CurrentmediviewcurativePolicy MM-PNP-060

Urinary Incontinence: Diagnostic Testing and Interventions

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Defines medical necessity criteria for diagnostic testing and a range of interventions for urinary incontinence for members under the Medical UM Department.

Policy Summary

Payermediviewcurative

PolicyUrinary Incontinence: Diagnostic Testing and Interventions

Policy CodePolicy MM-PNP-060

Change TypeNo material changes

Effective DateApr 12, 2024

Next Review Date

Key ActionObtain prior authorization when plan requires it and document symptoms, prior conservative treatment attempts, and objective response to test stimulation for neuromodulation candidacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+months required

>=50%SNM test success

3max bulking shots

12PTNS sessions

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CurrentmediviewcurativePolicy MM-PNP-060

Urinary Incontinence: Diagnostic Testing and Interventions

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Sign up for mediviewcurative Policy MM-PNP-060 alerts

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Defines medical necessity criteria for diagnostic testing and a range of interventions for urinary incontinence for members under the Medical UM Department.

Policy Summary

Payermediviewcurative

PolicyUrinary Incontinence: Diagnostic Testing and Interventions

Policy CodePolicy MM-PNP-060

Change TypeNo material changes

Effective DateApr 12, 2024

Next Review Date

Key ActionObtain prior authorization when plan requires it and document symptoms, prior conservative treatment attempts, and objective response to test stimulation for neuromodulation candidacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+months required

>=50%SNM test success

3max bulking shots

12PTNS sessions

Renessa/urethral inserts

25+experimental items

Medical Necessity and Coverage Criteria

General diagnostic testing — Multichannel urodynamic studies

Covered when ALL of the following are met:

Multichannel urodynamics medically necessary: Patient has both symptoms and physical findings of urinary incontinence or voiding dysfunction (e.g., stress incontinence, overactive bladder, lower urinary tract symptoms) and the provider is considering invasive, potentially morbid, or irreversible treatments after conservative management has been tried and failed.

Multichannel urodynamic studies are considered medically necessary in this context.

Artificial Urinary Sphincter (AUS) — Indications and selection criteria

AUS placement is considered medically necessary when ANY of the following indications are present:

AUS indications: Children with intractable urinary incontinence due to intrinsic urethral sphincter deficiency (IUSD) refractory to behavioral or pharmacologic therapies and unsuitable for other surgical correction; OR patients ≥ 6 months post‑prostatectomy with persistent urinary incontinence despite trials of behavioral and pharmacologic therapies; OR patients with epispadias‑exstrophy in whom bladder neck reconstruction has failed; OR women with intractable urinary incontinence who have failed behavioral, pharmacologic, and other surgical treatments.>= 6 months post‑prostatectomy for that indication

The artificial urinary sphincter is considered investigational for all other indications.

Periurethral bulking agents — Indications, limits, and related criteria

Covered when ALL of the following are met:

Bulking agent coverage: Periurethral injections of FDA‑cleared bulking agents are used for urinary incontinence due to intrinsic urethral sphincter deficiency that is refractory to conservative management (e.g., Kegel exercises, biofeedback, electrical stimulation, and/or pharmacotherapies).max 3 treatments

Patients whose incontinence does not improve after 3 treatments are considered treatment failures and further bulking agent treatment is not medically necessary. Injection for neurogenic bladder and other indications is considered investigational.

Implantable Sacral Nerve Stimulators (SNM) — Stage 2 permanent implantation criteria

Permanent (Stage 2) sacral nerve stimulator implantation is medically necessary when ALL selection criteria are met:

SNM — urge urinary incontinence or urge‑frequency: 1) Symptoms (urge UI or urge‑frequency) present for at least 6 months with significant disability (limiting daily activities); AND 2) Failed pharmacotherapies (at least 2 different anticholinergics or an anticholinergic plus mirabegron) and behavioral treatments (pelvic floor exercise, biofeedback, timed voids, fluid management); AND 3) Test stimulation (Stage 1) provides at least 50% decrease in symptoms. Test stimulation (Stage 1) is medically necessary for patients meeting criteria 1 and 2; no more than 6 total Stage 1 test stimulations are considered medically necessary. Permanent bilateral placement is considered experimental/investigational.>=50% symptom reduction; <=6 Stage 1 trials

SNM may also be considered for nonobstructive urinary retention when analogous criteria are met and Stage 1 reduces residual urine volume by >=50%.

