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.

The patient is requesting a radiofrequency ablation Stretta procedure. A progress note describes reflux, prior trial of omeprazole, amitriptyline, and histamine blockers. She is currently taking no medication. She has a body mass index (BMI) of 21.29. A Stretta or radiofrequency ablation procedure is recommended. There is a description of clearing the throat, chronic cough, symptoms worse with spicy food, recent weight gain, prior trial of omeprazole and over-the-counter antacids and a prior esophagogastroduodenoscopy (EGD) showing a hiatal hernia. A Bravo potential of hydrogen (pH) study showed no reflux. An EGD described a normal esophagus with a small hiatal hernia. A feeling of a lump in the throat, constant need to swallow and an impression of globus sensation is noted. It is noted that the lump in the throat sensation improved with changing her diet; extensive workup thus far with no significant findings. Improvement noted since starting a plant-based diet, worse with dairy; suspect the globus sensation is mostly sensory. At issue is whether the requested procedure 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.
Irrespective of the fact that there was no documentation of failing maximal medical therapy, the progress note describes that the patient is on no medications. The scientific literature has not shown a definitive improvement in health outcomes with the use of this technique versus maximal medical therapy or standard fundoplication. In addition the described Bravo study showed no evidence of pathologic acid reflux accounting for the patient's symptoms. The notes describe a "sensory" phenomenon with globus, and objective data not showing a clear cause for the patient's symptoms.
There are no randomized controlled studies proving efficacy of Stretta over standard fundoplication or maximal medical therapy for gastroesophageal reflux disease (GERD) treatment. The scientific evidence does not currently lead to any definitive conclusions about Stretta efficacy for GERD.
He et al. In a study of only 28 patients: "To compare the Stretta procedure with proton pump inhibitors for the treatment of nonerosive reflux disease (NERD). From July 2018 to April 2019, patients diagnosed with NERD and referred for treatment were enrolled. They were treated with either the Stretta procedure or proton pump inhibitor (PPI) medication and followed-up for 6 months. The symptom control, quality of life, lower esophageal sphincter (LES) pressure, 24-hour pH parameters, PPI usage and satisfaction rate were evaluated. The complications were assessed. The outcomes of the 2 groups were analyzed and compared. The Stretta procedure was safe and effective in the short term for the management of NERD. The Stretta procedure resulted in higher lower esophageal sphincter (LES) pressure and achieved better improvement of symptom control and PPI cessation than did PPI in the short term." There was limited statistical power in this study due to small amount of patients studied and no proof of durability of effect with only a 6 month followup. The authors stated: "A limitation of this study is that it was a single-center, uncontrolled, nonrandomized study, which made it impossible to control for baseline demographics. Although all of the patients underwent either the Stretta procedure or PPI therapy, the methods of therapy were not randomly chosen. The small number of enrolled patients and the intention of the patients to undergo the Stretta procedure did not permit us to perform any kind of randomization."
Ma et al. In a study: "Outcomes of gastroesophageal reflux disease (GERD) using Toupet fundoplication (TF) and Stretta radiofrequency (SRF) have not been compared and this study was conducted to compare therapeutic efficacy of the two methods. Taken together, we have found that SFR can significantly improve the esophageal pH and pressure in GERD patients without increasing the risk of poor prognosis and are equally effective and safe as compared to TF. Therefore, SFR could be an option for the treatment of refractory GERD." The authors described significant limitations to this study: "However, there are limitations in this study. It was single-center study with limited number of participants and relatively short follow-up time. The many adverse reactions and events may have not been included and only a few factors have been analyzed for their impact on prognosis. Further large scale and multiple-center studies and longer follow-up are needed to validate our conclusions."
Dumitru in a review with no firm conclusion of Stretta superiority versus standard fundoplication: "A comparative study between the role of Stretta and Toupet fundoplication in controlling the extraesophageal symptomatology highlighted the importance of both procedures; however, the latter is considered superior."
Das in a review that did not conclude this approach was better than a standard fundoplication: "A best evidence topic in surgery was written according to a structured protocol. The question addressed whether the Stretta procedure is as effective as the best medical and surgical treatments for patients with symptoms of gastro-oesophageal reflux disease (GORD). One hundred and forty Stretta-related papers were identified using the reported search, of which five represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group, study type, relevant outcomes and results of these papers are tabulated. One study was a randomised controlled trial comparing Stretta with proton pump inhibitors (PPIs), and four were prospective observational studies that compared Stretta with laparoscopic fundoplication. These studies provide limited evidence that Stretta is as effective as medical therapy at controlling symptoms of GORD and may allow some patients to reduce their PPI use, but laparoscopic fundoplication appears to be more effective than Stretta though with a higher rate of adverse events. Further studies are required to determine the long-term efficacy of Stretta compared to the current best medical and surgical treatments."
Kalapala in a randomized trial from India: "Gastroesophageal reflux disease (GERD) is the most common chronic gastrointestinal disorder, affecting one third of the population worldwide. Recently, there has been a renewed interest in Stretta therapy in view of potential long-term side effects of PPIs and the durability of relief with fundoplication.
Prospective randomized study comparing the Stretta treatment with controls receiving PPIs. Patient (greater than [>]18 years, number [n] = 20) with symptoms of heartburn, regurgitation, abnormal esophageal acid exposure (greater than or equal to [>=]4%), and endoscopically confirmed esophagitis were included into the study. The primary measure was improvement in quality of life (QOL) and decrease in the frequency and severity of GERD symptoms. After Stretta treatment, 60% of the patients were free of PPIs whereas there was no change in the control group. Almost 80% of the patients on Stretta treatment were satisfied with the treatment compared to 30% of the patients in the control group. Conclusion: Stretta was effective in the short-term for the management of GERD." Limitations of this study were only 20 patients analyzed with limited statistical power, only 3 month followup with no demonstrated durability of effect, 30% satisfaction in the control group with a high placebo effect, and 40% of Stretta patients not free of PPI's at 3 months.
Lipka in a review: "In a meta-analysis of trials, we 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, lower esophageal sphincter pressure (LESP), ability to stop PPIs, or health related quality of life (HRQOL)."
Arts et al conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the gastroesophageal junction (GEJ) were done before the start of the study and after 3 months. In all, 22 GERD patients (17 females, mean age 47 plus/minus () 12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contrast, symptom score was significantly improved and GEJ compliance was significantly decreased. Conclusions: The limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance." Limitations: only 22 patients studies with only 3 months followup. Despite reported symptom improvement three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure.