Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: CPT 43284 (Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed)

The insurer denied coverage for CPT 43284 (Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed). The denial was reversed.

This patient is a female with a history of gastroesophageal reflux disease (GERD), failing medical therapy. Her body mass index (BMI) is 25.6 and the LINX Reflux Management System has been recommended. 

There is growing, sufficient, published peer-reviewed data from well-constructed clinical studies to permit a scientific conclusion regarding the benefit of laparoscopic magnetic sphincter augmentation procedure for the treatment of GERD using the (CPT) code 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device) as an alternative to the Nissen surgical approach. The requested service is a beneficial option for the standard treatments/procedures for this patient.     

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes with use of the requested service. Surgical procedure, CPT 43284 (Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed) has final approval from the appropriate regulatory bodies for this diagnosis. The LINX device was approved by the FDA in early 2012.     

This patient is a good candidate for surgical procedure, CPT 43284 (Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed).     

It is the best available treatment for this patient at this time.

The LINX Reflux Management System (a sphincter augmentation device) (Torax Medical, Shoreview, MN) is used, according to the FDA, "to treat gastroesophageal reflux disease (GERD) in patients who continue to have GERD symptoms despite the use of maximum medical therapy for the treatment of their reflux." 

Furthermore, the "LINX device is used in patients who continue to have symptoms of GERD, such as heartburn and reflux, despite maximum medical therapy (daily use of medicines such as proton pump inhibitors). It is intended to be used by patients who would be considered candidates for anti-reflux surgery."

From UpToDate; "In 2013, the US Federal Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. The device is a ring made up of a series of rare earth magnets that have sufficient attraction to increase the LES closure pressure, but allow for food passage with swallowing. Results from early studies at four years are encouraging. Based upon a prospective study that included 44 patients, the mean total percent time pH <4 was reduced from 11.9 percent at baseline to 3.8 percent at three years (p<0.001). Most patients at 4 years of observation experienced improved quality of life and complete cessation of the use of PPIs." 

After review of the clinical records, medical history, and physical examinations, supporting information, Plan provisions, and relevant guidelines and literature, the (CPT) code 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device) is likely to be more beneficial than any other standard treatment.

The carrier's denial of surgical procedure, CPT 43284 (Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed) should be reversed.