CurrentUnitedHealthcarePolicy CS258PA.E

Sacral Nerve Stimulation Pa Cs

Defines UnitedHealthcare Pennsylvania-specific medical policy criteria for sacral nerve stimulation (neurostimulation) screening trials, permanent implantation, revisions/replacements, and exclusions for urinary voiding dysfunction and fecal incontinence in individuals ≥18 years; notes SNS for constipation and chronic pelvic pain is not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation Pa Cs

Policy CodePolicy CS258PA.E

Change TypeRevised/Added definitions & documentation requirements

Effective DateDec 1, 2025

Next Review Date

Key ActionPatient medical records must document relevant history, exam, diagnostic test results, and objective >=50% test-phase improvement to justify permanent SNS implantation; documentation must be legible and available upon request.

SourceLink

POLICY UPDATE CHANGES

04/01/2026 Updated reference link to reflect the current policy title for Gastrointestinal Disorders Diagnostic Procedures (for Pennsylvania Only).

12/01/2025 Replaced references to 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)'; added language that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess clinical criteria.

Added requirement that the patient's medical record must contain documentation supporting medical necessity, including history, exam, and diagnostic test results; documentation must be legible and available upon request.

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; archived previous policy version CS258PA.D.

2Primary covered indications (Urinary, Fecal)

2Unproven indications (Constipation, Chronic Pelvic Pain)

>=50%Required symptom improvement during screening trial

59.4%-87.5%Per-protocol FI success rates reported

35.2%Aggregate revision rate (FI studies)

19.7%Explants rate (FI studies)

Coverage Summary

Overview: This Pennsylvania-specific policy (effective 12/01/2025, CURRENT) addresses Sacral Nerve Stimulation (SNS) (also called sacral neuromodulation) for adults. Primary covered indications include treatment of urinary voiding dysfunction (overactive bladder/urgency-frequency syndrome, urge urinary incontinence, and nonobstructive urinary retention) and fecal incontinence. Candidates must be ≥ 18 years of age, have symptoms refractory to conservative care, meet indication-specific selection criteria (e.g., bladder capacity ≥ 100 mL for urinary indications), and be capable of operating the device. The typical pathway requires a short screening trial (PNE or Stage 1) followed by permanent implantation only when the screening trial demonstrates at least 50% symptom improvement in one or more troublesome urinary or bowel parameters. The policy notes that SNS for constipation and chronic pelvic pain is considered unproven and not medically necessary due to insufficient evidence. Medical record documentation supporting medical necessity (history, exam, diagnostic tests) must be maintained and made available upon request.

Key thresholds & quick facts

Screening trial improvement>= 50%

Bladder capacity>= 100 mL

PNE duration (bladder)~7 days

PNE duration (bowel)10-21 days

Stage 1 duration2-3 weeks

Test success threshold>= 50% improvement in one or more troublesome urinary or bowel parameters

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

Medical Necessity Criteria

SNS permanent implantation - Urinary voiding dysfunction (proven and medically necessary)

Permanent implantation is medically necessary when prior screening trial demonstrates clinical benefit.

ALL of the following

All criteria for SNS screening trial for urinary voiding dysfunction have been met.
Demonstrated improvement of symptoms ≥ 50% during the SNS screening trial (patient-reported and/or objective measures).>= 50%
Improvement should be documented in the medical record (voiding diary, validated symptom score, pad weight, or other objective measure).

SNS permanent implantation - Fecal Incontinence (proven and medically necessary)

Permanent implantation for fecal incontinence is medically necessary when the screening trial demonstrates benefit.

Not Medically Necessary / Unproven Indications

Not medically necessary / Unproven

SNS is not covered when used for:

ANY of the following

Constipation
SNS for treatment of Constipation is unproven and not medically necessary due to insufficient evidence
Chronic Pelvic Pain
SNS for treatment of Chronic Pelvic Pain is unproven and not medically necessary due to insufficient evidence

Constipation and chronic pelvic pain: The evidence base for SNS in chronic constipation and chronic pelvic pain is inconsistent and insufficient. Some RCTs (including conflicting and cross-over trials) and one multicenter randomized trial report short-term benefits for selected patients with refractory slow-transit constipation, but results are not consistently replicated, long-term effectiveness is unclear, and sham-controlled trials often show no benefit. Systematic reviews and guideline panels conclude SNS is not routinely recommended for constipation and that more high-quality studies are required; similarly, evidence for chronic pelvic pain consists largely of case series with few RCTs and significant limitations. Because of these evidence gaps and limitations, this policy considers SNS for constipation and chronic pelvic pain not medically necessary / unproven.

