Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Gastroesophageal Reflux Disease/GERD.
Treatment:  Surgical Services (All)- LINX Procedure.

The insurer denied Surgical Services (All)- LINX Procedure.  The determination is overturned.

This patient has a body mass index (BMI) 30.8 kilograms per square meter (kg/m2) sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The patient's symptoms include heartburn and cough. Consequently, the patient is prescribed a proton pump inhibitor (PPI) medication for symptom control (Dexilant) but has refractory symptoms of gastroesophageal reflux disease (GERD). The patient has used Protonix and famotidine in the past for reflux symptoms. The patient was evaluated with the following diagnostics.

Esophagogastroduodenoscopy (EGD) identified esophagitis at the gastroesophageal junction and a tiny hiatal hernia. Pathology identified no intestinal metaplasia. Potential hydrogen (pH) testing was performed while off acid suppressing medication and showed a DeMeester score of 37 (normal less than 14.7). Esophageal manometry testing showed normal peristaltic pressures. All swallows normally peristaltic. 

There was no manometrically detected hiatal hernia. Lastly, an esophagram showed normal esophageal motility. There was no hiatal hernia and severe reflux to the level of the thoracic inlet. The treating surgeon has proposed the LINX procedure as treatment of gastroesophageal reflux disease (GERD). At issue is the proposed service/treatment, LINX procedure.

The LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use since 2012. LINX is not subject to review and approval by any institutional review board for the proposed use. LINX is not the subject of an ongoing clinical trial that meets the definition of Phase 1, 2 or 3 clinical trials set forth in the Food and Drug Administration (FDA) regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication) with less incidence of inability to belch or vomit (as can be associated with fundoplication).

Since the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to 5-years post implantation. The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device. At baseline, the median Gastroesophageal Reflux Disease- Health-Related Quality of Life (GERD-HRQL) scores were 27 in patients not taking a proton pump inhibitor (PPI) and 11 in patients on a proton pump inhibitor (PPI); 5 years after device placement this score decreased to 4. All patients used a proton pump inhibitor (PPI) at baseline; this value decreased to 15.3% (percent) at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. The study concluded that magnetic sphincter augmentation (MSA) with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with gastroesophageal reflux disease (GERD). This study provides the 5-year conclusion of the clinical trial NCT00776997 [Ganz et al., 2015]. The Food and Drug Administration (FDA) required 5-year follow up of 100 patients from the investigational device exemption pivotal study has been completed and supports the safety and efficacy of the procedure.

Clinical trial NCT01624506 is an Anti-Reflux Surgical Study that is an observational study designed to collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation [MSA] and Fundoplication) in clinical practice. This study also tracked the clinical course of patients. One-year data showed that both magnetic sphincter augmentation (MSA) and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates [Riegler M, et al., 2015].

Reynolds et al. found that analogous gastroesophageal reflux disease (GERD) patients had similar control of reflux symptoms after both magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication and the inability to belch and vomit were significantly fewer with magnetic sphincter augmentation (MSA). The authors concluded that the results support the use of magnetic sphincter augmentation (MSA) as first-line therapy in patients with mild to moderate gastroesophageal reflux disease (GERD). Finally, The American Society of General Surgeons has released a position statement that supports the inclusion of the LINX procedure into the armamentarium of treatment options for appropriately selected patients with gastroesophageal reflux disease (GERD).

The patient has symptoms of chronic gastroesophageal reflux disease (GERD). They have been appropriately evaluated with a potential hydrogen (pH) study, motility testing, esophagram, and upper endoscopy. There is confirmed pathologic esophageal acid exposure based on objective potential hydrogen (pH) testing. There is no contraindicating esophageal motor condition based on the motility testing or esophagram. An esophagogastroduodenoscopy (EGD) identified no contraindicating anatomic abnormality of the esophagus or stomach. Finally, the patient does not have specific contraindication to implantation of the LINX device, 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, morbid obesity, or age less than 21.

This treatment (LINX) is consistent with the diagnosis and treatment of this patient's condition. It is appropriate according to accepted standards of good medical practice. It is not for the convenience of anyone. It is not experimental or investigational. LINX is the most appropriate service required to provide safe and adequate care. LINX is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The LINX procedure is a minimally invasive procedure for the treatment of gastroesophageal reflux disease (GERD) and the published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure. There has been completion of ongoing clinical trials NCT00776997 and NCT01624506 that provide the necessary long-term follow-up regarding LINX. These studies, in conjunction with previously published data, support the long-term safety and efficacy of the LINX and reinforce that this procedure has withstood appropriate scrutiny and should be included in the armamentarium of proven-effective therapy for the treatment of gastroesophageal reflux disease (GERD) in selected patients.