Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease
Treatment: Scope test- esophagogastroduodenoscopy with radiofrequency ablation (RFA)
The insurer denied Scope test- esophagogastroduodenoscopy with radiofrequency ablation (RFA)
The determination is upheld.

This patient has a persistent globus sensation. She had an esophagogastroduodenoscopy (EGD) which revealed a small hiatal hernia but no endoscopic evidence of gastroesophageal reflux disease (GERD). Her symptoms are inadequately controlled with a proton pump inhibitor (PPI) and histamine (H2) receptor antagonist. A potential of hydrogen (pH) study was normal. Therefore, the attending physician would like to perform the Stretta procedure to treat this patient's GERD. At issue is whether the Stretta procedure, scope test- Esophagogastroduodenoscopy with radiofrequency ablation (RFA), is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed health service or treatment scope test- Esophagogastroduodenoscopy with radiofrequency ablation (RFA) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Based on current evidence and practice guidelines the Stretta procedure does not provide long term relief of GERD or decrease a patient's dependance on a PPI. Moreover, patients who have GERD refractory to PPIs, are unlikely to benefit from surgical or endoscopic therapy for their GERD. According to the current American College of Gastroenterology (ACG) Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease, published in 2013 the use of endoscopic therapies for GERD that have so far been developed have not demonstrated long-term efficacy. These therapies included radiofrequency augmentation to the lower esophageal sphincter, silicone injection into the lower esophageal sphincter, and endoscopic suturing of the lower esophageal sphincter (LES). None of these therapies demonstrated long-term improvement in esophageal pH levels or the ability for patients to stop antireflux therapy. The Stretta procedure was Food and Drug Administration (FDA) approved in 2000. It delivers radiofrequency energy to the lower esophageal sphincter (LES) and gastric cardia. The mechanism of action of radiofrequency treatment for GERD has yet to be fully elucidated but is thought to work via neurolysis or tissue necrosis causing local inflammation, collagen deposition and muscular thickening of the LES, resulting in fewer transient relaxations in LES pressure. Published reviews of the literature are conflicted in their recommendations of Stretta in the management of GERD. Overall, the data suggest that the Stretta procedure has an acceptable safety profile and may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention. A recent meta-analysis of trials by Lipka and colleagues found that Stretta for patients with GERD does not produce significant changes, compared with sham therapy, in physiologic parameters, including time spent at a pH less than 4, mean change in LES pressure, ability to stop PPIs, or health related quality of life.