Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

POLICY NUMBER

A.7.01.19

DESCRIPTION

Bulking agents are injectable substances used to increase tissue bulk. They can be injected periurethrally to treat urinary incontinence and perianally to treat fecal incontinence. The U.S. Food and Drug Administration (FDA) has approved several bulking agent products for treating urinary incontinence and one for treating fecal incontinence.

Incontinence

Incontinence, especially urinary, is a common condition and can have a substantial impact on quality of life. Estimates from the National Center for Health Statistics have suggested that, among noninstitutionalized persons 65 years of age and older, 44% have reported issues with urinary incontinence and 17% issues with fecal incontinence.

Treatment

Urinary IncontinenceInjectable bulking agents are space-filling substances used to increase tissue bulk. When used to treat stress urinary incontinence, bulking agents are injected periurethrally to increase tissue bulk and thereby increase resistance to the outflow of urine. The bulking agent is injected into the periurethral tissue as a liquid that 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.

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); however, products developed to date have not necessarily met all criteria of the ideal bulking agents. The first FDA-approved product was cross-linked collagen (eg, Contigen). The agent was found to be absorbed over time and symptoms could recur, requiring additional injections. Contigen production was discontinued in 2011. 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®), cross-linked polyacrylamide hydrogel (Bulkamid®), and ethylene vinyl alcohol copolymer implants (e.g., Tegress®, formerly Uryx®). Tegress was voluntarily removed from the market due to safety concerns.

Fecal IncontinenceAfter the success of periurethral bulking agents for treating stress urinary incontinence, bulking agents injected into the anal canal have been proposed to treat fecal incontinence. In particular, bulking agents are a potential treatment for passive fecal incontinence associated with internal anal sphincter 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, pelvic floor muscle exercises), sacral nerve stimulation, and surgical interventions to correct an underlying problem.

Several agents identical or similar to those used for urinary incontinence (e.g., Durasphere, silicone biomaterial) have been studied for the treatment of fecal incontinence. To date, only one bulking agent has been approved by the FDA for fecal incontinence. This formulation is a non-animal-stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx), marketed by Palette Life Sciences 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 Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux (VUR)  medical policy 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 does not have 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 has been hypothesizedthat transplanted stem cells would undergo self-renewal and multipotent differentiation, which could result in the regeneration of the sphincter and its neural connections.

Several periurethral bulking agents have been approved by the 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:

• In 1993, Contigen (Allergan), a cross-linked collagen, was approved. A supplemental approval in 2009 limited the device’s indication to the treatment of urinary incontinence due to intrinsic sphincter deficiency in patients (men or women) who have shown no improvement in incontinence for at least 12 months. Allergan ceased production in 2011; no reason for discontinuation was provided publicly.

• In 1999, Durasphere (Advanced UroScience), a pyrolytic carbon-coated zirconium oxide sphere, was approved.

• In 2004, Uryx (CR Bard), a vinyl alcohol copolymer implant, was approved. In 2005, approval was given to market the device under the name Tegress. In 2007, Tegress® was voluntarily removed from the market due to safety concerns.

• In 2005, Coaptite (Boston Scientific, previously BioForm Medical and Merz Aesthetics), spherical particles of calcium hydroxylapatite, suspended in a gel carrier, was approved.

• In 2006, Macroplastique (Laborie, previously Cogentix Medical), polydimethylsiloxane, was approved.

• In 2020, Bulkamid Urethral Bulking System (Axonics Modulation Technologies, Inc.), a soft hydrogel that consists of 97.5% water and 2.5% polyacrylamide, was approved.

In 2011, NASHA Dx, marketed as Solesta (Q-Med now Palette Life Sciences), was approved by the FDA through the premarket approval process as a bulking agent to treat fecal incontinence in patients 18 years and older who have failed conservative therapy.

The following policies address other treatment approaches for urinary incontinence:

• Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux (VUR)

• Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

• Sacral Nerve Neuromodulation/Stimulation

• Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

• Biofeedback

• Transanal Radiofrequency Treatment of Fecal Incontinence

• Percutaneous Tibial Nerve Stimulation

POLICY

The use of carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, 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 EXCEPTIONS

Federal 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Individuals should have had an inadequate response to conservative therapy or therapies; in general, these treatments should have been used for at least 3 months. Conservative therapy for stress incontinence includes pelvic floor muscle exercises and behavioral changes, such as fluid management and moderation of physical activities that provoke incontinence. Additional options include intravaginal estrogen therapy, use of a pessary, and treatment of other underlying causes of incontinence in individuals amenable to these treatments.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

6/1/2007: 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 as investigational procedures.

04/30/2014: Policy reviewed; description updated to add information regarding the FDA-approved product, Contigen®. Policy statement unchanged.

05/14/2015: Policy description updated regarding the discontinuation of Contigen. Medically necessary policy statement updated to remove "cross-linked collagen" as an agent. Policy guidelines updated to add medically necessary and investigational definitions.

08/26/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure code 59.72. Added 0377T to the Investigational Codes table.

05/31/2016: Policy number A.7.01.19 added.

10/14/2016: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding conservative therapy for stress incontinence.

09/13/2017: Policy description updated regarding products. Policy statements unchanged.

08/22/2018: Policy description updated regarding incontinence. Policy statements unchanged.

09/11/2019: Policy reviewed; no changes.

12/19/2019: Code Reference section updated to make note of deleted CPT code.

09/09/2020: Policy reviewed; no changes.

07/27/2022: Policy description updated regarding periurethral bulking agents cleared by the FDA for urinary incontinence. Policy section updated to add polyacrylamide hydrogel as medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted CPT code 0377T.

02/02/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

11/16/2023: Policy description updated regarding products. Policy statements unchanged.

01/14/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 7.01.19

CODE REFERENCE

This 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.

Covered Codes

Investigational Codes

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