Plugs for Anal Fistula Repair

POLICY NUMBER

A.7.01.123

DESCRIPTION

Anal fistula plugs (AFPs) are biosynthetic devices used to promote healing and prevent the recurrence of anal fistulas. They are proposed as an alternative to procedures including fistulotomy, endorectal advancement flaps, seton drain placement, and use of fibrin glue in the treatment of anal fistulas.

Anal Fistulas

An anal fistula is an abnormal communication between the interior of the anal canal or rectum and the skin surface. Rarer forms may communicate with the vagina or other pelvic structures, including the bowel. Most fistulas begin as anorectal abscesses, which are thought to arise from infection in the glands around the anal canal. When the abscess opens spontaneously in the anal canal (or has been opened surgically), a fistula may occur. Studies have reported that 26% to 37% of cases of perianal abscesses eventually form anal fistulas.

Other causes of fistulas include tuberculosis, cancer, prior radiotherapy, and inflammatory bowel disease. Fistulas may occur singly or in multiples. Symptoms include a purulent discharge and drainage of pus and/or stool near the anus, which can irritate the outer tissues causing itching and discomfort. Pain occurs when fistulas become blocked, and abscesses recur. Flatus may also escape from the fistulous tract.

The most widely used classification of anal fistulas is the Parks classification system, which defines anal fistulas by their position relative to the anal sphincter as transsphincteric, intersphincteric, suprasphincteric, or extrasphincteric. More simply, anal fistulas are described as low (present distally and not extending up to the anorectal sling) or high (extending up to or beyond the anorectal sling). The repair of high fistulas can be associated with incontinence. Diagnosis may involve a fistula probe, anoscopy, fistulography, ultrasound, or magnetic resonance imaging.

Several plugs for anal fistula repair have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process and are outlined in the table below.

Devices for Anal Fistula Repair

FDA: U.S. Food and Drug Administration; PGA-TMC: polyglycolide-co-trimethylene carbonate; SIS: small intestinal submucosa

POLICY

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

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

04/20/2010: New policy added.

07/29/2011: Policy reviewed; no changes.

07/17/2012: Policy reviewed; no changes.

11/15/2013: Policy reviewed; no changes.

12/02/2014: Policy reviewed; description revised. Policy statement unchanged.

08/04/2015: Code Reference section updated for ICD-10.

11/17/2015: Policy title changed from "Plugs for Fistula Repair" to "Plugs for Anal Fistula Repair." Policy description updated regarding devices. Policy statement revised to clarify that biosynthetic fistula plugs are considered investigational for the repair of anal fistulas. It previously stated: Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material are considered investigational for all indications including, but not limited to, repair of anal and rectal fistulas. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.123 added.

12/06/2016: Policy description updated regarding devices. Policy statement unchanged.

01/09/2018: Policy description updated. Policy statement unchanged.

01/10/2019: Policy reviewed; no changes.

12/12/2019: Policy description updated regarding devices. Policy statement unchanged.

01/19/2021: Policy description updated regarding devices. Policy statement unchanged.

02/01/2022: Policy reviewed; no changes.

01/23/2023: Policy description updated. Policy statement unchanged.

01/05/2024: Policy description updated. Policy statement unchanged.

10/16/2024: Code Reference section updated to remove CPT codes 57300, 57305, 57307, and 57308.

01/31/2025: Policy description updated. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.123

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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