CurrentBlue Cross Blue Shield - IowaPolicy N/A

Plugs for Anal Fistula Repair

Policy on the use of biosynthetic or porcine small intestinal submucosa (SIS) anal fistula plugs for repair of anal, rectal, and enterocutaneous fistulas; governs clinical coverage determinations for Blue Cross Blue Shield - Iowa members. Affects providers performing fistula repair and payers adjudicating benefits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyPlugs for Anal Fistula Repair

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateN/A

Key ActionDo not submit claims for biosynthetic fistula plug placement as covered care because plugs are considered investigational and not supported by this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4RCTs

510(k)510(k) devices

InsufficientNet outcome

12Studies in 2023 review

35% vs 18%Complication rate (FIAT)

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Coverage Determinations

inv-01: Investigational / Not established

Covered when ALL of the following are met:

Investigational stance: Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa (SIS) or synthetic materials, are considered investigational for the repair of anal fistulas and are not medically necessary because the evidence is insufficient to demonstrate an improvement in net health outcome.

Based on randomized trials and systematic reviews showing heterogeneous and conflicting results for healing and recurrence; some RCTs report higher complication or recurrence rates with AFPs.

inv-02: Evidence-based coverage considerations

Summary of comparative effectiveness evidence and implications:

Evidence summary: Randomized and comparative studies report variable results; systematic reviews and RCTs show lower pooled healing rates for AFP compared with endoanal advancement flap and inconsistent effects on recurrence and complications.

Key trials: FIAT (Jayne et al 2021, n=304) found 12-month clinical healing 54% (AFP) vs 55% (surgeon’s preference) but significantly higher complication rate at 6 weeks with AFP; van Koperen (2011, n=60) and Ortiz (2009, n=43) reported higher recurrence with AFP in some comparisons. An et al (2023) meta-analysis (12 studies, n=847) found pooled healing rates 48.3% (AFP) vs 64.4% (EAFR) favoring advancement flap (p=0.03).

Biosynthetic anal fistula plugs — including devices composed of porcine small intestinal submucosa (SIS) and plugs made from synthetic materials — are not supported for repair of anal fistulas under this policy. The available randomized trials, nonrandomized studies, and systematic reviews show heterogeneous and conflicting results without consistent evidence of improved clinical outcomes. Because the evidence is insufficient to demonstrate a net health benefit, these products are considered investigational for anal fistula repair.

None listed.

No HCPCS code(s) are specified in this portion of the policy.

Placement of an anal fistula plug (AFP) is considered investigational and therefore not medically necessary because current evidence is insufficient to determine whether AFP placement improves net health outcomes compared with established surgical therapies.

Clinical practice guidance from the American Society of Colon and Rectal Surgeons (2022) provides a strong recommendation, based on moderate-quality evidence, that anal fistula plug and fibrin glue are relatively ineffective treatments for fistula-in-ano compared with standard surgical options.

Procedure and Device Codes

Device FDA product codes listedmixed

FTM	FDA product code listed for multiple Cook Biotech SIS fistula plug devices (e.g., SIS Fistula Plug, Surgisis RVP, Biodesign Enterocutaneous Fistula Plug, Biodesign Anal Fistula Plug).
FTL	FDA product code listed for Gore Bio-A Fistula Plug (W.L. Gore & Associates).

Device FDA product codes listed (summary)mixed

FTM / FTL

FDA product codes referenced for fistula plug devices as listed in the regulatory table.

Reported procedure codesCPT | HCPCS

46707	Repair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS])
C9796	Repair of enterocutaneous fistula small intestine or colon (excluding anorectal fistula with plug (e.g. porcine small intestine submucosa [sis])

Listed Procedure CodesCPT | HCPCS

46707	Repair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS]).
C9796	Repair of enterocutaneous fistula small intestine or colon (excluding anorectal fistula with plug (e.g. porcine small intestine submucosa [sis]).

HCPCS — not specifiedHCPCS

No code(s)

No HCPCS code(s) listed.

Provider Responsibilities and Billing Instructions

Prior Authorization

Prior Approval

Prior approval is not applicable for anal fistula plug (AFP) procedures.

Prior approval: Not applicable

Denial Risk

Investigational Status and Denial Risk

Biosynthetic fistula plugs are considered investigational for the repair of anal fistulas. Investigational services may be denied. Providers should confirm medical necessity and consider standard surgical therapies given the investigational status of AFPs.

Policy status: AFPs investigational — coverage not supported
Denial risk: Investigational services may be denied; confirm with payer before proceeding
Clinical consideration: Consider standard surgical options (fistulotomy, advancement flaps, seton placement, fibrin glue, LIFT) as appropriate

Clinical Background

An anal fistula is an abnormal communication between the lumen of the anal canal or rectum and the perianal skin. Fistulas most commonly arise following an anorectal abscess and may also be associated with inflammatory bowel disease, malignancy, prior radiation, or other local infection. Fistulas are described by their relationship to the anal sphincter complex (for example, using the Parks classification) or as low versus high, with repair of high fistulas carrying greater risk of fecal incontinence. Anal fistula plugs are designed as scaffold devices inserted into the tract to support tissue ingrowth while allowing distal drainage, but clinical outcomes and complication profiles vary across studies.

Definitions and Procedure Descriptions

Anal fistula plug (AFP) — biosynthetic/synthetic scaffold definition

DefinitionBiosynthetic or synthetic scaffold device (e.g., porcine small intestinal submucosa [SIS] or a bioabsorbable synthetic copolymer) that is pulled through the fistula tract and secured at the proximal opening to provide a scaffold for tissue ingrowth while leaving the distal opening for drainage.