Other procedures and devices — Grouped list

These procedures and devices are considered medically necessary when the specified condition‑specific criteria are met:

Various covered interventions: Weighted vaginal cones (vaginal weights) as DME when used with a structured pelvic floor muscle exercise program for simple (pure) stress UI; pessary as DME for women with stress or mixed UI and pelvic organ prolapse; tension‑free vaginal tape (TVT) and transobturator tape (TOT) procedures for stress UI refractory to behavioral and pharmacologic treatments; colposuspension and conventional suburethral sling procedures for stress UI refractory to conservative management; transurethral radiofrequency therapy (Renessa) for stress UI in non‑pregnant women unable or unwilling to undergo surgery; urethral inserts for female stress UI; percutaneous tibial nerve stimulation (PTNS) for urge UI/urge‑frequency when meeting the first two SNM criteria (typically 12 weekly treatments with continuation monthly only if improved).PTNS: 12 initial weekly treatments; continue monthly if improved

Many listed procedures are investigational for other, non‑specified indications.

Medically necessary interventions — Condition‑specific coverage statements

Covered when the following condition‑specific criteria are met:

Renessa (transurethral radiofrequency therapy): Covered for treatment of stress urinary incontinence in non‑pregnant women who are either not able or not willing to undergo surgery for their condition.

Urethral inserts: Covered for treatment of female stress urinary incontinence.

Cunningham clamp: Covered for treatment of postprostatectomy urinary incontinence in men with stress incontinence and adequate bladder storage function.

Intravaginal electrical stimulation: Covered for women with stress, urgency, or mixed urinary incontinence.

Experimental / Investigational — Interventions not covered

Not covered (experimental/investigational) when requested because effectiveness has not been established:

Experimental/Investigational interventions: Neocontrol System (extracorporeal magnetic innervation, ExMI); SURx radiofrequency micro‑remodeling (paraurethral or transvaginal); laser therapies including Genityte and FemiLift; pudendal nerve stimulation; adjustable retropubic suburethral sling for SUI; autologous myoblast or muscle‑derived cell transplantation; collagen porcine dermis mesh; stem cell therapies (including mesenchymal); magnetically controlled end‑urethral artificial urinary sphincter; transcutaneous electrical nerve stimulation (TENS) for overactive bladder; transperineal permanent adjustable balloon continence devices (e.g., ProACT); vibratory perineal stimulation; bariatric surgery for UI outside obesity surgery criteria; Adjustable Transobturator Male System; magnetic stimulation for women with SUI; moxibustion for post‑stroke UI; dynamometry for pelvic floor quantification; genetic testing for SUI; and periurethral bulking agent injections in specified high‑risk or contraindicated situations (e.g., acute infection, severe allergies/anaphylaxis history, prior pelvic radiation, unstable or noncompliant bladder, planned desensitization to meat products).

Requests for these interventions are considered experimental/investigational and are not covered.

The policy specifies important limitations on sacral neuromodulation (SNM). SNM is considered to have no proven value for individuals with mechanical obstruction (for example, benign prostatic hypertrophy or urethral stricture), for persons with stress urinary incontinence, and for patients whose urinary dysfunction is due to neurologic disease origins (for example, multiple sclerosis or diabetes with peripheral nerve involvement).

Permanent bilateral SNM placement is considered experimental and investigational, and failure to demonstrate an appropriate response to test stimulation (Stage 1) or inability to operate the neurostimulator are contraindications noted in the device labeling and reflected in the policy.

Pelvic muscle trainers (for example, Athena, Gyneflex, Kegelmaster, Leva Pelvic Floor Trainer) and similar exercise devices are not covered as durable medical equipment (DME). The policy states these devices are considered exercise machines and do not meet the plan's definition of covered DME because they are not primarily medical in nature and/or are normally of use to patients without an illness or injury.

The policy lists specific scenarios in which interventions such as the artificial urinary sphincter (AUS), periurethral bulking agents, sacral neuromodulation (SNM), and percutaneous tibial nerve stimulation (PTNS) are not medically necessary when applied outside their indicated uses. Examples include AUS or bulking agents used for indications other than intrinsic urethral sphincter deficiency (IUSD), bulking agents for neurogenic bladder, SNM or PTNS when the selection criteria (duration of symptoms, failed conservative and pharmacologic therapies, and successful test stimulation) are not met, and continued bulking agent treatment after three unsuccessful injections.

For PTNS specifically, continued treatment after failure to improve following the initial course (typically 12 weekly treatments) is considered not medically necessary. Similarly, SNM permanent implantation may be denied when test stimulation (Stage 1) does not achieve the required response or when selection criteria are unmet.

Periurethral injections of bulking agents are considered experimental and investigational (not covered) for certain perioperative or high‑risk situations. The policy explicitly excludes bulking agent injections for patients undergoing or planning desensitization injections to meat products, patients with acute cystitis, urethritis, or infection, patients with severe allergies including prior anaphylaxis or multiple severe allergies, those with prior pelvic radiation therapy, and patients with an unstable or non‑compliant bladder.

In addition, the policy states that patients whose incontinence does not improve after three bulking agent treatments are considered treatment failures and further bulking treatments are not medically necessary.

