CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria Treatments for Urinary Incontinence

Kaiser Permanente Clinical Review Criteria covering multiple treatments for urinary incontinence (extracorporeal magnetic innervation, biofeedback, sacral nerve stimulation, radiofrequency procedures, intravaginal electrical stimulation, slings, urethral bulking agents, PTNS/Urgent PC). This part provides background, MTAC evidence reviews, Medicare/NCD notes, and references to MCG criteria for non-Medicare determinations.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria Treatments for Urinary Incontinence

Policy CodePolicy N/A

Change TypeClarified / Revised (multiple MPC actions)

Effective Date

Next Review Date

Key ActionWhen requesting non‑Medicare services (e.g., EMI, radiofrequency, IVES, TRETRTSUI), send last 6 months of clinical notes from requesting provider and/or specialist to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

MPC approved the adoption of the proposed changes in the Sacral Nerve Stimulator policy defining conservative therapy to sacral nerve stimulator placement.

MPC approved criteria for PTNS.

MPC approved to discontinue medical necessity review of biofeedback for treatment of urinary incontinence, effective August 1, 2024; required 60-day notice.

MPC approved revised clinical criteria for sling procedures and urethral bulking agents, effective August 1, 2024; required 60-day notice.

Paraphrased the criteria from Medicare NCD 230.10.

MultipleTreatments addressed in part 1

ConditionalPTNS coverage status

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Insufficient evidenceIVES status

SeveralMTAC reviews summarized

Coverage Summary & Scope

Scope: Part 1 is Kaiser Permanente Clinical Review Criteria covering multiple treatments for urinary incontinence, including Extracorporeal Magnetic Innervation (EMI), Biofeedback, Sacral Nerve Stimulation / Bladder Pacemaker (InterStim), Transurethral and Transvaginal Radiofrequency procedures (TRETRTSUI / bladder neck suspension), Intravaginal Electrical Stimulation (IVES), SPARC and other Sling procedures, Urethral bulking agents (collagen, Durasphere, other implants), and Percutaneous Tibial Nerve Stimulation (PTNS / Urgent PC) (listed therapies and scope summarized from the criteria header and background).

Status and coverage stance: The overall stance is mixed—some interventions are considered medically necessary when criteria are met (e.g., sling procedures and urethral bulking agents under applicable policy statements; PTNS is conditionally medically necessary for OAB when specific criteria are met), some are not medically necessary (e.g., intravaginal electrical nerve devices, transurethral radiofrequency energy tissue remodeling is listed as not medically necessary by code 53860), and several technologies were judged by MTAC to not meet Kaiser Permanente Medical Technology Assessment Criteria or have insufficient evidence (biofeedback, IVES, many radiofrequency procedures, SPARC sling, earlier determinations for sacral nerve stimulation/PTNS across MTAC reviews).

High-level criteria and processes: For Non‑Medicare members, Kaiser elects to use specified MCG clinical guidelines (e.g., MCG Implanted Electrical Stimulator, Sacral Nerve KP-0645; Sling Procedures KP-S-850; Urethral Bulking Agent Injections KP-0268) for medical necessity determinations and requires documentation (e.g., last 6 months of clinical notes) for requests. Medicare NCD/LCD references (e.g., NCD 230.8, 230.10 and retired LCDs/A52965) are used for Medicare determinations where applicable. Recent MPC actions include discontinuing non‑Medicare medical necessity review for biofeedback and revising sling and bulking-agent criteria effective August 1, 2024, and adoption of a sacral nerve stimulator conservative therapy definition effective April 1, 2025 (60‑day notices).

Quick threshold facts

PTNS regimen30-minute weekly sessions for 12 weeks

Max collagen injection sessionsUp to 5 separate treatment sessions; failure if no improvement after 5

Abdominal leak pressure expected<100 cm H2O on urodynamic testing for certain SUI patients

PTNS maintenance/limitsMaintenance therapy often required; more than 12 treatments not medically necessary if no improvement

PTNS indicationMedically necessary for overactive bladder syndrome when behavioral therapy and either failure of ≥2 meds or contraindication to meds

Coverage Criteria by Therapy (Initial / Limits / Determinations)

Percutaneous Tibial Nerve Stimulation (PTNS) / Urgent PC Neuromodulation System (Non-Medicare)

Percutaneous tibial nerve stimulation (PTNS) — sometimes delivered via devices such as the Urgent PC Neuromodulation System — is an electrical neuromodulation therapy delivered as a regimen of 30-minute sessions, typically weekly for 12 weeks, for treatment of overactive bladder (OAB) with urgency, frequency, and/or urgency urinary incontinence.

