CurrentCareSource GeorgiaPolicy MP-MM-1304

ProACT Adjustable Continence Therapy

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Medical policy governing coverage and clinical criteria for ProACT adjustable continence therapy for male post-surgical stress urinary incontinence for CareSource Georgia members.

Policy Summary

PayerCareSource Georgia

PolicyProACT Adjustable Continence Therapy

Policy CodePolicy MP-MM-1304

Change TypeRoutine review — no material changes

Effective DateSep 1, 2025

Last ReviewMar 29, 2023

Next Review DateSep 1, 2025

Key ActionObtain prior authorization and document ≥12 months since prostate surgery, ≥3 incontinence episodes/day, failed conservative therapy, and two 24-hour pad tests showing ≥8 g increase.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsminimum time since prostate surgery required before ProACT

>=3/dayminimum incontinence episodes per day required

>=8 gpad weight increase required (two tests)

5%estimated proportion needing additional procedure

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CurrentCareSource GeorgiaPolicy MP-MM-1304

ProACT Adjustable Continence Therapy

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Sign up for CareSource Georgia Policy MP-MM-1304 alerts

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Medical policy governing coverage and clinical criteria for ProACT adjustable continence therapy for male post-surgical stress urinary incontinence for CareSource Georgia members.

Policy Summary

PayerCareSource Georgia

PolicyProACT Adjustable Continence Therapy

Policy CodePolicy MP-MM-1304

Change TypeRoutine review — no material changes

Effective DateSep 1, 2025

Last ReviewMar 29, 2023

Next Review DateSep 1, 2025

Key ActionObtain prior authorization and document ≥12 months since prostate surgery, ≥3 incontinence episodes/day, failed conservative therapy, and two 24-hour pad tests showing ≥8 g increase.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsminimum time since prostate surgery required before ProACT

>=3/dayminimum incontinence episodes per day required

>=8 gpad weight increase required (two tests)

5%estimated proportion needing additional procedure

Coverage and Medical Necessity Criteria

Initial Therapy - Medical Necessity Criteria

Covered when ALL of the following are met

ProACT medical necessity criteria: A. Member underwent radical prostatectomy or transurethral resection of the prostate at least 12 months prior without radiation therapy.

B. Member has documented primary stress urinary incontinence arising from intrinsic sphincter deficiency of at least 12 months duration.

C. Member has documentation of conservative therapy failure (e.g., lifestyle modification, pads, catheter use, pelvic floor muscle training).

D. Member experiences at least 3 incontinence episodes per day.>= 3 episodes/day

E. Member has positive 24-hour pad weight test: at least an 8-gram pad weight increase demonstrated in two separate 24-hour pad weight tests.>= 8 g on two 24-hour pad tests

Contraindications for ProACT include urge incontinence and detrusor instability or overactivity. Additional contraindications are a residual urine volume of at least 100 mL or a residual volume equal to at least 25% of total bladder capacity after voiding, active systemic or urinary tract infections, history of bladder stones, hemophilia or other bleeding disorders, reduced bladder compliance, suspected bladder cancer, and radiotherapy within the past 6 months.

ProACT is not medically necessary when urinary incontinence is due to detrusor instability or overactive bladder, or when post-void residual urine volume exceeds the specified thresholds (for example, ≥100 mL or ≥25% of bladder capacity). Requests may also be considered not medically necessary when other listed contraindications are present.

Testing, Timeframes, and Key Definitions

24-hour pad weight test

RequirementAt least an 8-gram pad weight increase demonstrated in two separate 24-hour pad weight tests

Test frequencyTwo 24-hour pad weight tests required

PurposeDocument objective urine loss confirming stress urinary incontinence severity

Time since prostate surgery

Minimum intervalAt least 12 months since radical prostatectomy or transurethral resection of the prostate (TURP)

Radiation therapyMust be without radiation therapy (i.e., surgery ≥12 months prior and no radiation)

Documentation

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required for ProACT

ProACT implantation requires prior authorization and will be considered medically necessary only when all policy clinical criteria are satisfied (see Coverage Criteria: member underwent prostate surgery ≥12 months prior; documented primary SUI ≥12 months; failed conservative therapy; ≥3 daily incontinence episodes; two 24-hour pad tests with ≥8 g increase).

Step Therapy

Document failed conservative therapy before ProACT

Conservative therapies must have been tried and documented as failed before requesting ProACT. Conservative management includes lifestyle modification, pads, compression, catheters, and pelvic floor exercises; surgical treatment is usually deferred for at least 12 months post-prostatectomy.

