Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: gastroesophageal reflux disease

Treatment: Linx Reflux Management System and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed

The insurer denied coverage for Linx Reflux Management System and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed

The denial is overturned

According to the documentation submitted this is the case of a patient with a history of gastroesophageal reflux disease (GERD). As per the progress note the patient presented to the doctor's office for evaluation of GERD. He recently developed worsening heartburn. His doctor noted on an Esophagogastroduodenoscopy (EGD) that he had Los Angeles Classification (LA) grade B esophagitis on omeprazole 20 mg (milligrams). Daily proton pump inhibitors (PPI) controlled his symptoms. If he skipped doses or ran out of treatment, he would have an exacerbation of symptoms within 2 days. The patient admitted to regurgitation when laying flat. He reported heartburn and regurgitation daily. A barium swallow showed a hiatal hernia small type II; a pH study that showed a Demeester score of 86.1; and a manometry with zero failed swallows. The provider noted the patient's Body Mass Index (BMI) to be 27.32. The provider discussed several anti-reflux surgery options.

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 (Food and Drug Administration). It has been recognized by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) and ASGS (The American Society of General Surgeons) 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. In terms of the actual literature one can find numerous articles that document the efficacy of the LINX. This procedure is FDA approved.

It appears that this patient is a suitable candidate for this device given the fact that the patient has LA Grade B reflux esophagitis on endoscopy and a Demeester score of 86. In addition, there is no evidence of Barrett's esophagus. 

The reviewer does believe that in this case scenario the LINX is as good as the Nissen fundoplication and most likely is the best available treatment for this patient as this patient has GERD with a LA Grade B esophagitis. It is the least invasive and there is enough data that supports it provides durable results for this patient. 

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

Thus, the reviewer has to disagree with the insurer that in this case as the LINX reflux management system (LINX) and one bed day - 43284- laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e. Magnetic band), including cruroplasty shouldbe approved. The LINX can be considered as good as a treatment modality as the gold standard which is fundoplication for this patient. The reviewer would therefore have to say that the LINX may be as beneficial for this patient as the standard treatment.

In summary, the denial of  LINX Reflux Management System (LINX) and one bed day - 43284 - laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of augmentation device (i.e., magnetic band), including cruroplasty when performed 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.