Latest Review Date: November 2024

Category: Surgical                                                                 

POLICY:

Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material are considered investigational for the repair of anal fistulas.

DESCRIPTION OF PROCEDURE OR SERVICE:

Anal fistula plugs (AFPs) are biosynthetic devices used to promote healing and prevent the recurrence of anal fistulas (fistula-in-ano). They 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.

Anal Fistulas

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 into the anal canal (or has been opened surgically), a fistula may occur. Studies have reported that 26% to 37% of cases of perianal abscesses eventually form anal fistulas.

Other causes of fistulas include tuberculosis, cancer, prior radiotherapy, 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 fistulous tract.

The most widely used classification of anal fistulas is the Parks’ classification system, which defines anal fistulas by their position relative to the anal sphincter as trans-sphincteric, intersphincteric, suprasphincteric, or extrasphincteric. More simply, anal fistulas are described as low (present distally and not extending up to anorectal sling) or high (extending up to or beyond the ano-rectal sling).  The repair of high fistula can be associated with incontinence.  Diagnosis may involve fistula probe, anoscopy, fistulography, ultrasound, or magnetic resonance imaging.

KEY POINTS:

The most recent literature search was performed for the period through October 1, 2024.

Summary of Evidence:

For individuals who have anal fistula(s) who receive placement of AFP(s), the evidence includes 4 RCTs, a number of nonrandomized studies, and systematic reviews of these studies. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, and treatment-related morbidity. Two RCTs comparing AFP with surgical flap treatment have reported disparate findings: 1 found significantly higher rates of fistula recurrence with AFP; the other found similar rates of recurrence for AFP and surgical treatment. Another RCT that compared AFP with seton drain removal alone for patients with fistulizing Crohn disease, found no significant difference in healing rates at 12 weeks between groups. An RCT comparing AFP with surgeon's preference reported significantly higher complication rates with AFP. Systematic reviews of AFP repair have demonstrated a wide range of success rates and heterogeneity in study results. Nonrandomized studies have also reported conflicting results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society of Colon and Rectal Surgeons

The 2022 practice guideline on the treatment of anorectal abscess, fistula-in-ano, and rectovaginal fistula from the Society provided a strong recommendation based on moderate-quality evidence that anal fistula plug and fibrin glue are relatively ineffective treatments for fistula-in-ano.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2019) published an updated guidance on the suturable bioprosthetic plug. The Institute determined that evidence that "evidence on the safety and efficacy of bioprosthetic plug insertion for anal fistula is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent, and audit." Though, it was noted that "the procedure should only be done by a surgeon experienced in managing anal fistulas."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Biosynthetic fistula plugs, SIS Fistula Plug, modified SIS Fistula Plug, GORE BIO-A Fistula Plug, porcine small intestine submucosa plugs, synthetic fistula plug, suturable bioprosthetic plug, anal fistula plug, fistula plug, LIFT technique, SURGISIS soft Tissue Graft, STRATASIS Urethral Sling

APPROVED BY GOVERNING BODIES:

Several plugs for anal fistula repair have received clearance for marketing from FDA through the 510(k) process and are outlined in Table 1.

Table 1: Devices for Anal Fistula Repair

FDA: Food and Drug Administration; PGA:TMC: polyglycolide-co-trimethylene carbonate; SIS: small intestinal submucosa.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT Codes:

REFERENCES:

