Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)
Treatment: Procedure code 43284 (LINX Reflux Management System)
The insurer denied coverage for procedure code 43284 (LINX Reflux Management System)
The denial is overturned

According to the documentation submitted this is the case of a patient with a history of gastroesophageal reflux disease (GERD), obesity and Peyronie's disease. The patient was seen by the provider who noted that the patient had a history of Hodgkin's lymphoma and had chemotherapy and radiation therapy. Ever since then he has had acid reflux. He has been on proton pump inhibitors (PPI) and histamine (H2) blockers. His body mass index (BMI) was 29.99. The provider discussed at length with the patient LINX versus fundoplication. The patient was seen again at which time the results from the esophagogastroduodenoscopy (EGD) and Bravo capsule test were reviewed. It was noted that the EGD showed no esophagitis, no hiatal hernia, no gastritis and negative H. (Helicobacter) Pylori. The DeMeester score was 63. He noted that there was normal anatomy with significant acid exposure and good symptom correlation. The plan was LINX pending insurance approval.

This procedure is Food and Drug Administration (FDA) approved.

It appears that this patient is a suitable candidate for this device given the fact that the patient had an upper endoscopy which showed no esophagitis, no hiatal hernia, no gastritis and negative H pylori. The DeMeester score was 63 on Bravo study. There was normal anatomy with significant acid exposure and good symptom correlation. Furthermore 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 (&gt; (greater than) 3 cm (centimeters)) or paraoesophageal hiatal hernias, severe (Los Angeles class C or D) esophagitis, Barrett esophagus, obesity (body mass index &gt;35), esophageal dysmotility, or prior upper gastrointestinal tract surgery. The workup for GERD includes endoscopy "to assess the esophageal and gastric mucosa for signs of malignancy, esophagitis, stricture, or intestinal metaplasia (Barrett's esophagus); Ambulatory pH testing as the gold standard for diagnosing pathologic GERD. Prior to antireflux surgery, all patients with nonerosive GERD should undergo standard pH testing to document abnormal distal esophageal acid exposure; esophageal manometry is the most reliable way to assess lower esophageal sphincter competence and esophageal peristalsis. It can diagnose scleroderma or achalasia, for which antireflux surgery may be contraindicated. And finally, barium esophagram can demonstrate esophageal length, presence and size of any hiatal hernia, presence of any esophageal diverticulum or stricture, and the extent of reflux with provocation." Thus, this patient has significant reflux up to the mid thorax by barium study and with the elevated DeMeester score and symptoms associated is a good candidate for LINX.

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 significant GERD without any esophagitis noted or other pathology on endoscopy. It is the least invasive and there is enough data that supports it provides durable results for this patient. 

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

The LINX can be considered as good as a treatment modality as the gold standard which is fundoplication for this patient. LINX may be as beneficial for this patient as the standard treatment.

In summary, the denial of procedure code 43284 (LINX Reflux Management System) 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.