Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  GERD (gastroesophageal reflux disease).
Treatment:  LINX Procedure (Magnetic Sphincter Augmentation [MSA]).

The insurer denied the LINX Procedure (Magnetic Sphincter Augmentation [MSA]).  The denial is upheld. 

The patient is a woman.  The patient has BMI (body mass index) of 24.8.  She sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease).  Her symptoms have existed for the past several years.  The patient has been treated with Famotidine and Nexium.    

The patient was evaluated for her complaints with the following:

Esophageal manometry testing was normal. Ninety-six hour pH (potential of hydrogen) testing was performed and recorded an overall DeMeester score of 10.2 (normal < 14.7).  The daily DeMeester scores were 2.2, 5.7, 24.8, and 5.7.  EGD (esophagogastroduodenoscopy) showed a small hiatal hernia, no mention of esophagitis, and a regular Z-line.  Esophagram showed no hiatal hernia and no reflux during the study.

The treating surgeon has proposed the LINX procedure as treatment of GERD.  The health plan has denied this treatment based on the contention that LINX is E/I (experimental/investigational).  

No, the health plan should not cover the LINX Procedure.

No, considering the submitted documentation, the published literature, and the clinical details of this case, the requested LINX procedure is not likely to be more beneficial than any standard alternative treatment for the condition being treated in this case.  

The submitted pH (potential of hydrogen) study does not confirm that there is elevated esophageal acid exposure.  The diagnosis of surgically amenable GERD is not established based on the submitted clinical material.

LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the treatment of GERD for several years.  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) for the treatment of GERD in appropriately selected patients with proven pathologic esophageal acid exposure, preserved esophageal motility, and no alternative diagnosis.  

Since the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Safety and Effectiveness Analysis and a study by Ganz et al., there has been additional analysis that provides long-term data to five-years post implantation.  The follow up analysis a couple years later 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 (health-related quality of life) scores were 27 in patients not taking PPIs (proton pump inhibitors) and 11 in patients on PPIs (proton pump inhibitors); five years after device placement this score decreased to 4.  All patients used PPIs at baseline; this value decreased to 15.3% at five years.  Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at five years.  All patients reported the ability to belch and vomit if needed.  The study concluded that MSA (magnetic sphincter augmentation) with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications.  No new safety risks emerged over a five-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 five-year conclusion of the clinical trial NCT00776997. [Ganz et al]  The FDA-required five-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 (magnetic sphincter augmentation) and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates.  [Riegler M, et al]

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.

However, in this case, the patient is reported to have GERD, but the pH (potential of hydrogen) study that is submitted does not identify pathologic esophageal acid exposure, as the overall DeMeester score was within normal limits over 96-hours.  She was reported to be off acid suppressing medication at the time of the study.  The EGD (esophagogastroduodenoscopy) report that is submitted reports makes no mention of esophagitis.  Esophageal manometry testing was normal.

General precautions listed by the manufacturer for LINX implantation include a diagnosis of Barrett's, as the safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA [Los Angeles] classification) esophagitis.  Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include the following:  1) Scleroderma, 2) Suspected or confirmed esophageal or gastric cancer, 3)	Prior esophageal or gastric surgery or endoscopic intervention, 4) Distal esophageal motility less than 35 mmHg (millimeters of mercury) peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES (lower esophageal sphincter), 5) Symptoms of dysphagia more than once per week within the last three months, 6) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, hiatal hernia, etc.), 7)	Esophageal or gastric varices, 8) Lactating, pregnant or plan to become pregnant, 9) Morbid obesity (BMI [body mass index]>35), or
10) Age < 21 years.

In this patient's case, pathologic esophageal acid exposure is not confirmed by objective pH (potential of hydrogen) testing.  While the body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation for the diagnosis of GERD in specific clinical circumstances, LINX is not a proven primary therapy in the absence of proven and documented pathologic esophageal acid exposure, preserved esophageal motility and no alternative diagnosis.  This patient does not have confirmed abnormal esophageal acid exposure.  Therefore, based on the status of peer-reviewed literature and the case specific details of this case, the proposed LINX procedure is not medically appropriate for this patient and should not be covered by the health plan.