General guideline, test-phase criteria, and contraindications

General guideline/test-phase criteria and contraindications

Guideline-based statements regarding patient selection, test-phase success, and contraindications:

Offer and selection: Offer SNS for overactive bladder (OAB)/urge urinary incontinence (UUI) refractory to conservative measures and pharmacotherapy (multiple guideline recommendations).

Fecal guidance: Consider SNS as second-line therapy for fecal incontinence (FI) after failure of conservative measures (ACG/ICS/AGA guidance).

Constipation guidance: SNS for constipation: not recommended routinely; consider only in selected refractory cases after >1 year of symptoms and failure of conservative therapy (ICS/ASCRS/ACG conclusions).

Test success criterion:

Evidence, Guidelines and Regulatory Context

NICE and specialty society recommendations (selection)

Key recommendation logic extracted from NICE, ASCRS, and other guidelines:

NICE OAB: NICE supports adoption of SNM for refractory OAB when conservative treatment or medicines have not worked; discuss long-term implications and test stimulation needs.

NICE percutaneous criteria: NICE (2019) recommends offering percutaneous SNM to women after MDT review when OAB has not responded to non-surgical management including medications and either symptoms have not responded to botulinum toxin type A or individuals decline BTX due to catheterization risk.

NICE counseling points: NICE recommends discussing need for test stimulation, probability of test success, risk of failure, long-term commitment, need for surgical revision, and adverse effects.

Relevant Procedure and Diagnosis Codes

Relevant CPT/HCPCS codes listed for referencemixed

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.
L8679	Implantable neurostimulator, pulse generator, any type.

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Urinary diagnosis codes (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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Fecal diagnosis codes (reference)ICD-10

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

Provider Actions and Documentation Requirements

Documentation Required

Medical record documentation requirement

The patient's medical record must include documentation that supports the medical necessity of the requested sacral nerve stimulation service. Required documentation includes a clear history, focused physical examination, and results of pertinent diagnostic tests or procedures. Records must be legible and made available upon request.

history
physical exam
diagnostic test results
legible and available upon request

Documentation Required

Document test-phase improvement

For a permanent implant to be considered medically necessary, objective documentation of the test-phase outcome must show a clinical improvement of 50% or greater during the percutaneous nerve evaluation (PNE) or Stage 1 (trial) stimulation. The documented trial result must be included in the medical record submitted for review.

Evidence Details and Study Summaries

Source	Key finding / metric
Hayes emergent technology review (2025)	Limited evidence for miniaturized integrated SNS; first-in-human feasibility/safety study in 5 participants; no conclusions on efficacy/long-term safety
Amundsen network/systematic review (2025)	Weighted UUI responder rates similar: SNM 71.8% vs iTNM 71.3%; OAB responder rates SNM 73.9% vs iTNM 79.4%
Van Ophoven meta-analysis (2021)	Pooled test SNM success ~66.2%; permanent SNM success ~84.2%; adverse events reported in <25% (common AEs: loss of effectiveness 4.7%, infection 3.6%, implant site pain 3.2%, lead migration 3.2%)
Eggers systematic review (2025) for FI	Long-term per-protocol success 59.4%–87.5% (ITT 20.9%–87.5%); aggregate revision rate 35.2%; explant rate 19.7%; improvements in bowel diary, St Mark's/Cleveland Clinic scores, QoL
Heemskerk et al. 2024 STC trial	SNM success 53.7% vs 3.8% with personalized conservative treatment at 6 months (OR 36.4; p=0.003); more AEs with SNM; long-term effectiveness unclear
Zerbib et al. 2017 cross-over RCT	No significant difference between active and sham stimulation for refractory constipation; sustained response limited (only 11 individuals sustained response at 1 year)
Pires et al. 2023 LARS meta-analysis	Overall clinical success 77% after permanent implantation; decreases in incontinence episodes and Wexner scores; improved QoL

Limitations across the evidence: Major limitations noted include serious risk of bias in many included studies, heterogeneity in study populations and outcome definitions, small sample sizes, and a lack of long-term randomized controlled trials for several indications. Sham-controlled and crossover trials for constipation have produced conflicting or negative results, and many FI and CPP reports are uncontrolled case series, limiting causal inference and generalizability. These limitations constrain confidence in effect estimates and inform the policy's conservative stance for unproven indications.

