The use of periurethral bulking agents approved by the U.S. Food and Drug Administration (e.g., collagen, Durasphere, Coaptite, Macroplastique implantation) to treat patients with stress urinary incontinence due to intrinsic sphincter deficiency is considered medically necessary for the following types of patients who have shown no improvement in their incontinence for at least 12 months:

• Male or female patients with congenital sphincter weakness, secondary to conditions such as myelomeningocele or epispadias;
• Male or female patients with acquired sphincter weakness secondary to spinal cord lesions;
• Male patients following trauma, including prostatectomy and/or radiation; and
• Female patients without urethral hypermobility and with abdominal leak point pressures (ALPP) of less than 100 cm H2O.

Patients whose incontinence does not improve with five injection procedures (five separate treatment sessions) are considered treatment failures. Therefore, no further treatment of urinary incontinence with a periurethral bulking agent is covered.

In addition, patients who have a reoccurrence of incontinence following successful treatment with FDA approved periurethral bulking agent implants in the past (e.g., 6-12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be allowed but must be supported by medical record documentation.

Prior to collagen implant therapy, a skin test for collagen sensitivity (95028) should be administered and the patient should be evaluated over a four-week period prior to the implant. Payment may also be made for the collagen skin test material (Q3031) when used in conjunction with these services.

The use of periurethral bulking agents for any indications other than those referenced above is considered not medically necessary, and therefore, not covered.  A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Place of Service: Outpatient

Outpatient: Treatment of Urinary Incontinence/Periurethral Bulking Agents is typically an outpatient procedure.

Description

Stress urinary incontinence can result from intrinsic sphincter deficiency (ISD). ISD is a cause of stress urinary incontinence in which the urethral sphincter is unable to contract and generate sufficient resistance in the bladder, especially during stress maneuvers (e.g., coughing, bending, and lifting). In order to treat this condition, an endoscopic injection of implant material (51715) can be performed.

Periurethral bulking agents (L8603, L8604, L8606), (e.g., cross-linked collagen implant, carbon-coated beads, e.g., Durasphere, spherical particles of calcium hydroxylapatite, e.g., Coaptite, or polydimethylsiloxane, e.g., Macroplastique) are substances used in the treatment of stress urinary incontinence. The implant is injected into the submucosal tissues of the urethra and/or the bladder neck and into the tissues adjacent to the urethra either suburethrally through a cystoscope with a spinal needle inserted percutaneously, or transvaginally with cystoscopic control. This procedure may be performed over the course of two to three visits to a physician.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

National Blue Cross Blue Shield Medical Policy, 7.01.19, Periurethral Bulking Agents for the Treatment of Incontinence, 10/2009

Transurethral Polydimethylsiloxane Implantation: a Valid Option for the Treatment of Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency Without Urethral Hypermobility, The Journal of Urology, Vol. 173, No. 3, 03/2005

Is There a Role for Periurethral Collagen Injection in the Management of Urodynamically Proven Mixed Urinary Incontinence?, Urology, Vol. 67, No. 4, 04/2006

Multicenter Prospective Randomized 52-Week Trial of Calcium Hydroxylapatite Versus Bovine Dermal Collagen for Treatment of Stress Urinary Incontinence, Urology, Vol. 69, No. 5, 05/2007

Current Trends in the Evaluation and Management of Female Urinary Incontinence, Canadian Medical Association Journal, Vol. 175, No.10, 11/2006

InterQual® Level of Care Criteria 2010, Acute Care Adult, McKesson Health Solutions; LLC; 2010: ADLT-147.