Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Gastric Electrical Stimulation (Enterra™), Gastric Pacing

Policy #:11.03.15h

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

GASTROPARESIS

Gastric electrical stimulation (e.g., Enterra™ Therapy) is considered medically necessary and, therefore, covered for the following humanitarian device exemption (HDE) indication granted by the US Food and Drug Administration (FDA):
  • For the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology

An institutional review board (IRB) must approve the use of gastric electrical stimulation for the treatment of gastroparesis to ensure that it will be used in accordance with the HDE indication(s) granted by the FDA. In addition, documentation of IRB approval may be requested by the Company to ensure compliance with such indication(s).

OBESITY

Gastric electrical stimulation (e.g., Transcend Implantable Gastric Stimulator [IGS®] ) for the management of obesity is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published literature.

OTHER USES

Gastric electrical stimulation requested for any off-label use (i.e., outside the FDA-labeled HDE indication listed above) is considered experimental/investigational and, therefore, not covered. Noncovered off-label uses include, but are not limited to, initial treatment of gastroparesis or gastroparesis of any other etiology.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

Subject to the terms and conditions of the applicable benefit contract, gastric electrical stimulation (Enterra™) for all other uses is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

On May 31, 2000, the Enterra™ gastric electrical stimulator (Medtronic, Inc. Minneapolis, MN) was approved by the FDA under the HDE process for use in individuals with chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

WARNINGS ISSUED FROM THE MANUFACTURER AND THE FDA

Magnetic resonance imaging (MRI) is not compatible with the neurostimulator and leads.

Use of diathermy in an individual with an implantable gastric electrical stimulator is contraindicated per the manufacturer’s literature because the energy produced by diathermy can be transferred through the implant system or any of the device components. This may contribute to tissue damage that could result in severe injury or death. Diathermy can also damage parts of the stimulation system.

The system may be affected by or may adversely affect cardiac pacemakers or therapies, cardioverter defibrillators, electrocautery, external defibrillators, ultrasonic equipment, radiation therapy, theft detectors, and screening devices. The safety and effectiveness of this device for children and pregnant women has not been established. Leads may fail to function for a variety of reasons including, but not limited to: medical complications, body rejection phenomena, lead breakage, breech of lead insulation covering, fibrotic tissue, or improper handling or use.

Description

Gastric electrical stimulation uses an implantable electric stimulator (or pacemaker) on the stomach musculature to aid in the management of gastroparesis. Gastroparesis is defined as delayed gastric emptying without evidence of obstruction; it is most notable with solid foods. This condition mainly affects individuals with diabetes, but it can also be found in individuals with connective tissue disorders, Parkinson's disease, chronic pseudo-obstruction, or in those who have undergone gastric surgery (e.g., vagotomy). Gastroparesis can also be idiopathic in origin. In individuals with diabetes, gastroparesis is the result of gastroneuropathy and is associated with injury to the vagus nerve. The symptoms of gastroparesis include bloating, belching, distention, nausea, vomiting, and early satiety. The chronic nausea and frequent episodes of vomiting associated with chronic or severe gastroparesis can lead to dehydration, malnutrition, and, in individuals with diabetes, poor glycemic control.

Medical management of gastroparesis begins with dietary recommendations for frequent smaller meals that are low in fat and fiber, since fat can delay gastric emptying and fiber can be difficult to digest. If stomach emptying is delayed, undigested fiber may be retained and accumulate to form a bezoar (hardened mass). When dietary measures alone are not sufficient to alleviate the symptoms of gastroparesis, pharmaceutical management with antiemetics to control nausea (e.g., metoclopramide, granisetron, ondansetron) and prokinetics to promote gastric emptying (e.g., metoclopramide, erythromycin) are used with some success. However, many of these medications are associated with unwanted side effects that limit their use. In severe cases of gastroparesis, enteral or total parenteral nutrition may be required. Surgical management (e.g., insertion of a gastrostomy tube and/or feeding jejunostomy tube, pyloroplasty, gastrectomy, or gastrojejunostomy) may be utilized when gastroparesis remains refractory.

Gastric electrical stimulation, also referred to as a gastric pacemaker or gastric pacing, is an alternative surgery to treat gastroparesis that remains refractory to medical management. An electrical stimulator (pulse generator) is inserted either by laparoscopy or laparotomy into a subcutaneous pocket and connects to unipolar leads (electrodes) that are sutured to the greater curvature of the stomach muscle. An external stimulator programmer is used to set or adjust the settings or to turn the stimulator on and off. The procedure can be done on an inpatient or outpatient basis.