ALL of the following

Diagnosis of overactive bladder syndrome (urgency, frequency, and/or urgency urinary incontinence).
Symptoms not attributable to spinal cord injury or other neurologic conditions causing neurogenic bladder.
Medication trial or contraindication
- Documented failure of at least two oral medications for OAB with adequate trials (e.g., two anticholinergic agents, or one anticholinergic plus a beta-3 agonist such as mirabegron).

Relevant Codes & Coverage Status

Referenced Coverage/NCD/LCD Guidancemixed

230.8	CMS NCD: Non-Implantable Pelvic Floor Electrical Stimulator (reference number)
230.10	CMS Incontinence Control Devices (reference)
230.18	Biofeedback Therapy for the Treatment of Urinary Incontinence (reference)
L144432	Noridian LCD Biofeedback Therapy Policy (retired but referenced)
A52965	Local Coverage Article (retired but referenced)

Referenced Coverage/NCD/LCD Guidance (notes)mixed

No codes listed

Transurethral radiofrequency micro-remodeling (Not Medically Necessary)CPTNot Covered

53860

Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence

Percutaneous tibial nerve stimulation (PTNS) / relatedCPT|HCPCS

64566	Posterior tibial neurostimulation, percutaneous needle electrode, single treatment; includes programming
0587T	Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed - posterior tibial nerve
0588T	Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

Sacral Nerve Stimulation / Bladder PacemakerCPT|HCPCS

64561	Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance if performed
64581	Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
64590	Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct
C1767	Generator, neurostimulator (implantable), nonrechargeable
C1778	Lead, neurostimulator (implantable)
C1820	Generator, neurostimulator (implantable) with rechargeable battery and charging system

BiofeedbackCPT

90901	Biofeedback training by any modality
90912	Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry; initial 15 minutes
90913	Biofeedback training, perineal muscles... each additional 15 minutes

Sling procedures and related urethropexy (Medically Necessary when criteria met)CPTCovered

51840	Anterior vesicourethropexy, or urethropexy Marshall-Marchetti-Krantz, Burch; simple
51841	Anterior vesicourethropexy, or urethropexy Marshall-Marchetti-Krantz, Burch; complicated
51845	Abdomino-vaginal vesical neck suspension, with or without endoscopic control
51990	Laparoscopy, surgical; urethral suspension for stress incontinence
57288	Sling operation for stress incontinence (eg, fascia or synthetic)
57289	Pereyra procedure, including anterior colporrhaphy
53440	Sling operation for correction of male urinary incontinence (eg, fascia or synthetic)
53442

Urethral bulking agents (Medically Necessary when criteria met)CPT|HCPCSCovered

51715	Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
L8603	Injectable bulking agent, collagen implant, urinary tract; 2.5 ml syringe, includes shipping and necessary supplies
L8604	Injectable bulking agent; dextranomer/hyaluronic acid copolymer implant; urinary tract, ml; includes shipping and necessary supplies
L8606	Injectable bulking agent, synthetic implant; urinary tract; ml syringe, includes shipping and necessary supplies

Intravaginal electrical nerve devices (Not Medically Necessary)HCPCSNot Covered

E0740	Nonimplanted pelvic floor electrical stimulator, complete system
E0746	Electromyography (EMG) biofeedback device

Authorization, Documentation & Denial Risk

Prior Authorization

Documentation for non-Medicare procedures

When requesting non-Medicare services (e.g., EMI, radiofrequency, IVES, TRETRTSUI), send the last 6 months of clinical notes from the requesting provider and/or specialist to support medical necessity.

Prior Authorization

MCG criteria use / access

Kaiser uses MCG clinical guidelines for non‑Medicare determinations (specified KP- document numbers). Providers may request a copy of the specific MCG criteria used by calling Kaiser Clinical Review staff or accessing the MCG Guideline Index via the provider portal.

Denial Risk

PTNS treatment limits

More than 12 PTNS treatments are not medically necessary when there is no improvement in overactive bladder symptoms; claims for treatments beyond 12 sessions without demonstrated improvement may be denied.

