Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Heartburn, epigastric pain and bloating
Treatment: Upper GI endoscopy- esophagogastroduodenoscopy with radiofrequency ablation (RFA)
The insurer denied Upper GI endoscopy- esophagogastroduodenoscopy with radiofrequency ablation (RFA).
The determination is upheld.

This patient has a (body mass index (BMI) 35 kilograms per square meter (kg/m2)) with a history of gastro-esophageal reflux disease (GERD). She has a history of a prior Roux-en-Y gastric bypass with subsequent weight loss from 400 pounds (lbs) to her current weight of 230 lbs. She is also status post hiatal hernia repair. Her symptoms include heartburn, epigastric pain and bloating. She has been treated with proton pump inhibitor (PPI) therapy, Gaviscon, and baclofen without any relief of symptoms. She reports no dysphagia. She sought consultation and has completed evaluation.
A potential hydrogen (pH) study was performed that showed esophageal acid exposure that was within normal limits. The DeMeester score was 0.3 (normal less than [<] 14.7). There was no clear symptom correlation for heartburn.
Esophageal manometry showed low lower esophageal sphincter pressure. There was ineffective esophageal peristalsis. 70% of swallows had failed peristalsis and 20% were weak. 90% were ineffective. There was no manometric hiatal hernia.
An esophagram showed anatomic changes of a prior Roux-en-Y gastric bypass. The esophagus is described as being of increased caliber, but stable from a prior contrast upper gastrointestinal (UGI) study.
The treating doctor has proposed Stretta for the treatment of GERD.
At issue is whether this is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Based on the submitted clinical data, the proposed upper endoscopy with RFA (Stretta) is not likely to be more beneficial for this patient's condition that other standard treatment.
Based on Food and Drug Administration (FDA) approval and the extensive body of peer-reviewed literature in specific clinical circumstances, in this case the diagnosis of surgically-amenable GERD is not established based on objective testing. The patient has had prior Roux-en-Y gastric bypass that confounds her symptoms of heartburn, epigastric pain and bloating. The pH study does not identify elevated or pathologic esophageal acid exposure as the DeMeester score was within the normal range. Finally, the esophageal motility study showed showed low lower esophageal sphincter pressure. There was ineffective esophageal peristalsis. 70% of swallows had failed peristalsis and 20% were weak. 90%were ineffective. This study suggests an esophageal motility disorder may be contributing to her symptoms and would not be anticipated to resolve with the proposed intervention.
Recent literature regarding Stretta includes a meta-analysis of 18 studies involving 1441 patients that found significant improvement in heartburn and GERD quality of life scores after the Stretta procedure. This study confirmed that there was also significant reduction in DeMeester score (esophageal acid exposure) after treatment. Adverse events were infrequent and typically minor. Art et al reported in a double blind randomized sham-controlled cross-over study of the Stretta procedure. In this study, the Stretta procedure was associated with a significant decrease in tissue compliance with corresponding symptom score improvement and reduced medication usage. These reports and the others cited below document a positive effect on medication use, quality of life satisfaction, and symptoms that is superior to that achieved with anti-secretory therapy.
However, this patient does not have GERD as the etiology of her symptoms based on the submitted diagnostics noted above. In this case, the clinical documentation does not definitively confirm that this patient has surgically-amenable GERD that is likely to respond favorably to the proposed intervention with Stretta.