The Enterra™ Therapy system (Medtronic Inc., Minneapolis, MN) is currently the only gastric electrical stimulator approved by the US Food and Drug Administration (FDA) under a humanitarian device exemption (HDE). Enterra™ Therapy received FDA approval on March 31, 2000, as a humanitarian use device (HUD) for the "treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology." The FDA has not demonstrated the efficacy of Enterra™ Therapy for this use.

The Transcend® Implantable Gastric Stimulator (IGS®) (Medtronic, Inc., Minneapolis, MN) is currently available in Europe for the treatment for obesity. Presently, there are no gastric electrical stimulators with FDA approval for this use. The mechanism of action for gastric pacing for weight loss is not fully known, but it is believed that early satiety is produced by either a neurohormonal modulation or by stimulation of the stomach muscle. There is insufficient peer-reviewed literature and scientific evidence to draw conclusions about the safety and efficacy of this procedure and its long-term effects. More research is needed to support gastric electrical stimulation as a treatment for obesity.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (HDE) process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Since clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.
References

Abell TL, Johnson WD, Kedar A, et al. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc. 2011;74(3):496-503.


Abell T, Lou J, Tabbaa M, et al. Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate and long-term follow-up. J Parenter Enteral Nutr. 2003;27(4):277-281.

Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003;125(2):421-428.

Anand C, Al-Juburi A, Familoni B, et al. Gastric electrical stimulation is safe and effective: a long-term study in patients with drug-refractory gastroparesis in three regional centers. Digestion. 2007;75(2-3):83-89.

Andersson S, Ringstrom G, Elfvin A, et al. Temporary percutaneous gastric electrical stimulation: a novel technique tested in patients with non-established indications for gastric electrical stimulation. Digestion. 2011;83(1-2):3-12.

Ang D, Tack J. Gastric electrical stimulation for the treatment of gastroparesis: ready for prime time? Digestion. 2007;75(2-3):80-82.

Brody F, Vaziri K, Saddler A, et al. Gastric electrical stimulation for gastroparesis. J Am Coll Surg. 2008;207(4):533-538.

Brody F, Zettervall SL, Richards NG, et al. Follow-up after gastric electrical stimulation for gastroparesis. J Am Coll Surg. 2015;220(1):57-63.

Camilleri M, Parkman HP, Shafi MA et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013; 108(1):18-37.

Chu H, Lin Z, Zhong L et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J Gastroenterol Hepatol. 2012; 27(6):1017-26.

Cigaina V. Gastric pacing as therapy for morbid obesity: Preliminary results. Obes Surg. 2002;12(suppl 1):12S-16S.

Cigaina V, Hirschberg AL. Gastric pacing for morbid obesity: Plasma levels of gastrointestinal peptides and leptin. Obes Res. 2003;11(12):1456-1462.

D'Argent J. Gastric electrical stimulation as therapy of morbid obesity: Preliminary results from the French study. Obes Surg. 2002;12(suppl 1):21S-25S.

De Luca M, Segato G, Busetto L, et al. Progress in implantable gastric stimulation: Summary of results of the European multi-center study. Obes Surg. 2004;14(suppl 1):S33-S39.

Elfvin A, Gothberg G, Lonroth H, et al. Temporary percutaneous and permanent gastric electrical stimulation in children younger than 3 years with chronic vomiting. J Pediatr Surg. 2011;46(4):655-661.

Favretti F, De Luca M, Segato G, et al. Treatment of morbid obesity with the Transcend Implantable Gastric Stimulator (IGS): A prospective survey. Obes Surg. 2004;14(5):666-670.

Forster J, Sarosiek I, Lin Z, et al. Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surg. 2003;186(6):690-695.

Gourcerol G, Leblanc I, Leroi AM, et al. Gastric electrical stimulation in medically refractory nausea and vomiting. Eur J Gastroenterol Hepatol. 2007;19(1):29-35.

Harrison NS, Williams PA, Walker MR, et al. Evaluation and Treatment of Gastric Stimulator Failure in Patients With Gastroparesis. Surg Innov. 2013;21(3):244-249.

Hayes, Inc. Hayes Medical Technology Directory. Gastric Electrical Stimulation for Gastroparesis. Lansdale, PA: Hayes, Inc.; July 2004 (updated July 2005).

Jayanthi NV, Dexter SP, Sarela AI, et al. Gastric electrical stimulation for treatment of clinically severe gastroparesis. J Minim Access Surg. 2013;9(4):163-167.

Lahr CJ, Griffith J, Subramony C, et al. Gastric electrical stimulation for abdominal pain in patients with symptoms of gastroparesis. Am Surg. 2013;79(5):457-64.

Lal N, Livemore S, Dunne D, et al. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015;2015:762972.

Levinthal DJ, Bielefeldt K. Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. Auton Neurosci. 2017;202:45-55.

