CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Medical coverage position for injectable periurethral and perianal bulking agents for treatment of stress urinary incontinence and fecal incontinence for Blue Cross Blue Shield - Rhode Island commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInjectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMay 2, 2013

Next Review DateN/A

Key ActionCheck member benefits and eligibility with the provider call center for member-specific coverage before billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercialapplicability

Several (urinary)FDA-approved agents

SolestaFecal product

09/03/2020Last updated

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Urinary incontinence — medically necessary agents

Covered when ALL of the following are met:

Stress urinary incontinence - covered agents: Use of carbon-coated spheres, calcium hydroxylapatite (CaHA), or polydimethylsiloxane for treatment of stress urinary incontinence in men and womenfailed appropriate conservative therapy

Conservative therapy implies noninvasive measures prior to injection; member must have failed appropriate conservative therapy.

inv-02: Urinary incontinence — not medically necessary

Not medically necessary:

Urinary incontinence - not medically necessary agents: Use of autologous cellular therapies (including myoblasts, fibroblasts, muscle- or adipose-derived stem cells), autologous ear chondrocytes, autologous fat, polytetrafluoroethylene (Teflon), or any periurethral bulking agent not listed as medically necessary is considered not medically necessary due to insufficient evidence.

Urge urinary incontinence: Use of periurethral bulking agents to treat urge urinary incontinence is considered not medically necessary.

inv-03: Fecal incontinence — not medically necessary / Insufficient evidence

Not medically necessary / Insufficient evidence:

Fecal incontinence: Use of perianal (anal canal) bulking agents to treat fecal incontinence is considered not medically necessary because the evidence is insufficient to determine effects on health outcomes; randomized trials and systematic reviews report mixed results and uncertain durability despite one FDA‑approved product (NASHA Dx/Solesta).

Evidence includes RCTs with mixed outcomes and limited long‑term durability; see evidence summary for details.

Benefits for injectable periurethral and perianal bulking agents may vary between groups and contracts. Refer to the member's Subscriber Agreement for specific limitations of benefits and coverage when services are determined to be not medically necessary.

Member-specific subscriber agreements and employer agreements supersede this medical policy. For information on member-specific benefits and eligibility, contact the provider call center. If services are determined to be not medically necessary (or are medically necessary but non-covered benefits), the provider may not bill the member unless the member was informed and agreed in writing in advance to accept financial responsibility.

Certain agents are considered not medically necessary due to insufficient evidence. This includes autologous cellular therapies (eg, myoblasts, fibroblasts, muscle- or adipose-derived stem cells), autologous ear chondrocytes, autologous fat, polytetrafluoroethylene (Teflon), and any periurethral or perianal bulking agent not specifically listed as medically necessary in this policy. The use of periurethral bulking agents for urge urinary incontinence and perianal bulking agents for fecal incontinence is also considered not medically necessary because the evidence is insufficient to determine effects on health outcomes.

Services determined to be not medically necessary (or medically necessary services that are non-covered benefits) may not be billed to the member unless the member has been informed and has provided written agreement in advance to accept financial responsibility. Refer to participation agreements and the member's subscriber/employer documents for applicable provisions.

Provider Actions / Billing

Prior Authorization

Prior authorization: Not applicable.

Note

Check Member Benefits / Eligibility

Benefits and eligibility for these services are determined by the member's subscriber agreement, member certificate, and/or employer agreement and may vary by contract. For member-specific benefit information, contact the provider call center.

Note

Coverage Varies by Contract

Coverage may vary between groups/contracts. Refer to the appropriate Subscriber Agreement for limitations of benefits/coverage when services are not medically necessary.

Denial Risk

Member Financial Responsibility if Not Medically Necessary

If services are determined to be not medically necessary (or if medically necessary services are non‑covered benefits under the member's plan), the provider may not bill the member for those services unless the member has been informed and has agreed in writing in advance to accept financial responsibility. Refer to your participation agreement(s) for applicable provisions.

Note

Provider Action

Provider action: Not specified.

Note

Benefits and Eligibility Source

For member-specific benefits, contact the provider call center. Benefits and eligibility are determined by the subscriber agreement or employer agreement, which supersede this medical policy.

Background

Injectable bulking agents are substances injected into periurethral or anal tissues to increase tissue bulk and resistance to outflow. Periurethral bulking agents are used to treat stress urinary incontinence (SUI) by increasing urethral resistance. Perianal (anal canal) bulking agents are intended to treat passive fecal incontinence related to internal anal sphincter dysfunction by narrowing the anal opening. Several agents have received regulatory clearance for urinary indications (eg, carbon-coated spheres, calcium hydroxylapatite, polydimethylsiloxane), and one formulation (NASHA Dx/Solesta) has FDA approval for fecal incontinence, but overall evidence on durability and comparative effectiveness varies across agents.

Definitions

Periurethral bulking agent

DefinitionAn injectable substance placed into the periurethral tissue that increases tissue bulk and resistance to urinary outflow to treat stress urinary incontinence.

Typical useInjected periurethrally as a liquid that solidifies into a spongy material to bulk the urethral wall and may be administered over several treatments until desired effect is achieved.

Indications noted in policyUsed to treat stress urinary incontinence in women and men (eg, postprostatectomy) who have failed appropriate conservative therapy.

Examples of agentsCarbon-coated spheres (eg, Durasphere), calcium hydroxylapatite (CaHA, Coaptite), polydimethylsiloxane (Macroplastique), ethylene vinyl alcohol copolymer implants.

LimitationsDurability varies; some agents (eg, early collagen products) may be absorbed over time requiring repeat injections.

Perianal (anal canal) bulking agent

DefinitionAn injectable substance placed into the submucosa of the anal canal to increase tissue bulk, narrowing the anal opening to treat fecal incontinence.

MechanismInjected into anal canal submucosa to increase tissue bulk and narrow the anal opening, proposed primarily for passive fecal incontinence related to internal anal sphincter dysfunction.

Regulatory statusOnly one formulation (NASHA Dx, marketed as Solesta) has FDA approval for fecal incontinence; other agents studied are similar to urinary bulking materials.

Related agents studiedAgents similar to urinary products (eg, Durasphere, silicone biomaterials) have been investigated for anal use.

Context and alternativesConservative measures (diet, meds, pelvic exercises), sacral nerve stimulation, and surgical interventions are current treatments; evidence for bulking agents shows mixed results and limited durability.

0377T	Anoscopy with directed submucosal injection of agent for fecal incontinence
L8605	Injectable bulking agent; dextranomer/hyaluronic acid copolymer implant; anal canal; 1 ml; includes shipping and necessary supplies

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

OpenPayer

Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence

Coverage Criteria

Coding

Provider Actions / Billing

Background

Definitions