Gastric Electrical Stimulation - Insertion Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 10|01|2021 POLICY LAST REVIEWED: 04|16|2025 OVERVIEW Gastric electrical stimulation is performed using an implantable device designed to treat chronic drug- refractory nausea and vomiting secondary to gastroparesis of diabetic, idiopathic, or post-surgical etiology. Gastric electrical stimulation has also been investigated as a treatment of obesity. The device may be referred to as a gastric pacemaker. This policy is intended to document the insertion or implantation of the device as not medically necessary. Note: For removal of the device, refer to the following policy, Removal of Implantable Devices MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans
Implantation of a gastric electrical stimulation device for any indication, including treatment of gastroparesis of diabetic, idiopathic, postsurgical etiology or for treatment of obesity, is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products Implantation of a gastric electrical stimulation device for any indication, including treatment of gastroparesis of diabetic, idiopathic, postsurgical etiology or for treatment of obesity, is not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.
COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for not covered/not medically necessary benefits/coverage.
BACKGROUND Gastroparesis 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 diabetic patients. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathologic conditions. Some cases may not be associated with an identifiable cause and are referred to as idiopathic gastroparesis. Gastric electrical stimulation (GES), also referred to as gastric pacing, using an implantable device, has been investigated primarily as a treatment for gastroparesis. Currently available devices consist of a pulse generator, which can be programmed to provide electrical stimulation at different frequencies, connected to intramuscular stomach leads, which are implanted during laparoscopy or open laparotomy. In 2000, the Gastric Electrical Stimulator system (now called Enterra™ Therapy System; Medtronic) was approved by the U.S. Food and Drug Administration through the humanitarian device exemption process for the treatment of gastroparesis. The GES system consists of 4 components: the implanted pulse generator, 2 Medical Coverage Policy | Gastric Electrical Stimulation - Insertion

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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 seconds alternating with an “off” time of 5.0 seconds. The Enterra II system features no magnetic activation switch which reduces electromagnetic interference.

Obesity Gastric electrical stimulation has also been investigated as a treatment of obesity. It is used to increase a
feeling of satiety with subsequent reduction in food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neurohormonal modulation and/or stomach muscle stimulation.

Currently, no GES devices have been approved by the Food and Drug Administration for the treatment of obesity. The Transcend® (Transneuronix; acquired by Medtronic in 2005), an implantable gastric stimulation device, is available in Europe for treatment of obesity.

For individuals who have gastroparesis who receive gastric electrical stimulation (GES), the evidence includes randomized controlled trials (RCTs), nonrandomized studies, and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. Several crossover RCTs have been published. A 2017 meta- analysis of 5 RCTs did not find a significant benefit of GES on the severity of symptoms associated with gastroparesis. Patients generally reported improved symptoms at follow-up whether or not the device was turned on, suggesting a placebo effect. A 2022 meta-analysis did find some improvements, but interpretation of its findings are limited by inconsistent benefits across different outcomes and timepoints, high heterogeneity (I2=70%), and inclusion of study populations not representative of the intended population. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obesity who receive GES, the evidence includes an RCT and several small case series and uncontrolled prospective trials. Relevant outcomes are change in disease status and treatment- related morbidity. The SHAPE trial did not show significant improvement in weight loss using GES compared with a sham stimulation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 43647 Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum 43881 Implantation or replacement of gastric neurostimulator electrodes, antrum, open
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 reprogramming 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 reprogramming

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

For Obesity Medicare Advantage Plans and Commercial Products The following code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: Laparoscopic procedures related to gastric stimulation electrodes for morbid obesity should be reported using code 43659 (unlisted laparoscopy procedure, stomach), and laparotomy procedures related to gastric stimulation electrodes for morbid obesity should be reported using 43999 (unlisted procedure, stomach).

