Diagnosis: Gastroesophageal Reflux Disease (GERD).
Treatment: LINX Procedure.
The insurer denied the LINX Procedure.
The determination is overturned.

The patient sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD) of several years duration. His symptoms include heartburn. He has been treated with anti-acid medications (Aciphex, Nexium). A gastroenterology consultation has been completed that includes the evaluation detailed below. An esophagogastroduodenoscopy (EGD) showed a normal esophagus without mention of esophagitis. An esophagram was performed and showed gastroesophageal (GE) reflux with provocation. There was no hiatal hernia. Esophageal motility was normal.
Potential hydrogen (pH) testing was performed while off acid suppression and showed an elevated esophageal acid exposure with a DeMeester score of 33 (normal less than [<] 14.7).
Manometry testing showed adequately preserved motility. There was no manometrically-detected hiatal hernia.
The treating surgeon has proposed the LINX procedure as treatment of chronic GERD and this is under review for medical necessity.
At issue is the medical necessity of the LINX procedure.

Yes, considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is medically necessary for this patient. This therapy 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 would like to not be dependent on PPI(Proton pump inhibitors)therapy. There is pathologic esophageal acid exposure as documented by the objective pH study that confirmed an elevated DeMeester score. The patient has been appropriately evaluated with an endoscopy, contrast upper gastrointestinal (UGI) study, 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. There are not equally effective treatments for GERD. 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.
There has been the completion of ongoing clinical trials National Clinical Trial (NCT) 00776997 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.

This therapy is medically necessary for this patient.