DESCRIPTION
Anal fistula plugs are biosynthetic devices used to promote healing and prevent recurrence of anal fistula (fistula-in-ano). The conical-shaped plug is anchored in the anal fistula and acts as a scaffold into which new tissue can grow to close the fistula. The plug is absorbed into the body in 6 to 8 weeks. The procedure may require 12-24 hours observation postoperatively. The procedure can be repeated in case of failure.
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. When the abscess opens spontaneously into the anal canal (or has been opened surgically), a fistula may occur. Other causes of fistulas include tuberculosis, cancer, 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. Anal fistulas are described as low (present in the lower part and not extending up to the anorectal sling) or high (extending up to or beyond the ano-rectal sling). High fistula can be associated with incontinence. Diagnosis may involve fistula probe, anoscopy, fistulography, ultrasound, or magnetic resonance imaging (MRI). Treatment is aimed at repairing the fistula without compromising continence. Treatments include fistulotomy/fistulectomy, endorectal/anal sliding flaps, seton drain, and fibrin glue. Lay-open fistulotomy in high fistulas carries risk of incontinence. Draining setons can control sepsis, but few individuals heal after removal of the seton, and they are poorly tolerated long term. Cutting setons can cause continence disturbances.
There are several plugs available for fistula repair. The SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) and is intended for repair of anal, rectal, and enterocutaneous fistulas. The modified SIS Fistula Plug, also manufactured from SIS, is supplied in a tapered configuration with a button to provide increased retention of the plug and improved blockage of the fistula. The GORE BIO-A Fistula Plug device is intended for use in anorectal fistulas. It is comprised of a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber, degraded via a combination of hydrolytic and enzymatic pathways, the same material, technology, and 3-dimensional disk with tubes mesh design as the predicate GORE Bioabsorbable Mesh hernia plug device. The indications for use and performance of the GORE BIO-A™ Fistula Plug are substantially equivalent to the predicate Cook SIS Fistula Plug.
POLICY
Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material, for all indications, including, but not limited to, repair of anal and rectal fistulas is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is limited published data regarding the use of anal plugs for fistula repair. Available evidence reports a wide-range of results and does not demonstrate that anal plugs improve healing rates or reduce recurrence of anal fistulas. Published studies that compare conventional treatments for anal fistula (eg., fistulotomy/fistulectomy, endorectal/anal sliding flaps, seton drain, and fibrin glue) with anal plugs are needed. Study outcomes should include safety, healing, fistula recurrence, and sphincter function so that that the impact of this technology on net health outcome can be established.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2011). Plugs for fistula repair (7.01.123). Retrieved July 18, 2011 from BlueWeb. (10 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. August, 2011.
Christoforidis, D., Pieh, M. C., Madoff, R. D., & Mellgren, A. F. (2009). Treatment of transsphincteric anal fistulas by endorectal advancement flap or collagen fistula plug: A comparative study. Diseases of the Colon and Rectum, 52 (1), 18-22. Abstract retrieved from PubMed July 18, 2011.
Jacob TJ, Perakath B, Keighley MR. Surgical intervention for anorectal fistula. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD006319. DOI: 10.1002/14651858.CD006319.pub2. Abstract retrieved from PubMed July 18, 2011.
National Institutes for Health and Clinical Excellence (NICE). (2007, June). Closure of anal fistula using a suturable bioprosthetic plug. Retrieved July 18, 2011 from: http://www.nice.org.uk/nicemedia/pdf/boardmeeting/IPG221guidance.pdf.
van Koperen, P. J., Bemelman, W. A., Gerhards, M. F., Janssen, L. W., van Tets, W. F., van Dalsen, A. D., et al. (2011), The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial. Diseases of the Colon and Rectum, 2011; 54 (4), 387-393. Abstract retrieved from PubMed July 18, 2011.
Whiteford, M. H., Kilkenny III, J., Hyman, N., Buie, W. D., Cohen, J., Orsay, C., et al. (2005). Standards Practice Task Force American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised). Diseases of the Colon and Rectum, 48 (7),1337-1342.
ORIGINAL EFFECTIVE DATE: 12/10/2011
MOST RECENT REVIEW DATE: 12/10/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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