Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3:

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.

This case involves an adult patient under review for revision of LINX device. The clinical note reported the patient had refractory and recurrent reflux symptoms requiring daily proton pump inhibitor therapy. The patient underwent previous magnetic sphincter augmentation that was initially successful, but had recurrent symptoms. It was noted that the diagnostic work-up demonstrated the existing implant was in good position, but the patient continued to have reflux through it. It was reported that surgeon initially utilized a slightly larger implant to avoid significant dysphagia given underlying dysmotility. The patient was recommended for resizing to a smaller implant. The letter of medical necessity reported the patient had LINX implantation surgery approximately three years ago, but developed recurrent symptoms of reflux requiring ongoing medical therapy. It was noted that the patient was found to be moderately impaired with motility with lower contractile indices on manometry. The provider felt revision of device and replacement with a smaller size implant would provide an appropriate antireflux barrier. The letter from the patient reported he had suffered from severe acid reflux since age 20. The patient reported taking proton pump inhibitors with side effects. The patient also reported exercise and diet changes. The patient did not want to undergo an fundoplication procedure. The patient requested revision of the LINX device. The determination letter stated the prior denial of the requested procedure was upheld.  It was noted there was a lack of scientific literature to support improvement in health. Therefore, the procedure was denied as investigational.

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. The device/procedure does have final approval from the appropriate regulatory bodies for this diagnosis. This patient a good candidate for surgery. The surgery is the best available treatment for this patient at this time. The adverse risks are not increased over standard treatment/services. As such, the requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.

In this case, the patient previously underwent the procedure. After initial success, symptoms returned. It was documented that a slightly larger device was used to avoid significant dysphagia given underlying dysmotility. However, given persistent symptoms the provider now wanted to replace with a smaller implant. Given that the procedure was been previously performed, revision would be supported given reoccurrence of symptoms. There is scientific literature to support safety and efficacy of the procedure. 

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.