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Date Printed: May 21, 2018: 06:21 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative 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.

02-45000-02

Original Effective Date: 07/15/10

Reviewed: 02/22/18

Revised: 03/15/18

Subject: Plugs for Fistula Repair

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
           
   
           

DESCRIPTION:

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.

Fistula plugs are designed to provide a structure that acts as a scaffold for new tissue growth. The scaffold, which can be derived from animal (eg, porcine) tissue or a synthetic copolymer fiber, is degraded by hydrolytic or enzymatic pathways as healing progresses. The plug is pulled through the fistula tract and secured at the fistula’s proximal opening; the fistula tract is left open at the distal opening to allow drainage. Several fistula plugs have been cleared for marketing by the U.S. Food and Drug Administration (FDA).

POSITION STATEMENT:

Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material, are considered experimental or investigational for all indications including the repair of anal fistulas. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding

46707

Repair of anorectal fistula with plug (e.g., porcine small intestine submucosa [SIS]) (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L33777) located at fcso.com.

DEFINITIONS:

Fistula: a small tract or tunnel that connects one part of a body with another. Fistulas can happen between any two parts. Common examples of fistulas are anal fistula, recto-vaginal fistula. Fistulas are generally caused by trauma, infection, or radiation therapy.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual, 7.01.123 Plugs for Fistula Repair, 11/17.
  2. ClinicalTrials.gov, Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial; sponsored by Zhen Jun Wang, accessed 01/18/18.
  3. ClinicalTrials.gov, A Pilot Study to Assess the Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening (Curaseal AF) as a Treatment for Perianal Fistula; sponsored by London North West Healthcare NHS Trust, accessed 01/18/18.
  4. ClinicalTrials.gov, A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas; sponsored by Cook Group Incorporated, accessed 01/18/18.
  5. ECRI Product Brief. Product Brief: Surgisis Biodesign Fistula Plug (Cook Medical, Inc.) for Repairing Anal and Rectovaginal Fistulas (June 2012).
  6. Ellis, CN. et al. Long-Term Outcomes With the Use of Bioprosthetic Plugs for the Management of Complex Anal Fistulas. Dis Colon Rectum. 2010 May; 53(5):798-802.
  7. Ellis, CN. Bioprosthetic Plugs for Complex Anal Fistulas: An Early Experience. J Surg Educ. 2007 Jan-Feb; 64(1):36-40.
  8. First Coast Service Options (FCSO), Local Medicare. Noncovered Services LCD L33777; accessed at fcso.com.
  9. Girona et al. Percutaneous Embolization of Vascular Fistulas Using Coils or Amplatzer Vascular Plugs. Rev Esp Cardiol. 2009 Jul; 62(7):765-73.
  10. Leng Q, Jin H-Y. Anal fistula plug vs mucosa advancement flap in complex fistula-in-ano: A meta-analysis. World J Gastrointest Surg. 2012 November 27; 4(11): 256–261. Published online 2012 November 27.
  11. National Institutes for Health and Clinical Excellence (NICE). Closure of anal fistula using a suturable bioprosthetic plug. (11/2011).
  12. Saba RB, Tizmaghz A, et al. Treating anal fistula with the anal fistula plug: case series report of 12 patients. Electron Physician. 2016 Apr 25;8(4):2304-7.
  13. Schwandner et al. Surgical treatment of complex anal fistulas with the anal fistula plug: a prospective, multicenter study. Dis Colon Rectum. 2009 Sep;52(9):1578-83.
  14. Song KH. New techniques for treating an anal fistula. J Korean Soc Coloproctol. 2012 Feb;28(1):7-12. Epub 2012 Feb 29.
  15. Steele SR, Kumar R, et al. Practice parameters for the management of perianal abscess and fistula-in-ano. Dis Colon Rectum. 2011 Dec;54(12):1465-74.
  16. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) 510(k). Surgisis RVP (Recto-vaginal Fistula Plug). Cook Biotech, Inc. (10/10/06).
  17. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) 510(k). SIS (Small Intestinal Submucosa) Fistula Plug. Cook Biotech, Inc. (03/09/05).
  18. Vogel JD, Johnson EK, Morris AM, et al. Clinical practice guideline for the management of anorectal abscess, fistula-in-ano, and rectovaginal fistula. Dis Colon Rectum. Dec 2016;59(12):1117-1133; accessed at fascrs.org.
  19. Wang et al. Treatment of transsphincteric anal fistulas:are fistula plugs an acceptable alternative? Dis Colon Rectum. 2009 Apr;52(4):692-7.
  20. Whiteford MH, Kilkenny J 3rd, Hyman N, Buie WD, Cohen J, Orsay C, Dunn G, Perry WB, Ellis CN, Rakinic J, Gregorcyk S, Shellito P, Nelson R, Tjandra JJ, Newstead G. Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised). Dis Colon Rectum 2005 Jul;48(7):1337-42.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/22/18.

GUIDELINE UPDATE INFORMATION:

07/15/10

New Medical Coverage Guideline.

07/15/12

Scheduled review; position statement unchanged; coding and references updated.

07/15/13

Scheduled review; position statement unchanged; Program Exceptions section updated; references updated.

07/15/14

Scheduled review; position statement unchanged; references updated.

11/01/15

Revision: ICD-9 Codes deleted.

03/15/18

Review; investigational position maintained; description, position statement, and references updated.

Date Printed: May 21, 2018: 06:21 PM