Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD). 

Treatment: Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (LINX Reflux Management System) including cruroplasty (code 43284) and an associated one-day stay. 

The insurer denied coverage for laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (LINX Reflux Management System) including cruroplasty (code 43284) and an associated one-day stay. 

The denial is overturned. 

This case involves a female with a history of gastroesophageal reflux disease (GERD), anxiety, irritable bowel syndrome, and idiopathic gastroparesis who was being recommended for laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (LINX Reflux Management System), including cruroplasty (code 43284) and an associated one day stay. Records stated that the patient underwent surgery consultation whereupon it was noted that she had a 2-year history of worsening reflux. Her main symptoms included heartburn and chest pain. She previously trialed multiple medications to include proton pump inhibitors without significant relief.  Her physician was recommending the laparoscopic LINX procedure.  The surgery was denied with claims that the requested LINX procedure to place a magnetic ring of heads around the lower esophagus remains one that is considered experimental and investigational per insurer clinical policy.  Even though many publications suggest that the LINX procedure is useful, the long-term safety and success in managing reflux has not been shown to be equal to other surgical methods. An appeal was submitted stating that the patient's physician furnished a treatment plan with a comprehensive history and physical, medical records, and relevant supporting literature that clearly supports the LINX procedure. This information included that the LINX procedure was unanimously endorsed by the selected FDA (Food and Drug Administration) advisory panel and approved by the FDA in 2012. This review pertains to the denial of coverage for laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (LINX Reflux Management System)), including cruroplasty (code 43284) and an associated one day stay. 

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

LINX does not need to have final approval from the appropriate regulatory bodies for this diagnosis. It was approved by the FDA in 2012. 

This patient is a good candidate for the LINX procedure. 

The LINX reflux management system is one of the best available treatments for this patient at this time. 

The adverse risks are not increased over standard treatment/services. 

The requested service is likely to be as beneficial or more beneficial than other standard treatment/procedures such as the Nissen fundoplication for this patient. 

Literature states that magnetic sphincter augmentation (MSA) was conceived as a safe, stomach sparing, minimally invasive, reversible implantable device for patients seeking an alternative to laparoscopic Nissen fundoplication.  Records noted that she was having difficulty managing GERD with conservative measures. Current literature noting that since the introduction of magnetic sphincter augmentation with the Lynx device, it has become a proven invaluable alternative therapy to laparoscopic fundoplication.  The proposed surgery would be appropriate to address the patient's condition and relieve her symptoms. 

The carrier's denial of laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (LINX Reflux Management System)), including cruroplasty (code 43284) and an associated one-day stay should be overturned.