Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease). 
Treatment: LINX Reflux Management System (LINX) (43284). 

The insurer denied the LINX Reflux Management System (LINX) (43284). 
The denial is upheld. 

The patient is a female who is being evaluated for treatment of GERD (Gastro-Esophageal Reflux Disease). This patient has a DeMeester Score of 27.8 (Normal being < [greater than] 14.7). 

The issue being reviewed is the LINX Reflux Management System (LINX) (43284), which the health plan denied as being experimental/investigational. 

No, the health plan should not cover the LINX system. 
The LINX device is considered MR (magnetic resonance) Conditional in a magnetic resonance imaging (MRI) system up to 0.7-Tesla (0.7T). Scanning under different conditions may result in serious injury to the patient and/or interfere with the magnetic strength and function of the device. 

The proposed LINX is still not evidenced at this time not to be as beneficial as any established procedure, such as the Nissen Fundoplication. 

As per the Medical Literature based on MCG (Milliman Care Guidelines) Criteria [1-17]: The Current Role Remains Uncertain. Based on review of existing evidence, there are currently no clinical indications for this technology. 

A systematic review of 39 studies (one randomized controlled trial, 5 cohort studies, 3 case control studies, 25 case series, and 5 case reports) evaluating the methodological quality of the magnetic sphincter augmentation literature found variability in documentation related to patient selection, governance and consent, surgeon experience, techniques performed, and outcomes reported. The authors state that due to heterogeneity in existing studies, the long-term safety and efficacy of magnetic sphincter augmentation have not been sufficiently established.[7] 

A systematic review and meta-analysis of 7 observational cohort studies (1211 patients) comparing the efficacy of magnetic sphincter augmentation and laparoscopic fundoplication for the treatment of gastroesophageal reflux disease found, at a follow-up range of 6 to 12 months, that although magnetic sphincter augmentation was associated with less gas/bloat symptoms and increased ability to vomit and belch, there was no significant difference between the groups with regard to proton pump inhibitor suspension, post-procedure dysphagia requiring endoscopic dilatation, and reoperation. The authors cautioned against drawing conclusions from these findings, which were based on studies that were not randomized controlled trials and had small sample sizes; further studies were recommended to study magnetic sphincter augmentation and evaluate factors such as appropriate patient selection.[5] 

A national guideline indicates that there is insufficient long-term evidence of efficacy for laparoscopic insertion of a magnetic ring for the treatment of gastroesophageal reflux disease; evidence of short-term efficacy is limited.[11] 

A specialty society expert consensus panel concluded that the LINX device results in long-term control of gastroesophageal reflux disease based on symptomatic outcomes, proton pump inhibitor use, and pH studies. However, the current evidence is limited by lack of randomization and blinding in the literature, the duplication of patients in multiple publications, potential publication bias, and the potential lack of generalizability of findings outside of high-volume centers with highly selected patients.[2] 

No, the LINX procedure is not more beneficial. 

This patient could be considered for a Laparoscopic Nissen fundoplication, which remains standard of Care.