Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease)
Treatment: Linx Procedure (43284)
The insurer denied: Linx Procedure (43284)
The denial is overturned

The patient is an adult female with BMI (body mass index) of 32. She sought surgical evaluation for the symptoms related to GERD (gastroesophageal reflux disease), including heartburn, cough, regurgitation, and a hiatal hernia. The records indicate that she is treated for dyspepsia with acid suppressing medications (Famotidine, Pantoprazole, and Carafate), but does have breakthrough symptoms. There is no reported dysphagia. There is no reported history of prior gastroesophageal surgery in the surgical consultation. The surgical assessment states that 
esophageal motility testing was normal. The patient has been evaluated for this condition with the following:
Contrast UGI (upper gastrointestinal series) showed significant reflux, normal swallowing function, and a normal anatomic esophagus without mention of hiatal hernia.
EGD (esophagogastroduodenoscopy) showed a small hiatal hernia and a Schatzki ring at the gastroesophageal junction.
96-hour pH testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a composite DeMeester score of 29.2 (normal is less than 14.7).
The treating surgeon has proposed the LINX procedure and hiatal hernia repair as treatment of GERD (gastroesophageal reflux disease). The health plan determination is that the Plan considers LINX to be experimental / investigational for the treatment of GERD (gastroesophageal reflux disease).

The health plan should cover the requested LINX procedure.

The requested LINX (43284) is medically appropriate. This treatment (LINX) is medically appropriate for the treatment of pathologic esophageal acid exposure and is not experimental or 
investigative. This treatment is in accordance with generally accepted standards of medical practice, is clinically appropriate and considered effective for the condition being treated. It is not for the convenience of anyone and is the most appropriate care that can be safely provided to this patient.
The proposed LINX has been granted FDA (United States Food and Drug Administration) 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 (gastroesophageal reflux disease) as is documented to exist in this case. LINX is
a proven effective therapy for the condition of GERD (gastroesophageal reflux disease) 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 experimental or investigational. 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.
Since the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to 5-years post implantation. The 2015 follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device. 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 5-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).