UnitedHealthcare SNM coverage update Prior Auth

Coverage Criteria

inv-01: SNS screening trial — urinary

Covered when ALL of the following are met for urinary voiding dysfunction screening trial

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

inv-02: SNS permanent implantation — urinary

Covered when ALL of the following are met for urinary permanent implantation

Urinary permanent implant criteria: Improvement in reported symptoms of ≥50% in response to a screening trial of sacral nerve stimulation; all criteria for sacral nerve stimulation screening trial have been met.

inv-03: SNS screening trial — fecal

Covered when ALL of the following are met for fecal incontinence screening trial

Fecal screening trial criteria: Individual capable of operating sacral nerve stimulating device; symptoms refractory to conservative care (e.g., bowel training, bulking agents, pelvic floor rehabilitation, pharmacologic therapy); fecal incontinence not secondary to neurologic disease (e.g., Parkinson's, stroke, spinal cord injury, multiple sclerosis); lack of distorted anorectal anatomy (e.g., anorectal malformation, abscess or fistula, prior rectal surgery); fecal incontinence not secondary to constipation.

inv-04: SNS permanent implantation — fecal

Covered when ALL of the following are met for fecal permanent implantation

Fecal permanent implant criteria: Improvement in reported symptoms of ≥50% in response to a screening trial of sacral nerve stimulation; all criteria for sacral nerve stimulation screening trial have been met.

inv-05: Device replacement or revision

Replacement or revision

Replacement/revision criteria: Individual previously met initial indications for sacral nerve stimulation and the existing device is nonfunctional and either cannot be repaired or is no longer under warranty.

inv-06: Unproven indications

Not covered / investigational

Unproven indications: Sacral nerve stimulation 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: Permanent implant criteria (evidence-derived)

Covered when ALL of the following are met (as reflected in the clinical evidence):

Primary requirements: 1) Patient has refractory symptoms (e.g., OAB, fecal incontinence/LARS, or selected chronic pelvic indications) after appropriate conservative/medical therapies; 2) Patient underwent a documented test stimulation/PNE or Stage 1 test with ≥50% symptom reduction prior to permanent implant; 3) Expected benefit outweighs risks including known device revision and explantation rates reported in long-term reviews.>=50% test response

Derived from randomized trials and systematic reviews requiring ≥50% improvement during test phase before permanent implant

inv-08: Coverage criteria summary

Covered when ALL of the following are met (per guideline-concordant indications summarized in this document portion):

General eligibility: 1) Documented failure of conservative/medical therapies appropriate to the indication (often ≥3 months); 2) Patient willing to undergo surgery and long-term device management; 3) Patient (or caregiver) capable of operating the device.

Based on ACG, AGA, AUA/SUFU, ICS guidance

Urinary indications supported by evidence: SNM may be offered for overactive bladder (with or without incontinence) refractory to conservative/medical therapy, for Fowler's syndrome, voiding dysfunction, and nonobstructive urinary retention in selected patients; consider as a later-line therapy for severe refractory OAB.

AUA/SUFU, ICS, EAU guidance

Fecal incontinence and LARS: SNM should be considered for moderate or severe fecal incontinence refractory to conservative measures; trials and meta-analyses report substantial response rates (e.g., ~77% success after permanent implant in LARS reviews).

AGA, Marinello and Ram systematic reviews

inv-09: Coverage for SNM (general)

Covered when ALL of the following are met

General coverage criteria: 1) Documented failure of appropriate conservative measures for the indication (urinary or bowel); 2) Successful test stimulation (PNE or Stage 1) demonstrating ≥50% improvement in one or more target symptoms; 3) Patient is able to operate the device or has supportive caregivers; 4) No absolute contraindications (e.g., pregnancy, or inability to operate device).as described

Based on ICS, NICE, ASCRS guidance and device approvals

inv-10: Fecal incontinence — ASCRS position

ASCRS fecal incontinence recommendation

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

ASCRS 2023 guidance

inv-11: NICE guidance for OAB and related indications

NICE recommendations (selected)

Refractory OAB (NICE): Consider SNM (including Axonics) for refractory overactive bladder when conservative and medical treatments have failed; discuss long-term implications, need for test stimulation, surgical revision risks, and device-specific characteristics (e.g., MRI considerations).

NICE 2019/2020/2023 guidance

Voiding dysfunction or fecal incontinence that is secondary to neurologic disease (for example, Parkinson’s disease, stroke, spinal cord injury, or multiple sclerosis) is excluded from coverage for sacral nerve stimulation screening trials and permanent implantation. This exclusion applies to both urinary and bowel indications and is based on the policy’s stated criteria that the target dysfunction not be of neurologic origin.

The presence of a bladder outlet or mechanical obstruction (for example benign prostatic hyperplasia, obstruction from tumor or prior radiation therapy, or urethral stricture) excludes candidacy for sacral nerve stimulation for urinary indications. Per the policy, device evaluation and implantation require an absence of obstructive causes before proceeding.

Fecal incontinence that is secondary to constipation or that occurs in the setting of distorted anorectal anatomy (for example anorectal malformation, abscess or fistula, or prior rectal surgery) is excluded from consideration for sacral nerve stimulation trials and permanent implantation.

There is insufficient evidence to support sacral nerve stimulation (SNS) for chronic pelvic pain. The policy notes that additional high-quality studies are required to demonstrate clinical efficacy and utility; SNS for chronic pelvic pain is therefore not considered proven and may be investigational or not medically necessary in many contexts.

