Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested coverage for laparoscopic placement of an esophageal sphincter augmentation device (LINX) and cruroplasty.  The record indicates the enrollee has gastroesophageal reflux disease and esophagitis. Medications have included ondansetron, famotidine, hycosamine, Dexilant and aluminum magnesium hydroxide.  The UGI (upper gastrointestinal series) performed revealed esophageal dysmotility, with increased gastroesophageal junction transit time and a small hiatal hernia without evidence of gastroesophageal reflux.  The Bravo pH testing revealed a DeMeester score of 61.5.  The findings strongly support a diagnosis of excessive gastroesophageal acid reflux and substantiate an excellent correlation between symptoms of chest pain, regurgitation and reflux of acid.  Findings from the esophageal manometry are suggestive of a normal esophageal manometry profile.  A  note indicated the enrollee was refractory to maximal medical therapy and continued to describe regurgitation symptoms a few minutes after eating with associated epigastric pain that were not relieved with proton pump inhibitors.  The enrollee had been eating mostly carbohydrates due to his symptoms and gaining weight. According to the medical literature, enrollees eligible for the LINX prosthesis include those who have typical GERD symptoms,  an abnormal pH study, a partial response to daily proton pump inhibitor  therapy and the absence of a large hiatal hernia (>3 cm) or severe esophagitis. Long term follow-up supports the FDA conclusion that the device is safe.  It is efficacious in that the LINX implant results in pH normalization, improved quality of life, and cessation of regular proton pump inhibitor use on a consistent basis.  The long-term follow-up data demonstrates that the LINX is effective in the management of GERD. The results of a trial on laparoscopic magnetic sphincter augmentation versus double dose proton pump inhibitor for management of moderate to severe regurgitation in GERD concluded that enrollees with moderate to severe reflux especially if on proton pump inhibitor therapy should be considered for minimally invasive treatment rather than increased proton pump inhibitor therapy. The enrollee is a good candidate for laparoscopic placement of an esophageal sphincter augmentation device (LINX) and cruroplasty as he failed maximum medical therapy, continued to have typical gastroesophageal reflux disease symptoms, had a DeMeester score of 61.5, no large hiatal hernia and did not have severe esophagitis.  Final Result: Three of the three reviewers determined that the requested service is likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in Gastroenterology and are actively practicing.  All three reviewers are experts 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.