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

Physician 1: This patient is a 55-year-old male who has well-documented gastroesophageal reflux disease (GERD) with breakthrough symptoms on a twice daily proton pump inhibitor, which is a standard medical treatment for this condition. Alternative therapies for GERD include endoscopic anti-reflux procedures and surgical anti-reflux therapies. The treating physician has recommended an endoscopic anti-reflux procedure (Stretta) as an alternative therapy. The Health Plan has denied this request on the grounds that the procedure is investigational and experimental.Review of the evidence provided demonstrates this patient is not a candidate for the Stretta procedure, as the device has never been evaluated in clinical studies as a therapy for incomplete responders to medical therapy such as this patient. As such, performing this procedure in this patient is not the standard of care as the device has not been investigated in this type of clinical situation. Furthermore, the patients symptoms have not been proven to be related to GERD. In the absence of a pH and/or impedance study (performed while on therapy) documenting continued acid or non-acid reflux despite his PPI treatment, it cannot be assumed that the patient has GERD related symptoms. Furthermore, if GERD related symptoms are documented while the patient is on a usually effective medical therapy (such as twice daily PPI), then the only proven therapy would be anti-reflux surgery. The Stretta procedure and other endoscopic anti-reflux procedures have not been studied in this clinical situation.Based upon the information set forth above, 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 2: The patient is a 55-year-old man who has gastroesophageal reflux disease (GERD). He had an EGD performed in April 2005, which revealed a normal esophagus to the Z-line at 41 cm, a small hiatal hernia, and mild erythema in the antrum and duodenum. An esophageal motility study performed in May 2005 showed incomplete relaxation of the lower esophageal sphincter and some high amplitude esophageal body contractions. A 24-hour pH study demonstrated esophageal reflux.The patient complains of heartburn that is incompletely controlled by PPI medications. He has hypertension and osteoarthritis, and has recently recovered from gallstone pancreatitis with cholecystectomy and a post-cholecystectomy bile leak. He drinks five cups of coffee a day and maintains his weight at 285 pounds, but has quit alcohol and tobacco completely. He continues to have GERD symptoms of heartburn and reflux, and wishes to have the Stretta procedure. The procedure has been denied by the Health Plan as experimental and investigational.The Stretta procedure has been investigated and to date appears to be helpful in many patients with reflux and symptoms who do not have more than small hiatal hernias, with minimal or no esophagitis, and with normal esophageal motility with normal LES relaxation. This patient does not have normal LES relaxation and therefore, does not fit into that category. As of this time, the Stretta procedure has not been accepted as standard practice on the basis of large randomized, controlled clinical trials. The available studies indicate that the Stretta procedure is associated with improvement in symptoms, but evidence for changes in esophageal physiology or reflux is not as convincing. Some patients are able to discontinue their anti-reflux medications, but most continue to be dependent on these medications after the procedure. It is particularly difficult to generalize the results to patients such as this patient, who have conditions such as failure of lower esophageal sphincter relaxation or obesity. 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 3: This patient is a 55-year-old male with gastroesophageal reflux disease (GERD). His pH study showed a DeMeester score of 79. The manometry study showed an incomplete relaxation of the GE junction. An endoscopy revealed a hiatal hernia of 1 cm. The patient is taking Protonix on a twice-daily basis and continues to be symptomatic. He has requested authorization for a Stretta procedure. The Health Plan has denied this request indicating the Stretta procedure has not been proven to be efficacious for patients such as this patient.Although there are many articles and studies available regarding the Stretta procedure, there is a lack of long-term outcome data involving a large number of patients. While an abstract by Wolfsen found that the treatment effect of the Stretta procedure was superior after one-year follow-up versus less than one year, the number of people followed for more than one year was 14% of the group. A scientifically sound comparison is difficult to make when 86% of a group is being compared with 14%.Though the Stretta procedure may be more commonly utilized in the future, it currently remains in its infancy. This procedure is not the current standard of care for patients with GERD. The current options for treatment include PPI with addition of H2blockers and promotility agents, if needed. If complete resolution of symptoms is achieved and if the patient declines to continue with medications, then a fundoplication procedure may be appropriate.Accordingly, 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.