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. 

According to the documentation submitted this is the case of a male with a history of gastroesophageal reflux disease (GERD), ankylosing spondylitis with Crohn's colitis and perianal fistulous disease. As per progress note, the patient presented with a history of symptoms related to GERD and has been taking daily proton pump inhibitor (PPI) since. He now takes omeprazole 20 mg [milligrams] bid which controls his heartburn. He admits to intermittent regurgitation of food and acid, as well as oropharyngeal dysphagia with every meal. Patient had an esophagram which revealed normal motility, spontaneous reflux, no hiatal hernia. Esophagogastroduodenoscopy (EGD) done revealed regular Z line 37 cm [centimeter], antral gastritis, and normal path. Manometry revealed normal esophageal motility with 80% [percent] clearance and pH [potential of hydrogen] impedance off PPI revealed significant pathologic reflux, greater upright with borderline correlation to heartburn. Patent also had Video Fluoroscopic Swallowing Exam (VFSE) which revealed mild dysphagia and mildly reduced upper endoscopic ultrasound (UES) opening. At this point patient discussed anti- reflux surgery but wanted to monitor LINX data. Per the office visit, the patient has pathologic GERD with proton pup inhibitor dependence and normal esophageal motility.  The doctor felt the patient was a good candidate for the LINX procedure especially with his biologic immunosuppressive therapy, which can lead to hiatal hernia recurrence after his stomach is mobilized for a fundoplication. 

Swallowing study was done with the findings of abnormal oropharyngeal swallow
Esophagram done showed normal esophageal motility, spontaneous gastroesophagal (GE) reflux to the level of the aortic arch with no radiologic evidence of esophagitis. No hiatal hernia was noted. 

Ambulatory reflux monitoring- pH impedance was done which showed a Demeester score of 40 with a symptom association probability of 95.8.  The impression was significant acid reflux by all metrics. 

High resolution motility study showed normal esophageal motility. 

EGD showed normal esophagus. 

This procedure is Food and Drug Administration (FDA) approved. 

It appears that this patient is a good patient for this device given the fact that the patient has reflux with a Demeester score of 40 with a symptom association probability of 95.8 and no hiatal hernia noted. Furthermore, Schwaitzberg noted "eligible patients must have GERD confirmed by a pH study. In addition, the manufacturer of the LINX device also suggests that the patient have no large (>3 cm) or paraesophageal hiatal hernias, severe esophagitis, Barrett esophagus, obesity esophageal dysmotility, or prior upper gastrointestinal tract surgery." Thus, the patient does have indications based upon his condition for an anti-reflux procedure with significant reflux. 

In this case, the LINX may be an excellent available treatment for this patient as this patient has GERD with a Demeester score of 40 and does require treatment. It is the least invasive and would provide durable results for this patient and as noted by the provider he is a good candidate fort the LINX especially given his biologic immunosuppressive therapy for his Crohn's. There is no reason to do a very invasive procedure such as a Nissan fundoplication when one can get a durable result with the LINX. The LINX offers several advantages over the fundoplication approach; the fundus wrap is extremely invasive and is non-reversible; the fundoplication often leaves the patient with the inability to vomit and vent their stomach. 

Furthermore, Schwaitzberg also noted that "MSA [magnetic sphincter augmentation] implantations have consistently demonstrated reduced GERD symptoms and improved GERD-related quality of life scores, cessation of PPI use, and substantial normalization of objective GERD measurements in the majority of patients." 

The adverse risks are not increased over standard treatment services as this procedure is less invasive that the standard fundoplication. The LINX 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.