CurrentBlue Cross Blue Shield - IowaPolicy 02.01.75

Artificial Urinary Sphincter

This policy governs coverage and medical necessity criteria for implantation of an artificial urinary sphincter (AUS) to treat urinary incontinence due to intrinsic urethral sphincter deficiency, primarily following prostate surgery, for members of Blue Cross Blue Shield - Iowa (Wellmark).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyArtificial Urinary Sphincter

Policy CodePolicy 02.01.75

Change TypeAnnual review (no material changes)

Effective DateSep 1, 2010

Next Review DateSep 1, 2025

Key ActionDocument at least 6 months of failed conservative therapy and confirm adequate bladder function and manual dexterity before AUS implantation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

58%–68%reported dry rates after AUS

20%–35%re-operation/revision rates reported

6–12 mowait after prostate surgery

6 mominimum conservative therapy

53445-53449, C1815CPT/HCPCS codes listed

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Coverage and Medical Necessity Criteria

Medically Necessary

Covered when ALL of the following are met:

AUS medical necessity: 1) Individual has urinary incontinence due to intrinsic sphincter deficiency following prostate surgery; 2) Symptoms have been refractory to at least 6 months of conservative therapy (e.g., bladder training, prompted voiding, pelvic muscle exercise training, or pharmacologic therapies); 3) Preoperative evaluation excludes severe detrusor instability and demonstrates adequate bladder stability and compliance; 4) The individual has adequate manual dexterity and motivation to operate the device; 5) Post-prostatectomy patients have waited 6 to 12 months and attempted behavioral and pharmacologic therapies first.

All conditions must be met for coverage.

Investigational

Not covered when ANY of the following apply:

Investigational or not medically necessary: Implantation of an artificial urinary sphincter when the medical necessity criteria above have not been met and for all other indications beyond those specified (evidence insufficient to determine improvement in net health outcomes).

Considered investigational due to insufficient evidence for other indications.

General coverage criteria

Covered when ALL of the following are met

Primary coverage conditions: 1) Patient has urinary incontinence due to intrinsic urethral sphincter deficiency following prostate surgery or other indicated etiology; 2) Patient has failed conventional/conservative treatments for at least 6 months (for post-prostate surgery patients); 3) Patient has adequate physical and cognitive ability to operate the device; 4) Clinician documents discussion of risks including erosion, infection, device failure, and likelihood of loss of effectiveness over time and need for reoperations.

Derived from policy section summary and guideline guidance.

Coverage for non–post-prostate-surgery populations

Use in other subgroups

Other populations: Evidence is insufficient to draw conclusions regarding the safety and efficacy of AUS for other subgroups (for example, non–post-prostate-surgery males, children with intractable incontinence, and certain female populations); coverage for these groups should be considered investigational or require additional evidence (e.g., RCTs with long-term follow-up).

Section summary indicates insufficient evidence.

AUS clinical recommendations

Guideline-based clinical recommendations relevant to AUS use

AUS candidate counseling and selection: Clinicians should discuss the option of artificial urinary sphincter with patients experiencing mild to severe stress urinary incontinence after prostate treatment and ensure patients have adequate physical and cognitive abilities to operate the device.

Strong Recommendation; Evidence Level: Grade B (AUA/SUFU).

Surgical approach: Clinicians should preferentially utilize a single cuff perineal approach for AUS implantation.

Moderate Recommendation; Evidence Level: Grade C (AUA/SUFU).

Post-radiotherapy recommendation: For patients with stress urinary incontinence after primary, adjuvant, or salvage radiotherapy who are seeking surgical management, clinicians should offer AUS over male slings or adjustable balloons.

Moderate Recommendation; Evidence Level: Grade C (AUA/SUFU).

The implantation of an artificial urinary sphincter (AUS) is considered investigational when the policy's medical necessity criteria are not met and for all other indications beyond those specified, because the evidence is insufficient to demonstrate an improvement in net health outcomes.

Evidence is insufficient to establish the safety and efficacy of AUS in other subgroups (for example, non–post-prostate-surgery males, children with intractable incontinence, and certain female populations). Use of AUS in these populations should be considered investigational or subject to additional requirements pending higher-quality randomized controlled trial data.

No additional explicit exclusions beyond those described in the policy text are stated in the cited guideline excerpts; the guideline focuses on candidate selection, counseling, and management rather than listing other specific 'none' statements.