Definitions

Key definitions

Chronic Pelvic PainPersistent or recurrent episodic pelvic pain with LUT, sexual, bowel, or gynecologic dysfunction and no proven infection or obvious pathology

Chronic Urinary RetentionPostvoid residual (PVR) >= 300 mL that persists >= 6 months and is documented on >= 2 separate occasions

ConstipationSyndrome of difficult/infrequent passage of stool, hard stool, or feeling of incomplete evacuation

Fecal IncontinenceInvoluntary passage of fecal matter or inability to control discharge; severity from flatus to complete evacuation

Fowler's SyndromeLarge bladder capacity, reduced sensation, increased maximal urethral closure pressure, detrusor underactivity; typically post-menarche young women

Urge Incontinence (UUI)Sudden compelling urge to void resulting in involuntary leakage of urine

Revision History

04/01/2026updatedLatest

Updated reference link to reflect the current policy title for Gastrointestinal Disorders Diagnostic Procedures (for Pennsylvania Only).

12/01/2025revised

Replaced references to 'Sacral Nerve Stimulation' with 'Sacral Nerve Stimulation (neurostimulation)'; added language that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess clinical criteria.

12/01/2025added

Policy Summary

PayerUnitedHealthcare

PolicySacral Nerve Stimulation Pa Cs

Policy CodePolicy CS258PA.E

Change TypeRevised/Added definitions & documentation requirements

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

ALL of the following

All criteria for SNS screening trial for fecal incontinence have been met.
Demonstrated improvement of symptoms ≥ 50% during the SNS screening trial (patient-reported and/or objective measures such as bowel diaries or validated incontinence scores).>= 50%
Improvement should be documented in the medical record.

Replacement or revision of sacral nerve stimulator

Replacement or revision of sacral nerve stimulator is medically necessary when ALL of the following are met:

ALL of the following

Individual met the original indication criteria for SNS (urinary voiding dysfunction or fecal incontinence) at the time of initial implantation.
Existing device or lead is nonfunctional or malfunctioning and cannot be repaired, or device malfunction is not covered by warranty or device is out of warranty.
Documentation of device status, prior attempts at repair, and warranty information should be provided.
Current clinical status indicates the individual continues to meet the intended indication (i.e., persistent symptoms that previously responded to SNS or ongoing need for therapy).

Trial/test-phase success criterion: ≥ 50% improvement in one or more troublesome urinary or bowel parameters during PNE or Stage 1 testing may lead to offering full implantation.

Level of Evidence: III; Grade of Recommendation: 3 (see source)

Test durations: Typical PNE/test durations: bladder ~7 days; bowel 10-21 days; Stage 1 typically 2-3 weeks (repeat Stage 1 at physician discretion).

Level of Evidence: III/IV as noted in source

Absolute contraindications: insufficient clinical response to therapeutic trial, inability to operate device (and no supportive caregiver), pregnancy.

Level of Evidence: IV; Grade: C

Relative contraindications: severe or rapidly progressive neurologic disease, established complete spinal cord injury, expected need for MRI below the head, abnormal sacral anatomy.

Level of Evidence: III; Grade: C

Preoperative counseling: discuss lifelong follow-up, battery replacement, potential complications (implant site pain, infection, paresthesia, leg pain), need for reprogramming or device revision.

Level of Evidence: IV; Grade: C

Screening for success during the test period

Criteria used to determine offering full implantation after test stimulation:

Success definition: Individual achieves 50% improvement in one or more troublesome urinary or bowel parameters during the PNE or Stage 1 test period>= 50% improvement

Level of Evidence: III; Grade of Recommendation: 3

PNE duration: PNE test stimulation period duration: typically 7 days for bladder and 10-21 days for bowel indications

Level of Evidence: III; Grade of Recommendation: 3

Stage 1 duration: Stage 1 test period duration: typically 2-3 weeks; repeat Stage 1 test may be performed at physician's discretion

Level of Evidence: IV; Grade of Recommendation: C

Clinical responses: Clinician should consider both sensory and motor responses important for success

Level of Evidence: IV; Grade of Recommendation: C

Key definitions and background: PNE (percutaneous nerve evaluation) is a short temporary test stimulation prior to permanent implantation; a Stage 1 test is a surgical implanted lead test-phase typically lasting 2–3 weeks. Fecal Incontinence (FI) is the involuntary passage of fecal matter, and Urge Incontinence (UUI) is a sudden compelling urge to void with involuntary leakage. Non-obstructive urinary retention (NOUR) and Chronic Urinary Retention (PVR ≥ 300 mL persisting ≥ 6 months, documented on ≥ 2 occasions) are defined and considered in patient selection. The policy uses the term Sacral Nerve Stimulation (SNS), also known as Sacral Neuromodulation (SNM) or Urologic Nerve Stimulation.

