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
Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material, for the repair of anal fistulas are considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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. (2022). Clinical practice guideline for the management of anorectal abscesses, fistula-in-ano, and rectovaginal fistulas. Retrieved August 9, 2023 from https://www.fascrs.org/healthcare-providers/education/clinical-practice-guidelines.
BlueCross BlueShield Association. Evidence Positioning System. (12:2022). Plugs for anal fistula repair (7.01.123). Retrieved August 9, 2023 from https://www.evidencepositioningsystem.com/. (23 articles and/or guidelines reviewed)
Cheung, X.C., Fahey, T., Rogers, A.C., Pemberton, J.H., & Kavanagh, D.O. (2021), Surgical Management of idiopathic perianal fistulas: A systematic review and meta-analysis. Digestive Surgery, 1 (38), 104-119. (Level 1 evidence)
Jayne, D., Scholefield, J., Tolan, D., Gray, R., Senapati, A., Hulme, C., et al. (2021). A multicenter randomized controlled trial comparing safety, efficacy, and cost-effectiveness of the surgisis anal fistula plug versus surgeon's preference for transsphincteric fistula-in-ano: the FIAT trial. Annals of Surgery, 273 (3), 433-441. (Level 2 evidence)
Lin, H., Jin, Z., Zhu, Y., Diao, M., & Hu, W. (2019). Anal fistula plug vs rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a systematic review and meta-analysis of studies with long-term follow-up. Colorectal Disease, 21 (5), 502-515. Abstract retrieved July 29, 2019 from PubMed database.
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). (2019, September). Bioprosthetic plug insertion for anal fistula. Retrieved April 30, 2021 from http://www.nice.org.uk.
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.
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.
ORIGINAL EFFECTIVE DATE: 12/10/2011
MOST RECENT REVIEW DATE: 9/14/2023
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.