Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3:

This is a male patient with a history of gastroesophageal reflux disease (GERD), hiatal hernia, esophagitis, esophageal diverticulum, Zenker's diverticulectomy, and cricopharyngeal myotomy. It was reported that at the time of his surgery he was advised of anti-reflux surgery but refused stating he wanted to pursue medical intervention as treatment. He had an esophagram that revealed a Zenker's diverticulum with associated cricopharyngeal enlargement/spasm. He had a DeMeester score of 27 with normal upper esophageal sphincter (UES) and lower esophageal sphincter (LES) relaxation. Normal peristalsis was noted as well with no hiatal hernia. It was advised that he undergo a LINX procedure. 

The appealer noted in an appeal letter that noted that the patient has a long history of GERD and the use of daily acid suppressing medications taken by the patient do not provide complete relief of symptoms. They added that the LINX is a safe and effective fundic sparing surgical treatment option for GERD that addresses the underlying mechanical and anatomical etiology of the disease and is associated with fewer side effects and complications. In addition, multiple studies and peer reviewed articles clearly support the use of the LINX system and its proven safety and efficacy.  References were attached. 

A predetermination undated letter for this patient noted the FDA approved the LINX in March 2012. The LINX is indicated for patients diagnosed with GERD as defined by abnormal pH testing and who are seeking an alternative to continuous acid suppression therapy in the management of their GERD. The provider noted that the LINX has been independently evaluated and recommended by both the Society of American Gastrointestinal and Endoscopic Surgeons [SAGES] and the American Society of General Surgeons [ASGS] as an appropriate alternative to fundoplication, and therefore requests coverage for the procedure for this patient. 

This reviewer does not believe that in this case scenario that the LINX is the best available treatment for this patient as this patient has a recurrent Zenker's diverticulum for which he had undergone surgery in 2017.  Given the history of GERD and DeMeester score of 27, the patient does need treatment.  However, this reviewer does not believe that the LINX is appropriate as noted by Telem in the SAGES TVAC report where it was noted that precaution should be taken in using the LINX in patients with prior esophageal or gastric surgery or endoscopic intervention which this patient did have in 2017.  Furthermore, the TVAC report notes that the safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions: gross esophageal anatomic abnormalities.  The LINX would be considered as good as a treatment modality as the gold standard which is fundoplication, but not for this patient given the recurrent Zenker's as well the previous esophageal surgery history in 2017.  Therefore, the gold standard is a Nissen fundoplication, and this reviewer maintains that the LINX would not be more beneficial for this patient than the standard treatment.

The carrier's denial of coverage for LINX procedure for GERD should be upheld.