Public Statement: Medical Policy

Transcription

1 ARBenefits Approval: 10/12/11 Medical Policy Title: Gastric Neurostimulation Effective Date: 01/01/2012 Document: ARB0166 Revision Date: Code(s): 0155T Laparoscopy, surgical; implantation or replacement of gastric stimulation electrodes, lesser curvature (ie, morbid obesity) 0156T Laparoscopy, surgical; revision or removal of gastric stimulation electrodes, lesser curvature (ie, morbid obesity) 0157T Laparotomy, implantation or replacement of gastric stimulation electrodes, lesser curvature (ie, morbid obesity) 0158T Laparotomy, revision or removal of gastric stimulation electrodes, lesser curvature (ie, morbid obesity) Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum Implantation or replacement of gastric neurostimulator electrodes, antrum, open Revision or removal of gastric neurostimulator electrodes, antrum, open Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver Public Statement: Administered by: 1) Gastric Pacemakers require preauthorization. 2) Gastric pacemakers are used to treat idiopathic or diabetic gastroparesis that has not responded to medical treatment. Page 1 of 5

2 Medical Policy Statement: 1) Gastric Pacemaker means a medical device that: (A) Uses an external programmer and implanted electrical leads to the stomach; and (B) Transmits low-frequency, high energy electrical stimulation to the stomach to entrain and pace the gastric slow waves to treat gastroparesis. 1) Gastric Pacemakers will only be used in medical centers in which an institutional review board has approved use of the device. 2) If a battery of the neurostimulator runs down, the physician will obtain prior written authorization and approval for a replacement surgery. 3) Gastric pacing is covered for gastroparesis when: a) The nausea and vomiting is debilitating and interfering with activities of daily living and; b) An adequate trial (at least 3 months) of medication has failed to control the nausea and vomiting. Limits: 1) Gastric pacing is not covered for: a) Treatment of obesity. b) Treatment of diabetes c) Initial treatment of gastroparesis. Background: Gastroparesis is a chronic gastric motility disorder of diabetic (both type 1 and type 2 diabetes) or idiopathic etiology. It is characterized by delayed gastric emptying of solid meals. Patients with gastroparesis exhibit bloating, distension, nausea, and/or vomiting. In severe and chronic cases, patients may suffer dehydration, poor nutritional status, and poor glycemic control (in diabetics). Although gastroparesis is often associated with diabetes, it is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathology. Therapeutic options of gastroparesis include prokinetic agents such as metoclopramide, and anti-emetic agents such as metoclopramide, granisetron, or odansetron. Patients with severe gastroparesis may require enteral or total parenteral nutrition. Gastric pacing (gastric pacemaker) entails the use of a set of pacing wires attached to the stomach and an external electrical device that provides a low-frequency, highenergy stimulation to entrain the stomach at a rhythm of 3 cycles per minute. However, the gastric pacemaker is cumbersome and problematic for chronic use because of external leads. Page 2 of 5

3 Thus, a newer, implantable device (the Enterra Therapy System by Medtronic, Minneapolis, MN) was developed to provide gastric electrical stimulation. Unlike gastric pacing, the Enterra delivers a high-frequency (12 cycles per minute), low-energy stimulation to the stomach. This stimulating frequency does not entrain the stomach, and therefore does not normalize gastric dysrhythmias; hence, the term gastric electrical stimulation is employed to differentiate between the Enterra and gastric pacing. The Enterra System was designed to treat intractable nausea and vomiting secondary to gastroparesis. Electrodes are implanted in the serosa of the stomach laparoscopically or during a laparotomy, and are connected to the pulse generator that is implanted in a subcutaneous pocket. The Enterra Therapy System (Medtronic, Minneapolis, MN) is currently the only gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA). It was cleared by the FDA as a humanitarian use device. Thus, the manufacturer was not required to submit the level of evidence that would be required to support a pre-market approval application. The data presented to the FDA documenting the "probable benefit" of gastric electrical stimulation (Gastric Electrical Stimulation System) were based on a multi-center doubleblind cross-over study (FDA, 2000), which included 33 patients with intractable idiopathic or diabetic gastroparesis. In the initial phase of the study, all patients underwent implantation of the stimulator and were randomly assigned to stimulation-on or stimulation-off for the first month, with cross-over to OFF and ON during the second month. The baseline vomiting frequency was 47 episodes per month, which significantly declined in both ON and OFF groups to 23 to 29 episodes, respectively. However, there were no significant differences in the number of vomiting episodes between the two groups, suggesting a placebo effect. Thus, long-term results of gastric electrical stimulation must be validated in longer term randomized studies. It is important to note that gastric electrical stimulation did not return gastric emptying to normal in the majority of the treated-patients. There exist preliminary data that suggested gastric pacing may be beneficial to patients with refractory gastroparesis. Forster et al (2001) reported the findings of 25 patients who underwent gastric pacemaker placement. Both the severity and frequency of nausea and vomiting improved significantly at 3 months and improvements were sustained for 12 months. Gastric emptying time was also numerically faster over the 12-month period. Three of the devices were removed and 1 patient died of causes unrelated to the pacemaker 10 months postoperatively. The authors stated that after placement of the gastric pacemaker, patients rated significantly fewer symptoms and had a modest acceleration of gastric emptying. Obesity is a major health problem among adults in the United States. It is also an increasing health concern among American children as well as adolescents. Various methods are employed in the management of obesity. One of the new approaches is gastric pacing, which is intended to induce early satiety through electrical stimulation of the gastric wall. However, the effectiveness of this technique in treating obesity has not Page 3 of 5

