Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence
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This policy governs coverage determinations for periurethral and perianal injectable bulking agents used to treat urinary and fecal incontinence for Blue Cross Blue Shield - Rhode Island members, including Medicare Advantage and commercial plan distinctions.
No material clinical or coverage changes in this revision.
Coverage Criteria — Urinary and Fecal Incontinence
Urinary incontinence — medically necessary agents for SUI
Covered when ALL of the following are met
Supports periurethral injection for SUI
Urinary incontinence — not medically necessary uses
Not medically necessary when ANY of the following apply
Evidence insufficient to determine improvement in net health outcome
Evidence insufficient to determine improvement in net health outcome
Evidence insufficient to determine improvement in net health outcome
Fecal incontinence — not medically necessary / not covered
Although one product (NASHA Dx/Solesta) has FDA approval, RCT evidence is inconsistent and longer-term controlled trials are needed
Coverage stance by indication
Policy differentiates urinary versus fecal incontinence:
Refer to Medicare Advantage Plans NCDs/LCDs for perianal bulking agents; no urinary-agent HCPCS are listed as not medically necessary in this policy.
Evidence from RCTs and systematic reviews is insufficient to conclude net health benefit; controlled long-term trials needed.
The policy states that the use of perianal bulking agents to treat fecal incontinence is considered not covered / not medically necessary because the available evidence is insufficient to demonstrate an improvement in net health outcome. This designation applies to perianal injections intended to treat fecal incontinence and is based on the policy conclusion that current data do not support clinical benefit for this indication.
The policy explicitly lists CPT code 0963T (Anoscopy with directed submucosal injection of bulking agent into anal canal) and HCPCS L8605 (dextranomer/hyaluronic acid copolymer implant, anal canal) as not covered / not medically necessary when used for anal/fecal canal bulking injections. Claims submitted with these codes for fecal incontinence should be considered at high risk for denial under this policy.
The policy identifies several agents and approaches that are not considered indicated for periurethral bulking: autologous cellular therapies (for example, myoblasts, fibroblasts, muscle-derived or adipose-derived stem cells), autologous fat, and autologous ear chondrocytes. It also specifies that other unspecified periurethral agents, including but not limited to Teflon (polytetrafluoroethylene), are considered not medically necessary due to insufficient evidence of net clinical benefit.
The policy clarifies the scope of the new CPT and HCPCS designations for anal/rectal procedures and products: CPT 0963T is defined as anoscopy with directed submucosal injection of bulking agent into the anal canal (new code effective 7/1/2025) and HCPCS L8605 describes dextranomer/hyaluronic acid copolymer implant for the anal canal. Both codes are listed as not covered / not medically necessary for treatment of fecal incontinence under this policy.
Coding — Procedure and Diagnosis Codes
| No codes listed |
| N39.3 | Stress incontinence (female) (male) |
Provider Actions — Authorization, Filing, and Documentation
Prior authorization — Not applicable
Prior authorization is not required for injectable bulking agents under this policy.
Conservative therapy required — failure ≥ 3 months
Ensure the patient has failed appropriate conservative therapy for at least 3 months before considering periurethral bulking agents for stress urinary incontinence.
- Conservative therapies include pelvic floor muscle exercises and behavioral changes (eg, fluid management, activity modification).
- Additional options may include intravaginal estrogen therapy, pessary use, and treatment of other underlying causes when amenable.
Benefit verification — check Evidence of Coverage/Subscriber Agreement
Verify member benefits and contract-specific coverage before performing or billing for bulking agent procedures, as benefits may vary between groups/contracts.
- Refer to the member's Evidence of Coverage or Subscriber Agreement for applicable benefits and any not medically necessary/not covered determinations.
Required ICD-10 with HCPCS — L8603/L8606 must be filed with N39.3
For commercially covered urinary injections, file HCPCS L8603 or L8606 with ICD-10 diagnosis code N39.3 (stress incontinence) to support medical necessity.
- N39.3 — Stress incontinence (female) (male)
- If no specific HCPCS applies, claims may be filed with an unlisted HCPCS code as noted in the policy.
Fecal incontinence — perianal bulking agents not covered
Perianal (anal canal) bulking agents to treat fecal incontinence are considered not covered / not medically necessary due to insufficient evidence of net health benefit.
- This policy differentiates urinary versus fecal incontinence; perianal bulking for fecal incontinence is not covered.
Denied codes — 0963T and L8605 designated not covered for fecal incontinence
Claims using anoscopy with directed submucosal injection into the anal canal (0963T) or HCPCS L8605 for dextranomer/hyaluronic acid implants in the anal canal risk denial; these codes are listed as not covered/not medically necessary for fecal incontinence.
Background
Injectable bulking agents are used in different anatomic contexts: periurethral injections are applied to treat stress urinary incontinence (SUI), whereas perianal injections have been used to treat fecal incontinence. The policy notes that certain periurethral agents (for example, carbon-coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, and polydimethylsiloxane) may be considered medically necessary for SUI in patients who have failed appropriate conservative therapy. By contrast, the policy finds the evidence for perianal bulking agents in fecal incontinence insufficient and therefore designates perianal injections as not covered / not medically necessary.
Definitions
Revision History
Policy effective date set to 2026-07-01.
Policy last reviewed on 2026-03-18.
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