This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Periurethral Bulking Agents for the Treatment of Urinary Incontinence

Periurethral Bulking Agents for the Treatment of Urinary Incontinence

 

DESCRIPTION

Periurethral 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:

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

Pelvic Floor Stimulation as a Treatment of Urinary Incontinence

Sacral Nerve Stimulation (SNS) for Urinary Incontinence

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence

Biofeedback

 

POLICY

The 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 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

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 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.

 

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 7.01.19

 

CODE REFERENCE

This 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. 

Covered Codes

Code Number

Description

CPT-4

51715

Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck

ICD-9 Procedure

59.72

Injection of implant into urethra and/or bladder neck

ICD-9 Diagnosis

599.81 Urethral hypermobility 
599.82 Intrinsic (urethral) sphincter deficiency (ISD)  
599.83 Urethral instability 
625.6 Female stress incontinence
788.30 Unspecified urinary incontinence
788.32 Stress incontinence, male
788.33 Mixed incontinence urge and stress (male)(female)
788.34 Incontinence without sensory awareness
788.35 Post-void dribbling
788.36 Nocturnal enuresis
788.37 Continuous leakage
788.39Other urinary incontinence
788.91 Functional urinary incontinence (new 10-1-2008)

HCPCS

L8603

Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies

L8606 

Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies

Q3031 Collagen skin test 

 

 

 

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