Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: LINX Procedure
The insurer denied the LINX Procedure.
The determination is upheld.

The patient has a history of gastroesophageal reflux disease (GERD). Notes describe he had Barrett's esophagus and breakthrough symptoms on proton pump inhibitor (PPI) medication. His body mass index (BMI) is 27. An endoscopy shows mild Grade A esophagitis and no significant hiatal hernia. A Bravo potential hydrogen (pH) study demonstrates abnormally high acid exposure with DeMeester scores in the 60s-99 range. Manometry demonstrates generally normal esophageal peristalsis. At issue is whether the LINX procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed LINX procedure is not likely to be more beneficial than standard treatments for this patient's gastroesophageal reflux disease.

Most of the data is short term, uncontrolled, or without meaningful comparison groups. While there does appear to be short term benefit in symptoms, the primary concern among experts remains the longer-term erosion risk and the paucity of data indicating the LINX device offers comparable or superior long-term results compared to standard therapies.

In Zhuang's 2021 meta-analysis, the authors reported on mostly short term and cohort studies, the authors found, "The incidence of postoperative dysphagia was 29% [percent] and endoscopic dilation was required in 7.4% of patients undergoing magnetic sphincter augmentation (MSA). MSA showed a better efficacy in symptom control than PPI (PPI cessation: 91% versus (vs) 0%; gastroesophageal reflux disease (GERD) - health related quality of life (HRQL) improvement: 81% vs 8%) and similar effectiveness but a lower risk of gas-bloat syndrome (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.51-0.93, P = 0.01) and better reserved ability to belch (RR 1.48, 95% CI 0.76-2.86, probability [P] = 0.25) compared with Laparoscopic Nissen fundoplication (LNF)." Their conclusions were that while "magnetic sphincter augmentation (MSA) was an effective and safe therapy for refractory gastroesophageal reflux disease (rGERD), well-designed randomized trials that compare the efficacy of MSA with other therapies are needed."

There remains a dearth of information or data available about longer term results from the LINX procedure. The rate of longer term, potentially serious erosions and dysphagia, remains unanswered. And inadequate data exists offering comparison directly between LINX and standard therapies of PPI or fundoplication.

In Guidozzi's meta-analysis and review, the author writes, "There is an urgent need for randomized data directly comparing fundoplication with MSA for the treatment of GERD to truly evaluate the efficacy of this treatment approach."

Schizas similarly reviewed 35 studies and reported the findings which, again, offered very few actual patients with long term results and comparisons. the authors similarly concluded, "The findings of our review suggest that MSA has the potential to bridge the treatment gap between maxed-out medical treatment and LF. However, further studies with longer follow-up are needed for a better elucidation of these results."

The LINX device may offer some near-term success which appears comparable to standard therapy of PPI and fundoplication, with unanswered questions about long term risks. The procedure is not medically necessary and not proven superior to standard therapies.