CurrentCignaPolicy 0573

Adjustable Continence Therapy

This Cigna medical coverage policy governs the coverage stance for Adjustable Continence Therapy (ACT® for women and ProACT™ for men) for treatment of stress urinary incontinence and applies to health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyAdjustable Continence Therapy

Policy CodePolicy 0573

Change TypeRoutine review — no material changes

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionObtain prior authorization and submit required clinical documentation including baseline pad count or 24-hour pad weight and history of failed conservative therapy when requesting ProACT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

experimentalACT (women) stance

PMAProACT FDA

47%Complication rate (ProACT)

26.5%Explantation rate (meta-analysis)

71%No/1 pad at 6 mo

Coverage Determinations and Criteria

Policy Summary

PayerCigna

PolicyAdjustable Continence Therapy

Policy CodePolicy 0573

Change TypeRoutine review — no material changes

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionObtain prior authorization and submit required clinical documentation including baseline pad count or 24-hour pad weight and history of failed conservative therapy when requesting ProACT.

SourceLink

On This Page

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Covered / Not Covered determinations

Coverage determinations in this document:

ACT for women: ACT® device (for women) is considered experimental, investigational or unproven for all indications.

Not covered per policy statement; evidence limited and device is not FDA-approved for women.

ProACT for men (regulatory/indication): ProACT™ has FDA premarket approval for treatment of adult men with stress urinary incontinence arising from intrinsic sphincter deficiency of at least 12 months duration following radical prostatectomy or TURP and who have failed conservative therapy.>= 12 months post-radical prostatectomy or TURP and failure of conservative therapy

Clinical evidence shows improvements in pad weight and quality-of-life but substantial device explant and complication rates reported in trials.

Coding and coverage impact: CPT codes 53451 and 53452 (ProACT insertion: bilateral and unilateral, respectively) are listed in the policy's experimental/unproven services group; coverage and prior authorization requirements follow the policy stance.

Claims for ACT device procedures billed with codes not covered under this policy or not accompanied by covered diagnosis/procedure codes will be denied.

The Adjustable Continence Therapy (ACT®) device for women is excluded from coverage because it is considered experimental, investigational, or unproven for all indications. This determination is based on limited and low-certainty evidence and the device is not established as medically necessary for treatment of female stress urinary incontinence.

Use of ACT® in women is not medically necessary due to insufficient evidence supporting its safety and effectiveness for female patients. As a result, the policy does not cover ACT® procedures for women under the terms of this medical coverage policy.

Patients with prior pelvic radiotherapy have been associated with substantially worse outcomes after adjustable balloon procedures; in the Lebret multicenter trial the subgroup with prior adjuvant radiotherapy had an 83% failure rate. Guideline recommendations from AUA/SUFU (2024) therefore advise offering an artificial urinary sphincter (AUS) rather than adjustable balloons for patients who received radiotherapy.

The policy lists CPT codes 53451 and 53452 under "Urology Services Considered Experimental/Investigational/Unproven," indicating that periurethral transperineal adjustable balloon continence device insertion (bilateral and unilateral) is categorized as unproven in this document.

Billing and Coding

Urology Services Considered Experimental/Investigational/UnprovenCPTExperimental

53451	Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance
53452	Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance

ProACT insertion CPT code — 53451

53451Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance.

Typical use contextBilateral insertion code for placement of periurethral transperineal adjustable balloons (ProACT) with intraoperative cystourethroscopy and imaging guidance.

Billing noteListed in this policy under 'Urology Services Considered Experimental/Investigational/Unproven.' Prior authorization is required per plan terms.

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for ProACT device insertion. Providers must obtain authorization before scheduling procedures coded with CPT 53451 (bilateral) or 53452 (unilateral). Claims submitted without prior authorization may be denied.

Prior authorization required for CPT 53451 and 53452
Submit request with planned procedure date and supporting documentation

Step Therapy

Step Therapy Context for ProACT

ProACT is intended for adult men with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) of at least 12 months duration following radical prostatectomy or TURP who have failed conservative therapy. Step-therapy expectations: members should have persistent SUI despite appropriate conservative measures prior to consideration of ProACT.

Indication: adult men with SUI from ISD ≥ 12 months after radical prostatectomy or TURP
Step therapy: documented failure of conservative therapy (see documentation callout)

Documentation Required

Conservative Therapy Attempted Prior to ProACT

Document prior conservative therapy attempts and outcomes. Providers must include evidence that conservative management (e.g., pelvic floor muscle training/rehabilitation, electrostimulation, behavioral measures) was attempted and did not adequately resolve incontinence before ProACT is considered.

