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Date Printed: August 18, 2017: 10:21 AM

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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: 06/26/14

Revised: 11/01/15

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.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates   Previous Version

DESCRIPTION:

Anal fistula plugs are biosynthetic devices used to promote healing and prevent recurrence of anal fistula. 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. 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 patients heal after removal of the seton and they are poorly tolerated long term. Cutting setons can cause continence disturbances.

Fistula plugs have been manufactured from porcine small intestinal submucosa (e.g. Surgisis SIS Fistula Plug) and using a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber (the GORE BIO-A Fistula Plug device). The intended indications for both types of plug include repair of anal, rectal, and enterocutaneous fistulas.

POSITION STATEMENT:

Fistula plugs, including plugs made of porcine small intestine submucosa or synthetic materials, are considered experimental or investigational for all indications including, but not limited to, repair of anal and rectal fistulas. There is insufficient published clinical evidence to support efficacy of these procedures or to determine clinical outcomes. Additional randomized controlled trials with sufficient numbers of patients and with long-term follow-up are needed.

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 (L29288) 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:

Other indexing terms for anal fistula plugs:

Note: 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.

• Surgisis SIS Fistula Plug

• GORE BIO-A Fistula Plug IS Fistula Plug

REFERENCES:

  1. American Society of Colon and Rectal Surgeons. Practice Parameters for the Management of Perianal Abscess and Fistula-in-Ano. Scott R. Steele MD, Ravin Kumar MD, Daniel L. Feingold MD, Janice L Rafferty MD, W Donald Buie MD. Dis Colon Rectum 2011; 54: 1465–1474.
  2. American Society of Colon and Rectal Surgeons paper, Anal Fistula / Abscess. Accessed 04/21/14.
  3. Blue Cross Blue Shield Association Medical Policy Reference Manual, 7.01.123 Plugs for Fistula Repair (09/12/13).
  4. ECRI Product Brief. Product Brief: Surgisis Biodesign Fistula Plug (Cook Medical, Inc.) for Repairing Anal and Rectovaginal Fistulas (June 2012).
  5. 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.
  6. Ellis, CN. Bioprosthetic Plugs for Complex Anal Fistulas: An Early Experience. J Surg Educ. 2007 Jan-Feb; 64(1):36-40.
  7. First Coast Service Options (FCSO), Local Medicare. Noncovered Services LCD L29288 (03/17/14).
  8. Girona et al. Percutaneous Embolization of Vascular Fistulas Using Coils or Amplatzer Vascular Plugs. Rev Esp Cardiol. 2009 Jul; 62(7):765-73.
  9. 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.
  10. National Institutes for Health and Clinical Excellence (NICE). Closure of anal fistula using a suturable bioprosthetic plug. (11/2011).
  11. 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.
  12. Song KH. New techniques for treating an anal fistula. J Korean Soc Coloproctol. 2012 Feb;28(1):7-12. Epub 2012 Feb 29.
  13. Steele SR, Kumar R, Feingold DL, Rafferty JL, Buie WD, Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of perianal abscess and fistula-in-ano. Dis Colon Rectum2011 Dec;54(12):1465-74.
  14. 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).
  15. 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).
  16. Wang et al. Treatment of transsphincteric anal fistulas: are fistula plugs an acceptable alternative? Dis Colon Rectum. 2009 Apr;52(4):692-7.
  17. 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 06/26/14.

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.

Date Printed: August 18, 2017: 10:21 AM