Appeal type: Experimental/Investigational
Decision: Upheld

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

This patient is a man (weight/BMI (body mass index) not submitted) who sought surgical evaluation for the condition of multiple hernias (hiatal hernia, umbilical hernia, and inguinal hernia). His symptoms regarding the hiatal hernia include progressive reflux and regurgitation. The surgical history and physical (H&P) does not indicate if he is treated with acid suppressing medication. He has no dysphagia and no prior related surgical history. He sleeps with the head of the bed elevated with 4 pillows to alleviate regurgitation. An esophagogastroduodenoscopy (EGD) showed a large hiatal hernia and esophagitis. A 48-hour potential hydrogen (pH) study showed a composite DeMeester score of 22.9 (normal < 14.7). Esophageal motility showed a 6.8 cm (centimeter) hiatal hernia noted on manometry. 81% of swallows had intact peristaltic waves. 19% of swallows were ineffective/weak.
The treating surgeon has proposed the LINX procedure in conjunction with hiatal hernia repair as treatment of chronic gastroesophageal reflux disease (GERD).
At issue is whether the proposed health service or treatment of the LINX Reflux Management System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination regarding the proposed health service is upheld, in whole.

No. Considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is not likely to be more beneficial than any standard treatment for the condition being treated in this case (large hiatal hernia and GERD).
LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the treatment of GERD 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 regulations. Also, there is sufficient long-term data to support that LINX, when performed in appropriate clinical circumstances is as efficacious as the established alternative (laparoscopic fundoplication) for the treatment of GERD.
However, in this case, the patient has a large hiatal hernia (6.8 cm hiatal hernia per motility testing and EGD). The primary diagnosis in this case is a large paraesophageal hiatal hernia and LINX would be considered to be experimental/investigational as the primary treatment of a large hiatal hernia as described in this case.
The submitted records support that the hiatal hernia is the primary diagnosis in this case. While LINX is a proven effective therapy for appropriately selected patients with GERD, LINX is not proven primary therapy for the condition of a large hiatal hernia.
The body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation for the diagnosis of GERD. LINX is not a proven primary therapy for the diagnosis of a large hiatal hernia. Standard therapy in this case would consist of repair of the paraesophageal hiatal hernia and fundoplication. Therefore, based on the status of peer-reviewed literature and the case specific details of this case, the proposed LINX procedure is not likely to be more beneficial than any standard treatment for the condition being treated in this case.