Background, Definitions & Evidence Summaries

Background: MTAC conducted multiple evidence reviews (1999–2014) summarizing epidemiology, definitions, conservative therapies, and device regulatory status. Urinary incontinence (UI) is common — estimates range widely by definition and population — and major UI types are SUI, UUI, and MUI. Conservative first‑line therapies include behavioral interventions (bladder training, timed/scheduled voiding, fluid management, weight loss), pelvic floor muscle training (PFMT/Kegels), and trial of pharmacotherapy (typically at least two oral medications such as two anticholinergics or an anticholinergic plus a beta‑3 agonist).

MTAC evidence synopses and FDA references: MTAC reviews found varying evidence by technology—EMI (extracorporeal magnetic innervation) is an FDA Class II device (FDA cleared June 1998) but MTAC in 2000 noted insufficient controlled evidence though FDA clearance allowed meeting MTAC criteria; biofeedback meta-analyses (including a 2011 Cochrane‑derived review) showed some patient‑reported benefit but small objective change (about 1 fewer leak every 8 days), and MTAC concluded biofeedback did not meet Kaiser Medical Technology Assessment Criteria across reviews; IVES had insufficient evidence for efficacy or safety (MTAC 2014); collagen/Durasphere bulking agents and some radiofrequency procedures had limited, mixed or case‑series evidence and did not meet MTAC criteria in earlier reviews.

PTNS and sacral nerve stimulation: PTNS is described as a minimally invasive office‑based neuromodulation therapy with a typical regimen of 30‑minute weekly sessions for 12 weeks; MTAC and subsequent trials (including SUmiT/OrBIT) produced mixed evidence and issues with study design, but MCG criteria specify PTNS is medically necessary for OAB when all criteria are met (OAB syndrome, symptoms not due to spinal cord injury, failure of ≥2 medications or contraindication to pharmacotherapy, and adequate behavioral therapy). PTNS beyond 12 sessions is not medically necessary when there is no improvement. Sacral nerve stimulation involves percutaneous test stimulation before implantation; RCTs showed short‑term superiority among test‑responders but were limited by selection bias and lack of blinding and MTAC concluded sacral nerve stimulation did not meet MTAC criteria for urinary incontinence (separate MTAC finding supported sacral stimulation for fecal incontinence).

Medicare NCD/LCD References

Name	Number	Type	Effective Date
Non-Implantable Pelvic Floor Electrical Stimulator	230.8	NCD
Referenced Medicare NCD 230.10	230.10	NCD

Policy Changes & Revision Timeline

03/07/2017MPC action

MPC approved criteria for PTNS.

03/12/2024MPC action (material)

MPC approved to discontinue medical necessity review of biofeedback for the treatment of urinary incontinence, effective August 1, 2024; Requires 60-day notice.

03/12/2024MPC action (material)

MPC approved revised clinical criteria for sling procedures and urethral bulking agents, effective August 1, 2024; Requires 60-day notice.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria Treatments for Urinary Incontinence

Policy CodePolicy N/A

Change TypeClarified / Revised (multiple MPC actions)

Effective Date

Next Review Date

SourceLink

On This Page

Documented contraindication or intolerance to pharmacotherapy for OAB preventing adequate medication trial(s).

Behavioral therapy (e.g., bladder training and pelvic floor muscle training) of sufficient duration to fully assess efficacy, unless contraindicated or not appropriate; documentation of attempted behavioral therapy is required.

PTNS is delivered as a course of 30-minute sessions, typically once weekly for 12 weeks.

PTNS Limitations

PTNS coverage limitations and usage constraints.

ALL of the following

PTNS is considered experimental, investigational, or unproven for any urinary indication other than overactive bladder (non-neurogenic).
More than 12 PTNS treatments are not medically necessary when there is no documented improvement in OAB symptoms; continuation beyond 12 sessions requires documentation of clinical benefit.

Biofeedback for Urinary Incontinence

Biofeedback (surface EMG or other biofeedback-assisted pelvic floor muscle training) may be used as an adjunct to pelvic floor rehabilitation for urinary incontinence.

ANY of the following

Evidence conclusions from MTAC: biofeedback may improve outcomes when combined with pelvic floor muscle training, but coverage varies by plan.
Coverage varies across plans; for specific FEHB or other plan members, refer to the member contract for plan-specific coverage details.

Extracorporeal Magnetic Innervation (EMI)

Extracorporeal magnetic innervation (EMI) has been assessed by MTAC; regulatory status and evidence summary are provided for background.

