Appeal type: Experimental/Investigational
Decision: Overturned

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

The patient has a body mass index (BMI) of 32.5 kilograms per square meter (kg/m2) and sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD) of several years duration. Her symptoms include heartburn and regurgitation. She has been treated with anti-acid medications (Omeprazole) with symptom improvement. There is no reported dysphagia. The patient is concerned about continued use of proton pump inhibitor (PPI) medications because of the risk for osteoporosis.
An esophagogastroduodenoscopy (EGD) showed no hiatal hernia and no esophagitis. Biopsy of the gastroesophageal junction was negative for dysplasia.
Manometry testing showed adequately preserved motility. There was no manometric-detected hiatal hernia. 90% of swallows had normal peristaltic activity. Distal wave amplitude was normal.
Potential hydrogen (pH) testing on confirmed elevated esophageal acid exposure with a DeMeester score of 72.4 (normal less than (<) 14.7). The study was performed while the patient was off acid suppressing medications. The study was positive on both days of the 48-hour study.
The treating surgeon has proposed the LINX procedure as treatment of chronic GERD.
At issue is whether the proposed health service or treatment laparoscopy and esophageal sphincter augmentation procedure (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.

Yes, considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is likely to be more beneficial for this patient compared with alternative surgical and non-surgical therapyand is proven safe and effective.
This patient has GERD. While the symptoms are partially controlled with medicinal therapy, there are breakthrough symptoms. There is pathologic esophageal acid exposure as documented by the objective pH testing that confirmed an elevated DeMeester score over 48-hours of study. The patient has been appropriately evaluated with an endoscopy and motility studies that confirm the absence of a precluding hiatal hernia and no alternative diagnosis or motor abnormality of the esophagus. An antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic Nissen fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure.
There are not equally effective treatments for GERD 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 the LINX procedure is likely to be more beneficial for this patient compared with alternative, standard therapy.
There has been completion of ongoing clinical trials National Clinical Trial (NCT)00776997 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 in selected patients as in this case.
LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the United States (US) 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 regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication). As stated above, the LINX procedure also preserves the ability to belch and vomit more favorably than the alternative surgical fundoplication procedure.
Since the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to 5-years post implantation. The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device. At baseline, the median GERD-health related quality of life (HRQL) scores were 27 in patients not taking proton pump inhibitors (PPIs) and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. The study concluded that magnetic sphincter augmentation (MSA) with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. This study provides the 5-year conclusion of the clinical trial NCT00776997. [Ganz et al, 2015] The FDA-required 5-year follow up of 100 patients from the investigational device exemption pivotal study has been completed and supports the safety and efficacy of the procedure.
Clinical trial NCT01624506 is an Anti-Reflux Surgical Study that is an observational study designed to collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation [MSA] and Fundoplication) in clinical practice. This study also tracked the clinical course of patients. One-year data showed that both MSA and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates. [Riegler M, et al, 2015]
The LINX procedure, approved by the Food and Drug Administration (FDA) in 2012, has demonstrated long term efficacy to support that it is as safe and effective as alternative therapy such as traditional fundoplication with improved risk exposure. Therefore, this procedure has been shown to be safe and effective for a patient such as this. This therapy is likely to be more beneficial for this patient compared with alternative surgical and non-surgical therapy.