DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Defines medical coverage stance for periurethral and perianal injectable bulking agents used to treat urinary and fecal incontinence for Blue Cross Blue Shield - Rhode Island Medicare Advantage Plans and commercial benefits; indicates which agents and indications are considered medically necessary or not medically necessary.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInjectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Policy CodePolicy N/A

Change TypeMinor / No material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionEnsure patients have failed appropriate conservative therapy for at least 3 months before considering injectable bulking agents for stress urinary incontinence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Covered w/criteriaUrinary coverage

Not coveredFecal coverage

>=3 monthsConservative therapy

L8603, L8606Covered HCPCS

0963T, L8605

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Coverage Criteria

Stress Urinary Incontinence — Medically Necessary Treatments

Covered when ALL of the following are met

SUI - eligible patients: Patient has stress urinary incontinence (male or female) who have failed appropriate conservative therapyconservative therapy >= 3 months

See definition of Failed Appropriate Conservative Therapy for SUI (chunk 11).

Covered bulking agents: Use of carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, or polydimethylsiloxane for treatment of stress urinary incontinence

These agents have evidence of efficacy and may be considered medically necessary when all criteria are met (see chunk 14).

Claims filing: Procedure billed with an appropriate ICD-10 diagnosis (eg, N39.3) and a covered HCPCS code (eg, L8603 or L8606)

See coding guidance for medically necessary HCPCS/ICD-10 (chunk 19).

Stress/Urge Urinary Incontinence — Not Medically Necessary Treatments

Not medically necessary when ANY of the following apply

Autologous cellular or fat therapy: Use of autologous cellular therapy (eg, myoblasts, fibroblasts, muscle-derived stem cells, adipose-derived stem cells), autologous fat, or autologous ear chondrocytes to treat stress urinary incontinence

Considered not medically necessary due to insufficient evidence (chunk 7, chunk 13).

Other periurethral agents: Use of any other periurethral bulking agent, including but not limited to polytetrafluoroethylene (Teflon), to treat stress urinary incontinence

Considered not medically necessary due to insufficient evidence (chunk 7, chunk 13).

Urge urinary incontinence: Use of periurethral bulking agents to treat urge urinary incontinence

Considered not medically necessary as evidence is insufficient to demonstrate improvement in net health outcome (chunk 7).

Fecal Incontinence — Not Medically Necessary / Not Covered

Not covered / Not medically necessary

Fecal incontinence bulking agents: Use of perianal (anal canal) injectable bulking agents to treat fecal incontinence

Considered not covered / not medically necessary because evidence is insufficient to determine improvement in net health outcome; specific CPT/HCPCS codes (0963T, L8605) are listed as not covered/not medically necessary (chunks 6, 8, 15, 16, 18, 20).

Coverage by condition and code

Coverage and non-coverage are specified by condition and code:

Urinary Incontinence - covered HCPCS: HCPCS L8603 and L8606 are medically necessary when filed with an appropriate ICD-10 diagnosis such as N39.3 (stress incontinence)

Claims for bulking agents not specifically identified should be filed with an unlisted HCPCS code (chunk 19).

Fecal Incontinence - not covered: CPT 0963T and HCPCS L8605 for anal canal bulking are not covered / not medically necessary.

0963T is a new code effective 7/1/2025 (chunks 18, 20).

Benefits may vary between employer groups or member contracts. For information about whether a specific service is covered under a member's benefits, refer to the member's Evidence of Coverage or Subscriber Agreement for applicable not medically necessary / not covered benefit language.

Anoscopy with directed submucosal injection of a bulking agent into the anal canal (CPT 0963T) and the injectable anal-canal bulking agent HCPCS L8605 (dextranomer/hyaluronic acid copolymer implant) are identified in this policy as not covered / not medically necessary for treatment of fecal incontinence.

Autologous cellular therapies (for example, myoblasts, fibroblasts, muscle-derived or adipose-derived stem cells), autologous fat, and autologous ear chondrocytes used as periurethral or perianal bulking agents are considered not medically necessary due to insufficient evidence. Similarly, polytetrafluoroethylene (Teflon®) and other unspecified periurethral/perianal bulking materials are listed as not medically necessary for treatment of incontinence in this policy.

For fecal incontinence, CPT 0963T and HCPCS L8605 are explicitly listed as not medically necessary for procedures and materials intended to provide anal-canal bulking.

Coding

Medically necessary HCPCS/ICD-10 for urinary incontinencemixedCovered

N39.3	Stress incontinence (female) (male)
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, 1ml syringe, includes shipping and necessary supplies

Not covered CPT/HCPCS for fecal incontinencemixedNot Covered

0963T	Anoscopy with directed submucosal injection of bulking agent into anal canal (New Code Effective 7/1/2025)
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies

HCPCS codes referenced for urinary incontinenceHCPCS

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, 1ml syringe, includes shipping and necessary supplies

Not Covered / Not Medically Necessary for Fecal IncontinenceCPT|HCPCSNot Covered

0963T	Anoscopy with directed submucosal injection of bulking agent into anal canal (New Code Effective 7/1/2025)
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies

Medically necessary HCPCS codes for Urinary Incontinence (when filed with ICD-10)HCPCSCovered

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, 1ml syringe, includes shipping and necessary supplies

Required Diagnosis for Urinary Incontinence CodesICD-10

N39.3

Stress incontinence (female) (male)

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization is not applicable for injectable bulking agents.

Documentation Required

Conservative Therapy Requirement

Patients must have failed appropriate conservative therapy prior to consideration of urinary bulking agents. Failed conservative therapy is defined as treatments used for at least 3 months and may include pelvic floor muscle exercises and behavioral interventions (fluid management, activity modification). Additional options include intravaginal estrogen therapy, pessary use, and treatment of other underlying causes when appropriate.

Background

Injectable bulking agents are space-filling substances placed periurethrally to increase tissue bulk and reduce symptoms of stress urinary incontinence, and perianally to attempt improvement in fecal incontinence. A variety of materials have been used; several agents (for example, carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, polydimethylsiloxane) may be considered medically necessary for stress urinary incontinence when clinical criteria are met, while evidence for anal-canal bulking agents is limited. Randomized controlled trials and systematic reviews for fecal incontinence show mixed and sometimes short-term benefits (for example, studies of NASHA Dx/Solesta and Durasphere), and longer-term comparative data are insufficient to demonstrate durable improvement in net health outcome.

Definitions

Failed Appropriate Conservative Therapy for SUI

DefinitionFailed appropriate conservative therapy = treatments used for at least 3 months; includes pelvic floor muscle exercises and behavioral changes (eg, fluid management, moderation of activities that provoke incontinence). Additional options include intravaginal estrogen, pessary, and treatment of other underlying causes when appropriate.

Minimum durationAt least 3 months of conservative therapy prior to considering injectable bulking agents for stress urinary incontinence.

Conservative treatments examplesPelvic floor muscle exercises; behavioral changes such as fluid management and activity modification.

Additional conservative optionsIntravaginal estrogen therapy, use of a pessary, and treatment of other underlying causes when amenable.

N39.3

ICD-10 code