Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal-Gastroesophageal Reflux Disease/GERD
Treatment: Surgical Services (All)-LINX
The health plan denied the surgical procedure as experimental/investigational. 
The health plan's determination is overturned in whole.

This patient has body mass index (BMI) 30 kilograms per meters squared (kg/m2) who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD) of several years duration. Her symptoms include heartburn, regurgitation, cough, bloating, and globus sensation. She has been treated with anti-acid medications (Prilosec), but has refractory symptoms. She consulted with ear, nose, and throat (ENT) and was told that her symptoms were due to reflux. A gastroenterology consultation was completed and was evaluated with upper endoscopy. The patient is concerned about continued use of Proton-pump inhibitors (PPI) medications because of the risk for osteoporosis.
An esophagogastroduodenoscopy (EGD) showed non-dysplastic erosive esophagitis (biopsy proven).
Contrast upper gastrointestinal (UGI) was performed and showed spontaneous gastroesophageal (GE) reflux. There was no hiatal hernia. Esophageal motility was normal. Manometry testing on showed adequately preserved motility. There was no manometric-detected hiatal hernia. The treating surgeon has proposed the LINX procedure as treatment of chronic GERD.

Yes, considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is likely to be more beneficial for this patient compared with alternative surgical and non-surgical therapy, is not investigational / experimental (E/I), and is proven safe and effective.
This patient has GERD. While the symptoms are partially controlled with medicinal therapy, there are breakthrough symptoms and the patient is concerned about the long-term risk of osteoporosis associated with PPI therapy. There is pathologic esophageal acid exposure as documented by the objective upper endoscopy that confirmed non-dysplastic esophagitis associated with reflux. The patient has been appropriately evaluated with endoscopy and motility studies that confirm the absence of a precluding hiatal hernia and no alternative diagnosis or motor abnormality of the esophagus. An antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic Nissen fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure.
There are not equally effective treatments for GERD as in this case. LINX offers improved esophageal acid reduction compared to ongoing medication usage. LINX also offers similar reduction in esophageal acid exposure compared to surgical fundoplication, but with an improved risk profile. The ability to belch and vomit are preserved with LINX compared to fundoplication. For these reasons the LINX procedure is likely to be more beneficial for this patient compared with alternative, standard therapy. 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 GERD in selected patients as in this case.

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 GERD in selected patients as in this case.