Plugs for Anal Fistula Repair
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This document governs the coverage stance and evidence review for biosynthetic and synthetic anal fistula plugs used to treat anal fistulas for Blue Cross Blue Shield - South Dakota members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Policy Stance
inv-01: Investigational / Not covered as medically necessary
Coverage stance
Policy explicitly states investigational status and insufficiency of evidence.
inv-02: Criteria for considering AFP
Coverage considerations reflect comparative evidence and guideline statements; AFP may be considered when criteria below are met:
Derived from randomized trials, systematic reviews, and the 2022 ASCRS guideline recommending consideration of established alternatives.
This policy takes an overall investigational stance: biosynthetic and synthetic anal fistula plugs (AFPs), including porcine small intestine submucosa and synthetic scaffold devices, are considered investigational for repair of anal fistulas because the evidence is insufficient to demonstrate an improvement in net health outcome. The policy does not list specific patient-level clinical exclusions; instead, it applies a broad investigational determination to these devices and their use for anal fistula repair.
Because the technology is designated investigational, placement of AFPs may be denied as not medically necessary under this policy when presented as the intended treatment; prior authorization requirements (if applicable under a member’s benefit plan) and documentation expectations should be followed when AFPs are proposed.
The 2022 American Society of Colon and Rectal Surgeons practice guideline gives a strong recommendation, based on moderate-quality evidence, that anal fistula plug and fibrin glue are relatively ineffective treatments for fistula-in-ano. Procedural selection should consider these guideline recommendations when evaluating plug-based or glue-based therapies.
Randomized and nonrandomized studies, including systematic reviews, show heterogeneous and conflicting results for AFPs. Several RCTs reported higher recurrence or complication rates with AFP compared with flap procedures or surgeon’s preference, and systematic reviews have found wide ranges of success rates. Given this mixed evidence base, AFPs are considered investigational due to insufficient evidence of improved net health outcome.
Multiple randomized trials and meta-analyses do not support use of AFP as a routine first-line replacement for established repairs such as endorectal or advancement flap for complex/high fistulas. A 2023 meta-analysis reported pooled healing rates of 48.3% for AFP versus 64.4% for endoanal advancement flap, and individual trials (e.g., van Koperen 2011, Ortiz 2009) documented higher recurrence with plugs versus flap procedures. Therefore, AFP is not supported as a first-line substitute
Coding and Device Codes
| No codes listed |
| FTM | FDA product code listed for multiple SIS fistula plug devices |
| FTL | FDA product code listed for Gore Bio-A Fistula Plug |
Provider Actions, Prior Authorization, and Documentation
Prior approval not applicable
Prior authorization is not required under this policy; however, the investigational policy stance may affect coverage determinations under member benefits.
No step therapy specified
The policy discusses AFPs as alternatives to standard surgical therapies but does not require a step-therapy sequence prior to AFP use.
Preferred surgical alternatives
Consider established surgical options (fistulotomy/fistulectomy, endorectal/advancement flap, seton placement, or LIFT) as preferred alternatives given guideline guidance and comparative outcomes.
- Fistulotomy or fistulectomy
- Endorectal or anal sliding/flap procedures (advancement flap)
- Seton drains (draining or cutting seton)
- Ligation of intersphincteric fistula tract (LIFT)
Coding and device documentation
Document the specific procedure codes and reference FDA‑cleared devices when reporting AFP use; see the Codes table and the regulatory/devices table for device listings.
- Use CPT/HCPCS codes from the Codes section when reporting services.
- Reference Table 1 for FDA‑cleared plugs (510(k) devices) when documenting device identity.
Required clinical documentation
Include documentation of clinical intent, fistula characteristics, prior treatments, and follow-up plans with AFP claims or prior authorization requests.
- Clinical intent (goal of repair/healing)
- Fistula characteristics (e.g., high vs low, transsphincteric, Crohn‑related)
- Prior treatments attempted and response
- Short‑term and long‑term follow‑up timeline
Investigational — potential denial
Placement of biosynthetic or synthetic anal fistula plugs is considered investigational; claims for AFP repair may be denied as not medically necessary because evidence is insufficient to demonstrate improved net health outcome.
Evidence-based denial risk
Randomized trials and systematic reviews showing higher recurrence or no superiority of AFP versus established surgical repair may result in denial if AFP is requested as a preferred or first‑line therapy without clinical justification.
- FIAT trial: similar healing but more complications with AFP in some outcomes
- Van Koperen and other RCTs reported higher recurrence with AFP compared with advancement flap
Background
Anal fistulas are abnormal communications between the anal canal or rectum and the skin surface that most commonly arise from anorectal abscesses; approximately 26% to 37% of perianal abscesses may form fistulas. Fistulas are characterized by their relationship to the sphincter complex (Parks classification) or described as low versus high, with high/complex fistulas carrying a greater risk of incontinence when repaired. AFPs are scaffold devices placed into the fistula tract to promote tissue ingrowth and closure; the available evidence on their effectiveness is mixed, leading to their investigational designation.
Definitions
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