Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease and chronic gastro esophageal reflux disease (GERD). 
Treatment: Magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284). 

The insurer denied coverage for magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284). 

The denial is overturned. 

The patient has Crohn's disease and chronic gastro esophageal reflux disease (GERD). He has been on long term proton pumpinhibitor (PPI) use. An esophagram revealed spontaneous gastroesophageal reflux anti-reflux surgery, LINX procedure, was advised. 

Some studies are as follows. 
 
"Background and aims: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy...Conclusion: Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.)." (Bell, R., et al. 2019). 

"In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997. opens in new tab.)" (Ganz, R.A., et al. 2013). 

"Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation." (Lipham, J.C., et al. 2012). 

The Laparoscopy Procedure, LINX Reflux Management System CPT Code: 43284- Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty is supported by peer literature. 

The LINX Reflux Management System (a sphincter augmentation device) (Torax Medical, Shoreview) is used, according to the FDA [food and drug administration], "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. 
 
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 [current procedural terminology]) code 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device) as an alternative the Nissen surgical approach. 

The requested procedure is likely to be more beneficial than any other standard service. 

The carrier's denial of the magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284) should be overturned.