Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD)
Treatment: LINX device (procedure code 43284)
The insurer denied coverage for LINX device (procedure code 43284).
The denial is overturned.

According to the documentation submitted, this is the case of an adult male who presented to his doctor for the evaluation of gastroesophageal reflux disease (GERD). The patient had started experiencing symptoms of belching. He enjoys running and will feel heartburn afterwards. He denied feeling heartburn or regurgitation throughout the day if he is on a strict diet. He sleeps on a wedge. He will wake up in the morning with a sour taste in his mouth and a dry raw feeling in his throat. He has had a Barium swallow and upper gastrointestinal (UGI) study which did not show a hiatal hernia, did not show a Schatzki ring but did show reflux. A pH (acid or alkaline) study off proton pump inhibitors (PPI) showed a Demeester score of 39.1. Manometry study showed 0 percent (%) failed or weak swallows. The assessment was that the patient does have reflux with objective testing and good correlation with belching. He does not have response to symptoms with PPI use. 

High resolution esophageal motility showed Chicago classification diagnosis being normal.

UGI study showed no hiatal hernia, reflux without radiologic evidence of esophagitis.

Esophagogastroduodenoscopy (EGD) showed Z line (squamocolumnar junction) irregularity. Esophageal biopsy was negative for intestinal metaplasia.

All articles included by the appealer were reviewed. 

There is scientific evidence in peer reviewed literature to support LINX and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the Food and Drug Administration (FDA). 

It appears that this patient is a suitable candidate for this device given the fact that the patient had an EGD which showed no esophagitis, no hiatal hernia. The Demeester score was 39.1. There was normal anatomy and good symptom correlation. 

Schwaitzberg notes in "Surgical management of gastroesophageal reflux in adults" UpToDate 2023 that eligible patients must have GERD confirmed by a pH study. In addition, the manufacturer of the LINX device also suggests that the patient have no large [greater than (&gt;) 3 centimeters (cm)] or paraoesophageal hiatal hernias, severe (Los Angeles class C or D) esophagitis, Barrett esophagus, obesity [body mass index (BMI) &gt; 35], esophageal dysmotility, or prior UGI tract surgery. Thus, this patient has reflux and an elevated Demeester score with symptoms associated probability and as such is a good candidate for LINX. In addition, Louie BE noted in "Magnetic sphincter augmentation (MSA)" in UpToDate 2023 that initial guidance provided by the manufacturer also suggested that patients should have: No hiatal hernia &gt; 3 cm or a paraoesophageal hernia; No esophagitis worse than Los Angeles (LA) class A or B; adequate esophageal motility; BMI less than (&lt;) 35; no Barrett esophagus and no prior esophageal or gastric surgery. Thus, given these references it appears that the patient is a suitable candidate for esophageal sphincter augmentation device.

The reviewer does believe that in this case scenario the LINX is as good as the Nissen fundoplication and most likely is the best available treatment for this patient as this patient has GERD without any esophagitis noted or other pathology on endoscopy. 

The adverse risks are NOT increased over standard treatment services as this procedure is less invasive than the standard fundoplication.

In summary, the denial of LINX device (procedure code 43284) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.