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.

According to the documentation submitted, this is the case of an adult male with a history of gastroesophageal reflux disease (GERD) and hiatal hernia. As per a telemedicine visit with his doctor the patient presented for a follow up regarding GERD and a hiatal hernia. Without medication he experiences acid reflux with throat burning and abdominal bloating. He is currently using Dexansoprazole 60 milligrams (mg) daily for relief. He was noted to be a candidate for laparoscopic, possibly robotic repair of his hiatal hernia. Review of studies included esophageal manometry where a small hiatal hernia was present and normal LESP (lower esophageal sphincter pressure) with good relaxation was noted. The diagnosis was normal esophageal function. UGI (upper gastrointestinal) series revealed a Schatzki's ring with a small hiatal hernia and mild GERD. Endoscopy revealed LA (Los Angeles) Grade C (erosion(s) extending over mucosal folds, but over less than three-quarters of the circumference) reflux esophagitis with biopsy negative for intestinal metaplasia. A bravo pH (potential for hydrogen) capsule test revealed abnormal esophageal acid exposure in the supine position on both days (D) (D1 and D2) with DeMeester score on Day 1 of 31 and Day 2 of 21. Symptom correlation was good for heartburn. The provider reviewed the surgical options and based upon the findings felt that the patient was a suitable candidate for a lap placement of the LINX device. In the prior visit the provider did note that the patient had an EGD (esophagogastroduodenoscopy) where it was noted an LA Grade A (mild reflux) esophagitis with moderate sliding hiatal hernia and reflux was seen. 

There is scientific evidence in peer-reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the FDA (food and drug administration). It has been recognized by SAGES (The Society of American Gastrointestinal and Endoscopic Surgeons) and ASGS (The American Society of General Surgeons) as an option for treating GERD. There are long-term results out to 5 years with improvement in the health outcomes for patients undergoing the LINX procedure. 

The reviewer does not believe that in this case scenario, the surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus is the best available treatment for this patient, as this patient has GERD with a LA Grade C esophagitis and an apparent Schatzki's ring on UGI. There are not enough studies in these patients to state if this procedure is the best available treatment and therefore at this time, the reviewer does not believe that it should be approved. Despite the fact that it is the least invasive procedure, there is not 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 that the standard fundoplication. The surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus cannot be considered as good a treatment modality as the gold standard, which is fundoplication for this patient, given the lack of data in this patient type with LA Grade C esophagitis and Schatzki's ring. Surgical procedure (43284) esophageal sphincter augmentation device around the lower part of the esophagus may not be as beneficial for this patient as the standard treatment.

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