Use of AUS without meeting the defined criteria — for example, when there has not been an adequate trial of conservative therapy (at least 6 months) or when preoperative evaluation is inadequate — is considered investigational/not medically necessary and is subject to denial under this policy.

Systematic review evidence has been rated as very low quality due to high risk of bias, publication bias, and imprecision; although postoperative continence rates may be high, the low quality and heterogeneity of studies limit conclusions about net health benefit and caution routine use.

The cited guideline excerpts do not include explicit phrasing that labels specific uses as 'not medically necessary'; rather, recommendations emphasize candidate selection, demonstration of adequate physical and cognitive ability, counseling on risks and durability, and preference statements for patient subgroups.

Procedure and Device Codes

Regulatory/Device Identifiermixed

P000053

FDA PMA ID for AMS Sphincter 800 Urinary Control System

Covered CPT/HCPCS Codes listedmixedCovered

53445	Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff.
53446	Removal of inflatable urethral/bladder neck sphincter, including pump, reservoir, and cuff.
53447	Removal and replacement of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff at the same operative session.
53449	Repair of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff.
C1815	Prosthesis, urinary sphincter (implantable)

Requirements for Providers and Billing

Prior Authorization

Prior Authorization / Preoperative Requirements

Prior authorization not required for this policy. However, providers must document that conservative therapies have failed and that the patient has the ability to operate the device when applicable.

Confirm failure of at least 6 months of conservative therapy after prostate surgery (e.g., bladder training, prompted voiding, pelvic muscle exercises, and/or pharmacologic therapies).
Ensure documentation of patient physical and cognitive ability and manual dexterity to operate the AUS prior to implantation.
Preoperative evaluation should exclude severe detrusor instability and demonstrate adequate bladder stability and compliance.

Step Therapy

Conservative Therapy and Step Therapy Requirements

An artificial urinary sphincter (AUS) is not first-line therapy. Providers must attempt and document conservative measures prior to AUS implantation.

Conservative measures to attempt/consider: behavioral modification, use of pads/incontinence briefs, penile compressive devices, condom catheters, intermittent self-catheterization where appropriate.

Clinical Background and Context

The artificial urinary sphincter (AUS) is an externally controlled urethral occlusion device composed of a fluid-filled cuff, a pressure-regulating balloon/reservoir, and a scrotal control pump. The cuff encircles the urethra to maintain continence until the patient compresses the pump to transfer fluid from the cuff to the reservoir, allowing timed voiding; adequate manual dexterity and motivation are required for device operation.

Terminology and Definitions

Artificial Urinary Sphincter (AUS) — device components and function

ComponentsCuff, pressure-regulating balloon (placed extra‑peritoneally in pelvis/abdomen), and control pump (scrotal subcutaneous pocket); fluid transfers between cuff and balloon to occlude and open urethra.

FunctionExternally controlled urethral occlusion device that allows timed voiding by squeezing the scrotal pump to transfer fluid from the cuff to the balloon; cuff re‑inflates automatically after several minutes.

Placement considerationsBalloon placed extra‑peritoneally in pelvis or abdominal cavity; pump placed in scrotal subcutaneous pocket; requires adequate bladder stability and compliance prior to implantation.

Patient requirementsCandidates must have adequate manual dexterity and motivation to operate the pump and meet preoperative evaluation criteria (exclude severe detrusor instability).

Intrinsic Urethral Sphincter Deficiency (IUSD) / ISD — definition and clinical context

Policy Revision History

2025-09Annual Review / RenewalLatest

Policy renewed after annual review in September 2025.

2024-09Annual Review / Renewal

Policy renewed after annual review in September 2024.

2023-08Annual Review / Revision

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyArtificial Urinary Sphincter

Policy CodePolicy 02.01.75

Change TypeAnnual review (no material changes)

Effective DateSep 1, 2010

Next Review DateSep 1, 2025

Key ActionDocument at least 6 months of failed conservative therapy and confirm adequate bladder function and manual dexterity before AUS implantation.

SourceLink

On This Page

Risk counseling and durability: Clinicians may counsel regarding risk factors for AUS erosion and should counsel that AUS will likely lose effectiveness over time and that reoperations are common.

Conditional/Strong Recommendations; Evidence Levels Grade C and Grade B respectively (AUA/SUFU).

Management of device complications: In patients with infection or erosion of an AUS or sling, clinicians should perform explantation and delay reimplantation; after explanting an eroded device, options include urethral catheter alone, in situ urethroplasty, or anastomotic urethroplasty.

