Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: This patient is a 40-year-old male who has had reflux symptoms for the past five years. An endoscopy showed normal esophagus, no evidence of hiatal hernia and antral gastritis. A Bravo capsule for pH measurement was mildly abnormal the first day and normal the second day. The patient has tried PPIs, which have stopped working for him and cause side effects. His esophageal manometry was also unremarkable.The patients provider has recommended the patient undergo a Stretta procedure. The Health Plan has denied authorization for the requested procedure on the basis it is considered investigational.Review of the relevant scientific literature reveals growing support for the Stretta procedure. There have been an increasing number of studies demonstrating the safety and efficacy of this procedure. An article by Torquati, et al (2004) concluded the Stretta procedure resulted in a statistically significant long-term decrease in GERD symptoms. In the case of this patient, medications are not tolerated due to side effects. The remaining options are endoscopic treatment (such as the Stretta procedure) versus Nissen fundoplication. Given the patients inability to tolerate PPIs, and the increasing data on the efficacy of the Stretta procedure, the requested procedure is the most appropriate treatment option for this patient.Based upon the information set forth above, I have determined that the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2: This patient is a 40-year-old man who has a diagnosis of gastroesophageal reflux disease that has worsened in the past five years. The notes indicate he cannot tolerate proton pump inhibitor (PPI) drugs. Over-the-counter medications incompletely relieve his symptoms.The patient had an EGD on 3/4/04, which revealed normal esophageal motility and mucosa. Biopsies were taken and revealed benign squamous mucosa with minimal esophagitis. The patient had a more recent EGD on October 25, 2004 with findings including normal esophagus. Biopsies of the esophagus showed normal esophageal mucosal. An attempt at standard 24-hour pH study failed because the patient could not tolerate the examination. Subsequently, another attempt at 24-hour pH study was made using the Bravo capsule (placed endoscopically). The patient had some reflux on the first day with a mildly elevated DeMeester score, and on the second day settled down to very little reflux with a DeMeester score of 6.5. The impression was of a mildly abnormal pH study that does support the diagnosis of GERD and explains the patients symptoms.The patient has requested coverage for the Stretta procedure; his physician believes this procedure can be helpful in patients who: have inadequate relief on anti-secretory drugs, are considering Nissen fundoplication, are candidates for conscious sedation, and have objective evidence of GERD (abnormal pH studies, esophagitis). The Health Plan has denied coverage for the procedure indicating it is considered investigational for treatment of the patients condition.Though there remains a lack of randomized controlled trials comparing the Stretta procedure to fundoplication surgery, the data regarding the Stretta procedure is promising. According to the Centers for Medicare and Medicaid (CMS), criteria that may support medical necessity for the Stretta Procedure include: a) inadequate symptom improvement while on a properly escalated anti-secretory regimen for at least one year, or b) intolerance to anti secretory therapy, or c) an unwillingness/inability to continue a long-term high-dose anti-secretory regimen because of accepted medical reasons, such as potential drug interactions, comorbidities, etc. and GERD, confirmed by, a) pathologic esophageal acid exposure, or b) biopsy proven esophagitis, or c) gross evidence of esophagitis, or d) Barretts metaplasia.In the case of this patient, he does have significant, if minimal, reflux and does not tolerate standard therapy. Thus, it would appear the patient meets the above criteria. Furthermore, in light of the growing evidence of efficacy, the Stretta procedure is medically reasonable and appropriate in this patient and likely to be more beneficial than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 3:This patient is a 40-year-old male with a long-standing history of gastroesophageal reflux disease (GERD), which has progressed over the last five years. The severity of reflux has impaired his daily activities and overall quality of life. The patient experiences severe nocturnal reflux and has to sleep over two to three pillows. Acid reflux, at times, is so severe that it causes him to become dizzy and light-headed. The patient has tried over-the-counter medications and prescription drugs, which he had to discontinue due to side effects.An EGD did not reveal any evidence of hiatal hernia or erosions, and his Bravo pH study was mildly abnormal, supporting the diagnosis of GERD. The patients provider has recommended the patient undergo a Stretta procedure. The Health Plan indicates the requested procedure remains experimental.The patient has acid reflux, which has been getting worse. He has failed all standard medications. Since the patient cannot tolerate medical therapy, his options are limited to either endoscopic therapy such as the Stretta procedure or Nissens fundoplication. The Stretta procedure has been approved by the FDA and over 5000 patients have undergone the procedure. There has been documented improvement in GERD-related symptoms in an open-label 12-month study as well as randomized, controlled sham trials. In a recently published abstract, the Stretta procedure was shown to be effective at three-year follow-up for improving GERD symptoms and eliminating the need for antisecretory drugs. In light of these results, I have determined the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.