Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Issue under review: Linx procedure

Determination:
The health plan should cover the Linx procedure.

This patient is an adult male (BMI 32 kg/m2). He sought surgical evaluation for the condition of GERD with cough of six-years duration. He does not complain of dysphagia.

The patient has been evaluated for this condition with the following:
EGD showed a no hiatal hernia and distal esophagitis.
The records include a pH study that showed a DeMeester score of 46.8 on Day 1 and 18.4 on Day 2 (normal < 14.7) over 48-hours. There was strong symptom correlation for heartburn.

Esophageal motility showed preserved esophageal peristalsis with normal distal amplitude.

Bronchoscopy was performed for the symptom of cough and was normal.

The treating surgeon has proposed the LINX procedure as treatment of GERD.

This patient is an adult male with GERD who has successfully completed a comprehensive evaluation that establishes the diagnosis of pathologic esophageal acid exposure, preserved esophageal motility and no alternative diagnosis.

An anti-reflux procedure such as LINX magnetic sphincter augmentation is medically appropriate in this case and is likely to be more beneficial for the patient's condition or disease than alternative treatment.

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. 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 has been approved by the U.S. 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) with less
incidence of inability to belch or vomit (as can be associated with fundoplication).

The patient has been appropriately evaluated with pH study, motility testing, bronchoscopy, and upper endoscopy. There is confirmed pathologic esophageal acid exposure based on objective pH testing. There is no contraindicating esophageal motor condition based on the motility testing. EGD identifies no
contraindicating anatomic abnormality of the esophagus or stomach. 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.

Standard of care treatment options include medicinal treatment, laparoscopic fundoplication, TIF, and the LINX magnetic sphincter augmentation procedure. However, these are not equally effective treatments for GERD in this case. LINX
offers improved reduction in esophageal acid exposure and regurgitation compared to ongoing medication usage. LINX 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. Therefore LINX is likely to be more beneficial than available alternate therapies.