Clinical Principle / Expert Opinion (AUA/SUFU).

Conservative therapy should generally be attempted for at least 6 months following prostate surgery before considering AUS.

Reserve AUS for patients who have not responded to conventional treatments and when medical necessity criteria are met.

Note

Guideline-Recommended Preference and Counseling

Follow guideline recommendations and counsel patients per AUA/SUFU guidance.

Discuss AUS as an option for mild to severe SUI after prostate treatment.
Ensure patients have adequate physical and cognitive abilities to operate the device.
Preferentially utilize a single cuff perineal approach when selecting AUS.
For patients with SUI after primary, adjuvant, or salvage radiotherapy, offer AUS preferentially over male slings or adjustable balloons.

Billing Rule

Coding and Billing Guidance

Report provider services using the appropriate CPT and HCPCS codes listed in the policy's codes section. Incorrect coding may result in claim denial.

Report AUS insertion, removal, revision, and repair with the applicable CPT codes: 53445, 53446, 53447, 53449.
Report the implantable prosthesis with HCPCS code C1815 (Prosthesis, urinary sphincter).
Include appropriate ICD-10 diagnosis codes and revenue/place of service codes as applicable.

DefinitionIntrinsic Urethral Sphincter Deficiency (IUSD) / Intrinsic Sphincter Deficiency (ISD) is a cause of urinary incontinence characterized by reduced outlet resistance, commonly occurring after prostate surgery.

Clinical contextIUSD is the primary indication for AUS in men with stress urinary incontinence following prostate procedures; AUS has shown effectiveness for IUSD after prostate surgery.

Preoperative considerationsPatients with IUSD should undergo conservative therapies first (≥6 months post‑prostate surgery) and have bladder stability and adequate manual dexterity before AUS implantation.

Dry rate (DR) — definition

DefinitionDry rate (DR) is the proportion of patients not needing to use any pads at follow‑up (i.e., patient is 'dry').

Example outcomeIn the Tutolo et al cohort (mean follow‑up 32 months), the DR was 58% for the cohort; 57% among those without prior incontinence surgery and 48% for those with prior incontinence surgery.

Use in studiesDR is reported as a primary effectiveness outcome in observational studies of AUS for post‑prostate surgery SUI.

Secondary surgery — removal or revision of the AUS

DefinitionSecondary surgery refers to removal or revision of the AUS device after initial implantation.

Reported ratesIn Boswell et al (mean follow‑up 5.4 years), the rate of secondary surgery (removal or revision) was 35% (404 of 1154 individuals).

ImplicationsHigh rates of secondary surgery reflect risks of erosion, infection, urethral atrophy, and mechanical failure leading to explantation or revision.

AUS — shorthand and brief definition

ShorthandAUS = Artificial Urinary Sphincter.

PurposeImplanted to treat urinary incontinence due to reduced outlet resistance, most commonly after prostate surgery.

Key recommendationCandidates should have stable bladder function, adequate manual dexterity, and have attempted conservative therapies before AUS implantation.

Policy revised following the August 2023 annual review.

2022-07Interim Review / Revision

Policy revised following an interim review in July 2022.

2022-06Annual Review / Revision

Policy revised after the June 2022 annual review.

2022-04Interim Review / Revision

Policy revised following an April 2022 interim review.

2021-06Annual Review / Revision

Policy revised after the June 2021 annual review.

2020-06Annual Review / Revision

Policy revised after the June 2020 annual review.

2019-06Annual Review / Revision

Policy revised after the June 2019 annual review.

2018-06Annual Review / Revision

Policy revised after the June 2018 annual review.

2017-06Annual Review / Revision

Policy revised after the June 2017 annual review.

2016-07Annual Review / Revision

Policy revised after the July 2016 annual review.

2015-07Annual Review / Revision

Policy revised after the July 2015 annual review.

2014-08Annual Review / Renewal

Policy renewed following the August 2014 annual review.

2014-05Interim Review / Revision

Policy revised following an interim review in May 2014.

2013-09Annual Review / Revision

Policy revised after the September 2013 annual review.

2012-10Annual Review / Renewal

Policy renewed following the October 2012 annual review.

2011-10Annual Review / Renewal

Policy renewed following the October 2011 annual review.

2010-09Annual Review / Renewal

Policy renewed following the September 2010 annual review.