1. An Y, Chen X, Tian M, et al. Comparison of clinical outcomes of anal fistula plug and endoanal advancement flap repair treating the complex anal fistula: a systematic review and meta-analysis. Updates Surg. Dec 2023; 75(8): 2103-2115.
2. Blom J, Husberg-Sellberg B, Lindelius A, et al. Results of collagen plug occlusion of anal fistula: a multicentre study of 126 patients. Colorectal Dis. Aug 2014; 16(8):626-630.
3. Campbell ML, Abboud EC, Dolberg ME, et al. Treatment of refractory perianal fistulas with ligation of the intersphincteric fistula tract: preliminary results. Am Surg. Jul 2013; 79(7):723-727.
4. Cheung XC, Fahey T, Rogers AC, et al. Surgical Management of Idiopathic Perianal Fistulas: A Systematic Review and Meta-Analysis. Dig Surg. 2021; 38(2): 104-119.
5. Cintron JR, Abcarian H, Chaudhry V, et al. Treatment of fistula-in-ano using a porcine small intestinal submucosa anal fistula plug. Tech Coloproctol. Apr 2013; 17(2):187-191.
6. Cirocchi R, Trastulli S, Morelli U, et al. The treatment of anal fistulas with biologically derived products: is innovation better than conventional surgical treatment? An update. Tech Coloproctol. Jun 2013; 17(3):259-273.
7. Fisher OM, Raptis DA, Vetter D, et al. An outcome and cost analysis of anal fistula plug insertion vs endorectal advancement flap for complex anal fistulae. Colorectal Dis. Jul 2015; 17(7):619-626.
8. Gaertner WB, Burgess PL, Davids JS, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anorectal Abscess, Fistula-in-Ano, and Rectovaginal Fistula. Dis Colon Rectum. Aug 01 2022; 65(8): 964-985. 
9. Hall JF, Bordeianou L, Hyman N, et al. Outcomes after operations for anal fistula: results of a prospective, multicenter, regional study. Dis Colon Rectum. Nov 2014; 57(11):1304-1308.
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. Jayne DG, Scholefield J, Tolan D, et al. 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.Ann Surg. Mar 01 2021; 273(3): 433-441.
12. Leng Q, Jin HY. Anal fistula plug vs mucosa advancement flap in complex fistula-in-ano:  a meta-analysis. World J Gastrointest SurgNov 27. 2012; 4(11):256-261.
13. Narang SK, Jones C, Alam NN, et al. Delayed absorbable synthetic plug (GORE(R) BIO-A(R)) for the treatment of fistula-in-ano: a systematic review. Colorectal Dis. Jan 2016; 18(1):37-44.
14. Nasseri Y, Cassella L, Berns M, et al. The anal fistula plug in Crohn's disease patients with fistula-in-ano: a systematic review. Colorectal Dis. Apr 2016;18(4):351-356.
15. National Institute for Health and Care Excellence (NICE). Bioprosthetic plug insertion for anal fistula [IPG662]. September 25, 2019; www.nice.org.uk/guidance/ipg662. 
16. National Institute for Health and Clinical Excellence (NICE).  Closure of anal fistula using a suturable bioprosthetic plug. June 2011. Accessible at www.nice.org.uk/guidance/IPG410. 
17. O’Riordan JM, Datta I, Johnston C et al. A systematic review of the anal fistula plug for patients with Crohn’s and non-Crohn’s related fistula-in-ano. Dis colon rectum. Mar 2012; 55(3):351-358.
18. Ozturk E. Treatment of recurrent anal fistula using an autologous cartilage plug: A pilot study. Tech Coloproctol. May 2015; 19(5):301-307.
19. Pu YW, Xing CG, Khan I et al. Fistula plug versus conventional surgical treatment for anal fistulas. A system review and meta-analysis. Saudi Med J. Sep 2012; 33(9):962-966.
20. Sahnan K, Askari A, Adegbola SO, et al. Persistent Fistula After Anorectal Abscess Drainage: Local Experience of 11 Years. Dis Colon Rectum. Mar 2019; 62(3): 327-332.
21. Senejoux A, Siproudhis L, Abramowitz L, et al. Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial. J Crohns Colitis. Feb 2016; 10(2):141-148.
22. Simpson JA, Banerjea A, Scholefield JH. Management of anal fistula. BMJ. 2012; 345:e6705.
23. Stamos MJ, Snyder M, Robb BW, et al. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. Mar 2015; 58(3):344-351.
24. Stewart DB, Sr., Gaertner W, Glasgow S, et al. Clinical Practice Guideline for the management of anal fissures. Dis Colon Rectum. Jan 2017;60(1):7-14.
25. Tan KK, Kaur G, Byrne CM, et al. Long-term outcome of the anal fistula plug for anal fistula of cryptoglandular origin. Colorectal Dis. Dec 2013; 15(12):1510-1514.
26. van Koperen PJ, Bemelman WA, Gerhards MF, et al. The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial. Dis Colon Rectum. Apr 2011; 54(4): 387-93.
27. 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.
28. Xu Y, Tang W. Comparison of an anal fistula plug and mucosa advancement flap for complex anal fistulas: a meta-analysis. ANZ J Surg. Dec 2016; 86(12): 978-982.

POLICY HISTORY:

Medical Policy Group, December 2009 (2)

Medical Policy Administration Committee, January 2010

Available for comment January 26-March 11, 2010

Medical Policy Group, January 2012 (2): Key Points & References

Medical Policy Panel, May 2012

Medical Policy Group, June 2012 (2): Updated Key Points and References

Medical Policy Panel, September 2013

Medical Policy Group, November 2013 (2): No change to policy statement.  Key Points and References updated based on literature search through August 2013

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (1): Update to Description, Key Points, Key Words, and References.  No Policy change.

Medical Policy Panel, September 2015

Medical Policy Group, September 2015(4):  Updates to Description, Key Points, and References.  Deleted “and rectal” and “all indications including, but not limited to” from the policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (4): Updates to Key Points, Approved Governing Bodies and References. No change in policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No changes to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Key Points, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Description, Key Points, Benefit Application, and References.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Key Points, and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.