Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease (GERD).

Treatment: procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus..

The insurer denied coverage for procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus.

The denial is overturned.

According to the documentation submitted this is the case of a patient who has a history of gastroesophageal reflux disease (GERD) diabetes, hyperlipidemia, hypertension (HTN), obstructive sleep apnea (OSA) and pancreatitis. As per the telehealth visit for clearance for the Linx procedure, the patient initially presented to the office for consultation; however, he was experiencing severe epigastric pain and subsequently underwent robotic cholecystectomy. He has been doing well at home and was ready to discuss antireflux surgery options. His primary symptom was heartburn which started years ago. He was stared on omeprazole, which was controlling his symptoms, so he tried to wean down to 20 milligrams (mg), but he had breakthrough symptoms. Now he was on 40 mg again and it was controlling his heartburn adequately. However, regurgitation was uncontrolled. He admitted to regurgitation and globus sensation at night, intermittent dysphagia to hard meats. He had an EGD (esophagogastroduodenoscopy) performed by which showed LA grade B esophagitis and small gastric ulcers. He more recently underwent pH (potential of hydrogen) testing off PPI (proton pump inhibitor) and motility studies which proved pathologic acid reflux exposure time of 24.6% (percent) while supine and upright with good symptom correlation to heartburn as well as normal esophageal motility. His body mass index (BMI) was 32.5. The plan was robotic Linx placement.

Recently Louie et al concluded "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results from a Post Approval Study" in Ann Surg ...that the safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA [Magnetic Sphincter Augmentation] as treatment for GERD. Telem et al noted in SAGES [Gastrointestinal and Endoscopic Surgeons] technology and value assessment committee (TAVAC) safety and effectiveness analysis: Linx reflux management system in Surg Endosc...that longer term (3-5 years) 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. 
Therefore, the Linx procedure can improve health outcomes and the insurer is wrong to claim that it is investigational as it does improve health outcomes as there is considerable literature to support this. This procedure is FDA approved.

The Linx is a good available treatment for this patient as this patient has GERD with a Demeester score of 81.6 and does require treatment. It is the least invasive and would provide durable results for this patient and as noted by the provider he is a good candidate fort the Linx. There is no reason to do a very invasive procedure such as a Nissan fundoplication when one can get a durable result with the Linx. The Linx offers several advantages over the fundoplication approach; the fundus wrap is extremely invasive and is non-reversible; the fundoplication often leaves the patient with the inability to vomit and vent their stomach. 

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

The Linx should be considered as good as a treatment modality as the gold standard which is fundoplication for this patient, and I would have to say that the Linx could be as beneficial for this patient as the standard treatment as it is less invasive.

The carrier's denial of procedure code 43284, surgery to place an esophageal sphincter augmentation device around the esophagus should be overturned.