Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transoral incisionless fundoplication (TIF) procedure (CPT code 43210) and anesthesia for upper gastrointestinal endoscopic procedures (CPT code 00740) for treatment of the enrollees gastroesophageal reflux disease (GERD). Findings:  2/3 of the physician reviewers found that the efficacy of TIF has been studied in randomized controlled trials. One large randomized trial including 60 patients found no improvement in esophageal acid exposure compared with baseline at 12 months with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%. The study concluded that no long-term objective reflux control was achieved. The American College of Gastroenterology guidelines for treatment of GERD report that the usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence). The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery. SAGES concluded that further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety. In addition, guidelines from the American Society for Gastrointestinal Endoscopy (ASGE) do not recommend endoscopic procedures for GERD in patients with complicated GERD, which is defined as dysphagia or Barretts esophagus, both of which this patient has, and report that the long-term follow-up data for TIF is limited. Moreover, there are recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF. Additionally, the efficacy of TIF compared with standard surgical management has not been evaluated in a high-quality trial with long-term follow-up. For these reasons, the request for TIF procedure (CPT code 43210) and anesthesia for upper gastrointestinal endoscopic procedures (CPT code 00740) is not definitively likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.  Final Result: 2/3 of the reviewers determined that the requested services are not likely to be more beneficial for treatment 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.