Test Thresholds and Coding-Related Key Values

inv-12: Test stimulation success threshold for SNM

Stage 1 (test stimulation) success threshold>= 50% reduction in symptoms (or >=50% decrease in residual urine for retention)

Role of Stage 1Temporary stimulation trial to assess clinical response prior to permanent (Stage 2) implantation

Medical necessityTest stimulation is considered medically necessary for patients who meet duration and failed-therapy selection criteria for SNM

inv-13: Post-prostatectomy waiting period for AUS candidacy

Minimum waiting period after prostatectomy>= 6 months post-prostatectomy with persistent UI despite behavioral and pharmacologic therapy

Context for AUS candidacyRequired duration applies to patients being considered for artificial urinary sphincter implantation for IUSD-related UI

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior authorization required; contingent on meeting medical necessity

Authorization is required and will only be granted when the member meets the medical necessity criteria for the requested diagnostic test or intervention (e.g., evidence of symptoms and physical findings and failed conservative care prior to invasive or irreversible treatments).

Prior Authorization

Prior authorization for specified UI interventions

Obtain prior authorization for the listed medically necessary urinary incontinence interventions when the plan requires it and include documentation of the specific indication and prior treatment attempts supporting medical necessity.

Step Therapy

Conservative therapy required before advanced interventions

Clinical Background

Background: Urinary incontinence encompasses several distinct clinical presentations, including stress urinary incontinence, urge urinary incontinence/overactive bladder, mixed urinary incontinence, and voiding dysfunction. Evaluation typically begins with history, physical examination, and conservative therapies such as pelvic floor muscle training, biofeedback, and pharmacologic agents, advancing to diagnostic testing and procedural or surgical interventions for refractory cases.

The policy reflects this stepped approach by describing medically necessary diagnostic multichannel urodynamic testing when invasive or irreversible treatments are being considered, and by specifying a range of interventions—from pessaries, vaginal cones, and pelvic floor modalities to minimally invasive procedures (e.g., Renessa), injectables (periurethral bulking agents), nerve stimulation therapies (PTNS and SNM), and surgical implants (AUS)—each with defined selection criteria and limits (for example, ≥6 months symptom duration and failed conservative/pharmacologic therapy before some device implants, and a ≥50% response threshold on SNM test stimulation).

Key Terms and Definitions

inv-26: Intrinsic urethral sphincter deficiency (IUSD)

DefinitionIntrinsic urethral sphincter deficiency (IUSD) is a cause of urinary incontinence in which the urethral sphincter is unable to maintain closure, leading to stress or other types of UI

Relevance to interventionsIUSD is an accepted indication for periurethral bulking agents and artificial urinary sphincter (AUS) implantation when conservative therapies fail

Treatment pathwayConservative measures (Kegels, biofeedback, electrical stimulation, pharmacotherapies) are expected prior to bulking agents or AUS for IUSD

inv-27: Test stimulation (Stage 1) for sacral neuromodulation

DefinitionStage 1 (test stimulation) is a temporary sacral neuromodulation trial used to assess response before permanent implantation

Success threshold

Policy Revision History

2024-04-12policy_effectiveLatest

Policy original effective date recorded and medical necessity criteria for urinary incontinence interventions established (MM-PNP-060).

2024-04-12content_added

Multichannel urodynamic studies and a range of device and procedure-specific medical necessity criteria (AUS, periurethral bulking agents, SNM, PTNS, Renessa, urethral inserts, Cunningham clamp, intravaginal electrical stimulation) were defined.

2024-04-12

Policy Summary

Payermediviewcurative

PolicyUrinary Incontinence: Diagnostic Testing and Interventions

Policy CodePolicy MM-PNP-060

Change TypeNo material changes

Effective DateApr 12, 2024

Next Review Date

Key ActionObtain prior authorization when plan requires it and document symptoms, prior conservative treatment attempts, and objective response to test stimulation for neuromodulation candidacy.

SourceLink

On This Page

Prior therapy requirementBehavioral and pharmacologic therapies must have been tried without improvement during the waiting period

Trials of conservative management are expected before advanced procedures; document attempts at pelvic floor training, biofeedback, behavioral measures and pharmacotherapies (including required drug trials for certain devices).

For SNM candidacy, document failure of at least two different anticholinergics or an anticholinergic plus mirabegron and behavioral therapy.
For bulking agents and sling procedures, document prior pelvic floor muscle training, electrical stimulation, and biofeedback as applicable.
PTNS: document initial course of ~12 weekly treatments and response before continuing.

Note

Document consideration of conservative/non‑surgical options

Consider and document non‑surgical alternatives when appropriate (for example, Renessa for non‑pregnant women who are unable or unwilling to undergo surgery), and include rationale if surgery is deferred.

Documentation Required

General medical necessity documentation

Document the patient’s symptoms and physical findings, prior conservative management attempts, and clinical reasoning that invasive testing or irreversible procedures are indicated.

