Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

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.

The patient has chronic gastroesophageal reflux disease (GERD) and previously had a LINX implant approximately three years ago. He had initial success but is now having recurrent reflux symptoms. He has been on PPI (proton pump inhibitor) therapy but there is a concern about long term side effects. He had an extensive workup including pH (potential for hydrogen) testing and manometry. His physician is now advising him to replace the initial LINX sphincter augmentation with a more appropriate size device. It is felt that a smaller sized device would likely alleviate his symptoms. 

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated Safety and Effectiveness Analysis of the Linx Reflux Management System in March 2017. With regards to safety, the conclusion was that long-term follow-up supports the Food and Drug Administration (FDA) conclusion that the device is safe. With regards to efficacy there were several conclusions. The LINX implant results in pH normalization, improved quality of life, and cessation of regular proton pump inhibitor (PPI) use on a consistent basis. When compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. The long term follow-up data demonstrates that the LINX Reflux Management System is effective in the management of GERD. 

The Annals of Surgery 2019 Aug 270(2):302-308 has an article titled "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study." The conclusion was that both safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm the procedure as treatment for GERD." 

The scientific peer-reviewed literature supports the use of the LINX system. It has been shown to be both beneficial and safe for patients with chronic GERD. The LINX system has been approved by the FDA (Food and Drug Administration). The patient is a good candidate since he has chronic GERD and has concerns about long term PPI therapy. There are multiple options for treating GERD, but the LINX system has been shown to be both effective and safe. His physician feels that putting in a new LINX system with a more appropriate size is the best option for this patient. The denial is overturned.

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.