Injectable Bulking Agents for the Treatment of Urinary and Fecal Incontinence
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - Rhode Island policy alerts
Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.
Monitor payer policy activity
This policy governs medical coverage determinations for injectable periurethral and perianal bulking agents used to treat urinary and fecal incontinence for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Injectable Bulking Agents
Initial therapy — Periurethral bulking agents for SUI (Commercial)
Covered when ALL of the following are met
Includes agents cleared by FDA for urinary incontinence
Medicare Advantage guidance
Referential coverage
See Related Policies section
Not medically necessary
Includes NASHA Dx evidence summarized in RCTs with mixed results
Experimental / Not medically necessary agents
Polytetrafluoroethylene (Teflon) and other non‑FDA‑approved agents are also considered not medically necessary.
Coverage distinctions: Urinary vs Fecal Incontinence
Supported by coding statements in document
Based on explicit coding and coverage statements
Evidence conclusion: insufficient to determine improvement in net health outcome
The use of perianal bulking agents to treat fecal incontinence is not covered / not medically necessary because the evidence is insufficient to determine that the technology results in an improvement in net health outcome.
Claims for the procedure described as 0963T — Anoscopy with directed submucosal injection of bulking agent into anal canal and the product code L8605 — Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml are identified as not covered / not medically necessary for treatment of fecal incontinence.
Autologous cellular therapies (for example, myoblasts, fibroblasts, muscle‑derived stem cells, adipose‑derived stem cells), autologous fat, and autologous ear chondrocytes used as periurethral bulking agents are considered not medically necessary for stress urinary incontinence because the evidence is insufficient to demonstrate improved net health outcome. Similarly, non‑FDA‑approved materials including polytetrafluoroethylene (Teflon®) and other unspecified periurethral agents are also considered not medically necessary.
Coding and Billing Guidance
| No codes listed |
| N39.3 | Stress incontinence (female) (male) |
Provider Requirements and Filing Instructions
Prior authorization: Not applicable
Prior authorization is not required for injectable bulking agents under this policy.
Use L8603 or L8606 with ICD-10 N39.3 for urinary SUI claims
Bill HCPCS L8603 or L8606 with ICD-10 code N39.3 for urinary (stress) incontinence to meet the policy’s medical necessity coding requirement; other bulking agents without specific HCPCS should be filed with an unlisted HCPCS code.
Document failure of ≥3 months of conservative therapy
Ensure patients have failed appropriate conservative therapy before periurethral bulking agents for SUI are considered; conservative therapies must have been used for at least 3 months.
- Includes pelvic floor muscle exercises and behavioral changes (eg, fluid management, activity modification).
- May include intravaginal estrogen, pessary use, and treatment of other amenable underlying causes.
Confirm coverage distinction between urinary and fecal indications
Follow policy coding and coverage distinctions: urinary indications may be covered when criteria are met, while perianal/fecal indications are generally not covered; confirm applicability to the member’s contract.
Verify member-specific benefits and contract terms
Benefits and coverage for injectable bulking agents may vary by contract; refer to the member’s Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered terms.
Perianal bulking agents for fecal incontinence are not covered
Do not use perianal bulking agents to treat fecal incontinence expecting coverage; the policy considers these not covered / not medically necessary due to insufficient evidence.
- Policy concludes evidence is insufficient to determine improvement in net health outcome for fecal incontinence.
Claims for 0963T and L8605 are not covered for fecal incontinence
Expect claims for anoscopy with directed submucosal injection (CPT 0963T) and HCPCS L8605 (dextranomer/hyaluronic acid implant, anal canal) to be identified as not covered / not medically necessary for fecal incontinence and subject to denial.
Background
Bulking agents are injectable substances administered periurethrally for stress urinary incontinence (SUI) and perianally for fecal incontinence. Several periurethral agents (for example, carbon‑coated spheres, calcium hydroxylapatite, polyacrylamide hydrogel, or polydimethylsiloxane) have been cleared for urinary incontinence and may be considered medically necessary for SUI in patients who have failed appropriate conservative therapy. In contrast, perianal bulking agents for fecal incontinence are considered not covered / not medically necessary because available evidence is insufficient to show a durable net health benefit.
Definitions and Key Terms
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.