Appeal type: Experimental/Investigational
Decision: Overturned

The patient is a male who sought surgical evaluation for the condition of heartburn. These symptoms are partially responsive to medications (proton-pump inhibitors [PPIs] and H2 blockers), but he does have breakthrough symptoms. He has no dysphagia.
He has been evaluated for this condition with:
Contrast upper gastrointestinal (UGI) that showed a small hiatal hernia. There was no gastroesophageal junction pathology noted.
Esophagogastroduodenoscopy (EGD) that showed an irregular Z-line without mention of esophagitis or hiatal hernia.
Esophageal motility showed adequate peristalsis of the esophagus. There was no manometric hiatal hernia. Distal contractile integral was normal at 1121.1 mmHg/cm/s. There were no failed contractions.
A pH study identified an elevated esophageal acid exposure with a DeMeester score of 39.7 over 48-hours (normal [nl] less than [<] 14.7). Symptom correlation was excellent for heartburn and regurgitation.
The treating surgeon has proposed the LINX procedure as treatment of gastroesophageal reflux disease (GERD).
The subject under review is whether the LINX procedure is likely to be more beneficial for this patient than other standard treatment for his GERD.

The health plan's determination is overturned.

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 for the patient's life-threatening or disabling condition or disease.
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 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.
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 Food and Drug Administration (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 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 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]
Reynolds et al. found that analogous GERD patients had similar control of reflux symptoms after both MSA and laparoscopic Nissen fundoplication and the inability to belch and vomit were significantly fewer with MSA. The authors concluded that the results support the use of MSA as first-line therapy in patients with mild to moderate GERD. Finally, The American Society of General Surgeons has released a position statement that supports the inclusion of the LINX procedure into the armamentarium of treatment options for appropriately selected patients with GERD as in this case.
The patient has symptoms of chronic GERD (heartburn, regurgitation). He has been appropriately evaluated with EGD that showed an irregular Z-line in the area of the gastroesophageal (GE) junction. There is no contraindicating esophageal motor condition based on the esophageal motility study. There is confirmed pathologic esophageal acid exposure with elevated esophageal acid exposure over the course of a 48-hour pH study. Finally, the patient does not have specific contraindication to implantation of the LINX device such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age < 21.
This patient's evaluation confirms that an antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure. The LINX procedure offers benefits over traditional surgical fundoplication with equivalent reduction in esophageal acid exposure with preservation of the ability to belch/vomit. LINX offers improved symptom control compared to ongoing medicinal therapy with reduction in need for anti-acid medications and reduction in regurgitation. It also avoids the need for ongoing PPI therapy.
Therefore, based on the status of peer reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA approval, the LINX procedure is likely to be more beneficial than alternative therapy. LINX should not be considered to be experimental or investigational for appropriately selected patients as in this case.