Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  GERD (gastroesophageal reflux disease).
Treatment:  LINX Procedure.

The insurer denied the LINX Procedure.  The denial is overturned. 

This patient is a woman (BMI [body mass index] 30 kg [kilograms]/m2 [meters squared]), who sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) associated with heartburn, regurgitation, and belching with occasional emesis.  Symptoms are worse when supine.  She treats symptoms with prescription medication (Omeprazole) with no improvement. 

The patient has been evaluated for this condition with the following:  1) EGD (esophagogastroduodenoscopy) showed a normal esophagus with retained food in the stomach; 2) Gastric emptying study showed normal liquid phase gastric emptying; 3) A pH (potential of hydrogen) study identified a DeMeester score of 74.4 over 24-hours (normal < 14.7); 4) Esophagram showed normally preserved esophageal motility.  There was a small hiatal hernia. There was gastroesophageal reflux to the midesophagus, and 5) Esophageal motility testing showed no hiatal hernia and normal esophageal motility.  Distal wave amplitude was normal.

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

Yes, the health plan should cover the LINX Procedure.

Yes, based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is medically appropriate and is likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.

The LINX procedure is a minimally invasive procedure for the treatment of GERD (gastroesophageal reflux disease), 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 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 (gastroesophageal reflux disease) 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.  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 (Food and Drug Administration) regulations.  Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication) with less incidence of inability to belch or vomit (as can be associated with fundoplication).

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 reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device.  At baseline, the median GERD (gastroesophageal reflux disease)-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 (proton pump inhibitors) 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 (gastroesophageal reflux disease).  This study provides the five-year conclusion of the clinical trial. [Ganz et al]  The FDA (Food and Drug Administration)-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.  

Another clinical trial 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 (gastroesophageal reflux disease) patients had similar control of reflux symptoms after both MSA (magnetic sphincter augmentation) and laparoscopic Nissen fundoplication, and the inability to belch and vomit were significantly fewer with MSA (magnetic sphincter augmentation).  The authors concluded that the results support the use of MSA (magnetic sphincter augmentation) as first-line therapy in patients with mild to moderate GERD (gastroesophageal reflux disease).  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 (gastroesophageal reflux disease).  

The patient has symptoms of chronic GERD (gastroesophageal reflux disease).  She has been appropriately evaluated with pH (potential of hydrogen) study, gastric emptying study, esophagram and upper endoscopy.  There is confirmed pathologic esophageal acid exposure based on objective 24-hour pH (potential of hydrogen) testing.  There is no contraindicating esophageal motor condition based on motility testing.  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.

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 (Food and Drug Administration) approval, the LINX procedure is medically appropriate in this case and is likely to be health beneficial for his proven condition of GERD (gastroesophageal reflux disease).  LINX should not be considered to be experimental or investigational for appropriately selected patients as in this case.