ALL of the following

MTAC conclusion: evidence is insufficient to establish that EMI is as safe and effective as standard therapies for urinary incontinence.
FDA: devices marketed for EMI may have various regulatory pathways; check device-specific clearance status and local contracting/policy for coverage determinations.

Intravaginal Electrical Stimulation (IVES)

Intravaginal electrical stimulation (IVES) has been evaluated by MTAC with insufficient evidence for routine coverage.

ALL of the following

MTAC conclusion: evidence is insufficient to demonstrate that IVES is as safe and effective as standard therapies for urinary incontinence.
Coverage determination: considered experimental, investigational, or unproven for treatment of urinary incontinence in the absence of compelling supporting evidence.

Collagen / Urethral Bulking Agents

Urethral bulking agents (including collagen and other agents) are intended to treat stress urinary incontinence due to intrinsic sphincter deficiency (ISD) in selected patients.

ALL of the following

MTAC / policy conclusions: injections are limited to patients with stress urinary incontinence due to intrinsic sphincter deficiency (congenital or acquired, e.g., spinal cord lesion, myelomeningocele, epispadias) or other specified indications per plan documentation.
Limit on repeat injections: patients whose incontinence does not improve after five injection sessions are considered treatment failures and further injectable therapy is not covered; repeat injections after recurrence following prior successful treatment may be allowed with medical justification.

Transurethral / Transvaginal Radiofrequency Procedures

Transurethral and transvaginal radiofrequency procedures (including radiofrequency bladder neck suspension and transurethral radiofrequency tissue remodeling for stress urinary incontinence) have been evaluated by MTAC.

ALL of the following

MTAC conclusion: evidence is insufficient to demonstrate these radiofrequency procedures provide durable benefit superior to standard surgical options for stress urinary incontinence.
Coverage determination: transurethral/transvaginal radiofrequency procedures and radiofrequency bladder neck suspension are considered experimental, investigational, or unproven and are not covered under standard medical benefits.

Implanted Sacral Nerve Stimulators (Non-Medicare)

Implanted sacral nerve stimulators (non-Medicare) are governed by MCG guideline criteria; documentation requirements apply for review.

ALL of the following

Kaiser Permanente uses the MCG Implanted Electrical Stimulator, Sacral Nerve guideline for medical necessity determinations for non-Medicare members.
Documentation required when requesting services: last 6 months of clinical notes from the requesting provider and/or specialist, documentation of prior conservative therapy, trial stimulation results (if applicable), and objective measures of symptom response.

Sling Procedures, Urethral Bulking Agents (Non-Medicare)

Sling procedures and urethral bulking agents for non-Medicare members follow MCG clinical guideline references and may require Level of Care Review.

ALL of the following

Kaiser Permanente uses the MCG Sling Procedures for Urinary Incontinence guideline (e.g., mid-urethral and pubovaginal slings) for medical necessity determinations for non-Medicare members.
Requests for sling procedures require Level of Care Review; submit clinical documentation per plan instructions and MCG criteria.

Transurethral/Transvaginal Radiofrequency Procedures (Additional)

Additional assessments for transurethral/transvaginal radiofrequency procedures reiterate MTAC findings and coverage determinations.

ALL of the following

MTAC assessment: available studies are limited in size and duration, with uncertain long-term efficacy and durability compared with established surgical procedures for SUI.
Coverage: these procedures (including TRETRTSUI and radiofrequency bladder neck suspension) are considered experimental/investigational and are not covered.

SPARC Sling

The SPARC sling and similar devices have been evaluated; MTAC conclusions inform coverage.

ALL of the following

MTAC conclusion: some sling devices have limited or mixed evidence; specific devices (e.g., SPARC) may not meet MTAC standards for coverage.
Coverage determination: if not meeting MTAC/MCG criteria, SPARC sling is not covered under standard benefits; follow MCG and Level of Care Review processes where applicable.

Percutaneous Tibial Nerve Stimulation (PTNS) / Urgent PC Neuromodulation System (General)

Broader MTAC evidence conclusions for PTNS and a consolidated coverage determination.

ALL of the following

MTAC summary: PTNS (12 weekly 30-minute sessions) has evidence of symptomatic improvement in some patients with non-neurogenic OAB but long-term durability and comparative effectiveness against other third-line therapies vary across studies.
Coverage determination (Non-Medicare): PTNS is medically necessary when all criteria listed in the PTNS group are met. PTNS for neurogenic bladder or other non-OAB urinary indications is considered experimental/investigational and not covered.

