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

Physician 1:  The patient is a 46-year-old female with idiopathic gastroparesis, gastroesophageal reflux disease, chronic abdominal pain and constipation. She had an extensive gastrointestinal work up which identified negative lower esophageal sphincter tone and severe gastroparesis. The patient has daily symptoms of reflux and regurgitation and has had multiple hospitalizations for recurrent abdominal pain, nausea, vomiting and dehydration. She was treated with Propulsid when the drug was available and Reglan until she developed an allergy to the drug. The patient failed treatment with erythromycin but was started on Zelnorm with some improvement in her symptoms of abdominal pain and constipation. She has still required hospitalization for recurrent abdominal pain, nausea and vomiting, failure to thrive, line sepsis and deep vein thrombosis. The patients provider recommends placement of a gastric electric stimulator (GES) for long-term treatment of her condition. The request for authorization was denied by the Health Plan citing the experimental/investigational nature of the therapy.Enterra Therapy System is one of only two FDA approved treatments for gastroparesis; the other being the medication Reglan which is contraindicated for this patient. GES is considered the standard of care for the management of medically refractory gastroparesis and has been shown to improve diabetic management and the quality of life for individuals with gastroparesis. The long-term efficacy of the Enterra Therapy System is well supported in peer-reviewed literature. Therefore, I have determined that the requested therapy 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 46-year-old woman with a history of dyspepsia and gastroesophageal reflux disease (GERD) dating back to 1997. Various diagnostic studies over the years have been negative for secondary causes and she was eventually diagnosed with gastroparesis by gastric emptying scintigraphy. The patient has had multiple hospitalizations for exacerbation of her symptoms. She has required prolonged total parenteral nutrition (TPN) and experienced numerous complications related to her central line catheters. Zelnorm has provided some relief, but her current symptoms are predominately pain and nausea requiring narcotics and Marinol respectively. The patients provider has recommended gastric electric stimulation therapy. The Health Plan has determined that this therapy remains unproven for the treatment of gastroparesis and therefore has denied authorization and coverage.  Gastroparesis is a difficult condition to treat, and cases such as this one are often referred to specialized practice groups in large academic medical centers. The patient in this case has received all of the usual care available for the treatment of gastroparesis without successful resolution of her symptoms. The only additional treatment that has shown promise is domperidone, which is currently an investigational drug. However, the patients very low/absent lower esophageal sphincter pressure does raise a concern for the possibility of scleroderma and this condition should be ruled out prior to stimulator placement. As such, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy once scleroderma has been ruled out. Therefore, the Health Plans denial should be overturned.Physician 3:  The patient is a 46-year-old female diagnosed with idiopathic gastroparesis. The underlying basis of her condition has not been identified despite a complete work up and she is quite symptomatic and requiring frequent hospitalization. The patient has not responded to standard therapies and wishes to proceed with the Enterra Therapy System as recommended by her provider. The Health Plan denied authorization and coverage for this therapy on the basis that it has not been shown to be efficacious in the treatment of patients such as this one.The gastric electric stimulation device was approved by the FDA in 2002. It was studied in the Worldwide Anti-Vomiting Electrical Stimulation Study (WAVESS), which demonstrated a 50% improvement in symptoms and quality of life over a 12-month period. The therapy reduced the rate of hospitalizations by 30% in the first year after implantation of the device. The benefits of this form of therapy were also reported by the 1997 and 1999 GEMS study groups and several other studies as noted above.The manufacturers study inclusion criteria is outlined in the Summary of Safety and Probable Benefit of the Gastric Electrical Stimulator. The patient meets these criteria as she has had symptomatic gastroparesis for greater than one year, been refractory or intolerant to at least two anti-emetic and prokinetic drug classes, had vomiting at a frequency greater than seven times per week and had delayed gastric emptying defined as greater than 60% retention at two hours and greater than 10% retention at four hours.  Multiple studies have demonstrated the safety and efficacy of the Enterra Therapy System for properly selected patients. This patients symptoms have continued despite a wide range of conservative therapies and treatment with the gastric electric stimulator is medically appropriate at this juncture. Based upon the information set forth above, I have determined that the requested therapy 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.