Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastric Reflux
Treatment: Outpatient Linx Procedure
The insurer denied the outpatient Linx procedure.
The denial is overturned.

This patient is an adult female with BMI (body mass index) of 34. She sought surgical evaluation for the symptoms of heartburn, coughing, and chest pain. The records indicate that she is treated for dyspepsia with acid suppressing medications (Dexilant) but does have breakthrough symptoms. In addition to PPI (proton pump inhibitor) medications, she has also used histamine blocker medication (Pepcid), cytoprotective medication (Carafate), diet change and behavior modification with the head of bed elevation. She has no reported dysphagia. The patient has been evaluated for this condition with the following: EGD (esophagogastroduodenoscopy) that showed no esophagitis. There was no mention of hiatal hernia. The Z-line was irregular. Esophagram showed a small hiatal hernia and normal esophageal motility. Potential hydrogen (pH) testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a DeMeester score of 66.8 (normal less than 14.7). Symptom correlation was 77% (percent) for heartburn and 73% for chest pain. Esophageal motility showed normal esophageal peristalsis. There was no hiatal hernia noted on manometry testing. There was normal distal contractile integral. There was no Chicago Classification abnormality found. The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease). This treatment option is offered as an alternative to Nissen fundoplication.

The health plan determination is that the LINX is experimental/investigational (E/I) for the treatment of GERD.

The health plan should cover the requested LINX procedure.

This patient has symptomatic GERD. She has completed evaluation with UGI (upper gastrointestinal study), EGD, pH testing, and esophageal motility testing. In this case LINX is consistent with the symptoms and diagnosis of proven pathologic esophageal acid exposure. LINX is performed by a licensed provider and is in accordance with the standards of good medical practice. LINX is not for the convenience of anyone. This treatment is FDA (Food and Drug Administration) approved. LINX is widely accepted as necessary and appropriate treatment for the condition of GERD as is documented to exist in this case and is not E/I based on the quality and quantity of published peer-reviewed literature. The requested LINX procedure is likely to be more beneficial than standard treatment for the insured's condition. The proposed LINX has been granted FDA approval since 2012. It is not the subject of phase I, II or III clinical trials. Based on the volume and quality of the peer-reviewed literature cited below, the safety, effectiveness, and effect on health outcomes has been established. Reliable evidence shows that the LINX procedure is safe and effective for the treatment of GERD as is documented to exist in this case. LINX is a proven effective therapy for the condition of GERD and is generally recognized by the medical community as effective and appropriate for the specific diagnosis of this patient. The LINX procedure as proposed in this case is not E/I. There has been completion of ongoing clinical trials NCT00776997 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.