Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: transoral incisionless fundoplication (TIF) procedure using EsophyX (code 43210) and associated inpatient stay

The insurer denied coverage for transoral incisionless fundoplication (TIF) procedure using EsophyX (code 43210) and associated inpatient stay

The denial is upheld

This is the case of a female with history of refractory gastroesophageal reflux disease (GERD), hiatal hernia, gastritis and duodenal erosions. In an op (operative) note noted that an esophagogastroduodenoscopy (EGD) was done and revealed normal upper, middle third of the esophagus. Mild granular changes were noted in the distal esophagus. A 3.0 centimeter (cm) hiatal hernia was noted as well as duodenal erosions. A biopsy of the esophagus was negative for intestinal metaplasia and dysplasia.

The Letter of Preservice authorization noted the patient's medical history of GERD and the clinical findings of a hiatal hernia of 3 cm, history of nausea and vomiting, abnormal manometry results, pH (acid level) testing and DeMeester score of 11.8. They noted that TIF is a minimally invasive treatment for GERD and the EsophyX system is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI (gastrointestinal) tract and is indicated for symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The letter notes that TIF is also indicated in patients with symptomatic GERD or with patients with hiatal hernia greater than 2 cm when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less. 

A systematic review and meta-analysis of 16 randomized controlled trials (1085 patients) found that although various endoscopic interventions including TIF for chronic, symptomatic gastroesophageal reflux were associated with improved outcomes (e.g., time in remission, GERD health-related quality-of-life scores) for up to 6 months as compared with sham procedure and proton pump inhibitor treatment, additional, larger, randomized studies were recommended to more clearly define the role of endoscopic therapy. 

Finally, MCG (Milliman care guidelines) noted that a manufacturer-sponsored randomized study of 60 patients with chronic GERD comparing transoral fundoplication and proton pump inhibitors found, at 6-month follow-up, that the procedure was associated with improved health-related quality-of-life, heartburn, regurgitation, reflux disease questionnaire, and reflux symptom index scores. The proton pump inhibitor group demonstrated significant improvement in the regurgitation score only. Additional longer-term studies were recommended. An extension study of 52 patients from this randomized trial that included 21 patients in the proton pump inhibitor group who crossed over to transoral fundoplication found, at a median post-procedure follow-up of 34 months, that there was significant improvement in mean symptom scores and that the significant improvement achieved in health-related quality-of-life scores at 1-year follow-up was sustained at 3 years. 

The TIF procedure using EsophyX does have approval from the appropriate regulatory bodies for this diagnosis.

This patient is not believed to be a good candidate for the TIF for several reasons. First, the patient's DeMeester score was 14.7 on one 24-hour pH study. The patient also has been shown to have a 3 cm hiatal hernia and TIF alone is not indicated for this unless it is done with a laparoscopic fundoplication.  

The TIF procedure using EsophyX is not the best available treatment at this time, as the gold standard is a fundoplication for GERD, especially given that the patient has a hiatal hernia of at least 3 cm.

Therefore, the procedure should not be approved as the insurer is correct in stating that the procedure is still considered experimental/investigational given the lack of long-term efficacy data. 

The carrier's denial of the transoral incisionless fundoplication (TIF) procedure using EsophyX (code 43210) and associated inpatient stay should be upheld.