Appeal type: Medical necessity
Decision: Upheld

Digestive System/Gastrointestinal
Surgical Services

Diagnosis: Gastroesophageal reflux disease
Treatment: Transoral incisionless fundoplication procedure
The insurer denied the Transoral incisionless fundoplication procedure.
The determination is upheld.

The patient has gastroesophageal reflux disease (GERD), a hiatal hernia, and asthma. She has had heartburn, a cough, wheezing, and recurrent pneumonia. She has failed proton pump inhibitors including omeprazole, pantoprazole, and Dexilant; she has also used famotidine. An esophagogastroduodenoscopy showed mild sloughing of the mucosa on contact in the middle third of the esophagus, and otherwise a normal esophagus, stomach, and duodenum. A potential of hydrogen (pH) study late summer showed no evidence of elevated acid exposure, with a DeMeester score of 5.9; impedance symptom correlation was 92% for belching, 75% for heartburn, 69% for wheezing, 43% for coughing, and 100% for bloating and abdominal pain. Esophageal manometry was normal. At issue is the medical necessity for transoral incisionless fundoplication for the treatment of gastroesophageal reflux disease (GERD).

The procedure is not medically necessary. The efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials (Sami, et al). However, the conclusions are contradictory: one large, randomized trial including 60 patients found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors (PPIs) in 61% (Witteman, et al). The study concluded that no long-term objective reflux control was achieved. The 2013 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)" (Katz, et al). Those guidelines also do not recommend endoscopic procedures for GERD in patients with Barrett's esophagus (Katz, et al). A recent systematic review and meta-analysis concluded that "future controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication" (McCarty, et al). In 2013 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 (Auyang, et al). Guidelines from the American Society for Gastrointestinal Endoscopy (ASGE) report that the long-term follow-up data for TIF is limited (ASGE Standards of Practice Committee, et al). These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF (Ashfaq, et al; Bell, et al; Edress, et al).

In this case, the patient did not have evidence of elevated esophageal acid exposure on pH testing, and current medical literature does not definitively support the use of transoral incisionless fundoplication as safe and effective for the treatment of gastrointestinal and pulmonary symptoms in that setting.