The following code(s) is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when used for gastric electrical stimulation AND filed with one of the ICD-10 Diagnosis Code(s)* listed below:
64590 Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver,
requiring pocket creation and connection between electrode array and pulse generator or receiver

*ICD-10 Diagnosis Code(s) E08.43
E09.43
E10.43
E11.43
E13.43 E66.01-E66.9 K31.89

RELATED POLICIES Removal of Implantable Devices Unlisted Procedures

PUBLISHED Provider Update, June 2025 Provider Update, September 2024 Provider Update, May 2023 Provider Update, June 2022 Provider Update, August 2021

REFERENCES

1. Levinthal DJ, Bielefeldt K. Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. AutonNeurosci. Jan 2017; 202: 45-55. PMID 27085627
2. Chu H, Lin Z, Zhong L, et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J GastroenterolHepatol. Jun 2012; 27(6): 1017-26. PMID 22128901
3. Lal N, Livemore S, Dunne D, et al. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015; 2015: 762972. PMID 26246804
4. Saleem S, Aziz M, Khan AA, et al. Gastric Electrical Stimulation for the Treatment of Gastroparesis or Gastroparesis-like Symptoms: A Systemic Review and Meta-analysis. Neuromodulation. Dec 02 2022. PMID 36464562
5. Ducrotte P, Coffin B, Bonaz B, et al. Gastric Electrical Stimulation Reduces Refractory Vomiting in a RandomizedCrossover Trial. Gastroenterology. Feb 2020; 158(3): 506-514.e2. PMID 31647902
6. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. Aug 2003; 125(2): 421-8. PMID 128915447.
7. U.S. Food and Drug Administration. Summary of Safety and Probable Benefit: EnterraTM Therapy System. 2010; http://www.accessdata.fda.gov/cdrh_docs/pdf/H990014b.pdf. Accessed January 3, 2025.
8. McCallum RW, Snape W, Brody F, et al. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. Nov 2010; 8(11): 947-54; quiz e116. PMID20538073

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

9. McCallum RW, Sarosiek I, Parkman HP, et al. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. Oct 2013; 25(10): 815-e636. PMID 23895180
10. Samaan JS, Toubat O, Alicuben ET, et al. Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis. Surg Endosc. Oct 2022; 36(10): 7561-7568. PMID 35338403
11. Laine M, Sirén J, Koskenpato J, et al. Outcomes of High-Frequency Gastric Electric Stimulation for the Treatment of Severe, Medically Refractory Gastroparesis in Finland. Scand J Surg. Jun 2018; 107(2): 124-
12. PMID 29268656
13. Shada A, Nielsen A, Marowski S, et al. Wisconsin's Enterra Therapy Experience: A multi-institutional review of gastric electrical stimulation for medically refractory gastroparesis. Surgery. Oct 2018; 164(4): 760-765. PMID 30072246
14. 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): 31-7. PMID 19071066
15. Cigaina V, Hirschberg AL. Gastric pacing for morbid obesity: plasma levels of gastrointestinal peptides and leptin. ObesRes. Dec 2003; 11(12): 1456-62. PMID 14694209
16. Cigaina V. Gastric pacing as therapy for morbid obesity: preliminary results. Obes Surg. Apr 2002; 12 Suppl 1: 12S-16S.PMID 11969102
17. D'Argent J. Gastric electrical stimulation as therapy of morbid obesity: preliminary results from the French study. ObesSurg. Apr 2002; 12 Suppl 1: 21S-25S. PMID 11969104
18. De Luca M, Segato G, Busetto L, et al. Progress in implantable gastric stimulation: summary of results of the Europeanmulti-center study. Obes Surg. Sep 2004; 14 Suppl 1: S33-9. PMID 15479588
19. 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. May 2004; 14(5): 666-70. PMID 15186636
20. Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg. Apr 2004; 14(4): 545-8. PMID15130236
21. Camilleri M, Kuo B, Nguyen L, et al. ACG Clinical Guideline: Gastroparesis. Am J Gastroenterol. Aug 01 2022; 117(8): 1197-1220. PMID 35926490

22. National Institute of Health and Care Excellence. Gastroelectrical stimulation for gastroparesis [IPG489 ]. 2014; https://www.nice.org.uk/guidance/ipg489. Accessed January 3, 2025.

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS