Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:

Diagnosis: Gastroesophageal Reflux Disease (GERD).

Treatment:  Surgery to place a device (esophageal sphincter augmentation device) around the esophagus, and surgery to take off a device (esophageal sphincter augmentation device); CPT (Current Procedural Terminology) codes 43285 and 43284.

The insurer denied coverage for surgery to place a device (esophageal sphincter augmentation device) around the esophagus, and surgery to take off a device (esophageal sphincter augmentation device); CPT codes 43285 and 43284.  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 considered more effective that other treatment options, and there are unique clinical circumstances, such as failure of medical therapy, to this particular individual, for which it is recommended making an individual exception to the medical policy.

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) (Torax Medical, Shoreview, MN) is used, according to the Food and Drug Administration (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." Note there is a lack of notable large trials for the surgical treatment of GERD and other indications.

From UpToDate; "In 2013, the US Food and 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 lower esophageal sphincter (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 (potential for hydrogen) < (less than) 4 was reduced from 11.9 percent at baseline to 3.8 percent at three years (p (probability) <0.001). Most patients at >= (greater than or equal to) 4 years of observation experienced improved quality of life and complete cessation of the use of PPIs (proton pump inhibitors)." 

The position statement from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) noted the implementation of the LINX device requires minimal dissection and relatively few technical steps when compared to the Nissen fundoplication and that the LINX device may provide an option currently lacking in clinical practice for patients with medically refractory GERD who have not yet progressed to end-stage reflux disease with associated complications. The conclusion was that "on the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD."

In summary, the denial of surgery to place a device (esophageal sphincter augmentation device) around the esophagus, and surgery to take off a device (esophageal sphincter augmentation device); CPT codes 43285 and 43284 and coverage for the requested treatment should be overturned. 

This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.