Document attempted strategies (e.g., lifestyle modification, pads, catheters, pelvic floor exercises).
Confirm persistence of symptoms despite conservative measures for the expected recovery period (often up to 12–24 months).

Device Background

ProACT is a minimally invasive, bilateral adjustable balloon system implanted near the bladder neck to treat male stress urinary incontinence following prostate surgery. Incontinence after prostate procedures commonly improves over time with conservative measures; therefore patient selection should exclude those with contraindications such as urge incontinence, detrusor overactivity, or excessive post-void residuals (≥100 mL or ≥25% of bladder capacity). Device migration and the potential need for revision or explantation have been reported; shared decision-making and documentation of prior conservative therapy and required objective testing are recommended.

Clinical Definitions

Stress Urinary Incontinence (SUI)

DefinitionUrinary leakage in the absence of a bladder contraction due to inadequate urethral sphincter function (mechanical damage or physiologic limitation)

Clinical contextOccurs after prostate surgery and is the primary indication for ProACT when chronic (≥12 months) and from intrinsic sphincter deficiency

DistinctionDifferent from urge or overflow incontinence and should be documented as the predominant type

Urge Urinary Incontinence (UUI)

DefinitionA sudden and compelling desire to pass urine that is difficult to defer and is accompanied by involuntary leakage

AssociationTypically associated with bladder outlet obstruction or detrusor overactivity

Policy Summary

PayerCareSource Georgia

PolicyProACT Adjustable Continence Therapy

Policy CodePolicy MP-MM-1304

Change TypeRoutine review — no material changes

Effective DateSep 1, 2025

Last ReviewMar 29, 2023

Next Review DateSep 1, 2025

Key ActionObtain prior authorization and document ≥12 months since prostate surgery, ≥3 incontinence episodes/day, failed conservative therapy, and two 24-hour pad tests showing ≥8 g increase.

SourceLink

On This Page

Date of prior radical prostatectomy or TURP must be provided in clinical records

Incontinence episodes

Frequency thresholdMember experiences at least 3 incontinence episodes per day

DocumentationClinical records must document frequency of incontinence episodes (≥3/day)

Role in criteriaOne of the required clinical criteria that must be met for ProACT coverage

Residual volume contraindication

Contraindication thresholdPost-void residual volume of at least 100 mL or at least 25% of total bladder capacity

MeasurementPost-void residual urine volume should be measured to assess eligibility

Policy effectResidual volume meeting or exceeding this threshold is listed as a contraindication to ProACT

Documentation Required

Required clinical documentation for authorization

Include clinical records showing prior radical prostatectomy or TURP date (at least 12 months prior without radiation), documentation of primary SUI of ≥12 months, evidence of failed conservative therapy, frequency of incontinence (≥3 episodes/day), and results of two 24‑hour pad weight tests demonstrating at least an 8‑gram increase.

Operative note or procedure date for radical prostatectomy or TURP (≥12 months prior; note absence of radiation).
Clinical notes documenting primary stress urinary incontinence from intrinsic sphincter deficiency for ≥12 months.
Documentation of conservative therapy attempts and failure.
Bladder diary or provider notes documenting ≥3 incontinence episodes per day.
Results of two 24‑hour pad weight tests each showing ≥8 g increase.

Denial Risk

Denial triggers — criteria not met or contraindications present

Requests may be denied if required clinical criteria or contraindication exclusions are present or not met — including insufficient time since prostate surgery, inadequate incontinence frequency, negative pad tests, or ongoing contraindications.

Less than 12 months since radical prostatectomy or TURP.
Fewer than 3 incontinence episodes per day.
Two 24‑hour pad weight tests do not show at least an 8‑gram increase.
No documentation of failed conservative therapy.
Presence of contraindications (e.g., urge incontinence, detrusor instability/overactivity, post‑void residual ≥100 mL or ≥25% of bladder capacity, active systemic or urinary tract infection, suspected bladder cancer, recent radiotherapy within 6 months).

Policy relevanceUrge urinary incontinence is listed as a contraindication for ProACT

Residual volume

DefinitionPost-void residual (PVR) urine volume

Contraindication thresholdPolicy lists PVR ≥100 mL (or ≥25% of bladder capacity) as a contraindication to ProACT

Clinical actionMeasure PVR after voiding to assess eligibility; excessive residual urine excludes coverage