Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 45-year-old male who has gastroesophageal reflux disease (GERD). His 24-pH study had a DeMeester score of 53. The esophageal manometry demonstrated the lower esophageal sphincter to be 5. An EGD showed evidence of esophagitis. It has been recommended that the patient undergo an endocinch Plicator procedure. The Health Plan indicates that the requested procedure is considered investigational for treatment of the patients medical condition.Review of the medical literature indicates endoscopic plication procedures, such as the Endocinch and Plicator procedures, are still in their infancy.  Endoscopic plication procedures are not the standard of care for treatment of reflux disease. The long-term efficacy of these procedures has not been established in randomized studies. Furthermore, according to an article in the June 2004 issue of Gastroenterology and Endoscopy News, up to 55% of patients would require some sort of PPI to control symptoms of GERD following an endoscopic plication procedure.  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 a 45-year-old male with gastroesophageal reflux disease (GERD) documented on pH monitoring. The submitted records indicate the patients chief complaint over the past four years has been a cough. He underwent extensive evaluation and it was felt that the cough and bronchoscopy changes were non-specific. An evaluation in 2001 did not demonstrate pathological reflux despite the patients cough having been present for some time. It was not until 2003 that the patient was found to have pathological intraesophageal acid exposure. It appears that at that time the patients consultants assumed his cough was GERD related. Review of the patients February 2004 surgical consult does not demonstrate which symptom is the primary reason for recommendation of a Plicator procedure. The Health Plan has denied authorization for the requested procedure on the basis that it is considered investigational. Review of the medical evidence reveals that the use of endoscopic anti-reflux procedures such as the Plicator procedure has been effective for patients with predominant heartburn that has been relieved with proton pump inhibitors. In this case, the submitted records indicate the patient has not had a good response to PPIs. As such, this patient cannot be considered an appropriate candidate for the Plicator procedure. Additionally, these devices have not yet been proven effective for managing regurgitation or supraesophageal GERD symptoms (cough, asthma, etc.), which this patient appears to have. Therefore, there is insufficient evidence that the Plicator procedure is likely to be of greater benefit to patients such as this patient than standard treatment options.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 3The patient is a 45-year-old man with a history of Crohns disease, hemolytic anemia, splenectomy, and long-standing gastroesophageal reflux disease (GERD). The GERD has been associated with, and suspected of causing, reflux pulmonary aspiration. The patient has undergone 24-hour esophageal pH recording, with the most recent test showing a DeMeester score of 53 (abnormal).  On endoscopy the patients esophagus appeared normal and biopsy showed mild changes of esophagitis. The patient has requested coverage for the endoscopic Plicator procedure. The Health Plan has denied the patients request on the basis that the Plicator procedure is considered investigational. The endoscopic Plicator has recently been approved as a medical device by the Food and Drug Administration. However, the Plicator procedure has not gained any significant acceptance as a clinical procedure. The most recent medical literature involving the requested procedure describes the results of an open label clinical trial involving 64 carefully selected patients with mild esophagitis, and without grade III esophagitis or Barretts mucosa. Though the results were promising, only 30% of patients had normalization of acid reflux on pH study. In addition, this clinical trial did not exclude or measure the probability of a powerful placebo effect or address the durability of any improvement. It is not possible to compare this trial to current expert surgical therapy for GERD. Furthermore, though the patient has had a splenectomy, which will make laparoscopic fundoplication more difficult, there is insufficient evidence that the Plicator procedure is likely to be more beneficial for this patient than standard treatment. 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.