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Date Printed: August 22, 2017: 06:58 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-04

Original Effective Date: 11/15/01

Reviewed: 02/27/14

Revised: 05/11/14

Subject: Gastric Electrical Stimulation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

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 glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson’s disease, and psychological pathology. Treatment of gastroparesis includes prokinetic agents such as metoclopramide, and antiemetic agents such as granisetron or ondansetron. Severe cases may require enteral or total parenteral nutrition.

Gastric electrical stimulation (GES) has been investigated as a treatment for chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic, idiopathic or post-surgical etiology. Gastric electrical stimulation is performed using an implantable device, which may be referred to as a gastric pacemaker or gastric pacer.

One gastric electrical stimulator, the Gastric Electrical Stimulator (GES) system (now called Enterra™ Therapy System), manufactured by Medtronic, has received approval from the U.S. Food and Drug Administration (FDA). This device received FDA approval through a humanitarian device exemption (HDE). This regulatory category allows a manufacturer to market a device in the United States on a limited basis to treat patients with rare medical conditions that affect fewer than 4,000 people annually. Continued approval of the HDE is contingent on the manufacturer’s submission of annual reports, indicating the number of devices sold and actually used by patients, the clinical use of information, and any adverse reactions or device malfunctions.

The Enterra™ Therapy System consists of 4 components: the implanted pulse generator, 2 unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. With the exception of the intramuscular leads, all other components have been used in other implantable neurologic stimulators, such as spinal cord or sacral nerve stimulation. The intramuscular stomach leads are implanted either laparoscopically or during a laparotomy and are connected to the pulse generator, which is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an “on” time of 0.1 sec alternating with an “off” time of 5.0 sec.

Gastric electrical stimulation has also been investigated as a treatment of obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neuro-hormonal modulation and/or stomach muscle stimulation. There are no gastric electrical stimulation devices approved by the FDA for the treatment of obesity. However, the Transcend® Implantable Gastric Stimulation device, manufactured by Transneuronix Corporation and acquired by Medtronic in 2005, is currently available in Europe for treatment of obesity.

POSITION STATEMENT:

Gastric electrical stimulation may be considered medically necessary when an FDA-approved device is used for the FDA-approved indication of chronic, intractable nausea and vomiting secondary to severe gastroparesis of diabetic or idiopathic etiology, and when ALL the following criteria are met:

Gastric electrical stimulation is considered experimental or investigational for all other indications, including but not limited to the treatment of obesity, as current available clinical data is inadequate to permit scientific conclusions regarding the effectiveness of this therapy.

BILLING/CODING INFORMATION:

CPT Coding:

43647

Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum

43648

Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum

43881

Implantation or replacement of gastric neurostimulator electrodes, antrum, open

43882

Revision or removal of gastric neurostimulator electrodes, antrum, open

64590

Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling

64595

Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver

95980

Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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

95981

Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 programming

95982

Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 programming

HCPCS Coding:

E0765

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

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Vagus Nerve Stimulation, 02-61000-22

OTHER:

None applicable.

REFERENCES:

