Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease/GERD
Treatment: LINX procedure
The health plan denied: LINX procedure.
The determination is: Overturned

This patient is a female (body mass index [BMI] of 30.6) who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD) and hiatal hernia. Her symptoms include heartburn. Consequently, she is prescribed proton pump inhibitor (PPI) medication for symptom control (Omeprazole), but she has refractory symptoms of GERD. The patient was evaluated with the following diagnostics.
An esophagram showed mild esophageal dysmotility with tertiary contractions. There was no hiatal hernia and moderate reflux. An esophagogastroduodenoscopy (EGD) identified a normal appearing esophagus without esophagitis without mention of hiatal hernia. The potential hydrogen (pH) testing was performed while off acid suppressing medication and showed a DeMeester score of 20.2 (normal less than 14.7). Esophageal manometry testing showed normal peristaltic pressures. Ninety-four percent of swallows normally peristaltic. There was no manometrically detected hiatal hernia.
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 experimental/investigational (E/I).
The health plan's determination regarding the proposed health treatment is overturned in whole.
LINX is likely to be more beneficial for this patient's condition of GERD (gastroesophageal reflux disease) than standard treatment.
LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the 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) with less incidence of inability to belch or vomit (as can be associated with fundoplication).
Reynolds found that analogous GERD 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. 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.
The patient has symptoms of chronic GERD. She has been appropriately evaluated with pH (potential hydrogen) study, motility testing, esophagram, 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 or esophagram. The EGD (esophagogastroduodenoscopy) identified 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 less than 21.
This treatment (LINX) is consistent with the diagnosis and treatment of this patient's condition. It is appropriate according to generally accepted standards of good medical practice. It is not for the convenience of anyone. It is not E/I. LINX is the most appropriate service required to provide safe and adequate care. LINX is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.