Lin Z, Forster J, Sarosiek I, McCallum RW. Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. Diabetes Care. 2004;27(5):1071-1076.

Lin Z, Sarosiek I, Forster J, McCallum RW. Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis. Neurogastroenterol Motil. 2006;18(1):18-27.

Lu PL, Teich S, Di Lorenzo C, et al. Improvement of quality of life and symptoms after gastric electrical stimulation in children with functional dyspepsia. Neurogastroenterol Motil. 2013;25(7):567-e456.

Mason RJ, Lipham J, Eckerling G, Schwartz A, Demeester TR. Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. Arch Surg. 2005;140(9):841-846.

McCallum RW, Lin Z, Forster J, et al. Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. Clin Gastroenterol Hepatol. 2011;9(4):314-319.

McCallum RW, Sarosiek I, Parkman HP, et al. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. 2013;25(10):815-e636.

McCallum RW, Snape W, Brody F, et al. Gastric electrical stimulation with Enterra™ therapy improves symptoms from diabetic gastroparesis in prospective study. Clin Gastroenterol Hepatol. 2010;8(11):947-954.

McElhinny C, Sarosiek I, Lin Z, et al. Comparison of hospitalization, medications and quality of life in patients receiving gastric electrical stimulation (GES) therapy for severe gastroparesis. Gastroenterology. 2002;122:A82.

Medtronic. What is gastric electrical stimulation? [Medtronic Web site]. Available at: http://www.medtronic.com/us-en/patients/treatments-therapies/neurostimulator-gastroparesis/what-is-it.html. Accessed June 14, 2018.

National Institute for Clinical Excellence. Gastroelectrical stimulation for gastroparesis. May 2014. Available online at: https://www.nice.org.uk/guidance/IPG489/chapter/1-Recommendations. Accessed June 14, 2018.

Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology. 2004:127(5):1589-1591.

Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg. 2004;14(4):545-548.

Shikora SA, Bergenstal R, Bessler M, et al. Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis. 2009;5(1):31-37.

Teich S, Mousa HM, Punati J, et al. Efficacy of permanent gastric electrical stimulation for the treatment of gastroparesis and functional dyspepsia in children and adolescents. J Pediatr Surg. 2013;48(1):178-183.

Timratana P, El-Hayek K, Shimizu H, et al. Laparoscopic gastric electrical stimulation for medically refractory diabetic and idiopathic gastroparesis. J Gastrointest Surg. 2013;17(3):461-470.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FDA dockets management branch re: citizen's petition to transfer from humanitarian device exemption (HDE) to premarket approval (PMA) for Enterra™ Therapy System. [FDA Web site]. 11/04/04. Available at: http://www.fda.gov/ohrms/dockets/dailys/04/nov04/110504/04p-0091-pdn00001-vol1.pdf. Accessed June 14, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Summary of Safety and Probable Benefit. Enterra Therapy System. [FDA Web site]. 09/23/1999. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H990014b.pdf. Accessed June 14, 2018.

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):38-42.

Zehetner J, Ravari F, Ayazi S, et al. Minimally invasive surgical approach for the treatment of gastroparesis. Surg Endosc. 2013;27(1):61-6.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT INSERTION, REPLACEMENT, REVISION, OR REMOVAL OF A GASTRIC ELECTRICAL STIMULATOR THAT IS APPROVED BY THE FDA HDE FOR THE TREATMENT OF NAUSEA AND VOMITING SECONDARY TO GASTROPARESIS:

43647, 43648, 43881, 43882, 64590, 64595


THE FOLLOWING CODES ARE USED TO REPRESENT THE ELECTRONIC ANALYSIS AND PROGRAMMING OF A GASTRIC ELECTRICAL STIMULATOR THAT IS APPROVED BY THE FDA HDE FOR THE TREATMENT OF NAUSEA AND VOMITING SECONDARY TO GASTROPARESIS:

95980, 95981, 95982


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODES ARE USED TO REPRESENT THE USE OF GASTRIC ELECTRICAL STIMULATION FOR THE MANAGEMENT OF OBESITY:

43999, 43659


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

K31.84 Gastroparesis


HCPCS Level II Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT INSERTION OF A GASTRIC ELECTRICAL STIMULATOR THAT IS APPROVED BY THE FDA HDE FOR THE TREATMENT OF NAUSEA AND VOMITING SECONDARY TO GASTROPARESIS:


E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Effective 10/05/2017 this policy has been updated to the new policy template
format.



07/18/2018As of 07/18/2018, this policy has been reviewed and reissued to communicate the Company’s continuing position on gastric electrical stimulation (Enterra™), gastric pacing.
Version Effective Date: 04/08/2015
Version Issued Date: 04/08/2015
Version Reissued Date: 07/18/2018

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