Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Diseae.
Treatment: LINX Procedure and 1 day inpatient stay.
The insurer denied the LINX procedure and 1 day inpatient stay.
The determination is upheld.

This patient sought surgical evaluation for the condition of reflux. She is status post gastric sleeve gastrectomy performed as treatment of morbid obesity. She subsequently underwent conversion of the gastric sleeve to Roux en Y gastric bypass due to the complication of a sleeve leak. She currently has the complaint of gastroesophageal reflux disease (GERD) characterized by heartburn, regurgitation and throat clearing. She is treated with proton pump inhibitor (PPI) medication (for the past 5-years) with breakthrough symptoms.
An esophagogastroduodenoscopy (EGD) showed esophagitis and anatomic changes of Roux en Y gastric bypass. Potential of hydrogen (pH) testing in early 2019 confirmed pathologic esophageal acid exposure with an elevated composite DeMeester score of 37.1 (normal less than [<] 14.7) over 48-hours.
A barium upper gastrointestinal (UGI) study showed a small hiatal hernia, reflux during the study, a normal gastric pouch, with prompt passage into the small bowel.
Manometry showed normal esophageal body peristalsis with a mean wave amplitude of 78.
The treating surgeon has proposed the LINX procedure as treatment of chronic GERD. At issue is whether the proposed health service or treatment laparoscopic esophageal surgery (LINX procedure) and inpatient stay likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure and the inpatient stay is not likely to be more beneficial than any standard treatment for the insured's condition or disease.
While LINX is indicated in the setting of pathologic esophageal acid exposure documented by pH testing and in the absence of specific contraindication to the LINX device, in this case there is a history of prior gastric surgery (sleeve gastrectomy and subsequent conversion to roux en Y gastric bypass). This is a listed precaution/contraindication to the application of the LINX device. There is very limited published data regarding LINX in the post bariatric surgery setting. While the one publication listed below does describe a favorable result in terms of decreased reflux symptomatology in seven patients post sleeve gastrectomy, this was a single, pilot case series, retrospective analysis that does not provide enough support for the wide spread application of LINX in this clinical circumstance. [Desart]
The LINX procedure is a minimally invasive, Food and Drug Administration (FDA) approved, procedure for the treatment of GERD and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure for a specific patient population. In this case the LINX procedure is not known to be effective, based on scientific evidence, professional standards and expert opinion, in improving health outcomes.
The patient has symptoms of GERD. However, she is status post bariatric surgery. She has been appropriately evaluated with EGD, pH study, motility, and UGI. Her bariatric surgical history would be a specific precaution to implantation of the LINX device and the associated inpatient stay. These listed precautions include conditions such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, or age less than (<) 21.
The body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation for a specific patient population with proven GERD and no prior gastroesophageal surgical history. The submitted clinical data supports the conclusion that this patient has elevated esophageal acid exposure. However, she is status post sleeve gastrectomy and subsequent gastric bypass. This gastric surgical history is a specific precaution to the application of LINX magnetic sphincter augmentation at this time. The quality and quantity of peer reviewed publication regarding LINX in the post bariatric surgical setting is insufficient to draw definitive conclusions regarding the long-term safety and efficacy of this procedure.
The proposed LINX procedure is offered to treat GERD in the post gastric bypass setting. This treatment is not known to be effective based on adequately powered clinical study. This treatment is not in accordance with generally accepted standards of medical practice.

The health plan's determination is upheld in whole.