Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal/Gastroesophageal Reflux Disease/GERD
Treatment: Surgical Services (All)
The health plan denied the requested LINX service.
The health plan's determination is overturned.

This patient is a man (body mass index (BMI)) 25 kg/m2 (kilogram meter squared) who sought surgical evaluation for the condition of heartburn of more than 10-years duration. These symptoms are partially responsive to proton pump inhibitor (PPI) medication (Omeprazole). He has no dysphagia.
The patient has been evaluated for this condition with an esophagogastroduodenoscopy (EGD) that showed no esophagitis and a small hiatal hernia. Esophageal motility showed adequate peristalsis of the esophagus. There was a no manometric hiatal hernia and 100% of swallows were normally peristaltic. A potential hydrogen (pH) study identified an elevated esophageal acid exposure with a composite DeMeester score of 38 over 48-hours of study. Symptom correlation was strong for chest pain. The treating surgeon has proposed the LINX procedure as the treatment of 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 is overturned, in whole.

Yes. Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is likely to be more beneficial than any standard treatment for this insured's condition of proven GERD.
The LINX procedure is a minimally invasive procedure for the treatment of GERD and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure. 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 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.
LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. 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).
Since the 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-HRQL (gastroesophageal reflux disease health related quality of life) scores were 27 in patients not taking 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 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.