Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1The patient is a 53-year-old female with numerous upper gastrointestinal complaints with no evidence of complicated GERD (e.g., esophagitis, stricture, Barretts syndrome). There is mild reflux physiology without evidence of a hiatal hernia, and an ambulatory pH study showing upright reflux only, not supine.  There are possibly other aggravating factors, such as gastroparesis, making symptom response difficult to judge. Additionally, the patient has functional elements including non-obstructive dysphagia and medication intolerance. The patient has requested authorization to undergo the Stretta procedure. The Health Plan has denied the request on the basis that the Stretta procedure is considered investigational.The Stretta procedure has proved useful in carefully selected patients with GERD, mainly in those with a complete or near complete symptom response to pharmacological therapy. As this patient is not responding to pharmacological therapy, she does not meet the criteria used in the randomized controlled trial, which showed benefit. Furthermore, medical management has not been exhausted as the patient has not been on a twice daily dose of PPI, which is standard escalating therapy in patients who do not respond to single daily doses of the agent (even if higher than normal doses are used once a day).The use of the Stretta procedure to manage what is thought to be GERD symptoms in a patient with an incomplete response to PPIs and possible gastroparesis is not the standard of care. The efficacy of the Stretta procedure for patients such as this patient is not demonstrated in the medical literature. It is unlikely to be of greater benefit than standard medical or surgical therapy. In fact, there is no evidence that the Stretta procedure is likely to be of benefit at all. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2The patient is described as a 53-year-old woman with gastroesophageal reflux disease (GERD) since her twenties who has undergone treatment with standard medical measures including antacids, proton pump inhibitor (PPI) drugs, and, when it was available, cisapride. She now has symptoms of GERD. She has undergone two 24-hour pH studies, one of which was performed with her normal routine producing a normal 24-hour pH study result, and one in which she slept without her bed propped up showing a DeMeester score of 25 (mildly elevated) on 24-hour pH monitoring. An endoscopy on 5/28/04, revealed a normal esophagus, which was dilated to 54 French on the supposition that an unrecognized Schatzki type ring might be causing symptoms of dysphagia.The patient has requested authorization to undergo the Stretta procedure. The Health Plan has denied the request on the basis that the Stretta procedure is considered investigational.Conventional treatment of GERD includes lifestyle alternations, over-the-counter antacids, H2 receptor antagonists, PPI drugs, and open or laparoscopic fundoplication surgery. Newer treatments include Endocinch (formation of plication by endoscopic sewing), Enteryx (injection of biodegradable polymers to bulk up the lower esophageal sphincter), and Stretta (endoluminal delivery of radiofrequency energy to the area of the gastroesophageal junction). The evidence for Stretta includes case series (multi-center and single center) and one randomized, controlled study (Corley, et al.). This double-blind randomized clinical trial of 64 patients from eight institutions included a sham procedure. There were 35 randomized to active treatment and 29 to sham control. The primary outcomes studied were quality of life and reflux symptoms. Secondary outcomes were esophageal acid exposure time and daily use of medications. This study included patients that were not refractory to medical therapy. (Forty percent of enrolled patients were still using PPIs at 12 months.) Patients with moderate to severe esophagitis and those with hiatal hernias over 2cm are not appropriate for the Stretta procedure. The study results showed an improved quality of life, no daily heartburn for 61% of the RF group versus 33% of the sham group. There was more than a 50% increase in reflux-associated quality of life, 61% in the RF group versus 30% in the sham group. There was no difference in daily medication use between RF and sham; however, medication use in both groups decreased. There was no difference in esophageal acid exposure times.Though there is evidence that the Stretta procedure is likely to control symptoms better than sham treatment at one year, there is not adequate available literature demonstrating that the Stretta procedure is equal to or better than standard treatment accepted by the national medical community. Furthermore, this patient has dysphagia, which has generally been a basis for exclusion in Stretta clinical trials. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3This is a patient with symptoms of gastroesophageal reflux disease (GERD) since 1986. She has had multiple procedures including an EGD in May 2003, which revealed a normal esophagus except for a web/ring. A 24-hour pH indicated her DeMeester score was normal. Apparently, the patient has tried multiple medications along with lifestyle modifications, but continues to be symptomatic. The patient wishes to undergo the Stretta procedure. The Health Plan has denied the patients request on the basis that the Stretta procedure is considered investigational.There is a lack of long-term data regarding the Stretta procedure. The most meaningful studies performed followed patients for only 12 months duration. An abstract by Wolfsen HC, states that the treatment effect of Stretta is superior after one year follow-up versus less than one year; however, the number of people followed for more than one year was 14% of the study group. A scientifically sound comparison is difficult to make when 86% of a group is being compared with 14% of a group. One of the most recent studies by Triadafilopoulos followed 118 patients for 12 months, and found improvement in patient symptoms, quality of life, and esophageal acid exposure; however, it was a nonrandomized clinical trial. The same author in 2001 followed 47 people for six months, finding the use of the Stretta device is safe and effective. However, we again see low number of patients and short duration of follow-up. In 2002, Richards, et al. looked at 25 patients and followed them for three months. Data was available for 13 of them and positive conclusions were seen.Although the Stretta procedure may be utilized more frequently in the future, it is st