greater is required for urinary SNS trial

Actions, Documentation, and Authorization Requirements

Prior Authorization

Prior authorization and benefit verification

Prior authorization is expected for procedures and implantable devices listed by CPT and HCPCS in the Applicable Codes section. Providers should verify benefit coverage, federal/state/contractual requirements, and any UnitedHealthcare utilization management tools (for example, InterQual) before submitting requests. Inclusion of a code in the policy does not guarantee coverage or payment.

Check member benefit, state or federal mandates, and utilization tools prior to authorization
Listing of codes in policy is for reference only and does not guarantee coverage

Documentation Required

Test stimulation success required before implant

A successful test stimulation (trial phase) demonstrating clinical improvement is required prior to permanent sacral nerve stimulation (SNS/SNM) implantation. Trials and randomized studies commonly define success as ≥50% improvement in targeted symptoms (for example, UI episodes or urgency-frequency) or return to <8 voids per day for urinary frequency.

Definitions and Key Terms

inv-50: Chronic Urinary Retention — Postvoid residual volume (PVR) ≥ 300 mL that persists for ≥ 6 months and is documented on ≥ 2 separate occasions.

Chronic Urinary Retention (definition)Postvoid residual volume (PVR) ≥ 300 mL that persists for ≥ 6 months and is documented on ≥ 2 separate occasions.

Documentation frequencyMust be documented on at least two separate occasions

Minimum durationCondition must persist for ≥ 6 months

inv-51: Fecal Incontinence — Involuntary passage of fecal matter or inability to control discharge of bowel contents, range from flatus to complete evacuation.

Fecal Incontinence (definition)Involuntary passage of fecal matter through the anus or inability to control discharge of bowel contents, ranging from flatus to complete evacuation.

Clinical severity range

Quick Reference — Provider-Facing Highlights

Note

Policy Revision History

2026-04-01related_policy_updateLatest

Updated related policy link/title for Gastrointestinal Disorders Diagnostic Procedures (for Tennessee only).

2025-12-01coverage_rationale_revision

Replaced references to 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)' and added detailed medical records documentation requirements to clarify documentation that may be required to assess coverage criteria.

2025-12-01supporting_information_update

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation for urinary and fecal indications (Tennessee Only) — coverage criteria for Medicaid/CoverKids

Policy CodePolicy CS358TN.E

Change TypeModified — documentation clarification and terminology updates (material change included)

Effective DateDecember 1, 2025

Next Review DateN/A

SourceLink

On This Page

Absolute contraindications include insufficient clinical response to a therapeutic trial, inability to operate the device without caregiver support, and pregnancy. Relative contraindications include severe/rapidly progressive neurologic disease, complete spinal cord injury, anticipated need for MRI below the head, and abnormal sacral anatomy.

Clinicians should consider contraindications when selecting candidates

Denial risk if below threshold

Bladder capacity <100 mL is a trigger for denial

ApplicabilityApplies to individuals ≥ 18 years of age

inv-27: Chronic Urinary Retention PVR threshold — PVR ≥ 300 mL on ≥ 2 occasions over ≥ 6 months

Chronic urinary retention definitionPostvoid residual volume (PVR) ≥ 300 mL that persists for ≥ 6 months and is documented on ≥ 2 separate occasions

Documentation requirementPVR must be documented on at least two separate occasions

Duration requirementPersistence for at least 6 months

inv-28: Test success threshold — >= 50% improvement in one or more troublesome urinary or bowel parameters during PNE or Stage 1

Test success threshold>= 50% improvement in one or more troublesome urinary or bowel parameters during PNE or Stage 1 test period

PNE typical durationPNE is typically ~7 days for bladder and 10–21 days for bowel indications

Stage 1 durationStage 1 test period typically lasts 2–3 weeks when longer screening is required

Documented ≥50% symptom improvement (or return to <8 voids/day when applicable) required before permanent implant
Insufficient clinical response to a therapeutic trial is an absolute contraindication to permanent implantation

Documentation Required

Require trial-phase documentation prior to permanent SNM

Providers must submit trial-phase documentation (screening/test stimulation) demonstrating the degree of symptom improvement and relevant objective data prior to approval for permanent SNM implantation.

