CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Commercial products policy describing medical necessity and non-medical necessity determinations for periurethral (urinary) and perianal (fecal) injectable bulking agents, including specific product categories and applicable HCPCS/ CPT codes for commercial plans (not BlueCHiP for Medicare).

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 TypeClarified (no material clinical changes)

Effective Date2002-05-2013

Next Review Date

Key ActionWhen filing codes for urinary tract bulking agent (L8606), submit with diagnosis code N39.3 (Stress incontinence male/female).

SourceLink

POLICY UPDATE CHANGES

Policy last updated 10/15/2019; document indicates published provider updates in 2019 and earlier.

3Medically necessary agent classes listed

MultipleUses deemed not medically necessary

1FDA-approved agent for fecal incontinence noted

Coverage Summary

This commercial-products policy addresses the use of injectable bulking agents to treat urinary and fecal incontinence. Scope: periurethral injections for stress urinary incontinence (SUI) and perianal/submucosal injections for fecal incontinence, including related CPT/HCPCS coding guidance. Effective date range shown in the policy is 05/2013 (effective) and the policy was last reviewed on 10/15/2019.

Background: Injectable bulking agents are used to increase tissue bulk—periurethrally to increase urethral resistance and treat SUI and perianally (submucosal anal canal injections) to narrow the anal opening for fecal incontinence. Several agents have FDA clearance for urinary incontinence and one product (NASHA Dx / Solesta) is FDA-approved for fecal incontinence. Evidence on durability and long-term outcomes is limited; controlled trials show mixed or short-term benefits for some products, and some agents or products have been voluntarily removed or discontinued from the market. Coding and billing guidance is included for specific HCPCS and CPT codes applicable to commercial plans.

Medical-Necessity Criteria

Urinary Incontinence – Medical Necessity

Covered when ALL of the following are met:

ALL of the following

Condition: Stress urinary incontinence (SUI) in men or women
Filed with diagnosis code N39.3 ~Stress incontinence (female) (male)
Failure of conservative therapy: Failure of appropriate conservative therapy
Policy states 'failed appropriate conservative therapy' but does not define specific duration or components
Agent list: Agent: Use of carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane
These agents may be considered medically necessary for SUI

Urinary Incontinence – Not Medically Necessary

The following uses are considered NOT medically necessary:

ANY of the following

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

Fecal Incontinence – Not Medically Necessary

Per policy statement for Commercial Products:

ALL of the following

Perianal bulking agents for fecal incontinence: Use of perianal bulking agents to treat fecal incontinence
Considered not medically necessary as evidence is insufficient to determine effects on health outcomes

Coding

Procedure / CPTCPT

0377T

Anoscopy with directed submucosal injection of bulking agent for fecal incontinence

Medically Necessary HCPCS (when filed with N39.3)HCPCSCovered

L8606

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

Not Medically Necessary HCPCSHCPCSNot Covered

L8605

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

Unlisted HCPCS for other non-covered bulking agentsHCPCSNot Covered

unlisted

No specific HCPCS for bulking agents that are not medically necessary: claims should be filed with an unlisted HCPCS code

Provider Actions

Documentation Required

Diagnosis linkage

Submit L8606 (Injectable agent synthetic implant, urinary tract; 1 ml syringe) with diagnosis code N39.3 (stress incontinence male/female) when filing for urinary tract bulking agent claims to establish medical necessity per policy.

Include L8606 and link to diagnosis code N39.3 on the claim.

Billing Rule

Fecal bulking procedure coding

When performing anoscopy with directed submucosal injection of a bulking agent for fecal incontinence, use CPT code 0377T for the procedure when applicable.

Use CPT 0377T: Anoscopy with directed submucosal injection of bulking agent for fecal incontinence.

Billing Rule

Non-covered bulking agent claims

For bulking agents that are considered not medically necessary and for which there is no specific HCPCS code, file claims using an unlisted HCPCS code as there is no specific HCPCS for non-covered bulking agents.

If no specific HCPCS exists for a non-covered bulking agent, submit the claim with an unlisted HCPCS code.

Background & Evidence

Injectable bulking agents are space-occupying substances injected periurethrally to treat stress urinary incontinence (increasing urethral tissue bulk and resistance) and injected into the anal submucosa to treat fecal incontinence (narrowing the anal opening). Several periurethral agents have FDA clearance for urinary incontinence (examples include carbon-coated beads/Durasphere, calcium hydroxylapatite/Coaptite, polydimethylsiloxane/Macroplastique, and ethylene vinyl alcohol copolymer/Tegress). For fecal incontinence, NASHA Dx (Solesta) is the FDA-approved formulation. Evidence is limited on long-term durability and clinical outcomes; some products (eg, Contigen, Tegress) were discontinued or removed from the market, and RCTs show mixed or short-term benefits for fecal incontinence. The policy provides coding guidance (eg, CPT 0377T for anoscopy with directed submucosal injection for fecal incontinence; HCPCS L8606 for synthetic urinary tract injectable implants when filed with diagnosis N39.3; L8605 listed as not medically necessary for the dextranomer/hyaluronic acid product in the anal canal).

Evidence source	Summary
AHRQ comparative effectiveness
Evaluated RCTs for NASHA Dx and Durasphere; evidence insufficient to determine effects on health outcomes
RCT findings (fecal incontinence)
One RCT of NASHA Dx vs sham improved some outcomes but not others; other RCTs showed limited/short-term benefits

Periurethral bulking agents: Injectable substances injected around the urethra to increase tissue bulk and improve urethral resistance to urine outflow.

Perianal bulking agents: Injectable substances injected into the submucosa of the anal canal to increase tissue bulk and narrow the anal opening.

Name	Number	Effective Year	Type
Incontinence Control Devices
230.10
1996
NCD

Revision History

2019-10-15policy_updateLatest

Policy last updated 10/15/2019; document indicates published provider updates in 2019 (Dec, Feb, Oct) and earlier (2017, Jan 2017).

2019-12provider_update

Provider Update December 2019 published.

2019-02provider_update

Provider Update February 2019 published.

2019-10provider_update

Provider Update October 2019 published.

2017-10provider_update

Provider Update October 2017 published.

2017-01provider_update

Provider Update January 2017 published.

2011market_change

Contigen production was discontinued in 2011; some products (eg, Tegress/Uryx) were voluntarily removed from the market due to safety concerns.

2013-02-05policy_effective

Policy effective date 02/05/2013 (policy document effective date).