Plugs for Anal Fistula Repair
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This policy governs coverage determinations for biosynthetic and synthetic fistula plugs used to repair anal fistulas for Blue Cross Blue Shield - Rhode Island members, including Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage Determination
Coverage stance
Use of biosynthetic or synthetic fistula plugs for repair of anal fistulas is excluded or considered not medically necessary because the available evidence is insufficient to determine the effects of these technologies on health outcomes. For Medicare Advantage plans, biosynthetic fistula plugs (including plugs made of porcine small intestine submucosa or synthetic materials) are not covered. For Commercial products, these plugs are considered not medically necessary for the repair of anal fistulas.
Services determined to be not medically necessary or non-covered benefits may result in charges to the member unless the member has been informed and has agreed in writing in advance to proceed at their own expense. Benefits and eligibility are determined by the member’s subscriber agreement, member certificate, or employer agreement; providers should verify member-specific benefits with the provider call center or refer to the Evidence of Coverage.
For Commercial products, biosynthetic fistula plugs, including plugs made of porcine small intestinal submucosa or synthetic material, are considered not medically necessary. The procedure code 46707 (Repair of anorectal fistula with plug) is listed as not medically necessary / not covered.
Coding and Billing
| 46707 | Repair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS]) |
Provider Actions and Operational Notes
Prior authorization not required by policy
No prior authorization is required under this policy; however, benefits may vary by contract so check the member's Evidence of Coverage or Subscriber Agreement for applicable coverage rules.
- Policy states: "PRIOR AUTHORIZATION Not applicable."
- See benefits variation note for Medicare Advantage and Commercial: "Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement..."
Verify benefits and prior authorization with the plan
The policy does not list specific prior authorization requirements; verify member-specific benefits and any required prior authorization with the provider call center or the member's plan documents before scheduling or performing the service.
- Policy: "For information on member-specific benefits, call the provider call center."
- Benefits may vary between groups/contracts; refer to Evidence of Coverage.
No step therapy or medical criteria specified
This policy includes no step-therapy requirements or medical criteria for use of fistula plugs; there are no specified clinical criteria in the document.
- Document: "MEDICAL CRITERIA Not applicable"
General provider note
Note to providers: follow payer instructions for benefit verification and authorization checks; do not assume coverage because the policy states plugs are not covered or not medically necessary for some products.
- Medicare Advantage: "Biosynthetic fistula plugs... are not covered..."
- Commercial: "Biosynthetic fistula plugs... are not medically necessary..."
- Benefits may vary—check Evidence of Coverage.
Refer to Evidence of Coverage for group-specific benefits
Confirm group- and contract-specific coverage by reviewing the member's Evidence of Coverage or Subscriber Agreement before providing services involving fistula plugs.
- Policy: "Please refer to the Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage."
Verify eligibility and benefits per subscriber/employer documents
Determine eligibility and covered benefits using the member's subscriber agreement, member certificate, or employer agreement; contact the provider call center for member-specific information.
- Policy: "Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement... For information on member-specific benefits, call the provider call center."
Coverage denial risk for CPT 46707
Claims for procedures using biosynthetic or synthetic anal fistula plugs (CPT 46707) may be denied because the policy lists these plugs as not covered for Medicare Advantage and not medically necessary for Commercial products.
- Coding: "46707 Repair of anorectal fistula with plug..." listed as not covered/not medically necessary.
- Medicare Advantage: plugs "are not covered..."
- Commercial Products: plugs "are not medically necessary..."
Member financial liability risk if service is non‑covered
If services are determined not medically necessary or are non‑covered, the member may be held financially responsible unless you obtain the member's prior written agreement to accept liability for charges.
- Policy: "If you provide services to a member which are determined to not be medically necessary... you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense."
Clinical Background
An anal fistula is an abnormal communication between the interior of the anal canal or rectum and the skin surface, commonly arising from an anorectal abscess. Approximately one-quarter to one-third of perianal abscesses may progress to fistula formation. Management balances achieving fistula closure with preservation of continence and includes options such as fistulotomy, seton placement, advancement flap procedures, ligation of intersphincteric fistula tract (LIFT), fibrin glue, and insertion of fistula plugs. Fistula plugs are intended to act as a scaffold—derived from porcine small intestinal submucosa (SIS) or synthetic copolymers—placed into the tract and secured proximally while allowing distal drainage to promote tissue ingrowth and healing.
Key Definitions
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