Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal 
Treatment: Surgical Services 

The insurer denied the TIF with EsophyX. The denial is upheld in whole. 

The patient is a male with chronic gastroesophageal reflux disease (GERD). He has had symptoms of GERD for 30 years. His symptoms consist of heartburn, regurgitation, belching, and dysphagia. He has had previous empiric esophageal dilatations. He had an esophagogastroduodenoscopy (EGD) revealing gastritis and reflux esophagitis. Biopsies from the stomach were negative for helicobacter (H.) Pylori, and biopsies from the esophagus were negative for intestinal metaplasia. He had an esophagogastroduodenoscopy (EGD) with Bravo study. On day #1, his DeMeester score was 18.4, and on day #2, the score was 223.5. It was felt that the probe had migrated into the stomach on day #2. He had esophageal manometry revealing a slightly elevated lower esophageal sphincter (LES) resting pressure with normal relaxation and peristalsis. He had an esophagogram which was unremarkable. He has been treated with Dexilant and Carafate. His body mass index (BMI) is 24.27. He has a medical history significant for nonalcoholic fatty liver disease (NAFLD). His hemoglobin was 15.4, alanine aminotransferase (ALT) was 16, aspartate aminotransferase (AST) was 12, alkaline phosphatase was 43, total bilirubin was 0.8, creatinine was 0.84, albumin was 4.1, glucose was 106, and cholesterol 201. A TIF [transoral incisionless fundoplication with Esophyx] procedure has been recommended for him. 

The subject under review is whether this procedure is likely to be more beneficial than any standard treatment. 

The TIF Procedure [transoral incisionless fundoplication with EsophyX is not likely to be more beneficial than standard treatments for this patient's GERD [gastroesophageal reflux disease]. There are significant issues with the long-term safety and efficacy of the TIF procedure. This is supported by current peer-reviewed medical literature.
"Studies have shown that approximately 3% to 10% of patients who undergo TIF will experience some type of adverse event. Some of the more concerning side effects of TIF include mucosal tear, perforation, bleeding, pneumothorax, and mediastinal abscess. Some gastroenterologists are hesitant to refer patients for TIF because of the concern about the durability of this procedure. More research is needed regarding the value of these techniques in different clinical scenarios." [1] "TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits versus risks, we do not recommend it as a long-term alternative to PPI or laparoscopic Nissen fundoplication (LNF) treatment of GERD." [2]  "TIF is a technically feasible and effective endoscopic therapeutic option... however, more controlled trials are required in the future to compare the efficacy and safety between TIF and Nissen Fundoplication." [3] 
"Transoral incisionless fundoplication and radiofrequency energy delivery were not judged appropriate in any scenario." [4] "Transoral incisionless fundoplication with the EsophyX device... is performed endoscopically, there is considerable variability in the outcome." [5] "At 12 months, the TIF procedure normalized esophageal acid exposure in only 29% of the patients, and 61% of patients returned to PPIs. Of the patients undergoing the TIF procedure, after 1 year, between 15% and 58% reported having GERD symptoms. A recent analysis evaluated medical, endoscopic, and surgical treatments for adults with GERD who require daily PPI therapy. In this model, the TIF procedure was dominated by laparoscopic Nissen Fundoplication at all points in time. Durability assessment of all endoscopic procedures is still needed, especially for the TIF." [6] 

The procedure is not likely to be more beneficial for the patient.