Remote Electrical Neuromodulation for Migraines Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 03|01|2024 POLICY LAST UPDATED: 11|19|2025 OVERVIEW
Migraine attacks due to episodic or chronic migraine require acute management. Current first-line therapy for treatment of acute migraine involves use of various pharmacologic interventions. Regular use of pharmacologic interventions can result in medication overuse and increased risk of progression from episodic to chronic migraine. Nonpharmacologic remote electrical neuromodulation (REN) may offer an alternative to pharmacologic interventions for patients with migraine. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Remote electrical neuromodulation for acute migraine or prevention of migraine is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes. Commercial Products Remote electrical neuromodulation for acute migraine or prevention of migraine is considered 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 applicable not covered/not medically necessary benefits/coverage. BACKGROUND Migraine is a neurologic disease characterized by recurrent moderate to severe headaches with associated symptoms that can include aura, photophobia, nausea, and/or vomiting. Overall migraine prevalence in the United States is about 15% but varies according to population group. Prevalence is higher in women (21%), among American Indian/AlaskaNatives (22%), and among 18- to 44-year-olds (19%). Social determinants including low education level (18%), use of Medicaid (27%), high poverty level (23%), and being unemployed (22%) are also associated with higher rates of migraine. Migraine is categorized as episodic or chronic depending on the frequency of attacks. Generally, episodic migraine is characterized by 14 or fewer headache days per month and chronic migraine is characterized by 15 or more headache days per month.
Remote electrical neuromodulation (REN) may offer an alternative to pharmacologic interventions for patients with acute migraine or it may decrease the use of abortive medications and the risk of medication overuse to treat acute migraines. The only currently available REN device (Nerivio™) cleared for use by the Food and Drug Administration (FDA) is worn on the upper arm and stimulates the peripheral nerves to induce conditioned pain modulation (CPM). The conditioned pain in the arm induced by the Nerivio REN device is believed to reduce the perceived migraine pain intensity. Control of the REN device is accomplished through Bluetooth communication between the device and the patient's smartphone or tablet. At onset of migraine or aura and no later than within 1 hour of onset, the user initiates use of the device through their Medical Coverage Policy | Remote Electrical Neuromodulation for Migraines

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

mobile application. Patient-controlled stimulation intensity ranges from 0 to 100%, corresponding to 0 to 40milliamperes (mA) of electrical current. Patients are instructed to set the device to the strongest stimulation intensity that is just below their perceived pain level. The device provides stimulation for up to 45 minutes before turning off automatically. The Nerivio manufacturer indicates that the device can be used instead of or in addition to medication.

For individuals with acute migraine due to episodic or chronic migraine who receive REN, the evidence includes 2 randomized controlled trials (RCTs) and nonrandomized, uncontrolled studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Use of an active REN device resulted in more patients with improved pain and symptoms at 2-hour follow-up compared with a sham device based on 2 small (N=212) RCTs with numerous relevance limitations. Based on the existing evidence, it is unclear how Nerivio™ would fit into the current acute migraine management pathway. The specific intended use and associated empirically-documented recommended regimen(s) must be specified in order to adequately evaluate the net health benefit. Additionally, functional outcomes and quality of life must be evaluated in well-designed and conducted studies in defined populations using documented Nerivio regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Regulatory Status In May 2019, Nerivio Migra™ (Theranica Bio-Electronics Ltd.) was granted a de novo classification by the FDA (class II, special controls, product code: QGT). This new classification applied to this device and substantially equivalent devices of this generic type. Nerivio Migra was initially cleared for treatment of acute migraine in adults who do not have chronic migraine.

In October, 2020, Nerivio was cleared for marketing by the FDA through the 510(k) process (K201824). FDA determined that this device was substantially equivalent to Nerivio Migra for use in adults. The device name changed to just “ Nerivio” and the exclusion of chronic migraine patients was removed. The Nerivio device can provide more treatments than the predicate Nerivio Migra (12 treatments vs. 8 treatments) and has a longer shelf life (24 months vs. 9 months). In January, 2021, the Nerivio device was cleared for use in patients aged 12 to 17 years.

