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DESCRIPTIONPeriurethral bulking agents are substances that are injected periurethrally to increase tissue bulk around the urethra as a treatment of stress incontinence. A number of products have been developed and are commercially available; key factors in determining the optimal product are biocompatibility, durability, and absence of migration.
Improvement in stress incontinence is achieved by increasing the tissue bulk and thereby increasing resistance to the outflow of urine. The bulking agent is injected into the periurethral tissue as a liquid that then solidifies into a spongy material to bulk the urethral wall. Bulking agents may be injected over a course of several treatments until the desired effect is achieved. Periurethral bulking agents have been widely used for incontinence in women. However, men have also been treated, typically those with post-prostatectomy incontinence. Except for Contigen, bulking agents are indicated by the U.S. Food and Drug Administration (FDA) for use only in women with stress urinary incontinence due to intrinsic sphincter deficiency.
Biocompatibility, durability, and absence of migration are key factors in the success of bulking agents. Cross-linked collagen (e.g., Contigen) has been commercially available for many years. Collagen is slowly absorbed over time and symptoms may recur, requiring additional injections. Carbon-coated beads (e.g., Durasphere) and ethylene vinyl alcohol copolymer implants (e.g., Uryx®, marketed under the trade name Tegress® since 2005) are thought to be more durable and have received approval (1999 and 2004, respectively) from the FDA for use as periurethral bulking agents. Tegress was later voluntarily removed from the market due to safety concerns.
In 2005, a bulking agent composed of spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite®) received FDA approval for use in women. Polydimethylsiloxane (silicone, Macroplastique®) received FDA approval in 2006 "for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency." The FDA approvals are conditional on the enrollment of a minimum of 200–250 patients into a 5-year registry to further evaluate safety and efficacy.
Q-Med has been collecting data in Europe for a dextranomer/hyalyuronic (Dx/HA) copolymer (Zuidex™) together with an injection system (Implacer™) for treatment of incontinence. A Dx/HA formulation (Deflux™) from the same company has been commercially available for a number of years for the treatment of vesicoureteral reflux in children. About 30,000 children with vesicoureteral reflux have been treated with Dx/HA with no emergent safety concerns.
Autologous fat and autologous ear chondrocytes have also been used as periurethral bulking agents; autologous substances do not require FDA approval. Polytetrafluoroethylene (Teflon®) has been investigated as an implant material but has not received FDA approval.
A more recently explored alternative is cellular therapy with myoblasts, fibroblasts, or stem cells (muscle-derived or adipose-derived). In addition to their use as periurethral bulking agents, it is hoped that transplanted stem cells will undergo self-renewal and multipotent differentiation, which could result in regeneration of the sphincter and its neural connections.
The following policies address other treatment approaches for urinary incontinence:
POLICYThe use of cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy.
The use of autologous cellular therapy (e.g., myoblasts, fibroblasts, muscle-derived stem cells, or adipose-derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered investigational.
The use of any other periurethral bulking agent, including, but not limited to Teflon®, to treat stress urinary incontinence is considered investigational.
The use of periuretheral bulking agents to treat urge urinary incontinence is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY6/1/2007: Policy added to specifically address periurethral bulking agents; subject was previously addressed in the "Incontinence Therapy" policy, policy statement revised. Removed the following policy statement: "The following treatments for urinary incontinence are considered medically necessary: (1) Medications to treat incontinence; (2) Collagen implantation and Durasphere, when all of the following are met: [A] One of the following indications: Stress urinary incontinence caused by intrinsic sphincter weakness, Post-traumatic or post surgical injury, Urethral hypermobility in females with abdominal leak point less than 100 cm H2O [B] Incontinence is not improved after at least 12 months of therapy [C] Up to five injections are covered, since beyond that, the patient would be considered a treatment failure; (3) Surgeries, in patients who do not respond to other therapy"
7/19/2007: Policy reviewed and approved by the Medical Policy Advisory Committee (MPAC)
5/21/2008: Policy reviewed, no changes
9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied
12/31/2008: HCPCS code L8604 added
06/24/2010: Policy description updated because ethylene vinyl alcohol copolymer (Tegress™) was withdrawn from the market. Policy statement updated to remove this agent from the list of medically necessary agents, and HCPCS code L8604 was deleted from the Covered Codes table. Deleted “autologous fat and autologous ear chondrocytes” from the third policy statement as these are addressed in the second statement. Added link to related policy, Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux (VUR). FEP verbiage added to the Policy Exceptions section.
12/30/2010: Policy title updated to change "incontinence" to "urinary incontinence." Medically necessary policy statement changed to specify that it applies to patients who have failed appropriate conservative therapy. Policy statement added to indicate that the use of periuretheral bulking agents for urge incontinence is considered investigational. Deleted ICD-9 code 788.31, Urge incontinence, from the Covered Codes table.
11/10/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.19
CODE REFERENCEThis is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.
The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.