Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD).

Treatment: Current procedural terminology (CPT) code 43284 (surgery to place a device around the lower part of the esophagus - Linx Reflux Management System).

The insurer denied coverage for current procedural terminology (CPT) code 43284 (surgery to place a device around the lower part of the esophagus - Linx Reflux Management System).

The denial is overturned.

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 not considered experimental/investigational, and there are unique clinical circumstances, such as failure to medical therapy, to this particular individual for which there is recommended making an individual exception to the medical policy under a medically necessary review.

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 the Nissen surgical approach.

The Linx Reflux Management System (a sphincter augmentation device) is used, according to the FDA (Food and Drug Administration), "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." Note there is a lack of notable large trials for the surgical treatment of GERD and other indications.

From UpToDate; "...the US (United States) 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 (centimeters). The device is a ring made up of a series of rare earth magnets that have sufficient attraction to increase the LES (lower esophageal sphincter) 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 (potential of hydrogen) <4 was reduced from 11.9 percent at baseline to 3.8 percent at three years (ph <0.001). Most patients at >=4 years of observation experienced improved quality of life and complete cessation of the use of PPIs (proton pump inhibitors)." 

Per The Linx Reflux Management System, "The use of the Linx device in patients with a hiatal hernia larger than 3 cm (centimeters) should include hiatal hernia repair to reduce the hernia to less than 3 cm. The Linx device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm. 


The safety and effectiveness of the Linx device have not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants.

The carrier's denial of current procedural terminology (CPT) code 43284 (surgery to place a device around the lower part of the esophagus - Linx Reflux Management System) should be overturned. It is more beneficial than any other standard treatments.