CODING Medicare Advantage Plans and Commercial Products The following code(s) is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when filed with the following ICD-10-CM codes:

HCPCS Code: A4540 Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm (New Code Effective 1/1/2024. For Dates of Service prior to 1/1/2024, HCPCS code K1023 must be used)

ICD-10-CM Codes G43.001 to G43.719

G43.801 to G43.919

RELATED POLICIES Not applicable

PUBLISHED Provider Update, January 2026 Provider Update, December 2024 Provider Update, January 2024 Provider Update, October 2022

REFERENCES

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

1. VanderPluym JH, Halker Singh RB, Urtecho M, et al. Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis. JAMA. Jun 15 2021; 325(23): 2357-2369. PMID 34128998
2. Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. Jan 2021; 61(1): 60-68. PMID 33349955
3. Singh RBH, VanderPluym JH, Morrow AS, et al. Acute Treatments for Episodic Migraine. Rockville (MD): Agency for Healthcare Research and Quality (US); December 2020. Accessed August 29, 2023.
4. Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. Jul 2021; 61(7): 1021-1039. PMID 34160823
5. Burch RC, Loder S, Loder E, et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. Jan 2015; 55(1): 21-34. PMID 25600719
6. Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence- based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. Sep 26 2000; 55(6): 754-62. PMID 10993991
7. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. Apr 24 2012; 78(17): 1337-45. PMID 22529202
8. Oskoui M, Pringsheim T, Billinghurst L, et al. Practice guideline update summary: Pharmacologic treatment for pediatric migraine prevention: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. Sep 10 2019; 93(11): 500-509. PMID 31413170
9. Nierenburg H, Stark-Inbar A. Nerivio ® remote electrical neuromodulation for acute treatment of chronic migraine. Pain Manag. Apr 2022; 12(3): 267-281. PMID 34538078
10. U.S. Food and Drug Administration. De Novo Classification Request for Nerivio Migra. Accessed August 27, 2023.
11. U.S. Food and Drug Administration. 501(k) Summary: Theranica Bio-Electronics LTDs Nerivio. Accessed August 29, 2023.
12. U.S. Food and Drug Administration. 510(k) Summary: Nerivio Approval in Adolescents. Accessed August 28, 2023.
13. U.S. Food and Drug Administration. 510(k) Summary (K223169): Nerivio Approval for Preventative Treatment. Accessed August 25, 2023.
14. Tassorelli C, Diener HC, Silberstein SD, et al. Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine. Cephalalgia. Oct 2021; 41(11-12): 1135-1151. PMID 33990161
15. Diener HC, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. May 2019; 39(6): 687-710. PMID 30806518
16. Yarnitsky D, Volokh L, Ironi A, et al. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. Mar 28 2017; 88(13): 1250-1255. PMID 28251920
17. Yarnitsky D, Dodick DW, Grosberg BM, et al. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. Sep 2019; 59(8): 1240-1252. PMID 31074005
18. Marmura MJ, Lin T, Harris D, et al. Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study. Front Neurol. 2020; 11: 226. PMID 32318014
19. Rapoport AM, Bonner JH, Lin T, et al. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. Jul 22 2019; 20(1): 83. PMID 31331265
20. Ailani J, Rabany L, Tamir S, et al. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front Pain Res (Lausanne). 2021; 2: 753736. PMID 35295483

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

21. Hershey AD, Irwin S, Rabany L, et al. Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis. Pain Med. Apr 08 2022; 23(4): 815-820. PMID 34185084
22. Hershey AD, Lin T, Gruper Y, et al. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. Feb 2021; 61(2): 310-317. PMID 33349920
23. Nierenburg H, Vieira JR, Lev N, et al. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther. Dec 2020; 9(2): 531-543. PMID 32648205
24. Tepper SJ, Lin T, Montal T, et al. Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine. Pain Med. Dec 25 2020; 21(12): 3522-3529. PMID 32935848
25. Grosberg B, Rabany L, Lin T, et al. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021; 6(4): e966. PMID 34667919
26. Nierenburg H, Rabany L, Lin T, et al. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. Dec 2021; 10(2): 1245-1253. PMID 34138449
27. Tepper SJ, Rabany L, Cowan RP, et al. Remote electrical neuromodulation for migraine prevention: A double-blind, randomized, placebo-controlled clinical trial. Headache. Mar 2023; 63(3): 377-389. PMID 36704988

28. Oskoui M, Pringsheim T, Holler-Managan Y, et al. Practice guideline update summary: Acute treatment of migraine in children and adolescents: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Headache Society. Headache. Sep 2019; 59(8): 1158-1173. PMID 31529481

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