Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for anal examination under anesthesia with fistula plug for treatment of the enrollees perirectal fistula. Findings:  2/3 of the physician reviewers found that the superior efficacy of the requested services have not been demonstrated in the medical literature The management of the anorectal fistulas remains one of the most challenging and controversial topics in colorectal surgery. However, surgery is the mainstay of therapy with the ultimate goal of draining local infection, eradicating the fistulous tract, and avoiding recurrence while preserving native sphincter function. The surgical approach depends on several factors, such as the etiology, location, type, and duration of the fistula as well as previously performed procedures and preoperative sphincter function. Primary fistulotomy alone is inadequate treatment of complex fistulas because of the high risk of postoperative incontinence, so alternative approaches are necessary. For patients with a complex fistula, including those who fail medical management, draining setons are used at the time of the first operation to preserve the sphincter mechanism and help eradicate the septic focus. The options for second stage management include endoanal advancement flaps, fibrin glue, fistula plugs, modified Hanley procedure, ligation of the intersphincteric fistula tract, or diversion. The biosynthetic fistula plug is made of lyophilized porcine small intestinal mucosa. It does not generate a foreign body reaction or necessitate disruption of the anal sphincter, and it eliminates the risk of sphincter dysfunction associated with other procedures, such as fistulotomy and setons. The fistula plug was designed to ameliorate postoperative incontinence in high risk fistula patients, such as fistulas with high internal openings, anterior fistulas, or those that transverse significant portions of sphincter muscle, such as in this case. Initial reports of the fistula plug were favorable, particularly in high risk fistula patients in whom treatment with fistulotomy, cutting setons, or mucosal advancement flaps were ineffective or caused unacceptably high incontinence rates.  However, subsequent observational studies had conflicting results. A prospective cohort study comparing the fistula plug technique with fibrin glue found that the fistula plug closure was significantly more successful than fibrin glue closure at three months. A follow up study that included the original fistula plug cohort found that the success rate of the fistula plug remained high at 83 percent at two years. However, the success achieved in these earlier reports has not been replicated in subsequent retrospective studies. Randomized trials are needed to determine the relative efficacy of these procedures over standard methods of treatment. For these reasons, the anal examination under anesthesia with fistula plug is not likely to be superior over other options for treatment of this patients medical condition.  Final Result: 2/3 of the reviewers determined that the requested services are not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.