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

Physician 1:  The patient is a 54-year-old woman with a history of diabetes mellitus for 22 years. She is status post a kidney/pancreas transplant in 2001, with a repeat pancreas transplant in 2002. In addition, she has had persistent nausea and vomiting secondary to diabetic gastroparesis for over two years. The patients gastric emptying study is consistent with gastroparesis with 2-hr retention of 65% and 4-hr retention of 38%. The patient has tried Reglan, erythromycin and domperidone without success. She has lost approximately 30 pounds in the last 2 years, and lost 8 pounds in the last 3 weeks. She also has a history of diarrhea secondary to bacterial overgrowth for which she has been treated with various antibiotics. Because of persistent nausea and vomiting, the patient is requesting gastric electrical stimulation (GES) using the Enterra device. The Health Plan has denied authorization for the requested procedure on the basis that it is considered experimental.There is sufficient evidence in the peer-reviewed journals to support the long-term efficacy of GES in the treatment of diabetic and idiopathic gastroparesis. The procedure is considered the standard of care for the management of medically refractory gastroparesis (both diabetic and idiopathic gastroparesis) and results in improvement in a patients quality of life and diabetic management.Currently, there are only two FDA approved treatments for gastroparesis: the medication, Reglan, and GES. All other medications are considered off-label for gastroparesis; Propulsid was removed from the market in January 2000 because of drug interaction. A randomized, double-blind, cross-over study of 33 patients (WAVESS Study Group) concluded high frequency/low energy gastric electrical stimulation significantly decreased vomiting frequency and GI symptoms and improved quality of life in patients with severe gastroparesis. In Phase II of the study, compared to baseline, the vomiting frequency declined by approximately 80% in 54% of patients and by 50% in 79% of the patients. Another study evaluated the nutritional status of patients with drug refractory gastroparesis before and after GES. It concluded GES results in improvement in symptoms and nutritional status in patients with drug-refractory gastroparesis. A recent study has shown that GES is more effective in improving long-term GI symptoms in this sample of patients with symptoms of gastroparesis followed for three years. A single center study published recently has shown that GES is safe and significantly improves upper GI symptoms, quality of life measures, glycemic control, and nutritional status while reducing hospitalization days in patients with medically refractory gastroparesis. Therefore, this technology offers new hope and better outcomes than those achieved by conventional medical therapy for this group of patients. All studies have consistently shown that with GES, there is marked reduction in the symptoms of nausea and vomiting in a majority of the patients. This has been shown in the short-term, as well as long-term studies, including a double-blind randomized study in patients with gastroparesis. A majority of studies have shown a modest but consistent improvement in solid gastric emptying at 12 months as measured by radionucleotide using a standardized low fat meal. Use of GES results in clinical and statistical improvement of nutritional status of gastroparetic patients as measured by body weight and serum albumin. Several studies including data from a randomized study have shown a reduction in the length of hospital stays. In one study, the mean number of hospital days per year was reduced by 50%. For the reasons 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:  The patient is a 54-year-old female with diabetes since the age of 19 with multiple complications. She has had renal failure, severe gastroparesis, diabetic diarrhea, and focal incontinence. In addition, the patient has failed islet cell transplant.She has undergone an extensive work-up to rule out other causes of nausea and vomiting. The diagnosis of gastroparesis is well established. She was treated with several medications without relief of symptoms. She is now seeking authorization for Enterra therapy, as she has had multiple hospitalizations and requires TPN. The Health Plan has denied the patients request indicating there is insufficient evidence of the efficacy of Enterra therapy for patients such as this patient.Severe gastroparesis that has failed medical and dietary therapy is difficult to treat. Feeding jejunostomy or gastric electrical stimulation (Enterra therapy) are essentially the only options left. The decision to place a stimulator at this time is medically reasonable and appropriate. There is adequate evidence demonstrating the efficacy of gastric electrical stimulation to justify its use in this clinical setting. Accordingly, 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 3:  The patient is a 54-year-old female with a history of gastroparesis due to diabetes. She is status post a kidney and pancreas transplant. She has had an abnormal gastric emptying study, significant weight loss, multiple hospitalizations, and lack of response to promotility agents. Her provider has recommended Enterra therapy. The Health Plan has determined the requested procedure is considered experimental/investigational and therefore has denied authorization.The gastric electrical stimulation device was approved by the Food and Drug Administration in March 2000. It has been studied in the multicenter Worldwide Anti-vomiting Electrical Stimulation Study (WEAVESS) trial and although there were low numbers of patients, the 12-month improvement in symptoms and quality of life was greater than 50%. The patient meets entry criteria as outlined by the manufacturer for use of the gastric electrical stimulator. These include symptomatic gastroparesis for greater than one year, refractory or intolerant to at least two anti-emetic and prokinetic drug classes, frequency of vomiting greater than seven times per week, and delayed gastric emptying defined by greater than 60% retention at 2-hrs and greater than 10% at 4-hrs.As the patient meets criteria for the Enterra procedure and since all conservative medical therapy to this point has failed, 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. Therefore, the Health Plans denial should be overturned.