Document type and duration of conservative therapies tried (pelvic floor training, electrostimulation, pharmacotherapy, behavioral interventions)
Include outcomes showing inadequate response and dates of therapy
State duration of incontinence (must be ≥ 12 months post-prostatectomy/TURP)

Documentation Required

Prior Radiotherapy Affects Outcomes

Prior pelvic or adjuvant radiotherapy is associated with substantially higher failure rates and should be documented. Evidence indicates poor outcomes in patients with prior radiotherapy (high failure/explant rates), which is an important operational consideration when evaluating candidacy and making coverage determinations.

Explicitly document any history of pelvic or adjuvant prostate radiotherapy and dates
Consider impact of prior radiotherapy on expected benefit and counsel patient; include this in prior authorization package

Billing Rule

Billing and Documentation Requirements

Billing and documentation requirements: submit claims with the appropriate CPT code (53451 or 53452) and include supporting clinical documentation demonstrating covered diagnosis, prior conservative therapy failure, duration of incontinence, and prostate treatment history. Claims lacking required supporting documentation or billed with non-covered codes may be denied.

Include CPT 53451 (bilateral) or CPT 53452 (unilateral) on the claim
Attach clinical notes showing baseline severity (pad counts/weights), prior therapies tried and dates, prior prostate surgery and any radiotherapy history
Claims without supporting covered diagnosis/procedure documentation are subject to denial

Denial Risk

Denial Triggers and Risk Factors

Denial triggers: procedures coded with CPT 53451 or 53452 may be denied when ProACT is considered experimental/investigational for all indications per policy, when supporting documentation of conservative therapy failure or required clinical details are absent, or when prior radiotherapy indicates high likelihood of failure.

Denial likely if CPT 53451/53452 billed without prior authorization
Denial likely if documentation does not show failed conservative therapy or duration of SUI ≥ 12 months post-prostatectomy/TURP
Denial likely if prior radiotherapy is present and not addressed in justification

Device Status and Indications

ProACT indication

IndicationProACT™ is indicated for adult men with stress urinary incontinence (SUI) from intrinsic sphincter deficiency (ISD) of at least 12 months duration following radical prostatectomy or TURP who have failed conservative therapy.

Timing thresholdAt least 12 months after radical prostatectomy or transurethral resection of the prostate (TURP).

Prior therapy requirementFailure to respond adequately to conservative therapy (e.g., pelvic floor training, conservative measures) is required before ProACT.

ACT® (female device) regulatory status

Regulatory statusACT® device (for women) is currently not FDA-approved.

Contrast with ProACTProACT™ (for men) received FDA premarket approval (PMA) in November 2015; ACT® (female device) lacks FDA approval.

Policy implicationUse of ACT® for women is considered experimental, investigational or unproven for all indications per this policy.

ProACT insertion CPT codes

53451Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance.

53452Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance.

Policy listingBoth codes (53451 bilateral, 53452 unilateral) are listed under 'Urology Services Considered Experimental/Investigational/Unproven' in this policy.

Clinical Background and Evidence Context

Adjustable Continence Therapy (ACT®) is a minimally invasive, balloon-based procedure proposed to treat female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). The ACT system is intended to provide periurethral balloon support that can be adjusted to improve continence. However, ACT® for women is not FDA‑approved and, per this policy, remains classified as experimental, investigational, or unproven because available studies are limited in size and quality and do not provide sufficient evidence of durable benefit to support coverage.

Guideline-informed selection — context from literature and guideline recommendations

Context from literature and guideline recommendations relevant to patient selection:

Guideline-aligned patient selection: AUA/SUFU (2024) states clinicians may offer adjustable balloon devices to non-radiated patients with mild to severe stress urinary incontinence after prostate treatment (Conditional Recommendation, Grade C). For patients with prior radiotherapy, AUS is recommended over adjustable balloons.

Guideline emphasizes device-specific complications, need for implanter experience, and higher device removal rates compared with AUS.

Evidence-based selection considerations: Clinical trials of ProACT enrolled men who had failed conservative rehabilitation (pelvic floor training, electrostimulation); trials report meaningful reductions in pad use and pad weight but also notable explantation and complication rates (e.g., 24.2% explant in pivotal PMA cohort; high failure in radiated patients).

Select non-radiated patients who have failed conservative measures and counsel regarding explant/removal and complication risks.