Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD [gastro esophageal reflux disease]

Treatment: stomach surgery (procedure code 43284), placement of esophageal sphincter augmentation device

The insurer denied coverage for stomach surgery (procedure code 43284), placement of esophageal sphincter augmentation device.

The denial is overturned.

According to the documentation submitted this is the case of an adult female with a history of GERD [gastroesophageal reflux disease] without esophagitis, hernia, and Barrett's esophagus without dysplasia, chronic diarrhea, depression, and migraine. The patient was seen noted that the patient had an esophagogastroduodenoscopy (EGD) with Bravo test with no dysplasia noted, with DeMeester score of 40.4. The patient had manometry with normal swallowing noted. He noted that the potential hydrogen (pH) study shows significant acid reflux exposure. This was contrary to her previous problem. He noted that she believes she did not stop her proton pump inhibitor (PPI) during that study. She has breakthrough symptom and wishes to proceed with surgical treatment. The assessment was GERD with Barrett's esophagus without dysplasia and the plan was to proceed to request insurance coverage for the Linx. 

Ambulatory esophageal pH monitoring was done and showed abnormal acid reflux and symptoms association probability of 99.9 for heartburn. DeMeester score was 40.4 with score on day 1 of 25.8 and score on day 2 of 49.9. EGD was done with biopsy and showed a 3 cm [centimeter] hiatal hernia. 

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 Association]. It has been recognized by Society of American Gastrointestinal and Endoscopic Surgeons [SAGES] and American Society of General Surgeons [ASGS] 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. In terms of the actual literature one can find numerous articles that document the efficacy of the Linx. Recently, peer review literature concluded in "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study" that the safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm Magnetic Sphincter Augmentation (MSA) as treatment for GERD. 

As noted in SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: Linx reflux management system that longer term experience with the Linx confirms the initial safety profile and the device has been demonstrated to result in long term GERD control. The article concluded that implantation of the Linx device should be covered and reimbursed by insurance for appropriate patients who meet the selection criteria. 

Finally, an additional article reviewed by Smith et al noted in "Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant" and reported that "during a period in more than 3000 patients, no unanticipated MSAD [magnetic sphincter augmentation device] complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD."  

It appears that this patient is a good patient for this device given the fact that the patient has reflux with a DeMeester score of 40 on ambulatory pH monitoring with a small hiatal hernia. The patient does have indications based upon his condition for an anti-reflux procedure with significant reflux and symptoms which correlated with pH study.  The Linx should not be considered investigational. The Linx should be considered as good as a treatment modality as the gold standard, which is fundoplication, and the Linx could be as beneficial for this patient as the standard treatment.  The procedure is likely to be more beneficial than any other existing standard health service.

The carrier's denial of stomach surgery (procedure code 43284); placement of esophageal sphincter augmentation device should be overturned.