Material examplesPorcine-derived SIS (animal tissue) or bioabsorbable synthetic copolymer fibers; devices degrade by hydrolytic or enzymatic pathways as healing progresses.

Placement techniquePlug is pulled through the fistula tract and secured at the proximal (internal) opening; distal opening remains patent for drainage.

PurposeIntended to promote tissue ingrowth and closure of the fistula tract without extensive division of sphincter muscle, aiming to preserve continence.

Regulatory statusSeveral fistula plugs have been cleared by the FDA through the 510(k) process (see regulatory/devices tables).

Policy Revision History

2026-01literature_updateLatest

Literature surveillance updated (most recent literature update noted January 2026).

2025-02-01policy_renewal

Policy renewed (administrative/policy renewal recorded for 2025).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyPlugs for Anal Fistula Repair

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2024

Next Review DateN/A

Key ActionDo not submit claims for biosynthetic fistula plug placement as covered care because plugs are considered investigational and not supported by this policy.

SourceLink

On This Page

Billing Rule

Procedure Coding and Authorization

Report fistula plug procedures using the appropriate CPT and HCPCS codes and include relevant diagnosis codes. Verify prior authorization requirements (if any) and select the correct code(s) for the service rendered.

Primary CPT: 46707 — Repair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS])
Related CPT: C9796 — Repair of enterocutaneous fistula small intestine or colon (note: excludes anorectal fistula with plug)
Place/type of service: Report appropriate inpatient or outpatient place of service and surgery type
Operational note: Verify any authorization or site-specific billing requirements prior to scheduling

Billing Rule

Claims Coding and Billing Requirements

Claims must use appropriate CPT, HCPCS, revenue, and ICD diagnosis codes. Incorrect or incomplete coding may lead to claim denials.

Use CPT 46707 for anorectal fistula repair with plug when applicable
Do not use C9796 for anorectal fistula with plug (C9796 refers to enterocutaneous fistula repair)
Include relevant ICD-10 diagnosis codes for anal fistula and any comorbid conditions
Include correct place of service and type of service on the claim

Documentation Required

Clinical Documentation Requirements

Maintain clinical documentation supporting the medical necessity of the procedure. Documentation should include fistula characteristics, prior therapies, treatment intent, and follow-up plan.

Document fistula anatomy: location (e.g., intersphincteric, transsphincteric), internal and external openings, and relation to sphincter complex
Document prior treatments and outcomes (e.g., seton placement, fibrin glue, prior surgeries)
Document rationale for selecting AFP and alternatives considered
Record operative details: device used (manufacturer/model if available), technique, and intraoperative findings
Document postoperative follow-up and outcomes monitoring (healing status, symptoms, complications, recurrence)

Note

Comparators and Usual Care

List of comparators and usual care options that should be considered prior to using an AFP.

Fistulotomy or fistulectomy
Endorectal or anal advancement flap procedures
Seton drain placement (draining or cutting seton)
Fibrin glue injection into the fistula tract
Ligation of the intersphincteric fistula tract (LIFT) technique

Note

Consideration of Alternative Standard Surgical Therapies

Given the investigational status of AFPs, providers should actively consider standard surgical therapies before electing to use a fistula plug and document the reasons alternative therapies are unsuitable when an AFP is used.

Operational recommendation: Favor established surgical options when clinically appropriate
If AFP selected: document why standard therapies are not appropriate or have failed

Note

Coding, Device Identification, and Claims Documentation

Refer to the Coding section and device regulatory descriptions for device-specific billing and identification. Report services with the listed CPT/HCPCS codes and include appropriate diagnosis codes.

See Coding section: CPT 46707 and C9796 as applicable
See Regulatory Status / Table 1 for FDA-cleared device names and descriptions
Ensure device/manufacturer details are documented in the operative report for claims and potential medical review

Note

Provider Action Notes

Provider actions — reserve this space for any additional payer-specific provider instructions or authorization confirmations.

Check pre-service processes or medical review requirements with the payer before performing investigational procedures

Anal fistula plug (AFP) — alternate definition/notes

Alternate definitionA scaffold device (porcine-derived or synthetic copolymer) inserted into a fistula tract and secured at the proximal opening to promote tissue ingrowth while allowing distal drainage; investigational variants include autologous cartilage plugs studied in small pilots.

MechanismProvides structural scaffold for new tissue growth and is progressively degraded as healing occurs.

Clinical considerationUsed as an alternative to standard surgical options (fistulotomy, advancement flaps, seton, LIFT, fibrin glue) with the goal of fistula closure while minimizing sphincter injury.

LimitationsEvidence is heterogeneous and insufficient to establish net health benefit; some trials report lower healing or higher short-term complications compared with other techniques.

Anorectal fistula plug — CPT 46707

CPT labelRepair of anorectal fistula with plug (e.g., porcine small intestine mucosa [SIS]).

Code46707

UseReport provider services for anorectal fistula repair using CPT 46707 when a plug is used as the repair method.

Enterocutaneous fistula repair — HCPCS C9796

HCPCS labelRepair of enterocutaneous fistula of small intestine or colon (excluding anorectal fistula with plug).

CodeC9796

ScopeApplies to enterocutaneous fistula repairs distinct from anorectal fistula plug procedures; bill separately from CPT 46707 as appropriate.