Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease.
Treatment: Esophagus Sphincter Augmentation Device (LINX).
The insurer denied: Esophagus Sphincter Augmentation Device (LINX).
The denial is overturned.

The patient is an adult female with long-standing GERD (gastroesophageal reflux disease). She is poorly managed on available medical and conservative treatments. She is currently using Pepcid and low-strength omeprazole. She sleeps with the head of her bed elevated. She has tried diet modification. In spite of these efforts, she has persistent breakthrough reflux that interferes with her long-term health. She has a history of Clostridium difficile, and therefore should not use proton pump inhibitors. PPI (proton pump inhibitor) use has been attributed to Clostridium difficile infections. She has a normal esophageal manometry and a grossly abnormal Bravo pH study. She had an EGD (esophagogastroduodenoscopy), which does not yet show Barrett's esophagitis. She is a good candidate for anti-reflux surgery. The patient's surgeon recommended a laparoscopic esophageal sphincter augmentation device over a laparoscopic Nissen fundoplication. The health plan has denied the requested procedure, stating that it is Experimental/Investigational. The health plan's decision is being appealed, based on the facts that the procedural has become a mainstream surgical option and is no longer considered experimental or investigational, and the procedure has been shown to have significantly decreased side effects as compared to traditional Nissen fundoplication. 

The health plan should cover the Esophagus Sphincter Augmentation Device. 

Laparoscopic esophageal sphincter augmentation has been studied for over a decade. A multitude of studies have proven its effectiveness compared to both PPI (proton pump inhibitor) medical management and Fundoplication. Due to her history of Clostridium difficile enteritis, this patient is not a candidate for long-term, standard treatment with PPIs (proton pump inhibitors). Studies have shown that laparoscopic esophageal sphincter augmentation has significantly less gas bloat syndrome compared to Nissen Fundoplication. Also, patients preserve the ability to belch and vomit with esophageal sphincter augmentation unlike with fundoplication. Laparoscopic esophageal sphincter augmentation involves less alteration of anatomy and less disruption of the tissue. It is also much easier to reverse if needed. The procedure is FDA (United States Food and Drug Administration) approved and recognized by many insurance companies as medically appropriate and not experimental/investigational. When a surgical procedure becomes mainstream and a viable treatment option in the community, it is no longer considered experimental or investigational. 

The requested health service is more beneficial. Studies have shown that laparoscopic esophageal sphincter augmentation has significantly less gas bloat syndrome compared to Nissen Fundoplication. Also, patients preserve the ability to belch and vomit with esophageal sphincter augmentation, unlike with fundoplication. Laparoscopic esophageal sphincter augmentation involves less alteration of anatomy and less disruption of the tissue. It is also much easier to reverse if needed.