Include therapy-evaluation visit notes, device settings used during trial, duration of trial, and measured symptomatic change
If trial stimulation did not meet success thresholds, document reason and that permanent implant is not indicated

Note

Device approvals and specialist treatment setting

Document in the medical record the device model and regulatory status when applicable, and ensure specialists performing SNM are appropriately trained. FDA-cleared/approved systems include multiple manufacturers with labeled indications for urinary and/or fecal incontinence.

FDA PMA/clearance examples: Medtronic InterStim (including InterStim Micro), Axonics r-SNM, Neuspera Sacral Neuromodulation System
Specialist setting: urology, urogynecology, colorectal surgery with expertise in neuromodulation

Denial Risk

Triggers for denial

Certain clinical situations and documentation shortcomings may lead to claim denial. Providers should address these triggers explicitly in submitted records.

Member age <18 years — policy applies to ≥18 years
Bladder capacity <100 mL (for urinary indications)
Urinary or fecal dysfunction secondary to neurologic disease (e.g., Parkinson's disease, stroke, spinal cord injury, MS) when excluded by policy
Presence of mechanical bladder outlet obstruction (e.g., BPH, urethral stricture, active tumor-related obstruction)
Insufficient or missing trial-phase documentation or failure to meet trial success criteria
Requests for SNM for constipation or chronic pelvic pain (considered unproven/not medically necessary for constipation)

Documentation Required

PTNS maintenance therapy evidence gaps

Evidence gaps exist regarding percutaneous tibial nerve stimulation (PTNS) maintenance therapy. Lack of long-term comparative studies, unclear patient selection criteria for maintenance, and uncertainty about durability of benefit may lead to denials for ongoing maintenance PTNS without supporting documentation.

Maintenance PTNS beyond initial treatment course: insufficient evidence on efficacy, durability, and patient selection
Document rationale and prior response to initial PTNS if requesting maintenance therapy

Denial Risk

Constipation — insufficient evidence / potential denial risk

SNM for constipation is considered unproven and not medically necessary in many situations due to lack of benefit in trials and high long‑term device-related adverse event rates. Providers requesting SNM for constipation should expect careful review and likely denial unless exceptional, well-documented circumstances exist.

Randomized trials have not shown benefit of SNM for constipation and long-term device-related adverse events are substantial
SNM for constipation may be considered only in select circumstances per specialty guidance and requires rigorous documentation

Documentation Required

Medical record documentation

Medical records must fully support medical necessity and be available on request. Insufficient documentation is a common reason for denial.

Records must be legible and include relevant history, physical exam, diagnostic test results, and prior conservative therapy attempts
Maintain and provide device trial documentation, informed consent, and follow-up plans

Documentation Required

Typical documentation elements from trials

Trials and many RCT protocols specify the documentation elements needed to define test stimulation success. Providers should mirror these elements when submitting records for review.

Voiding diaries (baseline and during trial) with UI episode counts, frequency, and urgency measures
Patient-reported outcome measures (for example, ICIQ-OABqol, PGI-I) and objective symptom counts
Duration of trial, stimulation parameters, and any adverse events during trial

Documentation Required

Required clinical documentation and testing

Required clinical documentation and testing should demonstrate failure of conservative and medical therapies, suitability for SNM, trial-phase results meeting success thresholds, and the absence of contraindications.

Evidence of failed conservative care (bladder/bowel training, pelvic floor rehab) and pharmacologic therapy
Bladder capacity measurement (≥100 mL for urinary indications) and evaluation excluding obstruction or neurologic cause
Trial stimulation documentation with quantified symptom improvement (≥50% or return to <8 voids/day)
Assessment of patient's ability to operate the device and informed consent discussion

Documentation Required

Preoperative counseling and consent

Preoperative counseling and informed consent must be documented and should address expected benefits, risks, and long-term commitments associated with SNM therapy.