Pregnancy is listed as an absolute contraindication to permanent sacral nerve stimulator implantation. The policy also requires that the individual be capable of operating the device (or have supportive caregivers); inability to operate the device without caregiver support is an additional contraindication to permanent implantation.

Sacral nerve modulation for constipation is not FDA-approved for this indication in the United States and the literature documents substantial event and reintervention rates in constipation populations. The policy cites the AGA technical review and recent trials and reviews that report inconsistent efficacy and appreciable rates of device-related events and reoperations.

The policy explicitly lists pregnancy as an absolute contraindication to sacral nerve stimulation implantation and advises that pregnant individuals should not undergo permanent device implantation.

Coverage determinations described in this policy are subject to and governed by applicable federal, state, or contractual benefit plan requirements. Providers must verify plan-specific coverage rules, Medicaid requirements, and any other governing contractual terms before applying this policy.

Sacral nerve stimulation for the treatment of constipation and chronic pelvic pain is considered unproven and not medically necessary in routine practice due to insufficient or conflicting evidence of safety and effectiveness. The policy cites randomized trials and systematic reviews that fail to demonstrate consistent benefit for these indications.

Use of sacral nerve stimulation for chronic pelvic pain lacks sufficient high‑quality evidence from randomized controlled trials and comparative studies; accordingly, SNM for this indication may be considered not medically necessary until further robust RCT data are available.

The policy states that sacral neuromodulation for chronic constipation/slow transit constipation (STC) is unsupported by conclusive evidence. Multiple randomized trials and systematic reviews report conflicting or negative results, variable safety and reoperation rates, and cost‑effectiveness concerns; routine coverage for constipation or STC is therefore not supported by the current evidence base.

An insufficient clinical response to a documented therapeutic trial (commonly defined in this policy as less than 50% improvement during the test stimulation period) is an absolute contraindication to proceeding with permanent implantation and will render permanent implantation not medically necessary.

Coding

Procedure CPT 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 generator or receiver, with detachable connection to electrode array pulse.

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 nonrechargeable, includes extension array.
L8687	Implantable neurostimulator pulse generator; dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension.

Relevant ICD-10 Diagnosis CodesICD-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 35

1/4

Applicable ICD-10 Codes — changes notedICD-10

R35.81	Added ICD-10 diagnosis code (urinary indication)
R35.89	Added ICD-10 diagnosis code (urinary indication)
R39.191	Added ICD-10 diagnosis code (urinary indication)
R39.192	Added ICD-10 diagnosis code (urinary indication)
R39.198	Added ICD-10 diagnosis code (urinary indication)
R35.8	Removed ICD-10 diagnosis code
R39.19	Removed ICD-10 diagnosis code

inv-28: Screening trial response threshold

Threshold>= 50% improvement in reported symptoms during screening trial

Applies toUrinary and fecal indications when documented during PNE or Stage 1 test

Reference policy statementPermanent implantation considered when improvement in reported symptoms of 50% or greater in response to a screening trial

inv-29: Screening trial duration

Typical duration3-7 days for initial screening trial

When to use longer testConsider Stage 1 test if longer screening period needed

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for sacral nerve stimulation (SNS)/sacral neuromodulation (SNM) services. Providers must obtain prior authorization consistent with UnitedHealthcare policies and the applicable InterQual medical necessity criteria before scheduling implantation (including test stimulation trials and permanent implants). Requests should include all required clinical documentation described below.

Prior authorization required for test stimulation and permanent implantation
Submit requests using InterQual criteria applicable to the indication
Coverage decisions governed by federal, state, and contractual benefit requirements

Documentation Required

Conservative Therapy Documentation

Document the conservative therapies tried and failed, including dates, duration, and responses. Examples include bladder or bowel training, pelvic floor rehabilitation/biofeedback, pharmacologic therapy (names, doses, duration), bulking agents (for fecal incontinence), and other noninvasive measures. For urinary indications, conservative care must have been attempted prior to a test stimulation/trial.

Background

Background: Sacral nerve stimulation (SNS), also called sacral neuromodulation (SNM), is a minimally invasive neuromodulation therapy used to treat refractory conditions such as overactive bladder, urinary retention/voiding dysfunction, urgency/frequency syndromes, and fecal incontinence. A trial stimulation period (for example PNE or Stage 1 testing) is used to identify responders; permanent implantation is considered when the trial demonstrates a demonstrable clinical response (typically defined as ≥50% improvement in symptoms). Evidence supporting SNS includes randomized controlled trials, systematic reviews, and meta-analyses showing symptomatic improvement in selected patient populations, balanced against device-related risks and long-term revision/explantation rates.

Definitions

inv-55: Fecal Incontinence

DefinitionThe involuntary passage of fecal matter through the anus or inability to control discharge of bowel contents; severity ranges from flatus to complete evacuation.

Severity spectrumRanges from minor leakage (flatus) to complete evacuation

Relevance to policyFI is an indicated condition for SNM screening and permanent implantation when criteria (including refractory conservative therapy and successful test) are met

inv-56: Chronic Pelvic Pain

DefinitionPersistent or recurrent episodic pelvic pain associated with lower urinary tract, sexual, bowel, or gynecological dysfunction without proven infection or other obvious pathology.

Evidence statusInsufficient high-quality evidence to support SNS for chronic pelvic pain; considered unproven/not medically necessary in many contexts

OpenPayer

Sacral Nerve Stimulation for Urinary and Fecal Indications (Kentucky)

Coverage Criteria

Coding

Provider Actions & Authorization

Background

Definitions