The use of periurethral bulking agents (e.g., collagen or Durasphere 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 (741.9) or epispadias (752.62, 753.8);
• Male or female patients with acquired sphincter weakness secondary to spinal cord lesions (336.9);
• 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 by collagen or Durashpere implant is covered and should be denied.

In addition, patients who have a reoccurrence of incontinence following successful treatment with collagen or Durasphere 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 skin test is not required for the implantation of Durasphere.

Polytetrafluoroethylene (Teflon) is another implant material that may be used. Periurethral Teflon injection for the treatment of urinary incontinence is considered experimental/investigational and, therefore, it is not eligible for reimbursement. A participating, preferred, or network provider can bill the member for the denied service. Polytetrafluoroethylene (Teflon) does not have FDA approval.

Description

Stress urinary incontinence can result from intrinsic sphincter deficiency (ISD). ISD (599.82) is a cause of stress urinary incontinence (625.6, 788.32) 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, e.g., a collagen implant (L8603), or carbon-coated beads, e.g., Durasphere (L8606) 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.

National Blue Cross Blue Shield Medical Policy, 7.01.19, Periurethral Bulking Agents for the Treatment of Incontinence, 05/2001