CurrentExcellus Health Plan IncPolicy 7.01.22

Bulking Agents for Treatment of Urinary or Fecal Incontinence

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This policy evaluates the medical necessity of FDA-approved urethral bulking agents for urinary incontinence and identifies qualifying clinical indications, exclusions, and investigational treatments.

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CurrentExcellus Health Plan IncPolicy 7.01.22

Bulking Agents for Treatment of Urinary or Fecal Incontinence

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Policy Summary

PayerExcellus Health Plan Inc

PolicyBulking Agents for Treatment of Urinary or Fecal Incontinence

Policy CodePolicy 7.01.22

Change TypeAnnual reviewno material changes

Effective DateMarch 19, 2026

Last ReviewMar 19, 2026

Next Review DateMarch 1, 2027

Key ActionUse an FDA-approved urethral bulking agent and document that the applicable policy criteria for the selected treatment category and indication are satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Treatment categories with criteria

4Named bulking agents

≤100 cm H2OMaximum leak point pressure

5Durasphere sessions

InvestigationalPerianal bulking agents

6CPT codes listed

Medical Necessity and Investigational Criteria

Collagen implants

Urethral collagen implants may be considered medically appropriate when FDA approval and all of the following criteria are met.

Collagen implant requirements

Required clinical criteria
- The urethral bulking agent is approved by the U.S. Food and Drug Administration (FDA).
- Stress incontinence is due to urethral sphincter dysfunction.
- The condition is unresponsive to conservative therapy.
ONE qualifying indication
- Congenital sphincter weakness secondary to conditions such as myelomeningocele or epispadias.
- Acquired sphincter weakness secondary to spinal cord lesion.
- Biological male patient following trauma, including prostatectomy and/or radiation.
- Biological female patient without urethral hypermobility and with abdominal leak point pressure of 100 cm H2O or less.100 cm H2O or less

Other urethral bulking agents

Urethral bulking agents may be considered medically appropriate when FDA approval and all of the following criteria are met.

Bulking agent requirements

Required clinical criteria
- The urethral bulking agent is approved by the U.S. Food and Drug Administration (FDA).
- Treatment is for stress incontinence due to intrinsic sphincter deficiency (ISD).
- The patient is a biological female.
- The condition is unresponsive to conservative therapy.
ONE qualifying bulking agent

Listed urethral bulking agents

The policy identifies the following urethral bulking agents in an ANY list.

Spherical particles of calcium hydroxyapatite (Coaptite).
Polydimethylsiloxane (silicone elastomer) particles (Macroplastique).

Not medically necessary urinary incontinence conditions

Urethral bulking agents are not medically necessary for ANY of the following urinary incontinence conditions.

Excluded conditions

Urinary retention with overflow incontinence.
Ectopic ureter.
Neurogenic bladder dysfunction.
Urinary fistulas.
Psychogenic incontinence.

Durasphere repeat-treatment limitation

Additional Durasphere implants are not medically necessary when the following condition is met.

Repeat-treatment limitation

Incontinence does not improve after five separate injection sessions.5 separate injection sessions
Applies to additional Durasphere implants.

Investigational urinary stress-incontinence agents

Urethral bulking agents are considered investigational for urinary stress incontinence when ANY of the following agents or approaches is used.

Investigational agents or approaches

Polytetrafluoroethylene (Teflon).
Autologous cellular therapy, including myoblasts, fibroblasts, muscle-derived stem cells, or adipose-derived stem cells.
Microballoons (UroVive).

Investigational perianal bulking agents

Perianal bulking agents to treat fecal incontinence are considered investigational.

Investigational fecal-incontinence treatment

Use of a perianal bulking agent to treat fecal incontinence.

Urethral bulking agents are considered not medically necessary when used to treat urinary retention with overflow incontinence, ectopic ureter, neurogenic bladder dysfunction, urinary fistulas, or psychogenic incontinence. The policy indicates that this list is not exhaustive.

Additional Durasphere implants are considered not medically necessary when the patient’s incontinence has not improved after five (5) separate injection sessions.

Codes and Coverage Parameters

Experimental CPT CodesCPTExperimental

0963T	Anoscopy with directed submucosal injection of bulking agent into anal canal (Effective 07/01/25)
0999T	Autologous muscle cell therapy, harvesting of muscle progenitor cells, including ultrasound guidance, when performed (Effective 01/01/26)
1000T	Autologous muscle cell therapy, administration of muscle progenitor cells into the urethral sphincter, including cystoscopy and post-void residual ultrasound, when performed (Effective 01/01/26)
1001T	Autologous muscle cell therapy, injection of muscle progenitor cells into the external anal sphincter, including ultrasound guidance, when performed (Effective 01/01/26)
46999	Unlisted procedure, anus (*E/I when used for Fecal incontinence ICD10 code range R15.0-R15.9)

