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 an adult who presented to his doctor's office for follow up to discuss his surgical options, including fundoplication versus LINX. The provider noted the patient still has regurgitation symptoms though the need for additional medication beyond his omeprazole has been reduced lately. He noted the following upper gastrointestinal (UGI) studywith normal esophagus and moderate to large gastroesophageal reflux elicited up to upper esophagus. Endoscopy showed Z line was regular at 44 centimeters (cm) from the incisors.  The Bravo pH (acid or alkaline ) capsule was applied and the patient had a Demeester score of 22.5. The provider felt he was a good candidate for the LINX.

High resolution esophageal motility study revealed normal lower esophageal sphincter (LES) relaxation, normal peristalsis.

Upper gastrointestinal (UGI) study was performed on and revealed moderate to large gastroesophageal reflux to the upper esophagus noted. There was normal peristalsis otherwise noted and a small hiatal hernia.

All articles provided were reviewed. 

There is clearly scientific evidence in peer reviewed literature that supports and substantiate the improvement in health outcomes as well as its safety and effectiveness by doing the LINX procedure.

 In addition, there are long term results out to 5 years with improvement in the health outcomes for patients undergoing the LINX procedure. One can find numerous articles that document the efficacy of the LINX. For example, Ayazi et al reported on the "Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients" in J Am Coll Surg 2020 and the authors concluded in this largest single-institution series that LINX implantation is associated with very good clinical and objective outcomes. In addition, Sterris et al noted "Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons" in Curr Opin Gastroenterol 2020 that "LINX is a safe and efficacious procedure originally approved for patients with medically refractory, uncomplicated gastroesophageal reflux disease. The accumulating body of evidence suggests patients with intestinal metaplasia or hiatal hernias can safely and effectively undergo the LINX procedure." The authors noted that "LINX is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far."  Therefore, there is sufficient literature to support that the LINX procedure can improve health outcomes in the appropriate case.

This procedure is FDA approved.

It appears that this patient is a suitable candidate for this device given the fact that the patient has Demeester score of 22.5 with moderate reflux to the upper esophagus noted. There was normal anatomy and motility study was normal. 

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. 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.

In summary, the denial of procedure code 43284, LINX Reflux Management System and coverage for the requested service/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.