NICE (2015) recommends considering implanted SNS for men with detrusor overactivity refractory to conservative and drug treatments.

ASCRS FI: ASCRS (2023) states SNM may be considered as a first-line surgical option for incontinent patients with or without sphincter defects (conditional; low-quality evidence).

ASCRS constipation: ASCRS guidance for constipation: SNM may be effective for chronic constipation with successful PNE when conservative measures have failed, but not FDA-approved for constipation in the U.S.; recommendation weak/moderate-quality evidence (2B).

FDA device approvals (informational)

Regulatory device approvals described in the document:

InterStim PMA P970004 (1997) for OAB; subsequent approvals: urinary retention (April 1999, S004) and InterStim Micro (July 2020, S302); labeled indication includes urinary retention and OAB symptoms in individuals who have failed or could not tolerate conservative treatments.

Informational

Axonics PMA: Axonics r-SNM System PMA P190006 (September 6, 2019) approved for chronic fecal incontinence in individuals who have failed or are not candidates for conservative treatments; approval contingent on annual safety reports.

Informational

Neuspera PMA: Neuspera Sacral Neuromodulation System PMA approved June 18, 2025 for UUI in individuals who failed/could not tolerate or were not candidates for conservative treatments (informational).

Informational; accessed July 31, 2025

Evidence summary: For fecal incontinence, systematic reviews report long-term improvements in bowel diaries, St Mark's/Cleveland Clinic scores, and quality of life, with per-protocol success rates typically reported in the range of 59.4%–87.5% and intention-to-treat ranges of 20.9%–87.5%. Aggregate device-related reintervention rates in FI series are substantial (reported revision rate ≈ 35.2% and explant rate ≈ 19.7%). For urinary voiding dysfunction (including NOUR and OAB/UUI), pooled test-phase success rates and permanent success rates from meta-analyses are commonly high (pooled test success ~66.2% and permanent SNM success ~84.2% in nLUTD series), and randomized trials show benefit versus conservative therapies for selected indications. However, the evidence is limited by heterogeneity in populations, variable outcome definitions, and predominance of nonrandomized designs in many long-term reports.

Prior Authorization

Test success requirement prior to implantation

Full permanent implantation will be approved only after demonstration of a successful test trial. A successful trial is defined as objective and documented improvement of ≥50% in symptoms during PNE or Stage 1 trial. Documentation of the trial results (including quantified improvement) is required for prior authorization and payment.

Prior Authorization

Patient selection and preoperative counseling requirements

Before proceeding with sacral nerve stimulation (trial or permanent implantation), the patient must receive and have documented preoperative counseling covering device expectations and therapy implications. Counseling must confirm that conservative therapies were attempted and failed and that the patient understands long-term follow-up, potential need for battery replacement, and possible complications.

Failure of conservative therapy (e.g., bladder/bowel training, pelvic floor rehabilitation, pharmacotherapy) must be documented
Lifelong follow-up requirements (device checks, programming)
Potential for battery depletion and replacement procedures
Possible complications and risks associated with trial and permanent implantation

Denial Risk

Exclusion-based denial risk

Sacral nerve stimulation for Constipation or Chronic Pelvic Pain is considered not medically necessary. Claims submitted for these indications are at risk for denial under this policy.

Constipation
Chronic Pelvic Pain

Prior Authorization

Pennsylvania-specific application

This policy applies to services provided in Pennsylvania. Requests that do not meet the policy criteria may be reviewed on a case-by-case basis per Pennsylvania regulations.

See Pennsylvania Code, Title 55, Chapter 1101 for exceptions and case-by-case review guidance

Documentation Required

Assess contraindications

Assess and document any contraindications prior to trial or implantation. Absolute and relative contraindications must be evaluated and recorded in the medical record.

Absolute contraindications: active infection at the implant site, untreated systemic infection, lack of ability to operate the device
Relative contraindications: coagulopathy or anticoagulation that cannot be managed perioperatively, pregnancy, anatomical abnormalities preventing lead placement, significant psychiatric illness that may interfere with informed consent or compliance

PNEPercutaneous nerve evaluation — temporary test stimulation prior to permanent implantation

Stage 1 testSurgical test-phase with implanted lead for 2-3 weeks to assess response prior to full implantation

NOURNon-obstructive urinary retention

Sacral Nerve Stimulation (SNS)Also known as Sacral Neuromodulation (SNM) or Urologic Nerve Stimulation; implanted electrode near sacral nerve to modulate voiding and bowel function

12/01/2025added

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

12/01/2025revised

Updated Clinical Evidence, FDA, and References sections to reflect the most current information; archived previous policy version CS258PA.D.