4 been established. Buchwald and Buchwald (2002) considered gastric pacing as an experimental procedure for the management of morbid obesity. An assessment of gastric pacing for obesity by the Swedish Council on Technology Assessment in Healthcare (SBU, 2004) found that "[t]here is insufficient scientific evidence on the short-term patient benefit of gastric pacing" for obesity, and that "[t]here is no scientific evidence on the long-term patient benefit of gastric pacing" for this indication. The assessment concluded: Gastric pacing is still an experimental method and should be used only in scientific studies that have been approved by a research ethics committee. Trials that include adequate control groups are very much needed. References: 1. Forster J, Sarosiek I, Delcore R, et al. Gastric pacing is a new surgical treatment for gastroparesis. Am J Surg. 2001;182(6): Horowitz M, Su YC, Rayner CK, Jones KL. Gastroparesis: prevalence, clinical significance and treatment. Can J Gastroenterol. 2001;15(12): Rabine JC, Barnett JL. Management of the patient with gastroparesis. J Clin Gastroenterol. 2001;32(1): Bortolotti M. The "electrical way" to cure gastroparesis. Am J Gastroenterol. 2002;97(8): Abell TL, Van Cutsem E, Abrahamsson H, et al. Gastric electrical stimulation in intractable symptomatic gastroparesis. Digestion. 2002;66(4): Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003;125(2): Smith DS, Ferris CD. Current concepts in diabetic gastroparesis. Drugs. 2003;63(13): Jones MP, Maganti K. A systematic review of surgical therapy for gastroparesis. Am J Gastroenterol. 2003;98(10): Forster J, Sarosiek I, Lin Z, et al. Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surg. 2003;186(6): Lin Z, Forster J, Sarosiek I, McCallum RW. Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. Diabetes Care. 2004;27(5): Lin Z, Forster J, Sarosiek I, McCallum RW. Effect of high-frequency gastric electrical stimulation on gastric myoelectric activity in gastroparetic patients. Neurogastroenterol Motil. 2004;16(2): National Institute for Clinical Excellence (NICE). Gastroelectrical stimulation for gastroparesis. Interventional Procedure Guidance 103. London, UK: NICE; December 15, Available at: Accessed April 22, Page 4 of 5

5 13. Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association medical position statement: Diagnosis and treatment of gastroparesis. Gastroenterol. 2004;127(5): Lin Z, Forster J, Sarosiek I, McCallum RW. et al. Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. Diabetes Care. 2004;27(5): McCallum R, Lin Z, Wetzel P, et al. Clinical response to gastric electrical stimulation in patients with postsurgical gastroparesis. Clin Gastroenterol Hepatol. 2005;3(1): van der Voort IR, Becker JC, Dietl KH, et al. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005;113(1): Cutts TF, Luo J, Starkebaum W, Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term health care benefits? Neurogastroenterol Motil. 2005;17(1): Lin Z, McElhinney C, Sarosiek I, et al. Chronic gastric electrical stimulation for gastroparesis reduces the use of prokinetic and/or antiemetic medications and the need for hospitalizations. Dig Dis Sci. 2005;50(7): Oubre B, Luo J, Al-Juburi A, et al. Pilot study on gastric electrical stimulation on surgery-associated gastroparesis: Long-term outcome. South Med J. 2005;98(7): Gourcerol G, Leblanc I, Leroi AM, et al. Gastric electrical stimulation in medically refractory nausea and vomiting. Eur J Gastroenterol Hepatol. 2007;19(1): Filichia LA, Cendan JC. Small case series of gastric stimulation for the management of transplant-induced gastroparesis. J Surg Res. 2008;148(1): McKenna D, Beverstein G, Reichelderfer M, et al. Gastric electrical stimulation is an effective and safe treatment for medically refractory gastroparesis. Surgery. 2008;144(4): ; discussion Soffer E, Abell T, Lin Z, et al. Review article: Gastric electrical stimulation for gastroparesis -- physiological foundations, technical aspects and clinical implications. Aliment Pharmacol Ther. 2009;30(7): O'Grady G, Egbuji JU, Du P, et al. High-frequency gastric electrical stimulation for the treatment of gastroparesis: A meta-analysis. World J Surg. 2009;33(8): Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 5 of 5