Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Gastroesophageal Reflux Disease (GERD)

Treatment:  Inpatient Hospitalization (LINX procedure)
 
The insurer denied Inpatient Hospitalization (LINX procedure).  The denial was modified. 

This is a young female, who was diagnosed with gastroesophageal reflux disease (GERD) confirmed by abnormal pH testing.  She has a significant history of acid reflux in spite of proton pump inhibitors (PPIs).  The patient consulted her doctor in the beginning of 2019 to discuss her options of revisional Roux-en-Y gastric bypass versus a LINX procedure.  The patient has opted for the LINX.  Several months earlier the patient underwent esophagogastroduodenoscopy (EGD) which was negative except for post-surgical changes of gastrojejunostomy.  Esophageal pH probe was placed for Bravo test.  The patient underwent esophageal 24-hour pH impedance monitoring which showed a DeMeester score of 23.7 with poor symptom index correlation to heartburn symptoms with not all episodes of acid reflux causing symptoms.

The patient does have significant GERD as her DeMeester score was 23.7 with normal esophageal manometry.  The patient did discuss with the surgeon a revision of Roux-en-Y gastric bypass versus a LINX procedure and has decided upon the LINX procedure.  The patient has GERD and does require treatment, and the LINX is a viable alternative for treatment.  There is scientific evidence in peer reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness.  It is approved by the FDA.  It has been recognized by SAGES and ASGS as an option for treating GERD.  There are long term results out to five years with improvement in the health outcomes for patients undergoing the LINX procedure.  LINX reflux management system in Surg Endosc 2017 that longer term (3-5 years) experience with the LINX confirms the initial safety profile, and the device has been demonstrated to result in long term GERD control.  The article concluded that implantation of the LINX device should be covered and reimbursed by insurance for appropriate patients who meet the selection criteria.  Finally, an additional article reviewed by 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 and reported that "during a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time.  The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD.  MSAD is considered safe for the widespread treatment of GERD."  Therefore, the LINX procedure does improve health outcome; there are clinical indications for this procedure, and it is supported in peer reviewed literature.  

The carrier's denial of coverage for the request for inpatient services (LINX procedure) and anticipated subsequent inpatient hospital admission is modified.  Approve inpatient services (LINX procedure).  Deny the anticipated subsequent inpatient hospital admission.