Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with chronic fatigue disorder and fibromyalgia. The patient reported bloating, burping and flatulence. He was noted to have had irritable bowel syndrome (IBS) since he was a teenager. His symptoms initially responded to erythromycin and worsened with dicyclomine. The provider reported concern for small intestinal bacterial overgrowth (SIBO), although testing was not possible due to COVID-19. The provider noted Xifaxan is indicated for the treatment of SIBO. The patient was noted to be allergic to penicillin. The provider noted a delay in treatment is causing the patient stress in the setting of his post-traumatic stress disorder, bipolar disorder, borderline personality disorder, and anxiety. The patient reported the return of abdominal pain after treatment with neomycin. The patient has requested authorization and coverage for Xifaxan (rifaximin) 550 mg three times daily for 14 days. The Health Plan denied the request and reported that the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Xifaxan (rifaximin) 550 mg three times daily for 14 days is medically necessary for the treatment of the patients medical condition. Authors noted, We suggest the use of antibiotics in symptomatic patients with SIBO to eradicate overgrowth and resolve symptoms. The authors also reported, A meta-analysis was performed on 32 clinical trials assessing the safety and efficacy of rifaximin in the treatment of SIBO through March of 2015. The analysis included seven randomized clinical trials, 24 cohort studies, and one randomized crossover trial, comprising a total of 1,331 patients. There was considerable heterogeneity among the trials, including the method of SIBO diagnosis; dose of rifaximin, which ranged from 600 to 1,600 mg a day; and duration of therapy, which ranged from five to 28 days. Only one study compared rifaximin with placebo. With these limitations in mind, the overall success of therapy with an intention-to-treat was 70.8%, and adverse reactions occurred in 4.6%. In this case, the patients symptoms are consistent with SIBO, including bloating, gas and diarrhea. Due to COVID-19, the patient was unable to obtain confirmatory breath testing. As noted by Pimentel and colleagues, there is reasonable evidence that rifaximin is effective in the treatment of SIBO. Rifaximin is poorly absorbed in the small intestine, which provides localized effectiveness with fewer side effects than standard antibiotics including Augmentin (the patient is allergic to penicillin) and fluoroquinolones. The medical evidence supports the requested medication in this clinical setting. Therefore, Xifaxan (rifaximin) 550 mg three times daily for 14 days is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer 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.