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    v1.0.31
    OpenPayerPolicy UpdatesGeneral SurgeryRegence Fistula Plug Coverage Update | OpenPayer
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    CurrentRegence BlueCross BlueShieldPolicy 175

    Plugs for Enteric and Anorectal Fistula Repair

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    This policy governs coverage of biosynthetic fistula plugs, including porcine small intestine submucosa and synthetic-material plugs, used to repair enteric and anal fistulas. Contract terms take precedence where applicable.

    Policy Summary
    PayerRegence BlueCross BlueShield
    PolicyPlugs for Enteric and Anorectal Fistula Repair
    Policy CodePolicy 175
    Change TypeNo material change
    Effective DateSeptember 1, 2026
    Last ReviewJul 1, 2026
    Next Review DateMay 1, 2027
    Key ActionInform members that they may be financially responsible because biosynthetic fistula plug repair is considered investigational and may be denied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    InvestigationalCoverage status of biosynthetic fistula plugs
    InvestigationalCoverage status for enteric and anal fistula plugs
    6–8 weeksFistula plug absorption time
    304FIAT randomized trial participants

    Coverage Criteria

    Enteric and anal fistula plugs

    The following service is considered investigational.

    Investigational biosynthetic fistula plug: Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or synthetic material, are considered investigational when used to repair enteric and anal fistulas.

    No clinical exception or covered indication is stated in this policy section.

    Enteric and anal fistula plug repair

    Biosynthetic fistula plugs are considered investigational for repair of enteric and anal fistulas.

    Investigational use: Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or synthetic material, are investigational for the repair of enteric and anal fistulas.

    Available research does not demonstrate improved healing or reduced recurrence, and no practice guidelines recommend these plugs for any indication.

    Repair of enteric or anal fistulas using biosynthetic fistula plugs—including plugs made from porcine small intestine submucosa or synthetic material—is considered investigational under this policy.

    Coding

    Examples of fistula plugs with FDA 510(k) approvalmixed
    K050337SIS Fistula Plug and Surgisis RVP Recto-Vaginal Fistula Plug; FDA 510(k) approval number; Cook Biotech Inc.; approved 3/9/2005 and 10/10/2006, respectively
    K062729Surgisis RVP Recto-Vaginal Fistula Plug; FDA 510(k) approval number; Cook Biotech Inc.; approved 10/10/2006
    K082682Surgisis Biodesign Enterocutaneous Fistula Plug; FDA 510(k) approval number; Cook Biotech Inc.; approved 2/27/2009
    K083266GORE BIO-A Fistula Plug; FDA 510(k) approval number; W.L. Gore & Associates, Inc.; approved 3/27/2009
    K150668Biodesign Enterocutaneous Fistula Plug; FDA 510(k) approval number; Cook Biotech Inc.; approved 12/09/2015
    CPT HCPCSCPTExperimental
    46707Repair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS])
    44799Unlisted procedure, small intestine
    45499Unlisted laparoscopy procedure, rectum
    58999Unlisted procedure, female genital system (nonobstetrical)

    Provider Actions

    Denial Risk

    Investigational fistula plug procedure

    Coverage may be denied because biosynthetic fistula plugs—including plugs made from porcine small intestine submucosa or synthetic material—are considered investigational for repair of enteric and anal fistulas. Applicable contract language takes precedence, and contracts may exclude investigational services.

    Denial Risk

    Investigational fistula plug repair

    Claims for biosynthetic fistula plugs used to repair enteric or anal fistulas may be denied because the policy considers these services investigational. This includes plugs made from porcine small intestine submucosa or synthetic material.

    • Applicable procedure codes include 46707, 44799, 45499, and 58999.

    Clinical Background

    Fistula plugs are placed within an abnormal enteric or anorectal passage and anchored to provide a scaffold for new tissue growth, promote healing and closure, and allow drainage while healing progresses. The plug is designed to be absorbed in approximately 6–8 weeks. Enteric fistulas may connect the gastrointestinal tract with abdominal organs, the chest, or the skin; anal fistulas connect the anal canal or rectum with the skin or other pelvic structures.

    Clinical management of fistulas may include drainage and infection control, nutritional therapy, fistulotomy or fistulectomy, advancement flaps, setons, LIFT procedures, or fibrin glue. The policy's evidence review describes limited and generally low-quality evidence for fistula plugs, including findings of higher healing with advancement flap in some analyses and more six-week complications in the plug group in the FIAT randomized trial.

    Definitions

    Fistula plug
    Abnormal opening or passageUsually involves the intestine or anus.
    PlacementThe fistula plug is anchored in the fistula.
    FunctionProvides scaffolding for new tissue growth to promote healing and fistula closure.
    Enteric fistula
    DefinitionAn abnormal passage between the gastrointestinal tract and other abdominal organs, the chest, or the skin.
    External fistulaDrains externally to the skin.
    Internal fistulaDrains internally to the gastrointestinal tract or another organ, such as the bladder or vagina.
    Anal fistula
    DefinitionAn abnormal communication between the interior of the anal canal or rectum and the skin surface.
    Rarer communicationsMay communicate with the vagina or other pelvic structures, including the bowel.
    ClassificationAnal fistulas may be classified as trans-sphincteric, intersphincteric, suprasphincteric, or extrasphincteric according to their position relative to the anal sphincter.
    Fistula plug placement
    MaterialsMade from animal tissue, such as porcine tissue, or a synthetic copolymer fiber.
    PlacementPulled through the fistula tract and secured at the proximal opening.
    DrainageThe distal opening is left open to allow drainage while healing progresses.
    Policy Summary
    PayerRegence BlueCross BlueShield
    PolicyPlugs for Enteric and Anorectal Fistula Repair
    Policy CodePolicy 175
    Change TypeNo material change
    Effective DateSeptember 1, 2026
    Last ReviewJul 1, 2026
    Next Review DateMay 1, 2027
    Key ActionInform members that they may be financially responsible because biosynthetic fistula plug repair is considered investigational and may be denied.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider ActionsClinical BackgroundDefinitions

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