| Highmark Commercial Medical Policy in West Virginia |
| Section: | Surgery |
| Number: | S-155 |
| Topic: | Gastric Electrical Stimulation, Gastric Pacing |
| Effective Date: | January 1, 2012 |
| Issued Date: | January 2, 2012 |
| Date Last Reviewed: | 06/2010 |
Indications and Limitations of Coverage
Gastric Electrical Stimulation for the Treatment of Gastroparesis (43647, 43648, 43881, 43882) The Gastric Electrical Stimulator (GES) System/Enterra Therapy System, manufactured by Medtronic, (H99001433) received approval from the U.S. Food and Drug Administration (FDA) on March 31, 2000. The GES system consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. The intramuscular leads are implanted either laparoscopically or during laparotomy and are connected to the pulse generator that is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an on time of 0.1 second alternating with an off time of 5.0 seconds. Please refer to the Glossary for the definition and requirements for HDEs and HUDs. Claims reporting gastric electrical stimulation will be reviewed on an individual consideration basis by the appropriate Medical Director. Consideration for coverage by the Medical Director should be based on the FDA approval for members for whom gastroparesis is refractory to medical management. Gastric electrical stimulation is FDA approved as a Humanitarian Device Exemption (HDE) for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. Gastric electrical stimulation is considered not medically necessary as an initial treatment for gastroparesis. Gastric electrical stimulation that is not approved by a Medical Director will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records. A Humanitarian Use Device (HUD) may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. Documentation of IRB approval may be requested to insure compliance with the FDA-labeled indications. This documentation must be available upon request; For electronic analysis of implanted neurostimulator pulse generator system, gastric neurostimulation pulse generator/transmitter; intraoperative, with programming or subsequent electronic analysis with or without reprogramming, use codes 95980-95982, as appropriate. Please refer to Medical Policy Bulletin G-24 for additional information on the treatment of obesity. Place of Service: Inpatient Description Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal. Symptoms include bloating, distension, nausea and vomiting. When severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status, and poor glycolic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathology. Treatment of gastroparesis includes dietary and pharmacological approaches, such as prokinetic agents, and antiemetic agents. Severe cases may require enteral or total parenteral nutrition. Gastric electrical stimulation is another option that may be considered for refractory cases. Gastric electrical stimulation is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The procedure may also be referred to as gastric pacing or Enterra Therapy. Gastric electrical stimulation or gastric pacing is being investigated for the treatment of morbid obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. This procedure employs an implantable, pacemaker like device to deliver low-level stimulation to the stomach. The Transcend IGS system consists of a battery-powered pulse generator, two leads with bipolar electrodes, and a remote handheld programmer. The pulse generator, which is about the size of a pocket watch, is implanted under the skin of the abdomen, and the leads and electrodes are inserted into the stomach wall and sutured to the stomach muscles. The minimally invasive surgical implantation procedure is usually performed laparoscopically in an outpatient setting and takes less than 1 hour. A few weeks after surgery, the stimulator is activated by the physician, who uses the handheld programmer to deliver patterned and adjustable electrical pulses to the stomach wall. Electrostimulation then induces an artificial feeling of fullness (satiety), which should result in reduced calorie consumption. The stimulator battery lasts 3 to 5 years, after which patients must have a minor surgical procedure to replace the battery. The mechanism of action for induced satiety is not yet fully understood, and may involve neurological processes, changes in digestive hormones, or altered gastrointestinal motility. Currently, the Transcend IGS system is not FDA approved and is undergoing clinical trials in the United States. |
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| 43647 | 43648 | 43881 | 43882 | 64590 | 64595 |
| 95980 | 95981 | 95982 |
This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits are determined by the Federal Employee Program. |
Provider News
02/2011, Place of Service Designation
02/2011, Criteria for Gastric Electrical Stimulation for Gastroparesis Expanded
National Blue Cross Blue Shield Association Medical Policy 7.01.73, Gastric Electrical Stimulation, Gastrointestinal Electrical Stimulation for Treatment of Gastrointestinal Disorders: Gastroparesis, Obesity, Fecal Incontinence, and Constipation, Gastroenterology Clinics, Volume 36, Number 3, 09/2007 EUS Guidance in Gastric Pacemaker Implantation, Gastrointestinal Endoscopy, Volume 55, No. 6, 05/2002 Motility Disorders, Pediatric Clinics of North America, Volume 49, No. 1, 02/2002 Shikora SA. Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis. 2009 Jan; 5(1): 31-7 Hasler WL. Methods of gastric electrical stimulation and pacing: a review of their benefits and mechanisms of action in gastroparesis and obesity. Neurogastroenterol Motil. 2009 Mar; 21(3): 229-43 Bohdjalian A. Improvement in glycemic control in morbidly obese type 2 diabetic subjects by gastric stimulation. Obes Surg. 2009 Sept; 19(9): 1221 Bohdjalian A. Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in overweight subjects with type 2 diabetes. Surg Endosc. 2009 Sept; 23(9): 1955-60 Lin Z, Sarosiek I, Forster J, McCallum RW. Treatment of Diabetic Gastroparesis by High-Frequency Gastric Electric Stimulation. Diabetes Care. 2004 May; 27(5): 1071-1076 Masaoka T, Tack J. Gastroparesis: Current Concepts and Management. Gut and Liver. 2009 Sept; 3(3): 166-73 Waseem S, Moshiree B, Draganov PV. Gastroparesis: Current Diagnostic Challenges and Management Considerations. World J Gastroenterol. 2009 Jan; 15(1): 25-37 Gourcerol G, Chaput U, LeBlanc I, Gallas S, Michot F, Leroi AM, Ducrotte P. Gastric Electrical Stimulation in Intractable Nausea and Vomiting: Assessment of Predictive Factors of Favorable Outcome. Journal of the American College of Surgeons. 2009 Aug; 209(2): 215-21 Soffer E. Review article: gastric electrical stimulation for gastroparesis--physiological foundations, technical aspects and clinical implications. Aliment Pharmacol Ther. 2009 Oct; 30(7): 681-94 McCallum RW. Mechanisms of symptomatic improvement after gastric electrical stimulation in gastroparetic patients. Neurogastroenterol Motil. 2010 Feb; 22(2): 161-7 O’Grady G, Egbuji JU, Du P, Cheng LK, Pullan AJ, Windsor JA. High-Frequency Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis. World Journal of Surgery. 2009; 33(8): 1693-1701 Ma J, Rayner CK, Jones KL, Horowitz M. Diabetic gastroparesis: diagnosis and management. Drugs. 2009 May 29;69(8):971-86 InterQual® Level of Care Criteria 2010. Acute Care Adult. McKesson Health Solutions, LLC. |
Covered Diagnosis Codes
Applicable to procedure codes 43647, 43881
| 536.3 |
| Term | Description |
|---|---|
Humanitarian Use Device (HUD) | Humanitarian Use Device (HUD) - According to the FDA, a Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer’s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the Safe Medical Devices Act of 1990 provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. |
Humanitarian Device Exemption (HDE) | Humanitarian Device Exemption (HDE) - An approved Humanitarian Device Exemption (HDE) authorizes marketing of the humanitarian use device. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is a humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated. To obtain approval for a humanitarian use device, a humanitarian device exemption (HDE) application is submitted to FDA. An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market. The FDA provides a listing of CDRH Humanitarian Device Exemptions at the following site: Further information regarding HUD/HDE can be found at the following FDA site: |