File name: Gastric Electrical Stimulation File code: UM.NS.06 Origination: 2007 Last Review: 06/2018 Next Review: 06/2019 Effective Date: 10/01/2018 Description/Summary Gastric Electrical Stimulation Corporate Medical Policy Gastric electrical stimulation (GES) 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. GES has also been investigated as a treatment of obesity. The device may be referred to as a gastric pacemaker. Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I - CPT Code List & Instructions When a service is considered investigational Gastric electrical stimulation is considered investigational for the treatment of gastroparesis of diabetic, idiopathic, or post-surgical etiology. Gastric electrical stimulation is considered investigational for the treatment of obesity. Reference Resources 1. Levinthal DJ, Bielefeldt K. Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. Auton Neurosci. 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 Gastroenterol Hepatol. Jun 2012;27(6):1017-1026. 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 Page 1 of 6
4. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. Aug 2003;125(2):421-428. PMID 12891544 5. U.S. Food and Drug Administration. FDA Summary of Safety and Probable Benefit. 2010; http://www.accessdata.fda.gov/cdrh_docs/pdf/h990014b.pdf. Accessed January, 2017. 6. 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):947-954; quiz e116. PMID 20538073 7. 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 8. 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. Jan-Feb 2009;5(1):31-37. PMID 19071066 9. Cigaina V. Gastric pacing as therapy for morbid obesity: preliminary results. Obes Surg. Apr 2002;12 Suppl 1:12S-16S. PMID 11969102 10. Cigaina V, Hirschberg AL. Gastric pacing for morbid obesity: plasma levels of gastrointestinal peptides and leptin. Obes Res. Dec 2003;11(12):1456-1462. PMID 14694209 11. D'Argent J. Gastric electrical stimulation as therapy of morbid obesity: preliminary results from the French study. Obes Surg. Apr 2002;12 Suppl 1:21S-25S. PMID 11969104 12. 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. Sep 2004;14 Suppl 1:S33-39. PMID 15479588 13. 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):666-670. PMID 15186636 14. Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg. Apr 2004;14(4):545-548. PMID 15130236 15. National Institute of Health and Care Excellence. Gastroelectrical stimulation for gastroparesis [IPG489 ]. 2014; https://www.nice.org.uk/guidance/ipg489. Accessed January 23, 2017. 16. Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. Jan 2013;108(1):18-37; quiz 38. PMID 23147521 Document Precedence Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language, or employer s benefit plan if an ASO group, determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract/employer benefit plan language, the member s contract/employer benefit plan language takes precedence. Page 2 of 6
Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to recoup all non-compliant payments. Benefit Determination Guidance Administrative and Contractual Guidance Prior approval is required and benefits are subject to all terms, limitations and conditions of the subscriber contract. An approved referral authorization for members of the New England Health Plan (NEHP) is required. A prior approval for Access Blue New England (ABNE) members is required. NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member s health plan. Federal Employee Program (FEP): Members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. It is important to verify the member s benefits prior to providing the service to determine if benefits are available or if there is a specific exclusion in the member s benefit. Coverage varies according to the member s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict. If the member receives benefits through an Administrative Services Only (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member s employer benefit plan documents or contact the customer service department. Language in the employer benefit plan documents takes precedence over medical policy when there is a conflict. Policy Implementation/Update information 02/2007 New Policy 03/2008 Policy reformatted to match BCBSA Medical Policy format and reviewed by CAC. 07/2009 Medical necessity criteria clarified and aligned with Anthem Blue Cross (New Hampshire) 0162T Code deleted and removed from Appendix. 8/2011 Policy presented in new format. References expanded and updated. Added coding. Revised ICD-9 codes. Deleted unlisted procedure CPT code. Added ICD-10 Diagnosis codes where applicable. Codes reviewed and approved by Medical/clinical coder SAR 9/26/11. Page 3 of 6
2/2014 ICD-10 remediated. New standard language added (document precedence, Audit information, Group and ASO language). 5/2014 Updated policy effective: 10/2014. Adopted BCBSA policy 7.01.73. Investigational for all indications. C code for neurostimulators kept in BCBSVT policy since they correlate with primary procedure. Category III codes 0155T-0158T removed- deleted in 2012002E 2/2017 Rearranged policy to align with Association as this is an adopted policy. No change to position statements. Updated references. No changes to coding updated coding table to reflect all codes require PA. 06/2018 Reviewed medical policy with no changes to policy statements. Eligible providers Qualified healthcare professionals practicing within the scope of their license(s). Approved by BCBSVT Medical Director(s) Date Approved Joshua Plavin, MD, MPH, MBA Chief Medical Officer Attachment I CPT Code List & Instructions Code Type Number Description Policy Instructions The following codes will be denied Investigational CPT 43647 CPT 43648 CPT 43881 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 Page 4 of 6
CPT 43882 CPT 64590 CPT 64595 CPT 95980 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 CPT 95981 Subsequent, without reprogramming CPT 95982 Subsequent, with reprogramming C1767 Generator, neurostimulator, implantable, non-rechargeable C1778 Lead, neurostimulator, implantable C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system L8680 Implantable neurostimulator electrode (with any number of contact points), each L8685 generator, single array, rechargeable, includes extension L8686 generator, single array, nonrechargeable, includes extension Page 5 of 6
L8687 generator dual array, rechargeable, includes extension L8688 generator, dual array, nonrechargeable, includes extension Page 6 of 6