Discuss risks: implant site pain, infection, paresthesia, lead migration, need for reprogramming or revision, device failure, and battery replacement
Explain need for test stimulation, probability of test success, possibility of device revision, and life-long follow-up
Document that patient is capable of operating device or has adequate caregiver support

Documentation Required

Medical records documentation required

Medical records submitted for review must contain comprehensive information to determine coverage eligibility and medical necessity for SNM/SNS procedures and devices.

Relevant medical history and prior treatments attempted (dates and outcomes)
Physical exam findings and diagnostic testing (for example, urodynamics when indicated)
Detailed trial stimulation records, informed consent, and proposed device details

Step Therapy

Conservative therapy required prior to SNS

Conservative therapy must have failed before considering SNM. SNM and PTNS are generally third-line therapies after behavioral and pharmacologic treatments have been attempted.

Document prior conservative measures: bladder/bowel training, pelvic floor rehabilitation, and pharmacologic therapy with dates and outcomes
SNM and PTNS should be considered when individuals are refractory to first- and second-line therapies

Note

Placement in therapy

Placement of SNM in the treatment pathway: SNM and PTNS are described as third-line options for refractory OAB and select non-neurogenic lower urinary tract dysfunctions after failure of behavioral and pharmacologic therapies and consideration of alternative second-line treatments (for example, botulinum toxin).

Consider SNM for severe refractory OAB or when second-line therapy is contraindicated or not tolerated
Discuss alternative options (BTX, PTNS) and document rationale for choosing SNM

Step Therapy

Step therapy sequencing

SNM is generally a third-line therapy after failed conservative measures and pharmacotherapy; documentation should reflect stepwise care and rationale for proceeding to SNM.

Ensure prior steps (behavioral therapy, pharmacologic therapy, and consideration of BTX when appropriate) are documented
State why SNM is being pursued instead of or after other second-line options

Step Therapy

Conservative therapy failure required

SNM should be considered only after failure of conservative and medical therapies for indicated conditions. Specialty guidance supports trial-phase testing to predict long-term benefit.

Failure of conservative and pharmacologic therapy is required before SNM for OAB, UUI, NOUR, and FI (as applicable)
Trial-phase success (documented) is required prior to permanent implantation

Step Therapy

Step therapy

No formal step therapy program specifics are required by this policy; however, the expectation of a stepwise approach (conservative → pharmacologic → second-line alternatives → SNM/PTNS) is reflected in coverage criteria and specialty guidance.

Document each step taken and outcome to support medical necessity for SNM
UnitedHealthcare may apply utilization management tools to adjudicate requests

Severity ranges from passage of flatus to complete evacuation

Relation to trial eligibilityFI must be refractory to conservative care to be eligible for SNS trial

inv-52: Chronic Pelvic Pain — Persistent or recurrent episodic pelvic pain associated with lower urinary tract, sexual, bowel, or gynecological dysfunction without pro...

Chronic Pelvic Pain (CPP) definitionPersistent or recurrent episodic pelvic pain associated with lower urinary tract, sexual, bowel, or gynecological dysfunction with no proven infection or obvious pathology

Evidence noteEvidence for SNM efficacy in CPP is limited; higher-quality randomized studies are needed

Clinical contextCPP may be considered investigational for definitive SNM therapy absent stronger evidence

inv-53: Sacral Nerve Stimulation (SNS/SNM) — Implanted electrical stimulation of sacral nerves (often at S3) to modulate bladder and pelvic floor function; may act as a pacemaker for...

Sacral Nerve Stimulation (SNS/SNM) definitionImplanted electrical stimulation of sacral nerves (often at S3) to modulate bladder and pelvic floor function; may act as a pacemaker for the bladder

Targeted symptomsUsed for overactive bladder, urge incontinence, and non-obstructive urinary retention; also used for fecal incontinence

Procedure componentsInvolves placement of an electrode near sacral nerve and connection to an implanted pulse generator

inv-54: Successful test stimulation — Defined in trial contexts as ≥50% improvement in urinary incontinence or urinary frequency symptoms or return to normal voiding of fewer ...