Include symptom duration, severity impact on activities, and prior behavioral/medical therapies tried and their outcomes.
For multichannel urodynamics, document that invasive testing is being considered because conservative care failed.

Documentation Required

Neuromodulation-specific documentation requirements

For neuromodulation requests, document symptom duration of at least 6 months, prior failed pharmacologic and behavioral therapies, and objective response to test stimulation (e.g., ≥50% symptom improvement or ≥50% reduction in residual urine).

Record the duration (≥6 months) and significant disability from symptoms.
Document failure of required medication trials (at least two anticholinergics or anticholinergic plus mirabegron) and behavioral therapies.
Provide test stimulation results showing ≥50% symptom reduction (or ≥50% reduction in residual urine for retention).

Documentation Required

Document indication‑specific support

Support the specific indication for the requested intervention in the record (e.g., Renessa for non‑pregnant women not candidates for surgery; urethral inserts for female stress UI; Cunningham clamp for postprostatectomy male stress incontinence with good bladder storage).

Denial Risk

Bulking agent treatment limit — max 3 injections

Continued periurethral bulking agent treatment after three unsuccessful injections is not considered medically necessary and may be denied.

If incontinence does not improve after 3 bulking treatments, further bulking injections should not be requested as they are considered treatment failures.

Denial Risk

SNM Stage 2 contingent on Stage 1 response (≥50%)

Permanent (Stage 2) sacral nerve stimulator implantation may be denied if the Stage 1 test stimulation did not provide at least a 50% reduction in symptoms or if selection criteria (duration and failed therapies) are unmet.

Test stimulation must show ≥50% symptom improvement (or ≥50% reduction in residual urine for retention) to qualify for Stage 2.
Symptom duration ≥6 months and failure of required pharmacologic/behavioral therapies must be documented.

Denial Risk

Denial risk: pelvic muscle trainer DME claims excluded

Claims for pelvic muscle trainer devices (e.g., Athena, Gyneflex, Kegelmaster, Leva Pelvic Floor Trainer) may be denied because these devices are considered exercise machines and not covered durable medical equipment.

Verify member benefit plan details, but anticipate denial/exclusion for these devices as non‑covered DME.

Denial Risk

Denial risk: experimental/investigational interventions

Requests for interventions listed as experimental and investigational (e.g., extracorporeal magnetic innervation systems, SURx radiofrequency micro‑remodeling, Genityte/FemiLift lasers, pudendal nerve stimulation, stem cell therapies, adjustable male systems, etc.) should be denied or excluded because effectiveness has not been established.

Confirm the requested device/procedure is not on the experimental/investigational list; if listed, expect denial.

>= 50% decrease in symptoms (or >=50% decrease in residual urine for nonobstructive retention)

Utilization limitsTest stimulation is considered medically necessary for eligible patients; no more than 6 total test stimulation trials (Stage 1) are considered medically necessary

inv-28: Transurethral radiofrequency therapy (Renessa)

DefinitionTransurethral radiofrequency therapy (Renessa) is a minimally invasive transurethral procedure that applies radiofrequency energy to the bladder neck/urethral tissues

Indicated useMedically necessary for treatment of stress urinary incontinence in non-pregnant women who are not able or not willing to undergo surgery

Position in care pathwayOffered as a non-surgical alternative for women unwilling or unable to have operative correction

inv-29: Urethral inserts

DefinitionUrethral inserts are devices inserted into the urethra to provide support and control for female stress urinary incontinence

Coverage noteConsidered medically necessary for treatment of female stress urinary incontinence

LimitationsUse for indications other than female stress UI is considered experimental and investigational

inv-30: Cunningham clamp

DefinitionThe Cunningham clamp is an external penile clamp designed to compress the urethra and reduce urinary leakage

Indicated useMedically necessary for postprostatectomy male stress urinary incontinence in men with stress incontinence and good bladder storage function

Patient selectionAppropriate for men after prostatectomy with preserved bladder storage function as a non‑surgical management option

inv-31: Intravaginal electrical stimulation

DefinitionIntravaginal electrical stimulation is a pelvic floor electrical stimulation therapy delivered intravaginally to strengthen pelvic muscles and modulate bladder function

Covered indicationsConsidered medically necessary for women with stress, urgency, or mixed urinary incontinence

Role in conservative therapyOffered as a pelvic floor therapy modality within conservative management prior to more invasive procedures

Key thresholds specified: >=6 months symptom duration for select device indications, >=50% improvement required from SNM test stimulation (Stage 1), maximum of 3 bulking agent treatments before deemed treatment failure, and PTNS typical course of 12 weekly treatments.

2024-04-12exclusions_specified

Numerous interventions were listed as experimental/investigational and pelvic muscle trainers were excluded as DME (not covered).