Transoral Incisionless Fundoplication denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transoral incisionless fundoplication (TIF) procedure utilizing EsophyX. Trad and colleagues reported on the TEMPO trial, which evaluated 63 patients with gastroesophageal reflux disease (GERD) symptoms refractory to proton pump inhibitor (PPI) therapy. The patients in the study underwent treatment with TIF or maximal standard dose PPI therapy. The authors reported that at six months, both regurgitation and extraesophageal symptoms were eliminated in more TIF than PPI patients and 90% of TIF patients were off PPIs. Overall, the current medical literature has demonstrated that TIF has been associated with fewer postoperative adverse effects such as gas bloating and dysphagia compared with surgical fundoplication.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for a transoral incisionless fundoplication (TIF) procedure. Government guidelines have approved the TIF procedure for the treatment of patients with gastroesophageal reflux disease (GERD) symptoms that have been refractory to proton pump inhibitor (PPI) therapy. As noted by clinical guidelines, TIF can be considered for patients who experience inadequate symptom relief with two- to four-week PPI treatment. This recommendation is supported by data from prospective randomized controlled trials using sham-controlled trial designs, showing that TIF is an effective treatment for patients with GERD symptoms, particularly patients with persistent regurgitation despite PPI therapy.

Where the denial was upheld

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 enrollee’s 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%.

A patient has requested authorization and coverage for transoral incisionless fundoplication. The Health Plan has denied this request, indicating that the requested services are investigational for the treatment of the patient’s gastroesophageal reflux disease. A review of the record indicates that the patient has been diagnosed with irritable bowel syndrome, gastroesophageal reflux disease with esophagitis, diaphragmatic hernia without obstruction or gangrene, alcohol abuse, and other lactose intolerance. Abdominal ultrasound revealed no acute process. A distal esophageal biopsy was performed. The pathology report noted mild chronic esophagitis with features suggesting reflux. The results were negative for intestinal metaplasia, dysplasia or malignancy.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Transoral Incisionless Fundoplication, then check the rights and deadlines that apply to your plan.