Successful test stimulation (trial) definitionDefined in trial contexts as ≥50% improvement in urinary incontinence or urinary frequency symptoms or return to normal voiding of fewer than eight voids/day

Trial as predictorSuccessful test stimulation is the primary predictor for offering permanent implantation

Typical documentationVoiding diaries and validated QoL questionnaires are used in trials to assess success

inv-55: LARS response — ≥50% reduction in Low Anterior Resection Syndrome (LARS) score during test phase.

LARS response threshold≥50% reduction in Low Anterior Resection Syndrome (LARS) score during test phase

Trial duration for LARS studyAdvanced test phase stimulation for 3 weeks used in randomized LARS trial

Observed effect size78% of participants achieved ≥50% LARS score reduction in cited trial

inv-56: Percutaneous nerve evaluation (PNE) / trial phase — A temporary test stimulation period used to predict likelihood of therapeutic success with permanent sacral neuromodulation; considered t...

PNE / trial phase definitionA temporary test stimulation period used to predict likelihood of therapeutic success with permanent SNM; the trial phase is the most valued predictor for urinary indications

Typical durationsPNE ~7 days for bladder indications and 10–21 days for bowel indications; Stage 1 typically 2–3 weeks

Use casePNE is used to screen responders before offering complete system implantation

inv-57: Interstitial cystitis / bladder pain syndrome (IC/BPS) — A chronic pelvic pain condition with bladder-centric pain and urinary symptoms; evidence for SNM efficacy in IC/BPS is limited and of low...

IC/BPS definition and evidence noteInterstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pelvic pain condition with bladder-centric pain and urinary symptoms; evidence for SNM efficacy in IC/BPS is limited and of low quality

GuidanceICS notes limited evidence but considers SNM a choice for IC/BPS non-responsive to conservative therapies after assessment

Research recommendationHigher-quality randomized studies are needed to define SNM role in IC/BPS

inv-58: PNE (percutaneous nerve evaluation) — A temporary test stimulation procedure typically lasting about seven days for bladder indications and 10-21 days for bowel indications us...

PNE procedure durationPNE is typically about seven days for bladder indications and 10–21 days for bowel indications

Role in screeningPNE is used to screen for likely success of SNM and guide offer of permanent implant

DocumentationSuccess during PNE is documented as ≥50% improvement in troublesome parameters

inv-59: Stage 1 test — A trial lead implantation phase typically lasting 2-3 weeks used when a longer test period or more robust screening is required.

Stage 1 test definitionA trial lead implantation phase typically lasting 2–3 weeks used when a longer test period or more robust screening is required

When usedStage 1 testing is used if PNE is questionable or a lengthier test is needed; may be repeated at physician's discretion

Success criterionStage 1 success measured by ≥50% improvement in troublesome parameters to consider permanent implantation

inv-60: Sacral Nerve Stimulation (SNS) / Sacral Neuromodulation (SNM) — Defined in the policy as Sacral Nerve Stimulation (also known as sacral neuromodulation or urologic nerve stimulation).

Policy terminologySacral Nerve Stimulation (SNS) also known as Sacral Neuromodulation (SNM) or Urologic Nerve Stimulation

Device functionAn implanted device stimulates sacral nerves to modulate bladder function, acting as a pacemaker for the bladder

ScopePolicy defines SNS/SNM terminology and requires trial-phase documentation for permanent implantation

Sacral nerve stimulation involves placing an electrode near the sacral nerves (commonly S3) to modulate bladder and pelvic floor function. A temporary trial stimulation (percutaneous nerve evaluation or Stage 1 lead) — typically lasting about 3–7 days for bladder indications or longer for bowel indications — is used to identify responders; permanent implantation is offered only when the trial demonstrates ≥50% improvement in relevant urinary or bowel symptoms.

Updated Clinical Evidence, FDA, and References sections to reflect the most current information and archived previous policy version CS358TN.D.