Sacral Nerve Stimulation / Bladder Pacemaker (InterStim)

Sacral nerve stimulation (e.g., InterStim) has MTAC evidence review and coverage guidance.

ALL of the following

MTAC conclusion: sacral nerve stimulation can provide benefit for selected patients with refractory OAB or fecal incontinence; trial stimulation demonstrating ≥50% improvement is typically required (per CMS guidance for Medicare patients).
Coverage determination: follow MCG criteria for non-Medicare members; for Medicare members, observe CMS NCD/LCD requirements including successful trial criteria.

Sling Procedures (e.g., TVT, SPARC, Marshall-Marchetti-Krantz, Burch)

Sling procedures (e.g., TVT, SPARC, Marshall-Marchetti-Krantz, Burch) are standard surgical options for stress urinary incontinence when criteria are met.

ALL of the following

Background: sling procedures are commonly used to treat SUI and require evaluation of symptoms, prior conservative management, and urodynamic or clinical findings per MCG criteria.
Medical necessity: sling procedures are medically necessary when MCG guideline criteria and plan-specific documentation requirements are satisfied; Level of Care Review may be required.

Biofeedback

Biofeedback coverage position varies by benefit type (Medicare vs non-Medicare).

ANY of the following

Medicare: follow Medicare LCD/LCA guidance where applicable; retired LCDs may still be used as clinical references for medical necessity review.
Non-Medicare: coverage varies across plans — consult member contract for specific coverage details.

Urethral Bulking Agents

Summary policy position for urethral bulking agents and related coding/limits.

ALL of the following

Coverage is limited to patients meeting indication criteria (e.g., ISD) and subject to limits on repeat injections as noted in the Urethral Bulking Agents group.
Providers should document prior therapies, objective findings, and previous response to injections when requesting coverage for bulking agent procedures.

Intravaginal Electrical Nerve Devices

Intravaginal electrical nerve stimulation devices and similar intravaginal electrical therapies have been reviewed and coverage determined.

ALL of the following

Coverage determination: intravaginal electrical nerve devices (IVES and related devices) are considered not medically necessary/experimental for treatment of urinary incontinence due to insufficient evidence supporting safety and effectiveness compared with standard therapies.

Documentation Required

Collagen injections limitation

Patients whose incontinence does not improve after 5 separate collagen injection treatment sessions are considered treatment failures and no further collagen implant injections are covered. Recurrence after prior successful collagen implants (e.g., 6–12 months previously) may allow additional sessions only with medical justification.

Documentation Required

Medicare trial stimulation requirement

For Medicare members under the Non‑Implantable Pelvic Floor Electrical Stimulator NCD, a successful trial with test stimulation demonstrating ≥50% improvement in symptoms is required prior to coverage of the device.

Documentation Required

Elective surgical procedures level-of-care review

Elective sling surgical procedures require a level‑of‑care review prior to service. Affected sling CPT codes include: 51840, 51841, 51845, 51990, 57288, 57289, 53440, 53442.

51840
51841
51845
51990
57288
57289
53440
53442

Prior Authorization

Pre-authorization code check

Verify authorization requirements for a specific code by plan type using the Pre-authorization Code Check prior to scheduling or billing services.

Documentation Required

PTNS treatment protocol documentation

Document the PTNS treatment protocol and baseline symptom burden. Typical regimen is 30‑minute weekly sessions for 12 weeks (CPT/HCPCS codes: 64566, 0587T, 0588T). Baseline symptom documentation (for example, ≥8 voids/24 hours where applicable) and documentation of response and need for maintenance therapy are required.

Typical regimen: 30 minutes weekly for 12 weeks
Codes: 64566, 0587T, 0588T
Document baseline symptoms (e.g., ≥8 voids/24 hours) and response

Documentation Required

Sacral nerve stimulation test-stimulation requirement

For sacral nerve stimulation, patients typically undergo percutaneous test stimulation and must demonstrate a positive test response prior to implantation. Relevant codes include 64561, 64581, 64590 and device HCPCS/C codes C1767, C1778, C1820; document the test‑stimulation response in the medical record before implantation.

Codes: 64561, 64581, 64590, C1767, C1778, C1820
Document test stimulation response prior to implantation

Billing Rule

Code deletions and non-inclusive codes note

Code lists in this document may not be all‑inclusive. Deleted codes and codes not in effect at the time of service may not be covered; verify current code validity and coverage.

