Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: Transoral incisionless fundoplication
The health plan should cover the Transoral incisionless fundoplication.

The TIF is no longer experimental in appropriate clinical scenarios based on scientifically published literature cited below, and because clinical outcomes have been demonstrated to be improved compared with non-surgical therapy and on par with more invasive surgical therapy in appropriately selected situations, as in this case.

The Transoral incisionless fundoplication is likely to be more beneficial.

This treatment is not considered by the medical community to be experimental or investigational for the treatment of the enrollee's condition and is likely to be more beneficial than alternative treatment.  

The clinical body of literature regarding the TIF procedure has expanded with published outcomes data. Current therapy for the surgical management of GERD that has withstood the scrutiny of peer-reviewed analysis consists of laparoscopic Nissen Fundoplication, LINX magnetic sphincter augmentation, ongoing medicinal treatment with acid suppression medications, and the endoluminal procedure of transoral fundoplication as has been offered in this case. The requested therapy offers excellent clinical results with a less invasive surgical approach. This therapy is likely to be more beneficial than alternative therapy because it offers equivalent esophageal acid exposure reduction with a less invasive, endoscopic approach.

The clinical information includes recently published peer-reviewed literature that supports the efficacy, safety, and application of the transoral incisionless fundoplication (TIF) procedure for selected patients with refractory GERD. The clinical documentation supports that this patient does have GERD with pathologic esophageal acid exposure. Therefore, fundoplication is a medically indicated treatment option for this patient and the TIF procedure is a therapy that has garnered the support of the peer-reviewed scientific community.  
The proposed TIF is appropriate to treat the patient's condition and is consistent with generally accepted standards of medical practice in the US based on credible scientific evidence published in peer reviewed medical literature that is generally recognized by the relevant medical community, national physician specialty society recommendations and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors.

The TIF procedure is an endoluminal procedure for the treatment of GERD. Published clinical literature supports that it is now accepted by the medical community for the surgical treatment of GERD in appropriately selected patients. The records also support that this patient is such an appropriate patient with documented symptomatic GERD, elevated esophageal acid exposure, no precluding hiatal hernia and no reported dysphagia to indicate abnormal esophageal motility. The motility study is normal.

Based on the patient specific clinical data, which confirms pathologic esophageal acid exposure, no dysphagia, normal motility, and based on the published literature regarding the transoral incisionless fundoplication procedure, this procedure is medically appropriate and is not E/I for this patient.