Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease). 
Treatment: LINX Procedure. 
The insurer denied: LINX Procedure
The denial is overturned

The patient is an adult male with BMI (body mass index) of 30.5. He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) of 10-years duration. His symptoms include heartburn and coughing. He has been treated with prescription medications (Omeprazole) with refractory symptoms. He has no reported symptoms of dysphagia. 
The patient has been evaluated for this condition with the following: 
- EGD (esophagogastroduodenoscopy) showed a small hiatal hernia. Pathology identified distal esophagitis without dysplasia/metaplasia. 
- pH study showed a DeMeester score of 160 (normal less than [<] 14.7) over 48-hours. 
- Esophageal motility showed normal esophageal peristalsis with adequately preserved esophageal function. 
- Esophagram on showed a small hiatal hernia, with severe gastroesophageal reflux seen during the study. 
The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease). 
The health plan denied coverage of the LINX procedure with the rationale that it is considered to be investigational. This denial is being appealed. 

The health plan should cover the LINX procedure. 

Based on the submitted clinical records and the body of published peer-reviewed literature, the health plan should cover the proposed LINX procedure as medically appropriate treatment of GERD (gastroesophageal reflux disease). This is a patient with GERD (gastroesophageal reflux disease) who has successfully completed a comprehensive evaluation that establishes the diagnosis of pathologic esophageal acid exposure, preserved esophageal motility and no alternative diagnosis. An anti-reflux procedure such as LINX magnetic sphincter augmentation is medically appropriate in this case. 

The LINX procedure is medically appropriate and is likely to be more beneficial for the insured's condition or disease. 

The LINX procedure is a minimally invasive procedure for the treatment of GERD (gastroesophageal reflux disease), and the recently 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 GERD (gastroesophageal reflux disease) in selected patients. 
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 a Phase 1, 2 or 3 clinical trial set forth in the FDA (United States Food and Drug Administration) regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative with less incidence of inability to belch or vomit (as can be associated with fundoplication). 
There are not equally effective treatments for GERD (gastroesophageal reflux disease) 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 and for this patient, the proposed LINX procedure is likely to be more beneficial for him than alternate therapies.