Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease.
Treatment: Esophagus Sphincter Augmentation Device (LINX).
The insurer denied: Esophagus Sphincter Augmentation Device (LINX).
The denial is overturned.

The patient is an adult female with a BMI (body mass index) of 29-32. She sought surgical evaluation for the symptoms of heartburn, abdominal pain, belching, globus sensation, hoarse voice, and nausea of more than one-year's duration. The records indicate that she is treated for dyspepsia Omeprazole and Famotidine but does have breakthrough symptoms. There is no reported dysphagia. The patient has been evaluated for this condition with the following: 
EGD (esophagogastroduodenoscopy) in the past showed distal esophagitis and a hiatal hernia. 
EGD (esophagogastroduodenoscopy) last year also identified esophagitis.
48-hour potential of hydrogen (pH) testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a composite DeMeester score of 48.5 (35.4 and 59.8 on Days 1 and 2) (normal less than 14.7). 

The treating surgeon has proposed the LINX procedure and hiatal hernia repair as treatment of GERD (gastroesophageal reflux disease). The health plan denied coverage as the Plan considers LINX to be experimental / investigational. 

The health plan should cover the Esophagus Sphincter Augmentation Device. 

The requested LINX (43284) is medically appropriate in this patient's case. This treatment is medically appropriate for the treatment of pathologic esophageal acid exposure and is not experimental or investigative. This treatment is in accordance with generally accepted standards of medical practice. 

The requested LINX has been granted FDA (United States Food and Drug Administration) approval since 2012. It is not the subject of phase I, II or III clinical trials. The safety, effectiveness, and effect on health outcomes has been established. Reliable evidence shows that the LINX procedure is safe and effective for the treatment of GERD (gastroesophageal reflux disease). LINX is a proven effective therapy for the condition of GERD (gastroesophageal reflux disease) and is recognized by the medical community as effective and appropriate for the specific diagnosis of this patient. 

The LINX procedure is not experimental or investigational. 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. 

The requested health service is more beneficial. This patient has symptomatic GERD (gastroesophageal reflux disease). 

The body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation. 
Reynolds et al found that analogous GERD (gastroesophageal reflux disease) patients had similar control of reflux symptoms after both MSA (magnetic sphincter augmentation) and laparoscopic Nissen fundoplication and the inability to 
belch and vomit were significantly fewer with MSA (magnetic sphincter augmentation). 
The NCT00776997 clinical trial validates the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD (gastroesophageal reflux disease) with 5-year follow up. 

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 GERD (gastroesophageal reflux disease). Therefore, based on the status of peer-reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA (United States Food and Drug Administration) approval, the medical appropriateness of the proposed LINX procedure is established for this patient.