  1. Abell T, McCallum R, Hocking M, Koch K, Abrahamsson H, Leblanc I, Lindberg G, Konturek J, Nowak T, Quigley EM, Tougas G, Starkebaum W. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003 Aug; 125(2): 421-8.
  2. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Guideline Summary NGC-9188. The role of endoscopy in gastroduodenal obstruction and gastroparesis. July 2011.
  3. Agency for Healthcare Research and Quality. National Guideline Clearinghouse. Guideline Summary NGC-7460. Type 2 diabetes. The management of type 2 diabetes. May 2009.
  4. American College of Gastroenterology: Gastroparesis (2004, updated December 2012). Accessed at http://www.acg.gi.org/patients/gihealth/pdf/gastroparesis.pdf on 01/25/13.
  5. American Diabetes Association. Gastroparesis. Accessed at http://www.diabetes.org/ on 01/28/14.
  6. American Gastroenterological Association. Medical Position Statement: Diagnosis and Treatment of Gastroparesis. Gastroenterol. 2004;127:1589-91.
  7. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.01.73 Gastric Electrical Stimulation, August 2013.
  8. Bortolotti M. Gastric electrical stimulation for gastroparesis: A goal greatly pursued, but not yet attained. World J Gastroenterol 2011 January 21; 17(3): 273-282.
  9. Bouras EP. Gastroparesis and electrical stimulation: can we afford the power bill? Neurogastroenterol Motil. 2005 Feb; 17(1): 2-3.
  10. Camilleri M, et al. American College of Gastroenterology Clinical Guideline: Management of Gastroparesis. Am J Gastroenterol 2013; 108:18–37.
  11. ClinicalTrials.gov. Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis). NCT00157755. Last Updated on February 23, 2010.
  12. ClinicalTrials.gov. Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis: NCT00432835. University of Mississippi Medical Center. Last updated 11/01/12.
  13. Cutts TF, Luo J, Starkebaum W, Rashed H, Abell TL. Is gastric electrical stimulation superior to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and long-term health care benefits? Neurogastroenterol Motil. 2005 Feb; 17(1): 35-43.
  14. ECRI, Health Technology Forecast. Gastric electrical stimulation for treatment of obesity. Plymouth Meeting, PA: ECRI, December 2007.
  15. ECRI, Health Technology Forecast. Gastric electrical stimulation for treating type 2 diabetes mellitus. 12/20/11.
  16. ECRI Institute Health Technology Forecast: Gastric Electrical Stimulation for Treating Type 2 Diabetes Mellitus. August 2012.
  17. ECRI, Target Database, Target Report 494. Gastric stimulation for medically refractory gastroparesis. Plymouth Meeting, PA: ECRI, December 2006.
  18. Enweluzo C, Aziz F. Gastroparesis: a review of current and emerging treatment options. Clinical and Experimental Gastroenterology 2013:6 161–165.
  19. Florida Medicare Part B Local Coverage Determination L29288. Noncovered Services. 02/02/09. Reviewed 01/13/14.
  20. Florida Medicare Part B Local Coverage Determination L5780 NCSVCS The List of Medicare Non-covered Services. Retired 02/01/09.
  21. Hayes, Inc. Hayes Medical Technology Directory – Gastric Electrical Stimulation Lansdale, PA: Hayes, Inc. July 2004. Updated July 2007.
  22. Hayes, Inc. Health Technology Brief. Gastric Electrical Stimulation with an Implantable Gastric Stimulator (IGS) for the Treatment of Obesity. Lansdale, PA: Hayes, Inc; July 2007
  23. InterQual® 2011. Adult Procedure, Gastric Stimulation.
  24. Jayanthi NVG, Dexter SP, Sarela AI, Team TLG. Gastric electrical stimulation for treatment of clinically severe gastroparesis. Journal of minimal access surgery, 9(4), 163.
  25. Keller DS, Parkman HP, Boucek DO, Sankineni A, Meilahn JE, Gaughan JP, & Harbison S. Surgical Outcomes After Gastric Electric Stimulator Placement for Refractory Gastroparesis. Journal of Gastrointestinal Surgery, 1-7.
  26. Koch K L. Gastric Electrical Stimulation and the “Eye of the Beholder” (Editorial). CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2010;8:908–909.
  27. Lahr CJ, Griffith J, Subramony C, Halley L, Adams K, Paine ER, Abell T. Gastric Electrical Stimulation for Abdominal Pain in Patients with Symptoms of Gastroparesis. The American Surgeon, 79(5), 457-464.
  28. Lin Z, Forster J, Sarosiek I, McCallum RW. Treatment of diabetic gastroparesis by high-frequency gastric electrical stimulation. Diabetes Care. 2004 May; 27(5): 1071-6.
  29. Lin Z, Sarosiek I, Forster J, Ross RA, Chen JD, McCallum RW. Two‐channel gastric pacing in patients with diabetic gastroparesis. Neurogastroenterology & Motility, 23(10), 912-e396.
  30. McCallum R, Lin Z, Wetzel P, Sarosiek I, Forster J. Clinical response to gastric electrical stimulation in patients with postsurgical gastroparesis. Clin Gastroenterol Hepatology. 2005;3: 49-54.
  31. McCallum RW, Sarosiek I, Parkman HP, Snape W, Brody F, Wo J, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterology & Motility, 25(10), 815-e636.
  32. Mintchev MP. Gastric Electrical Stimulation for the Treatment of Obesity: From Entrainment to Bezoars—A Functional Review. ISRN Gastroenterology Volume 2013, Article ID 434706.
  33. Mizrahi M, Ya'acov AB, Ilan Y. Gastric stimulation for weight loss. World J Gastroenterol 2012 May 21; 18(19): 2309-2319.
  34. Moga C, Harstall C. Gastric electrical stimulation (Enterra (TM) therapy system) for the treatment of gastroparesis. Edmonton: Alberta Heritage Foundation for Medical Research (AHFMR), 2006:88.
  35. National Institute for Clinical Excellence. Gastroelectrical stimulation for gastroparesis. London: National Institute for Clinical Excellence (NICE), 2004:2. Accessed at: http://www.nice.org.uk/ on 01/28/14.
  36. National Institutes of Health (NIH). National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH Publication No. 12–4348: Gastroparesis. June 2012. Accessed at http://www2.niddk.nih.gov/ on 01/28/13.
  37. Ontario Ministry of Health and Long-Term Care. Gastric electrical stimulation: health technology policy assessment. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care (MAS), 2006:77.
  38. Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov; 127(5): 1589-91. (Accessed 01/23/12).
  39. Policker S, Haddad W, Yaniv I. Treatment of Type 2 Diabetes Using Meal-Triggered Gastric Electrical Stimulation. Israel Medical Association World Fellowship Conference. IMAJ Volume 11 (April 2009).
  40. Sanmiguel CP, Conklin JL, Cunneen SA, Barnett P, Phillips EH, Kipnes M, et al. Gastric electrical stimulation with the TANTALUS System in obese type 2 diabetes patients: effect on weight and glycemic control. J Diabetes Sci Technol. 2009 Jul 1;3(4):964-70.
  41. Timratana P, El-Hayek K, Shimizu H, Kroh M,Chand B. Laparoscopic Gastric Electrical Stimulation for Medically Refractory Diabetic and Idiopathic Gastroparesis. Journal of Gastrointestinal Surgery, 17(3), 461-470.
  42. U.S. Food and Drug Administration (FDA) MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS COENTERRAINTESTINAL STIMULATOR (01/09/12). Accessed at http://www.fda.gov/ on 01/22/13.
  43. U. S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. Summary of Safety and Probable Benefit, Enterra™ Therapy System (formerly named Gastric Electrical Stimulation (GES) System). Humanitarian Use Device # H990014. 03/31/00. Updated Aug 22, 2000. Accessed at http://www.fda.gov/ on 01/22/13.
  44. U. S. Food and Drug Administration (FDA). FDA Dockets Management Branch re: Citizen’s Petition to transfer from Humanitarian Device (HUD) to Pre-market Approval (PMA) for Enterra™ Therapy System. 02/24/04.
  45. Van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan; 113(1): 38-42.
  46. Williams PA, Nikitina Y, Kedar A, Lahr CJ, Helling TS, Abell TL. Long-Term Effects of Gastric Stimulation on Gastric Electrical Physiology. Journal of Gastrointestinal Surgery, 17(1), 50-56.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/27/14.

