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 upheld. 

According to the medical records, the member is a female with a history of gastroesophageal reflux disease (GERD), anxiety, irritable bowel syndrome, and idiopathic gastroparesis. She had a surgery consultation, and it was noted that the patient had a 2-year history of worsening reflux. Her main symptoms were heartburn and chest pain. She had tried multiple medications, including proton pump inhibitors without significant relief. The surgeon recommended a laparoscopic LINX procedure. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome with LINX Reflux Management System, however there is insufficient peer-reviewed literature support to support the use of LINX Reflux Management System over Laparoscopic Nissen fundoplication which is considered the standard surgical approach for treatment of severe gastroesophageal reflux disease (GERD). 
On the other hand, the American College of Gastroenterology (ACG)'s guidelines on "Diagnosis and management of gastroesophageal reflux disease" (Katz et al, 2013) did not agree with the expert opinion rendered by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee.  The ACG guidelines stated that "Endoscopic therapies for GERD have been developed but have not demonstrated long-term efficacy.  These therapies included radiofrequency augmentation to the lower esophageal sphincter (LES), silicone injection into the lower esophageal sphincter, and endoscopic suturing of the LES.  None of these therapies demonstrated long-term improvement in esophageal pH levels or the ability for patients to stop antireflux therapy and were subsequently removed from the US (United States) marketplace. Recent alternative approaches have included transoral incisionless fundoplication, a suturing device designed to create a full thickness gastroesophageal valve from inside the stomach. Unfortunately, long-term data regarding efficacy of this device are limited to a small number of subjects and short duration of follow-up.  A recent study suggested that at 36 months of follow-up, the majority of patients had required additional medical therapy or a revisional fundoplication. 

The patient is an appropriate candidate for a surgical approach for her indication of GERD, however there is insufficient documentation to support the use of LINX over the standard Nissen fundoplication for this patient. 

Given the limited studies available, the need for long-term evaluation, and the controversy between Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and American College of Gastroenterology (ACG), the LINX procedure is still considered experimental/investigational has not yet been proven medically necessary and has not been shown to have beneficial effects on health care
outcomes. 

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 upheld.