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DESCRIPTIONBulking agents are injectable substances used to increase tissue bulk. They can be injected periurethrally to treat urinary incontinence and perianally to treat fecal incontinence. A number of products have been developed, and there are several U.S. Food and Drug Administration (FDA)-approved options for treating urinary incontinence. One product is commercially available to date for treating fecal incontinence.
Injectable bulking agents are space-filling substances used to increase tissue bulk. When used to treat stress urinary incontinence (SUI), bulking agents are injected periurethrally to increase the tissue bulk and thereby increase 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. Men have also been treated, typically those with post-prostatectomy incontinence.
Following the success of periurethral bulking agents for treating SUI, bulking agents injected into the anal canal have been proposed for treating fecal incontinence. In particular, bulking agents are a potential treatment for passive fecal incontinence associated with internal anal sphincter (IAS) dysfunction. The bulking agent is injected into the submucosa of the anal canal to increase tissue bulk in the area, which narrows the opening of the anus. Current treatment options for fecal incontinence include conservative measures e.g., dietary changes, pharmacotherapy and pelvic floor muscle exercises, sacral nerve stimulation, and surgical interventions to correct an underlying problem.
Key factors in determining the optimal product are biocompatibility, durability, and absence of migration. A number of periurethral bulking agents to treat urinary incontinence have been cleared for marketing by the U.S. Food and Drug Administration (FDA). Except for Contigen®, bulking agents are indicated by FDA for use only in women, specifically those with stress urinary incontinence due to intrinsic sphincter deficiency. 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. Other periurethral bulking agents cleared by the FDA for urinary incontinence include carbon-coated beads (e.g., Durasphere®), spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite®), polydimethylsiloxane (silicone, Macroplastique®), and ethylene vinyl alcohol copolymer implants (e.g., Uryx®, marketed under the trade name Tegress® starting in 2005). Tegress was later voluntarily removed from the market due to safety concerns.
Several agents identical to or similar to those used for urinary incontinence e.g., Durasphere, silicone biomaterial, etc. have been studied for the treatment of fecal incontinence. To date, only one bulking agent has been approved by the FDA for treating fecal incontinence. This is a formulation of non-animal stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) and is marketed by Q-Med as Solesta. A hyaluronic acid/dextranomer formulation (Deflux™) from the same company has been commercially available for a number of years for the treatment of vesicoureteral reflux in children (see policy No. 7.01.102 on the treatment of vesicoureteral reflux with bulking agents).
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.
Several periurethral bulking agents have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency; other than Contigen, approval is only for use in adult women. Products include:
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.
The use of perianal bulking agents to treat fecal 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.
09/01/2013: Policy title changed from "Periurethral Bulking Agents for the Treatment of Urinary Incontinence" to "Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence." Policy description updated to add information regarding perianal bulking agents. Added the following investigational policy statement: The use of perianal bulking agents to treat fecal incontinence is considered investigational. Added HCPCS code L8605 and CPT code 46999 an investigational procedures.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.19
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.