Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3:
According to the patient's medical chart this is a female. Per a thoracic surgeon the patient has a diagnosis of GERD, confirmed by abnormal pH testing. In a note the provider noted that the patient had a Bravo pH test which revealed a Demeester score of 35. In addition, an endoscopy showed a small hernia with moderate esophagitis. An esophogram shows a Schatzki's ring associated with a 3.7 x 3 cm hiatal hernia. The thoracic surgeon noted an extensive discussion with the patient and that he would seek prior authorization for the LINX. The surgeon noted that her BMI is in the upper limits for LINX with a BMI of 35. The surgeon noted that uncertainty if Schatzki's ring is contraindicated for LINX.

The patient had a prior endoscopy in mid-2017 which showed a 1 cm hiatal hernia with moderate esophagitis. Eosphagram done in mid-2019 showed a small sliding type hiatal hernia with associated non obstructive Schatzki ring with gastroesophageal reflux. Ambulatory reflux pH monitoring study was done in mid-2018 which showed a Demeester score of 35. High resolution esophageal motility study was performed which revealed normal upper esophageal sphincter (UES) and LES relaxation. Overall peristalsis shows normal morphology. The overall impression was borderline normal study with approximately 50% of the swallows showing weak peristalsis.
The letter from the department of health human services dated in early 2012 indicated that that the PMA was approved by FDA. Schwaitzberg noted in surgical management of gastro esophageal reflux in adults, in Up-to-date   http://www.uptodate.com/contents/surgical-management-of-gastroesophageal-reflux-in-adults, that eligible patients for the procedure include those with all of the following: Typical GERD symptoms; abnormal pH study; Partial response to daily PPI therapy; Absence of a large hiatal hernia (>3 cm) or severe esophagitis. There is scientific evidence in peer reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the FDA. It has been recognized by SAGES and ASGS as an option for treating GERD. There are long term results out to 5 years with improvement in the health outcomes for patients undergoing the LINX procedure. 
It does not appear that this patient is a good patient for this device given the fact that the patient has a Schatzki ring on esophagram and has a borderline BMI for which this device has been studied. That is the patient has a BMI of 35.  The manufacturer as well as Telem in TVAC for SAGES note that the safety and effectiveness of the device has not been shown for patients with a Schatzki ring; therefore, the patient is not a good candidate for this device. In this case scenario the LINX is not the best available treatment for this patient as this patient has a Schatzki ring and has borderline BMI of 35 for which the device has not been shown to be indicated for. Given the history of GERD and Demeester score of 35, the patient does need treatment. However, LINX is not appropriate as noted by Telem in the SAGES TVAC report.

Therefore, the LINX would not be more beneficial for this patient than the standard treatment.

Based on the above, the medical necessity for the LINX Reflux Management System is substantiated/ not substantiated.  The insurer's denial is upheld.