CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

Defines BCBSRI coverage stance for RF tissue remodeling procedures (transvaginal and transurethral) to treat female urinary stress incontinence for Commercial products; indicates Blue CHiP for Medicare handled separately.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTransvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 2, 2009

Next Review DateN/A

Key ActionVerify member-specific benefits and eligibility with the provider call center before submitting claims.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessarycoverage stance

Commercial onlyapplicability

53860procedure code

02/07/2009effective

Coverage Criteria

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Not medically necessary (Commercial Products)

Not covered for Commercial products.

Commercial products coverage stance: Transvaginal radiofrequency bladder neck suspension and transurethral radiofrequency tissue remodeling are considered not medically necessary because the evidence is insufficient to determine the effects on health outcomes.

Applies to Commercial products only; Blue CHiP for Medicare is addressed in a related policy.

This policy applies to Commercial Products only. Coverage and medical necessity determinations for Blue CHiP for Medicare are addressed in a related policy and are not covered by this document.

Radiofrequency (RF) tissue remodeling encompasses both transvaginal and transurethral approaches that aim to improve urethral support by applying nonablative RF energy to periurethral tissues or the endopelvic fascia. The transurethral technique (Renessa® and similar devices) uses a specially designed 4-needle RF probe passed through the urethra into the bladder; a balloon holds the probe in place while RF energy is delivered for 60 seconds at each deployment, producing focal collagen denaturation at tissue temperatures of 65–75 °C at multiple sites (typically 36 sites total across multiple deployments).

There is no specific CPT code for transvaginal RF bladder neck suspension; when billed the procedure is typically reported using CPT 53899 (unlisted procedure, urinary system). For transurethral RF micro-remodeling, the policy references CPT 53860 (Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence).

Provider Actions & Billing

Prior Authorization

Not applicable

Note

Conservative therapy

Conservative therapy is generally the initial approach for stress urinary incontinence. Standard conservative measures include pelvic floor muscle (Kegel) exercises, with or without biofeedback; pelvic electrical stimulation; and periurethral bulking agents such as collagen. These therapies should be attempted and documented prior to consideration of procedural interventions such as radiofrequency remodeling or bladder neck suspension.

Pelvic floor muscle exercises (Kegel)
Biofeedback
Pelvic electrical stimulation
Periurethral bulking agents (e.g., collagen)

Denial Risk

Denial risk — RF remodeling procedures (Commercial)

Transvaginal radiofrequency bladder neck suspension and transurethral radiofrequency tissue remodeling are considered not medically necessary for Commercial products; the evidence is insufficient to determine the effects on health outcomes. Providers should expect potential claim denials for these procedures when submitted for Commercial members.

Documentation Required

Verify member benefits and eligibility

Providers must verify member-specific benefits and eligibility prior to providing services. Benefits, coverage, and prior authorization requirements (if any) are determined by the member's subscriber agreement or employer contract and may vary by product.

Contact the provider call center or use the payer portal to confirm coverage and any applicable member cost-sharing.
Obtain written member agreement if providing services determined to be not medically necessary and member elects to proceed at own expense.

Background

Urinary stress incontinence is the involuntary loss of urine with increases in intra-abdominal pressure (for example with coughing, sneezing, or exertion). Initial management typically emphasizes conservative therapies such as pelvic floor muscle exercises, biofeedback, electrical stimulation, and periurethral bulking agents. Surgical bladder suspension procedures are considered when conservative measures fail to provide adequate symptom control.

RF tissue remodeling techniques are intended as minimally invasive alternatives that use thermal energy to shrink or denature collagen in support tissues — the transvaginal approach targets the endopelvic fascia to cause tissue blanching and shrinkage, while the transurethral (Renessa®) approach produces focal collagen denaturation in the bladder neck and proximal urethra. Current evidence is considered insufficient to determine their effect on health outcomes for Commercial products, and thus these RF procedures are regarded as not medically necessary under this policy.

Definitions

SURx transvaginal system — key facts about the device and approach

ApproachTransvaginal incision made lateral to the urethra to expose endopelvic fascia; RF energy applied over the fascia in a slow sweeping manner causing tissue blanching and shrinkage.

Clinical intentShrink and stabilize endopelvic fascia to improve support for the urethra and bladder neck in stress urinary incontinence.

Setting/anesthesiaPerformed as an outpatient procedure under general anesthesia (per background description).

Device exampleSURx transvaginal system (described in policy background).

Evidence summaryLiterature and scientific evidence for transvaginal RF micro-remodeling (SURx and similar) are insufficient; considered not medically necessary for Commercial products.

Renessa transurethral procedure — key facts about the procedure and device parameters

Probe and techniqueA specially designed 4-needle RF probe is passed through the urethra into the bladder; a small balloon is inflated to hold it stationary and the 4 needles are deployed into bladder neck and upper urethral tissue.

Energy and dosingRF energy delivered for 60 seconds to the 4 needles at each deployment; procedure is repeated 9 times to treat 36 tissue sites.

Tissue effectTissue temperatures of 65–75°C produce focal microscopic denaturation of collagen in the treated sites.

Device exampleRenessa transurethral procedure (Renessa™ described in policy background).

Evidence summaryCurrent literature and scientific evidence for transurethral RF micro-remodeling (Renessa and similar devices) are insufficient; considered not medically necessary for Commercial products.

Revision History

2019-05-07policy updatedLatest

Policy last updated — reaffirmed not medically necessary stance for transvaginal and transurethral radiofrequency tissue remodeling for Commercial products.

2009-02-07policy effective

Policy became effective; establishes coverage stance that transvaginal and transurethral radiofrequency tissue remodeling is not medically necessary for Commercial products due to insufficient evidence.