Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 53-year-old female with a history of diabetes mellitus of long-standing duration, with chest complaints of blocking, constipation, and severe pain in the stomach until she vomits. The patient underwent a gastric emptying study on 4/5/04, which was essentially normal. The results of a HIDA scan revealed biliary dyskinesia with gallbladder ejection fraction of 15%. The patients upper GI/small bowel series was normal. A request has been made for placement of a gastric pacemaker. The Health Plan has denied this request on the basis that the requested procedure is considered experimental for treatment of the patients medical condition. Based upon the results of the patients GI evaluation, it appears the patients symptoms of nausea, vomiting, and bloating are not due to gastroparesis. Thus, there is no objective evidence that a gastric pacemaker will improve the patients symptomatology. The patient requires further evaluation including antroduodenal motility testing at a tertiary care center with expertise in motility disorders of the gut. 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 2: Electrical stimulation of the stomach for control of gastroparesis in diabetes is well described. The GEMS trial was an uncontrolled, multi-center trial of gastric electromechanical stimulation (GEMS). In contrast to pacing studies in which the stomach was stimulated with higher energy depolarizations at a physiologic rate, gastric electrical stimulation in the GEMS study did not reliably entrain the slow wave, did not accelerate solid phase gastric emptying, and had only modest stimulatory effects on liquid phase gastric emptying. However, these stimulation parameters produced greater than 80 percent reductions in nausea and vomiting in 26 patients with diabetic and idiopathic gastroparesis for up to two years. Although subtotal gastrectomy or removal of the electrical stimulator was needed in 25 percent of patients, the remaining individuals experienced weight gain and significantly enhanced quality of life. In the WAVESS trial, thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The authors concluded that high-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis. The gastric electrical stimulator used in the WAVESS trial was submitted for review by the Food and Drug Administration. Because of the lack of a controlled trial showing clear-cut efficacy, the FDA did not approve the device for unrestricted marketing for the treatment of gastroparesis. However, because of the promise shown in the uncontrolled trials, the device was approved as a humanitarian use device (HUD). The FDA indicates the gastric pacemaker is intended for use in patients with chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. In the case of this patient, there is no documentation of gastroparesis. Her radionuclide gastric emptying study was normal. An EGD did not indicate any retention of food material, and there was no retention of material demonstrated on UGI. The clinical trials on which the basis of the gastric pacemaker was evaluated were all based on patients with demonstrated gastroparesis. Therefore, there is no evidence that the requested procedure is likely to be of any clinical benefit to this patient. 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 3: The use of a gastric pacemaker is not indicated in this patient. This device is indicated for patients with severe gastroparesis. Based upon the information provided, there is no evidence the patient has gastroparesis. The patient underwent only one gastric emptying study, which was reported to be normal. The EGD performed also did not show any evidence of food residual in the stomach. The manufacturers entry criteria for gastric pacemaker placement include symptomatic gastroparesis for greater than one year; refractory or intolerant to at least two antiemetic and prokinetic drug classes; frequency of vomiting greater than seven per week; and delayed gastric emptying defined by greater than 60% retention at two hours and greater than 10% at four hours. It does not appear that the patient meets these criteria. It also is not clear if the patient has been hospitalized for her symptoms or if she has lost any weight. Furthermore, the patients nephrologist indicates the patient is under his care for renal failure and is on several medications, which are causing her severe nausea and vomiting. He also states that the patient has constant diarrhea. This is contradicted by a note from the patients primary care physician, which states that the patients symptoms include daily bloating and constipation. Thus, it is not clear whether the patient has diarrhea or constipation and if her nausea is medication related. In addition, the normal gastric emptying study does not support the diagnosis of gastroparesis. As such, there is no evidence a gastric pacemaker is medically indicated or is likely to be beneficial for treatment of the patients condition. 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.