Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease (GERD).
Treatment: Surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus.
The insurer denied coverage for surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus.
The denial is upheld.

This case involves an adult male diagnosed with GERD (gastroesophageal reflux disease) and hiatal hernia who was being recommended for esophageal sphincter augmentation using the Linx device. The patient was denied approval for a LINX reflux management system. The final adverse determination letter stated the surgery was not approved because there is no proof or insufficient proof that it improves health.  The physician treating the patient responded in an appeal letter stating that there are multiple studies supporting the safety and effectiveness of the LINX reflux management system and its long-term outcomes. This review pertains to the denial of coverage for surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus.  

Scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes.

The surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus does not need final approval from the appropriate regulatory bodies for this diagnosis.

However, at present, the patient is not a good candidate for the surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus given that he was awaiting hiatal hernia repair and was reportedly responding favorably to the use of medications for treatment of gastroesophageal reflux.

The surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus is not the best available treatment for this patient at this time.

The adverse risks are not increased over standard treatment/services other than the use of proton pump inhibitors, which are noninvasive.

Current medical literature has noted that regurgitative gastroesophageal reflux disease refractory to medical treatment is common and caused by mechanical failure of the antireflux barrier, including the lower esophageal sphincter (LES). Proton pump inhibitors do nothing to restore a week lower esophageal sphincter, and are frequently ineffective in alleviating regurgitation despite, and misperception that medications are sufficient therapy.  

Antireflux surgery is the most effective therapy to control medically refractory regurgitative symptoms with the medic sphincter augmentation (MSA) and the LINX device as an alternative to fundoplication that uses medic traction from inside a series of titanium beads to augment the weak LES and re-establish the body's natural barrier to reflux. Literature was noted that this surgical procedure has been found effective and provides improvement in managing regurgitation and heartburn. The provided information noted that the patient was awaiting treatment for a hiatal hernia. He endorsed that he was willing to wait for the laparoscopic placement of the LINX device since medication appeared to be helpful. It would be prudent to determine his response to the hiatal hernia repair and how it affects his gastric reflux to determine if he still requires the esophageal sphincter augmentation device after the hernia repair surgery. 

At this time, the requested service is not likely to be more beneficial than any of the standard treatment/procedures for this patient.

The carrier's denial of surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus is upheld.