CurrentBlue Cross Blue Shield - MassachusettsPolicy 528

Anal fistula plugs (biosynthetic) for repair of anal fistulas

This policy governs coverage and prior authorization for biosynthetic fistula plugs (including porcine small intestine submucosa and synthetic plugs) used to repair anal fistulas for Commercial and Medicare members of Blue Cross Blue Shield Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAnal fistula plugs (biosynthetic) for repair of anal fistulas

Policy CodePolicy 528

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization when the procedure is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Investigationalcoverage stance for biosynthetic fistula plugs

46707CPT code listed as investigational

C9796HCPCS code listed in policy

Prior authPreauthorization requirement (inpatient)

Not coveredOutpatient coverage status

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Determinations for Anal Fistula Plugs

Investigational — Anal fistula plug repair

Covered when ALL of the following are met:

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

Evidence from randomized and nonrandomized studies is conflicting and insufficient to demonstrate improved net health outcome.

For outpatient services described in this policy, anal fistula plugs are not a covered service for the following product lines: Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO BlueSM, and Medicare PPO BlueSM. Providers submitting outpatient claims for plug placement in these products should expect the service to be non-covered per the outpatient section of this policy.

The available clinical evidence for anal fistula plugs (AFPs) is inadequate to demonstrate a consistent benefit. Randomized controlled trials and nonrandomized studies have reported conflicting results: some RCTs showed higher recurrence or complication rates with AFPs, others showed similar healing or recurrence rates compared with surgical alternatives, and systematic reviews have found high heterogeneity and a wide range of success rates. Because the evidence is insufficient to determine improvement in net health outcome, AFPs are considered investigational, and their use is not supported as medically necessary by this policy.

Coding and Billing Codes

Investigational CPT CodesCPTNot Covered

46707

Repair of anorectal fistula with plug (eg, porcine small intestine submucosa [SIS])

HCPCS Codes (informational)HCPCS

C9796

Repair of enterocutaneous fistula small intestine or colon (excluding anorectal fistula) with plug porcine small intestine submucosa [SIS]

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Required (inpatient)

For services described in this policy, precertification/preauthorization is required when the procedure is performed inpatient.

Applicable to all products when performed inpatient

Step Therapy

No Step Therapy Specified

No step therapy is specified for anal fistula plugs. Alternative procedures referenced in the evidence include fistulotomy, endorectal advancement flaps, seton drain placement, and use of fibrin glue.

Background and Clinical Context

An anal fistula is an abnormal communication between the interior of the anal canal or rectum and the skin surface. Fistulas commonly arise from anorectal abscesses and can be associated with conditions such as infection, inflammatory bowel disease (including Crohn disease), tuberculosis, or prior radiation. Fistulas are classified by their relationship to the sphincter complex (eg, Parks classification) and as low or high tracts; repair of high fistulas carries an increased risk of postoperative fecal incontinence. Anal fistula plugs are biosynthetic devices (for example, porcine small intestine submucosa or synthetic materials) intended to occlude the fistula tract to promote healing and reduce recurrence, and they have been proposed as alternatives to fistulotomy, endorectal advancement flap, seton placement, or fibrin glue.

Definitions

Anal fistula plug (AFP) — definition and examples

DefinitionA biosynthetic device used to promote healing and prevent recurrence of anal fistulas by occluding the fistula tract.

Material examplesPorcine small intestine submucosa (SIS) plug.

Material examplesSynthetic-material anal fistula plug.

Intended useProposed alternative to fistulotomy, endorectal advancement flap, seton drain placement, and fibrin glue for treatment of anal fistulas.

Evidence summaryRandomized and nonrandomized studies and systematic reviews report conflicting results; overall evidence is insufficient to demonstrate improved net health outcome.