Archived Policies - Surgery
Anorectal Fistula Repair Using an Acellular Xenogeneic Plug
This policy is no longer scheduled for routine literature review and update.
Anorectal fistula repair using an acellular xenogeneic plug (e.g., SIS Fistula Plug™) is considered experimental, investigational and unproven.
An anal fistula originates from the anal glands, within the layers of the anal sphincter, which drain into the anal canal. If the outlet of these glands becomes blocked, an abscess can form that may lead to the skin surface. The tract formed by this process is the fistula. An anorectal fistula repair involving the placement into the fistula tract of an acellular xenogeneic or bioprosthetic (biodegradable) “plug” is done under local, regional or general anesthesia. This procedure is minimally invasive and affords the surgeon a sphincter-sparing option to treat the anorectal fistula. The plug is derived from porcine small intestinal mucosa (SIS), which is a rolled and tapered configuration. The plug spans the entire length of the fistula tract from the internal to the external opening and is sutured into place. It was fashioned to close the primary opening of the fistula tracts, without incising into the sphincter muscle, to allow healing from point of blockage to skin surface.
In February 2005, the U.S. Food and Drug Administration (FDA) approved a 510(k) marketing clearance for the SIS Fistula Plug (manufactured by Surgisis, Cook Surgical, Inc.). The SIS Fistula Plug reinforces soft tissue to repair anal, rectal, and enterocutaneous fistulas.
A search of peer reviewed literature on MedLine through October 2006 revealed only one small prospective cohort study comparing fibrin glue and the anal fistula plug. Patients with high trans-sphincteric fistulas or deeper, were enrolled. Those with Crohn’s disease or superficial fistulas were excluded. Of the 25 patients enrolled, ten underwent fibrin glue, with the balance using the anal fistula plug. In the fibrin glue group, six patients (60%) had a persistence of one or more fistulas at three months, compared with two patients (13%) in the plug group. This procedure differs from other types of fistula repair in that it includes the preparation of the fistula tract and sutures the seton at both the internal and external openings. In addition, the procedure includes the fistula tract cleaning, irrigation, and debridement, which remains intact as well as the surrounding tissues. Other differences include the pull through of the fistula plug to insure proper alignment with the openings and the use of fibrin glue to maintain the fistula plug’s position.
The available data are inadequate to permit conclusions regarding the health benefit associated with utilization of the anal fistula plug. The anal fistula plug has been suggested as an alternative to and more reliable than fibrin glue closure. However, further prospective long-term studies comparing anal fistula plug to the established procedures and techniques to treat anorectal fistulas are required before establishing the effectiveness of anal fistula plug technique.
A literature search of MedLine database was performed through February 2009. No articles or studies were identified that would change the coverage position of this medical policy.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
eMedicine.com – Zagrodnik, Dennis, Fistula-in-Ano. June 11, 2004. eMedicine Continuing Education (2006 October 30) <http://www.emedicine.com>.
FDA – 510(k) Summary for SIS Fistula Plug. Food and Drug Administration – Office of Device Evaluation, Center for Devices and Radiological Health. (2005 March 5) <http://www.fda.gov>.
Surgisis® AFP™ Anal Fistula Plug – Product information. West Lafayette, Indiana: Cook Biotech, Inc., (2006).
Johnson, E.K., Gaw, J.U., et al. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Diseases of the Colon and Rectum (2006 March) 49(3):371-6.
5/1/2009 Revised/updated entire document
2/15/2007 New medical document
|Title:||Effective Date:||End Date:|
|Plugs for Fistula Repair||07-15-2018||03-31-2019|
|Plugs for Fistula Repair||04-15-2017||07-14-2018|
|Plugs for Fistula Repair||04-15-2016||04-14-2017|
|Plugs for Fistula Repair||04-15-2015||04-14-2016|
|Plugs for Fistula Repair||01-01-2014||04-14-2015|
|Plugs for Fistula Repair||08-15-2011||12-31-2013|
|Anorectal Fistula Repair Using an Acellular Xenogeneic Plug||05-01-2009||08-14-2011|
|Anorectal Fistula Repair Using an Acellular Xenogeneic Plug||02-15-2007||04-30-2009|
|Anorectal Fistula Repair using an Acellular Xenogeneic Plug||01-01-2007||02-14-2007|