CPT CodesCPT

51715

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

Experimental HCPCS CodesHCPCSExperimental

L8604	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1ml, includes shipping and necessary supplies
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies

HCPCS CodesHCPCS

L8603	Injectable bulking agent, collagen implant, urinary tract, per 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

ICD-10 CodesICD-10

N36.42-N36.43	Urethral functional and muscular disorders (code range)
N39.3	Stress incontinence (female) (male)
N39.41-N39.46	Other specified urinary incontinence (code range)
N39.498	Other specified urinary incontinence
R15.0-R15.9	Fecal incontinence (code range)
R32.0	Unspecified urinary incontinence

Abdominal leak point pressure

Maximum abdominal leak point pressure100 cm H2O or less

Applicable populationBiological female patients

Additional clinical featurePatients without urethral hypermobility

Durasphere injection sessions

Number of sessionsFive separate injection sessions

TreatmentDurasphere implants

Limitation

Documentation, Coverage, and Denial Guidance

Documentation Required

FDA Approval and Clinical Criteria Required

Before requesting coverage, verify that the urethral bulking agent is approved by the U.S. Food and Drug Administration (FDA) and document the applicable policy criteria and indication.

FDA approval is required.
Applicable clinical criteria must be documented.

Documentation Required

Durasphere Prescriber Qualification

Durasphere may be prescribed only by a doctor trained in cystoscope use who has completed the appropriate implant-training program.

Document prescriber training in cystoscope use.
Document completion of the appropriate Durasphere implant-training program.

Policy Background

This policy addresses urethral bulking treatment for urinary stress incontinence associated with urethral sphincter dysfunction, including intrinsic sphincter deficiency. Urethral bulking agents are injected at the bladder neck and proximal urethra to increase urethral resistance and reduce leakage. Coverage criteria distinguish collagen implants from other urethral bulking agents and require that the condition be unresponsive to conservative therapy; collagen criteria also address congenital or acquired sphincter weakness and selected clinical circumstances in biological male and female patients.

Clinical and Policy Terms

ISD

AbbreviationISD

Full termIntrinsic sphincter deficiency

Clinical contextA physiologic cause of urinary incontinence

Intrinsic sphincter deficiency (ISD)

ConditionIntrinsic sphincter deficiency (ISD)

CausesDamage to the urethral sphincter from surgery, neurological disorders, or trauma

ResultSphincter incompetence and urinary leakage

Policy Summary

PayerExcellus Health Plan Inc

PolicyBulking Agents for Treatment of Urinary or Fecal Incontinence

Policy CodePolicy 7.01.22

Change TypeAnnual reviewno material changes

Effective DateMarch 19, 2026

Last ReviewMar 19, 2026

Next Review DateMarch 1, 2027

Key ActionUse an FDA-approved urethral bulking agent and document that the applicable policy criteria for the selected treatment category and indication are satisfied.

SourceLink

On This Page

Carbon-coated beads (Durasphere).

Polyacrylamide hydrogel (Bulkamid).

Spherical particles of calcium hydroxyapatite (Coaptite).

Polydimethylsiloxane (silicone elastomer) particles (Macroplastique).

Additional implants are not medically necessary when incontinence does not improve

Prior Authorization

Coverage Requires FDA Approval and Medical Necessity

Coverage requires both an FDA-approved agent and satisfaction of the applicable clinical criteria for the covered indication. FDA approval alone does not establish medical necessity.

Confirm the agent is FDA approved for the intended use.
Confirm and document the required indication, patient characteristics, and treatment history.

Denial Risk

Required Indication or Clinical History Must Be Met

Expect denial when the required indication or clinical history is not documented. For collagen implants, documentation must support stress incontinence due to urethral sphincter dysfunction, failure of conservative therapy, and at least one qualifying clinical history; for other bulking agents, document intrinsic sphincter deficiency, biological-female eligibility, and failure of conservative therapy.

Collagen implants: stress incontinence due to urethral sphincter dysfunction and unresponsiveness to conservative therapy.
Qualifying collagen-indication history includes congenital sphincter weakness due to conditions such as myelomeningocele or epispadias; acquired sphincter weakness secondary to spinal cord lesion; biological male patients after trauma, including prostatectomy and/or radiation; or biological female patients without urethral hypermobility and with abdominal leak point pressure of 100 cm H2O or less.
Other bulking agents: stress incontinence due to intrinsic sphincter deficiency (ISD), use only in biological female patients, and unresponsiveness to conservative therapy.

Denial Risk

Excluded Urinary-Incontinence Conditions

Urethral bulking agents are not medically necessary for these urinary-incontinence conditions; identify the underlying diagnosis before submitting a request.

Urinary retention with overflow incontinence
Ectopic ureter
Neurogenic bladder dysfunction

Denial Risk

Additional Excluded Conditions

Additional exclusions include urinary fistulas and psychogenic incontinence. Claims for these conditions should not be submitted as medically necessary urethral-bulking-agent treatment.

