Appeal type: Experimental/Investigational
Decision: Overturned in Part

Diagnosis: Gastroesophageal Reflux Disease

Treatment: Laparoscopic Esophageal Surgery and Hospital Admission

The insurer denied the laparoscopic esophageal surgery and hospital admission.

The denial was partially overturned.

This is a female patient with chronic refractory gastroesophageal reflux disease (GERD) and scleroderma being considered for the LINX procedure. The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. The LINX device has been shown to be effective in treating gastroesophageal reflux with patients not needing subsequent medical therapy.

"The LINX device is a safe, well tolerated, and effective therapy for GERD in the short term. MSA should be considered for selected GERD patients without significant anatomic or motility defects." (Sheu, EG.et al. 2015)

"Magnetic sphincter augmentation appears to be an effective treatment for GERD with short-term outcomes comparable to the more technically challenging and time-consuming Nissen fundoplication. Long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation." (Skubleny, D. et al. 2017)

"After several years of clinical application, the Linx device has been shown to not only be effective for the management of GERD but also be as effective as fundoplication. With respect to safety, the most common complication of MSA is dysphagia. This often resolved without intervention, but esophageal dilation or device explanation are occasionally necessary. Not fully appreciated in earlier reviews, erosion of the device into the esophagus appears to be the most significant complication of the device after extended follow-up. While very rare, the potentially severe consequences of this phenomenon suggest that the device should be used with some restraint and that patients should be made aware of this potential morbidity. Fortunately, in the few cases of device erosion described in the literature reviewed, the Linx device was easily and safely removed." (Zadeh, J. et al. 2018)      
     
This patient is a good candidate for laparoscopic esophageal surgery. She has history of gastroesophageal reflux disease (GERD) and was evaluated by thoracic and esophageal surgeon and her diagnostic workup showed a DeMeester score of 94.8 by pH study, normal motility study with borderline low lower esophageal sphincter (LES) pressure and reflux, and hernia. There are no contraindications for laparoscopic esophageal surgery documented such as previous operations on the esophagus or previous abdominal operations. There is documented reflux on manometry and pH studies.     

Laparoscopic esophageal surgery is the best available treatment for this patient at this time. The LINX procedure is an effective, fundic-sparing, anti-reflex procedure that can be done with minimal mortality and morbidity. This patient has been non responsive to prior treatment with proton pump inhibitors for her GERD. She has no contraindications. All of this makes the proposed procedure the best available treatment for this patient at this time.     

This patient has a long history of chronic GERD symptoms that have been unrelieved with daily acid suppressing medications. This patient also has the additional problem of an incompetent lower esophageal sphincter. This can lead to disease progression to Barrett's esophagus which increases the risk of premalignant conditions. This procedure is less invasive than the traditional fundoplication procedures and is highly effective and can be done with minimal mortality and morbidity. The requested procedure is likely to be more beneficial than any standard treatments/procedures.

The carrier's denial of laparoscopic esophageal surgery and hospital admission should be partially overturned.