GUIDELINE UPDATE INFORMATION:

11/15/01

New Medical Coverage Guideline

12/15/02

Review of guideline; consisting of updated references and maintaining investigational status.

04/15/03

Revision to guideline; consisting of addition of E0765.

10/01/03

4th quarter HCPCS update; consisting of addition of S2213.

11/15/03

Review of guideline; maintain investigational status.

04/15/04

Review of guideline; consisting of updated references and no change to investigational status.

03/15/05

Review of guideline; consisting of updated references and no change to investigational status.

03/15/06

Review of guideline consisting of updated references.

07/01/06

HCPCS coding update consisting of the addition of 0155T, 0156T, 0157T and 0158T.

01/01/07

Annual HCPCS coding update: added 43647, 43648, 43881, 43882, 64590, 64595 and 0162T.

03/15/07

Review and revision of guideline consisting of updated references.

04/01/07

HCPCS coding update consisting of the deletion of S2213.

06/15/07

Reformatted guideline.

01/01/08

Annual HCPCS coding update: added codes 95980, 95981 and 95982.

03/15/08

Review and revision of guideline consisting of updated references.

01/01/09

Annual HCPCS coding update: deleted code 0162T.

03/15/09

Review and revision of guideline consisting of updated references.

03/15/10

Scheduled review; update in position statement for humanitarian device exemption. Update references

01/01/12

Annual HCPCS coding update. Deleted 0155T, 0156T, 0157T and 0158T.

03/15/12

Scheduled review; position statement maintained. Updated references.

03/15/13

Scheduled review. Revised description and position statement (deleted requirement that criteria for total parenteral nutrition are met). Updated references.

03/15/14

Scheduled review. Maintained position statement. Updated program exceptions section and references.

05/11/14

Revision: Program Exceptions section updated.

Date Printed: August 22, 2017: 06:58 AM