CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Commercial product coverage policy on periurethral and perianal injectable bulking agents for treatment of stress urinary incontinence (SUI) and fecal incontinence, defining medically necessary and not medically necessary uses and associated HCPCS/ICD-10 coding guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Policy CodePolicy N/A

Change TypeNo material clinical/coverage changes

Effective Date02/05/2013

Next Review Date

Key ActionProviders should document failure of appropriate conservative therapy (at least 3 months of treatments such as pelvic floor muscle exercises, behavioral changes, intravaginal estrogen, use of a pessary, and treatment of other underlying causes) when billing for medically necessary periurethral bulking agents for SUI.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

4Bulking agent types considered medically necessary for SUI

5Uses considered not medically necessary (listed examples)

1HCPCS code not medically necessary for fecal incontinence

Coverage Summary

This Commercial Products policy covers periurethral and perianal injectable bulking agents for the treatment of stress urinary incontinence (SUI) and fecal incontinence. Coverage stance is mixed: certain periurethral (urinary) bulking agents are considered medically necessary when criteria are met (e.g., failed conservative therapy), while the use of perianal injectable bulking agents for fecal incontinence is considered not medically necessary. Policy effective date: 02/05/2013; policy last review/updated: 12/21/2022.

Policy Metadata and Thresholds

Effective Date02/05/2013

Last Review12/21/2022

StatusCURRENT

SubjectInjectable bulking agents for urinary and fecal incontinence

Duration of conservative therapy (threshold)Treatments used for at least 3 months

Coding

Medically necessary HCPCS and ICD-10 for urinary incontinence bulking agentsmixedCovered

N39.3	Stress incontinence (female) (male) - ICD-10
L8603	Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies - HCPCS
L8606	Injectable bulking agent, synthetic implant, urinary tract, 1ml syringe, includes shipping and necessary supplies - HCPCS

Not medically necessary HCPCS for fecal incontinence bulking agentHCPCSNot Covered

L8605

Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies - HCPCS

Unlisted codes for non-covered/other bulking agentsHCPCS

unlisted

Claims for bulking agents identified as not medically necessary should be filed with an unlisted HCPCS code (no specific code listed in policy).

Provider Actions

Documentation Required

Document prior conservative therapy for SUI

Providers should document failure of appropriate conservative therapy (at least 3 months of treatments such as pelvic floor muscle exercises, behavioral changes, intravaginal estrogen, use of a pessary, and treatment of other underlying causes) when billing for medically necessary periurethral bulking agents for SUI.

N39.3
L8603
L8606

Billing Rule

File claims with specified HCPCS/ICD-10 codes

When billing for medically necessary urinary tract bulking agents, file with ICD-10 code N39.3 and HCPCS L8603 or L8606 as appropriate; for products or therapies not identified in the policy as medically necessary, file with an unlisted HCPCS code.

N39.3
L8603
L8606
unlisted (for products/policies not listed as medically necessary)

Billing Rule

Do not file L8605 for covered urinary agents

HCPCS L8605 (injectable dextranomer/hyaluronic acid copolymer implant, anal canal) is identified as not medically necessary for fecal incontinence and should not be billed as a covered urinary agent.

L8605 — not medically necessary for fecal incontinence

Background & Evidence

Injectable bulking agents are space-filling substances injected periurethrally to treat SUI and perianally to treat fecal incontinence. Multiple FDA-cleared products exist for urinary incontinence (examples: cross-linked collagen/Contigen [historical], carbon-coated beads/Durasphere, calcium hydroxylapatite/Coaptite, polydimethylsiloxane/Macroplastique, polyacrylamide hydrogel/Bulkamid, and others), and one FDA-approved product for fecal incontinence is NASHA Dx (Solesta). This policy applies to Commercial Products only and specifies medically necessary HCPCS/ICD-10 coding for urinary agents (eg, N39.3, L8603, L8606) and identifies L8605 as not medically necessary for fecal incontinence; claims for non-covered bulking agents should be filed with an unlisted HCPCS code. The policy defines failed appropriate conservative therapy as treatments used for at least 3 months (pelvic floor muscle exercises, behavioral changes, intravaginal estrogen, pessary, and treatment of other underlying causes where applicable).

Evidence summaries

Definitions

Unsupported block type: definition

Unsupported block type: coding

Year/Effective	Name	Number	Type
1996	Incontinence Control Devices	230.10	NCD

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Policy CodePolicy N/A

Change TypeNo material clinical/coverage changes

Effective Date02/05/2013

Next Review Date

SourceLink

On This Page

OpenPayer

Medical Coverage Policy | Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background & Evidence

Medicare Determinations

Revision History