CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Plugs for Anal Fistula Repair

This medical coverage policy addresses use of biosynthetic and synthetic anal fistula plugs (including porcine SIS and synthetic copolymers) for repair of anal, rectal, enterocutaneous and rectovaginal fistulas for Medicare Advantage and Commercial products, including coverage stance and coding guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Plugs for Anal Fistula Repair

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2022

Next Review Date

Key ActionVerify member-specific benefits and coverage in the Evidence of Coverage or Subscriber Agreement because benefits may vary and the policy states noncoverage/not medically necessary for plugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

1Primary CPT code explicitly noncovered

MultipleFDA-cleared fistula plug devices listed

Coverage Summary

Scope: This policy addresses use of biosynthetic and synthetic anal fistula plugs (including porcine small intestine submucosa [SIS] and synthetic copolymers) for repair of anal, rectal, enterocutaneous and rectovaginal fistulas for Medicare Advantage and Commercial products, including coverage stance and coding guidance. Subject: Anal fistula plugs for repair of anal/rectal fistulas. Effective date: 2022-06-01. Last review: 2024-10-16. Coverage stance: Not covered / Not medically necessary for Medicare Advantage and Commercial Products.

Key policy facts

Effective date2022-06-01

Last review2024-10-16

Policy subjectAnal fistula plugs for repair of anal/rectal fistulas

Scope summaryAddresses use of biosynthetic and synthetic anal fistula plugs (including porcine SIS and synthetic copolymers) for repair of anal, rectal, enterocutaneous and rectovaginal fistulas for Medicare Advantage and Commercial products, including coverage stance and coding guidance.

Coverage stanceNot covered for Medicare Advantage; not medically necessary for Commercial Products (insufficient evidence).

Not Covered / Not Medically Necessary

Primary noncoverage stance: Biosynthetic and synthetic fistula plugs (including plugs made of porcine small intestine submucosa and synthetic copolymers) are not covered for Medicare Advantage and are not medically necessary for Commercial Products because the evidence is insufficient to determine the effects of the technology on health outcomes. Benefits may vary between plans; refer to the Evidence of Coverage or Subscriber Agreement for applicable non-covered/not medically necessary benefits or coverage. Note: CPT code 46707 (repair of anorectal fistula with plug) is explicitly listed as not covered/not medically necessary.

Provider Actions

Documentation Required

Benefit verification

Verify member-specific benefits and coverage in the Evidence of Coverage or Subscriber Agreement because benefits may vary and the policy states noncoverage/not medically necessary for plugs.

Billing Rule

Do not bill covered code

Do not expect coverage for CPT 46707 (repair of anorectal fistula with plug); claims for this procedure are considered not covered for Medicare Advantage and not medically necessary for Commercial Products per this policy.

46707

Background & Evidence Summary

Background: Anal fistula plugs are scaffold devices (animal-derived or synthetic) placed into the fistula tract and secured at the proximal opening to facilitate tissue ingrowth while allowing distal drainage. Several devices have received FDA 510(k) clearance, including porcine SIS plugs and synthetic copolymer plugs (eg, GORE BIO-A). Clinical evidence, including randomized trials and systematic reviews, is considered insufficient to determine whether fistula plugs provide benefit compared with alternative surgical approaches.

Evidence

Evidence summaryMultiple randomized and comparative studies, systematic reviews, and meta-analyses are referenced, but overall the evidence is judged insufficient to determine benefit versus alternative surgical approaches.

Evidence sources (examples)Randomized and comparative studies and meta-analyses cited in policy references (RCTs, systematic reviews, meta-analyses).

Brief confidence0.88

Anal fistula: An abnormal communication between the interior of the anal canal or rectum and the skin surface; may result from anorectal abscesses or other causes such as Crohn disease, tuberculosis, radiotherapy, or cancer.

Fistula plug: A scaffold device (animal-derived or synthetic) placed into the fistula tract and secured at the proximal opening to facilitate tissue ingrowth while allowing distal drainage.