Urinary fistulas
Psychogenic incontinence

Denial Risk

No Improvement After Five Durasphere Sessions

Additional Durasphere implants are not medically necessary when incontinence has not improved after five separate injection sessions.

Do not request repeat treatment without documenting improvement within the five-session limit.
Five separate injection sessions without improvement trigger the denial condition.

Denial Risk

Investigational Urinary Stress-Incontinence Agents

The following approaches are considered investigational for urinary stress incontinence and are not eligible for coverage under this policy.

Polytetrafluoroethylene (Teflon)
Autologous cellular therapy, including myoblasts, fibroblasts, muscle-derived stem cells, or adipose-derived stem cells
Microballoons (UroVive)

Denial Risk

Investigational Fecal-Incontinence Treatment

Perianal bulking agents used to treat fecal incontinence are considered investigational. Do not represent this treatment as covered medically necessary care.

Perianal bulking agents for fecal incontinence (FI)

Billing Rule

Experimental or Investigational Coding

The listed experimental/investigational codes identify procedures or products that may be denied as experimental or investigational. Apply the code designation and associated diagnosis or service description when billing.

0963T — Anoscopy with directed submucosal injection of bulking agent into anal canal (E/I; effective 07/01/25).
0999T — Autologous muscle cell therapy: harvesting of muscle progenitor cells, including ultrasound guidance, when performed (E/I; effective 01/01/26).
1000T — Autologous muscle cell therapy: administration of muscle progenitor cells into the urethral sphincter, including cystoscopy and post-void residual ultrasound, when performed (E/I; effective 01/01/26).
1001T — Autologous muscle cell therapy: injection into the external anal sphincter, including ultrasound guidance, when performed (E/I; effective 01/01/26).
46999 — Unlisted procedure, anus; E/I when used for fecal-incontinence ICD-10 codes R15.0-R15.9.
L8604 — Injectable dextranomer/hyaluronic acid copolymer implant, urinary tract (E/I).
L8605 — Injectable dextranomer/hyaluronic acid copolymer implant, anal canal (E/I).

Denial Risk

Unapproved Synthetic Agents Are Not Covered

Other synthetic urethral bulking agents that do not have FDA approval may be denied. Confirm FDA approval for the specific agent and intended use before prescribing or submitting a claim.

FDA-approved agents identified in the policy include cross-linked collagen, Durasphere, Coaptite, Bulkamid, and Macroplastique, subject to their approved indications.
Durasphere, Coaptite, Bulkamid, and Macroplastique are approved only for use in biological females.
Other synthetic urethral bulking agents do not have FDA approval.

Billing Rule

Code-Specific Coverage Limitations

A listed billing code is not automatically covered. Coverage may vary by the circumstances of the service, including the agent, indication, patient eligibility, diagnosis, and satisfaction of the policy criteria.

Verify coverage for the specific code and circumstances before billing.
Do not infer coverage solely from a code appearing in the policy.

Total intrinsic sphincter deficiency

DefinitionConstant involuntary dripping of urine from the urethra

TimingOccurs day and night

Associated findingOccurs without bladder distention, as determined by abdominal examination and measurement of residual urine

Partial sphincter deficiency / stress incontinence

Also known asStress incontinence

DefinitionInvoluntary loss of urine during a maneuver that increases transabdominal pressure

ExamplesCoughing, bending, or lifting

Urethral bulking agents

DefinitionSubstances developed to treat stress incontinence due to intrinsic sphincter deficiency

Injection locationArea of the bladder neck and proximal urethra

MechanismIncreased bulk enhances urethral resistance to urine outflow and reduces urine leakage

Durasphere

ProductDurasphere is a urethral bulking agent made of pyrolytic carbon-coated beads

PopulationAdult women with stress urinary incontinence due to intrinsic sphincter deficiency

Injection and effectInjected submucosally at the bladder neck in females; the final bulking result combines the carbon-coated beads with the body's own collagen

Urethral bulking agents

DefinitionUrethral bulking agents are substances used to treat stress incontinence due to intrinsic sphincter deficiency

Injection siteBladder neck and proximal urethra

PurposeIncrease urethral resistance to urine outflow and reduce urine leakage

Internal anal sphincter dysfunction

ConditionInternal anal sphincter dysfunction

AssociationAssociated with fecal incontinence

Treatment contextBulking agents may be injected into the submucosa of the anal canal to increase tissue bulk and narrow the anal opening

E/I

AbbreviationE/I

MeaningExperimental/Investigational

Policy designationIdentifies a service or product as experimental or investigational

NMN

AbbreviationNMN

MeaningNot medically necessary/appropriate

Policy designationIdentifies a service or product as not medically necessary or appropriate