Surgery, slings, and bulking agents: Sling procedures (e.g., TVT, Burch, SPARC) are surgical options to support the bladder neck/urethra; MTAC found insufficient evidence for SPARC and other procedures have specific coverage when criteria are met. Urethral bulking agents (CPT 51715; HCPCS L8603/L8604/L8606) are considered medically necessary in defined scenarios (e.g., SUI due to intrinsic sphincter deficiency) with limits such as up to 5 injection sessions—failure after 5 injections precludes further collagen implant coverage unless medically justified; abdominal leak pressure <100 cm H2O is an expected finding in certain cases.

Operational notes and references: For non‑Medicare determinations Kaiser uses MCG guideline documents (KP numbered guidelines) and requests supporting clinical documentation (last 6 months). Medicare references include NCDs (230.8 Non‑Implantable Pelvic Floor Electrical Stimulator; 230.10 Incontinence Control Devices) and retired LCDs/A52965 may still be used for review. Codes and code‑level coverage positions are provided (e.g., 53860 transurethral RF listed not medically necessary; E0740/E0746 intravaginal electrical nerve devices not medically necessary) and procedural reviews require level‑of‑care review for elective surgeries such as sling procedures.

Term	Definition
Stress urinary incontinence (SUI)	Leakage of urine during activities that increase abdominal pressure (e.g., coughing, sneezing) in absence of detrusor contraction.
Urgency urinary incontinence (UUI)	Involuntary leakage accompanied by or immediately preceded by a sensation of urgency.
Mixed urinary incontinence (MUI)	Symptoms of both urgency and stress incontinence.
Intrinsic sphincter deficiency (ISD)	Urethral sphincter unable to contract and generate sufficient resistance, leading to SUI.
Overactive bladder (OAB)	Presence of urinary urgency with or without urge incontinence, usually accompanied by frequency and nocturia, in the absence of urinary tract infection or other obvious pathology.
Stress urinary incontinence (SUI)	Leakage of urine during activities that increase abdominal pressure such as exercise or coughing in the absence of a detrusor contraction.

Evidence item	Summary
Biofeedback MTAC conclusion (2011)	Cochrane/meta-analysis of trials (24 RCTs) found increased patient-reported improvement but only ~1 less leak every 8 days; trials small or at moderate/high risk of bias; MTAC concluded biofeedback does not meet Kaiser Permanente Medical Technology Assessment Criteria.
EMI MTAC conclusion (2000)	Extracorporeal magnetic innervation was FDA cleared (Class II); MTAC found insufficient scientific evidence from cohort studies to permit conclusions about health outcomes but noted FDA approval and thus it met MTAC criteria historically.
IVES MTAC conclusion (2014)	MTAC concluded insufficient evidence to support efficacy or safety of intravaginal electrical stimulation for stress, urge, or mixed urinary incontinence in females.
Collagen/Durasphere MTAC conclusion (1999/2002)	Evidence consisted mainly of small case series and limited RCT data with variable outcomes; MTAC concluded collagen injections did not pass Medical Technology Assessment Criteria; durability and safety concerns noted (particle migration reports).
Transurethral radiofrequency (2011)	A single RCT with methodological limitations suggested possible safety and effectiveness for transurethral radiofrequency micro-remodeling but durability and impact on subsequent surgeries remain unclear; transvaginal RF had insufficient evidence.
PTNS RCT response rate (SUmiT)	SUmiT randomized sham-controlled trial: 54.5% of patients receiving PTNS had a moderate/marked response versus sham; overall PTNS responder rates ranged 37–82% across studies and maintenance therapy often required.
PTNS responder range (meta-analysis)	Meta-analyses and reviews reported success rates across studies from about 37% to 82%; larger RCTs had manufacturer involvement and varied inclusion criteria and endpoints.
Sacral nerve stimulation RCT notes	Multiple RCTs showed superiority of sacral nerve stimulation versus standard medical care at 6 months among test-responders, but trials were limited by selection bias (only test-responders included), lack of blinding, and manufacturer involvement; MTAC concluded sacral nerve stimulation did not meet Kaiser Permanente Medical Technology Assessment Criteria for urinary incontinence.

07/16/2024Administrative update

Paraphrased the criteria from Medicare NCD 230.10.

11/05/2024MPC adoption (material)Latest

MPC approved adoption of proposed changes in the Sacral Nerve Stimulator policy defining conservative therapy to sacral nerve stimulator placement; Requires 60-day notice; Effective April 1, 2025.