CurrentCignaPolicy 0573

Adjustable Continence Therapy (ACT®) and ProACT™ devices

Cigna coverage policy addressing the use of the Adjustable Continence Therapy (ACT®) device for women and the ProACT™ device for men for treatment of stress urinary incontinence, including FDA status, literature review, professional society guidance, coding, and coverage determination.

Policy Summary

PayerCigna

PolicyAdjustable Continence Therapy (ACT®) and ProACT™ devices

Policy CodePolicy 0573

Change TypeAnnual review — no clinical policy statement changes

Effective Date

Next Review Date

Key ActionClaims billed with CPT codes 53451 or 53452 will be denied as services considered experimental, investigational or unproven.

POLICY UPDATE CHANGES

Annual Review dated 9/15/2025: No clinical policy statement changes.

2CPT codes listed as not covered

ACTNot FDA-approved (women)

ProACTPMA approved (men, Nov 2015)

No clinical changesMost recent annual reviews

Coverage Summary

Scope: Cigna coverage policy addressing the use of the Adjustable Continence Therapy (ACT®) device for women and the ProACT™ device for men for treatment of stress urinary incontinence, including FDA status, literature review, professional society guidance, coding, and coverage determination.

Coverage stance: Not covered — considered experimental, investigational, or unproven for all indications (not_covered_cosmetic). Policy number: 0573. Last review: 2025-09-15.

FDA status: ACT device (women) is not FDA-approved and therefore lacks FDA marketing approval. ProACT (men) has FDA premarket approval (PMA) granted November 2015 for specified post-prostatectomy/TURP male indications (adult men with ISD ≥12 months who failed conservative therapy).

Evidence summary (brief): Published studies for ACT in women are primarily retrospective and nonrandomized with variable success and substantial complication, explantation, and revision rates; ProACT evidence includes retrospective and prospective studies and meta-analyses reporting modest-to-moderate effectiveness but substantial complication and explantation/revision rates.

Coverage Determination

Policy decision:

Adjustable Continence Therapy (ACT®) is considered experimental, investigational or unproven for all indications.

Background and Evidence Summary

Background: ACT® is a minimally invasive adjustable balloon device proposed to treat female stress urinary incontinence due to intrinsic sphincter deficiency; ProACT™ is a minimally invasive adjustable balloon system for adult men with stress incontinence due to intrinsic sphincter deficiency ≥12 months after radical prostatectomy or TURP and who have failed conservative therapy.

FDA status differences: The ACT device for women is not FDA-approved, while ProACT has an FDA premarket approval (PMA) granted in November 2015 for specified male indications.

Evidence quality: Published evidence for both devices is largely retrospective and nonrandomized; studies include case series, retrospective cohorts, and meta-analyses. For ACT in women, studies are small, often lack controls, and report variable success with notable rates of intraoperative and postoperative complications, explantation, and reimplantation. For ProACT in men, systematic reviews and meta-analyses report measurable reductions in pad use and improvement/dryness rates but also report high overall complication, explantation, and reoperation/revision rates; methodological heterogeneity and limited comparative trials are noted.

Clinical evidence summary

Female ACT success rangeSuccess rates reported 13.6%–68%; improvement 16%–83% (systematic review)

Female ACT explantationExplantation rates reported 6%–38%; reimplantation after explantation 15.2%–63%

ProACT complication/explant ratesOverall complication rates reported up to ~47% in reviews; explantation rates ~22–26.5% and revision/reoperation rates ~22–27% in meta-analyses

ProACT dryness/improvementDryness rates around 55–60% (0–1 pads/day); proportion dry or >50% improved up to ~82% in meta-analyses

ACT®: Adjustable Continence Therapy device (balloon) intended for female stress urinary incontinence due to intrinsic sphincter deficiency.

ProACT™: Adjustable Continence Therapy system for men (adjustable periurethral balloons) indicated for adult men with stress incontinence from intrinsic sphincter deficiency ≥12 months after radical prostatectomy or TURP and who failed conservative therapy.

Relevant Coding

Urology Services Considered Experimental/Investigational/UnprovenCPTNot Covered

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.

Actionable Billing & Documentation Notes

Denial Risk

Claims for ACT/ProACT procedures

Claims billed with CPT codes 53451 or 53452 will be denied as services considered experimental, investigational or unproven.

53451
53452

Documentation Required

Use appropriate codes and plan terms

When billing, providers must use the most appropriate codes as of the effective date of the submission and ensure services are consistent with the member's specific benefit plan document; services not accompanied by covered codes under the applicable Coverage Policy will not be reimbursed.

Services not accompanied by covered codes under the applicable Coverage Policy will not be reimbursed.

Medicare Determinations

Medicare determinations: No National Coverage Determination (NCD) found.

Medicare determinations: No Local Coverage Determination (LCD) found.

Revision History

2025-09-15annual_reviewLatest