Appeal type: Medical necessity
Decision: Overturned

Diagnosis: GERD 
 
Treatment: LINX Procedure 

The insurer denied the LINX Procedure. The denial was reversed. 

This is a female patient with a medical history of multiple autoimmune disorders on chronic steroids, and a decade history of gastroesophageal reflux disease (GERD). It was reported that the patient experiences heartburn, regurgitation and chest pain multiple times a week that has caused significant distress to her life. She has been on proton pump inhibitors (PPI) for several years. She has had extensive gastrointestinal diagnostic work up that include a series of Esophagogastroduodenoscopy (EGD), Esophagram, Esophageal Function Test, reflux pH monitoring, and high resolution motility. Her most recent EGD revealed Z line was regular and gastroesophageal flap valve was visualized and classified as Hill grade 2 with a patulous lower esophageal sphincter. There was no evidence of a hiatus hernia at the GE junction, and her ambulatory reflux pH monitoring revealed DeMeester score of 100.6 with 100% symptom association probability with significant upright and supine acid reflux with good correlation to symptoms. LINX procedure was recommended. 

Many recent articles have been evaluated for this review, such as: 1) Bell, et al. who concluded in "Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial" Gastrointest Endosc 2019 that patients with gastroesophageal reflux disease (GERD) with moderate-to-severe regurgitation, especially despite once-daily proton pump inhibitor (PPI) treatment, should be considered for minimally invasive treatment with magnetic sphincter augmentation (MSA) rather than increased PPI therapy. 2)  Chen, et al. noted in "Efficacy of Magnetic Sphincter Augmentation versus Nissen Fundoplication for Gastroesophageal Reflux Disease in Short Term: A Meta-Analysis" Can J Gastroenterol Hepatol 2017 that magnetic sphincter aurgmentation (MSA) can be recommended as an alternative treatment for gastroesophageal reflux disease (GERD) according to their short-term studies, especially in main-features of gas-bloating, due to shorter operative time and less complication of gas or bloating. 3) Warren, et al. noted in "Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastro esophageal reflux disease" from Surg Endosc 2015 a multi-institutional retrospective cohort study of patients with gastroesophageal reflux disease (GERD) undergoing either magnetic sphincter augmentation (MSA) or Nissen fundoplication (NF). 

In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management; 4) Smith, et al. noted in "Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant" in  J Laparoendosc Adv Surg Tech A 2017, that "during a 4-year period in more than 3000 patients, no unanticipated magnetic sphincter augmentation device (MSAD) complications have emerged, and there is no data to suggest a trend of increased events over time. Saino, et al. noted in "Magnetic Sphincter Augmentation for Gastro esophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement" from J Laparoendosc Adv Surg Tech, a 2015 report on the final 5-year results of a pilot study. The authors concluded this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD. 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient. 

The carrier's denial of coverage for the LINX procedure is reversed. The medical necessity is substantiated.