Sunflower Health Plan Gastric Electrical Stimulation (PDF) Form

Gastric electrical stimulation (GES) has been used as compassionate care in patients who are proven refractory to conventional treatment for gastroparesis.1 It can be used as an alternative to surgery to reduce symptoms of gastroparesis.2 The GES device includes a pair of leads that are placed in the muscularis propria of greater curvature of the stomach about ten cm proximal to the pylorus.3 The leads are connected to a pulse generator that is typically placed subcutaneously in the right or left upper quadrants of the abdomen, and an external programming device controls the gastric stimulation parameters of the GES device.3 This stimulation has not shown a significant improvement in gastric emptying but has proven to be beneficial in those who have nausea and vomiting as primary symptoms.4,5 Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that gastric electrical stimulation (GES) is medically necessary for diabetic and idiopathic gastroparesis when all the following criteria are met: A. Diagnosis of idiopathic gastroparesis confirmed by gastric emptying scintigraphy; B. Severe nausea and vomiting occurring at least once daily on most days of the week for the duration of more than one year; C. Documented intolerance or failure of a trial of antiemetic, dietary modifications, and prokinetic drug therapy; D. Not currently pregnant; E. Technology is provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration (FDA). Note: • Current recommended combination prokinetic therapy includes metoclopramide and erythromycin, and centrally acting antidepressants used as symptom modulators. • A humanitarian device exemption (HDE) is granted by the FDA. A humanitarian use device (HUD) is a device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals in the United States annually. A HUD may only be used in facilities that have established a local institutional review board to supervise clinical testing of devices and after an independent review board has approved the use of the device to treat or diagnose the specific disease.14 II. It is the policy of health plans affiliated with Centene Corporation that GES is not medically necessary for the reduction of pain, fullness, bloating, or acid reflux symptoms as there is no evidence to support efficacy of such therapy. Page 1 of 6 CLINICAL POLICY Gastric Electrical Stimulation III. It is the policy of health plans affiliated with Centene Corporation that current evidence in peer-reviewed literature does not support the use of GES for any other indications, including, but not limited to the treatment of obesity. Background Gastric Electrical Stimulation (GES) for Gastroparesis Gastroparesis is a disorder in which there is delayed gastric emptying following ingestion of food in the absence of mechanical obstruction due to abnormal or absent motility of the stomach.2,6,7 The stomach is unable to contract normally and cannot crush food or propel food into the small intestine properly.2,8 There are numerous conditions associated with gastroparesis, but the majority of gastroparesis cases are either idiopathic or associated with diabetes.6,8 The main symptoms of gastroparesis include nausea, vomiting, early satiety, bloating, and abdominal discomfort.6,8 Nausea and vomiting may be so severe that it causes weight loss, dehydration, electrolyte disturbances, and malnutrition.3 It is theorized that GES works in the following ways: 1. Activation of the central mechanisms for nausea and vomiting control related to afferent nerves being stimulated by the constant high frequency current in the stomach wall; 2. Enhanced relaxation of the fundus of the stomach by the electrical current, thus providing better accommodation and decreased sensitivity to distention; 3. Augmentation of the amplitude of gastric slow wave after eating; 4. Increase in cholinergic function and decreased sympathetic functions; 5. Small and unpredictable improvements in gastric emptying. Multiple studies on GES for gastroparesis have shown an improvement in quality of life scores, even though on average, gastric emptying did not change. Quality of life scores improved along with weight gain, and there was a reduction in hemoglobin A1C (HbA1c) and a decrease in hospitalizations.5 Nausea and vomiting also improved for at least one year after surgery.4,5,9 Gastric Electrical Stimulation for Obesity GES is currently not supported by peer-reviewed literature as a treatment for obesity. Cha et al10 reviewed current approaches to evaluate the effect of GES on obesity and included 31 studies in their systematic review. Most of the studies showed weight loss during the first 12 months of treatment, but only a few studies performed follow-up past one year. Some of the evaluated GES treatments also showed positive effects in lowering HbA1c and blood pressure. The review concluded that GES is promising for the treatment of obesity, but stronger studies with longer follow-up are needed to determine long-term effects.10 Lebovitz11 reviewed the evidence on three different methods of GES, including the Transcend® Implantable Gastric Stimulator, the Maestro™ vagal blockade device, and the DIAMOND™ gastric electrical stimulatory device. Two randomized controlled trials failed to show a significant benefit in excess weight loss with the Transcend device. The other evaluated GES device, the DIAMOND, has been assessed in clinical trials with obese patients with type II diabetes. Findings were positive and included reduced HbA1c and weight loss, but these results Page 2 of 6 CLINICAL POLICY Gastric Electrical Stimulation varied among patients included in the treatment and seemed to be influenced by baseline HbA1c levels and triglyceride levels. Further research is needed to determine long-term effects and appropriate patient selection criteria to ensure the best outcomes.11 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are for informational purposes only. They are current at time of review of this policy. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to- date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT® Codes 43647 43648 43881 43882 64590 64595 95980 95981 95982 HCPCS Codes C1767 C1778 L8679 L8680 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 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance, and patient measurements) gastric neurostimulator pulse generator/transmitter, intraoperative, with programming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, with reprogramming Generator, neurostimulator (implantable), non-rechargeable Lead, neurostimulator (implantable) Implantable neurostimulator, pulse generator, any type Implantable neurostimulator electrode, each Page 3 of 6 CLINICAL POLICY Gastric Electrical Stimulation HCPCS Codes L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension Reviews, Revisions, and Approvals References reviewed and updated. Modified language regarding trial of antiemetic and prokinetic drug therapy. Added criteria that gastroparesis should be confirmed by scintigraphy. Modified criteria in I.B requiring daily vomiting to say that vomiting should happen at least once daily on most days of the week. References reviewed and updated. Codes updated. Added “gastric emptying” to scintigraphy in I.A. for clarification. Modified III. to state that GES is investigational for all other indications, including but not limited to the treatment obesity. References and codes reviewed and updated. Reference reviewed and updated. Removed contraindications of alcohol dependency, dialysis, and cancer w/limited life span. Specialist review. References reviewed and updated. Replaced “members” with “members/enrollees” in all instances. Annual review. Updated description with no impact on criteria. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date." References reviewed, reformatted, and updated. Specialist reviewed. Annual review. References reviewed and updated. Updated description and background with no clinical significance. Annual review. “Dietary modifications” added to I.C. and “FDA specifications” added as I.E. Updated verbiage in note at the end of criteria I. and added additional note about humanitarian device exemptions. ICD-10 code table removed. References reviewed and updated. External specialist reviewed. Revision Date 09/11 Approval Date 11/11 10/17 10/17 08/18 09/18 08/19 09/19 08/20 09/20 09/21 09/21 02/22 02/22 02/23 02/23