BlueCross BlueShield of Tennessee Medical Policy Manual

Plugs for Anal Fistula Repair

DESCRIPTION

Anal fistula plugs (AFPs) are biosynthetic devices designed to provide a structure that acts as a scaffold for new tissue growth.  The scaffold, which can be derived from porcine tissue or a synthetic copolymer fiber, is degraded by hydrolytic or enzymatic pathways as healing progresses.  Anal fistula plugs 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.

Since 2005, several plugs for fistula repair have received clearance for marketing from the U.S. Food and Drug Administration.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Systematic reviews of studies of anal fistula plugs demonstrate a wide range of success rates and heterogeneity in study results.  The body of evidence consists of randomized controlled trials and nonrandomized studies that have conflicting results.  The evidence is insufficient to determine the effects of the technology on health outcomes.

SOURCES

American Society of Colon and Rectal Surgeons. (2011). Practice parameters for the management of perianal abscess and fistula-in-ano. Retrieved October 7, 2016 from the National Guideline Clearinghouse (NGC: 008980).

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2016). Plugs for anal fistula repair (7.01.123). Retrieved August 8, 2017 from BlueWeb. (25 articles and/or guidelines reviewed)

Heydari, A., Attinà, G. M., Merolla, E., Piccoli, M., Fazlalizadeh, R, &, Melotti, G. (2013). Bioabsorbable synthetic plug in the treatment of anal fistulas. Diseases of the Colon and Rectum, 56 (6), 774-779. (Level 4 evidence)

Narang, S., Jones, C., Alam, N., Daniels, I., & Smart, N. (2016). Delayed absorbable synthetic plug (Gore® BIO-A®) for the treatment of fistula-in-ano: a systematic review. Colorectal Disease, 18 (1), 37-44. Abstract retrieved October 7, 2016 from PubMed database.

Nasseri, Y., Cassella, L., Berns, M., Zaghiyan, K., & Cohen, J. (2016). The anal fistula plug in Crohn’s disease patients with fistula-in-ano: a systematic review. Colorectal Disease, 18 (4), 351-356. Abstract retrieved October 7, 2016 from PubMed database.

National Institutes for Health and Clinical Excellence (NICE). (2012, March). Closure of anal fistula using a suturable bioprosthetic plug: Guidance. Retrieved April 29, 2013 from http://www.nice.org.uk/nicemedia/live/11331/57184/57184.pdf.

U. S. Food and Drug Administration. (2009, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K083266. Retrieved April 29, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083266.pdf.

U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062729. Retrieved April 29, 2013 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062729.pdf.

ORIGINAL EFFECTIVE DATE:  12/10/2011

MOST RECENT REVIEW DATE:  9/14/2017

ID_BA

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.

This document has been classified as public information.