DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Plugs for Anal Fistula Repair

This policy addresses coverage and medical necessity for biosynthetic and synthetic plugs used to repair anal fistulas for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPlugs for Anal Fistula Repair

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDo not authorize biosynthetic or synthetic fistula plugs (CPT 46707) because they are considered not covered / not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

DRAFTDocument status

Apr 2022Publication

FDA 510(k)Regulatory

Coverage Determination

Not covered / Not medically necessary

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Policy stance: Biosynthetic fistula plugs (including plugs made of porcine small intestine submucosa and synthetic materials) for the repair of anal fistulas are not covered / not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes.

Applies to Commercial Products and Medicare Advantage Plans as stated.

This policy considers biosynthetic fistula plugs — including those derived from porcine small intestine submucosa (SIS) and synthetic copolymers — to be not medically necessary for the repair of anal fistulas. The procedure code explicitly identified is CPT 46707 (Repair of anorectal fistula with plug porcine small intestine mucosa [SIS]), which is listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Provider Responsibilities and Billing Notes

Prior Authorization

Prior Authorization and Code-level Note

Prior authorization: Not applicable. Note that CPT 46707 (repair of anorectal fistula with plug, porcine small intestine submucosa [SIS]) is explicitly listed as not covered / not medically necessary for Medicare Advantage and Commercial products.

Affected code: CPT 46707

Step Therapy

Step therapy: Not applicable — no step therapy or medical-necessity sequencing requirements are specified in this policy.

Note

Verify Member Benefits

Verify member benefits and coverage terms before scheduling services. Benefits and eligibility are determined by the member's Evidence of Coverage / Subscriber Agreement and employer/contract documents; coverage may differ by group or contract.

Contact provider call center for member-specific benefit verification

Denial Risk

Coverage Denial Risk for Fistula Plug Procedures

Coverage denial risk: Biosynthetic fistula plugs (including porcine small intestine submucosa or synthetic material) are considered not covered / not medically necessary. Submitting claims for these plugs, including CPT 46707, may result in denial.

Affected code: CPT 46707

Billing Rule

Benefit Variance by Contract

Benefit variance by contract: This policy reflects general coverage positions; however, specific member coverage may vary by contract. Absence of coverage in this policy could result in a denial depending on the member's Evidence of Coverage or Subscriber Agreement. Confirm plan-specific benefits prior to performing non-emergent procedures.

If services are non-covered per member contract, obtain written agreement from member before billing them directly as required by participation agreements.

Clinical Background

Anal fistulas are abnormal communications between the anal canal or rectum and the skin surface and commonly result from anorectal abscesses. Management focuses on eradicating the fistula tract while preserving continence; conventional surgical options include fistulotomy, seton placement, advancement flaps, fibrin glue, and intersphincteric techniques. The policy notes that evidence for biosynthetic or synthetic fistula plugs is insufficient to determine their impact on health outcomes, which underlies the decision to designate these devices as not covered/not medically necessary.

Key Definitions

Anal fistula — definition

TermAnal fistula

DefinitionAn abnormal communication between the interior of the anal canal or rectum and the skin surface; may originate from anorectal abscesses and can communicate with nearby pelvic structures (eg, vagina) or bowel.

Common causesAnorectal abscesses, tuberculosis, cancer, radiotherapy, inflammatory bowel disease

Typical symptomsPurulent discharge, drainage of pus or stool, pain with blockage/abscess recurrence, possible fecal or gas passage via tract

Fistula plug — definition

TermFistula plug

DefinitionA scaffold device pulled through the fistula tract and secured at the proximal opening to allow tissue ingrowth while leaving the distal opening open for drainage.

MaterialsDerived from animal tissue (eg, porcine small intestine submucosa) or synthetic copolymer fibers

MechanismScaffold degrades via hydrolytic/enzymatic pathways as healing progresses

Regulatory noteSeveral fistula plug devices have received FDA 510(k) clearance (see Regulatory Status).