Remote Electrical Neuromodulation (REN)

Remote electrical neuromodulation (REN) is a nonpharmacologic option that is being proposed as an alternative to pharmacological interventions in individuals with migraines. The current first-line therapy is pharmacological interventions that can lead to medication overuse with regular use. An individual also has the risk of increased progression of migraines with continued use of medication.

Nerivio™ is the only current available REN device approved by the FDA in 2019. This device is worn on the upper arm and stimulates the peripheral nerves to induce conditional pain control and is presumed to reduce the sensed migraine intensity. The device is controlled via Bluetooth communication with an individual’s smartphone or tablet.

POLICY

Remote electrical neuromodulation (REN) for the prevention of migraine is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Remote electrical neuromodulation (REN) for the treatment of acute migraine is considered investigational.

MEDICAL APPROPRIATENESS

Remote electrical neuromodulation (e.g., Nerivio) for the prevention of migraine is considered medically appropriate if ANY ONE of the following criteria are met:
- Initial treatment for the prevention of migraine with ALL of the following:
- - Individuals 8 years or older
  - Headaches meet the ICHD-3 diagnostic criteria for migraine with or without aura (See Additional Information.)
- 6 to 24 headache days per 28-day period (regardless of severity or duration) 3 months prior to initiating REN therapy and ANY ONE of the following:
- - Individuals with insufficient response, contraindication or unable to tolerate 2 or more preventative headache medications (e.g., anticonvulsants, antihypertensives, antidepressants, CGRP inhibitors)
  - Pregnant, breastfeeding, or planning to conceive
  - History or at risk of medication overuse
  - Risk of drug interactions with medication for comorbid conditions
  - Absence of ALL of the following:
    - Uncontrolled epilepsy
    - Active implanted medical device (e.g., pacemaker, implanted hearing aid, any electronic implant)
- Continuation of a REN device and/or accessories for prevention of migraines appropriate if ALL the following are met
- - Compliance has been ongoing
  - Documentation of clinical benefit of ANY ONE of the following:
  - - Improvement in pain relief or freedom
    - Less frequent headaches, duration or severity
    - Improvement in functional disability
    - Reduction in headache medication being used concurrently with the REN device
    - Less absenteeism from school

IMPORTANT REMINDERS

Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

Does not apply to BlueCare or MedAdvantage members.

ADDITIONAL INFORMATION

To access the international classification of headache disorder (ICHD-3) criteria, use the link below:

https://ichd-3.org/1-migraine/.

SOURCES

Ailani, J., Burch, R.C., & Robinson, M.S. (2021). The american headache society consensus statement: update on integrating new migraine treatments into clinical practice. Headache, The Journal of Head and Face Pain, 61 (7), 1021-1039. (Level 1 evidence)

Ailani, J., Rabany, L., Tamir, S., Ironi, A., & Starling, A. (2022). Real-world analysis of remote electrical neuromodulation (REN) for the acute treatment of migraine. Frontiers in Pain Research, 2:753736. doi: 10.3389/fpain.2021.753736. (Level 2 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (11:2025). Remote electrical neuromodulation for Migraines. (7.01.171). Retrieved November 5, 2025, from www.bcbsaoca.com/eps/.

Hayes, a Sympir Company. (2025, May) Evolving Evidence Review. Nerivio (theranica bio-electronics Ltd.) for treatment of acute migraine episodes in adults. Retrieved October 9, 2025, from www.Hayesinc.com/subscribers. (30 articles and/or guidelines reviewed)

Hershey, AD., Irwin, S., Rabany, L., Gruper, L., Ironi, A., Harris., D., et al. (2022). Comparison of remote electrical neuromodulation and standard-care medications for acute treatment of migraine in adolescents: a post hoc analysis. Pain Medicine, 23(4), 815-820. Abstract retrieved October 10, 2025, from PubMed database.

Hershey, AD., Lin, T., Gruper, Y., Harris, D., Ironi, A., Bank, T., et al. (2021). Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headaches, 61(2), 310-317. Abstract retrieved October 10, 2025, from PubMed database.

Nierenburg, H., & Stark-Inbar, A. (2022). Nerivio® remote electrical neuromodulation for acute treatment of chronic migraine. Pain Management, 12 (3), 267-281. Abstract retrieved October 10, 2025, from PubMed database.

Tassorelli, C., Diener, HC., Silberstein, SD., Dodick, DW., Goadsby, PJ., Jensen, R.H., et al. (2021). Guidelines of the international headache society for clinical trials with neuromodulation devices for the treatment of migraine. Cephalalgia: An International Journal of Headaches, 41 (11-12), 1135-1151. Abstract retrieved October 10, 2025, from PubMed database.

Tepper, SJ., Rabany, L., Cowan, RP., Smith, TR., Grosberg, BM., Torphy, BD., et al. (2023). Remote electrical neuromodulation for migraine prevention: A double-blind, randomized, placebo-controlled clinical trial. Headache, 63(3), 377-389. (Level 1 evidence)

U.S. Food and Drug Administration. (2024, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K241756. Retrieved October 9, 2025 from https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241756.pdf.

VanderPluym, J.H., Singh, R.B.H., Urtecho, M., Morrow, A.S., Nayfeh, T., Roldan, V.D.T., et al. (2021). Acute treatments for episodic migraine in adults: a systematic review and meta-analysis. JAMA, 325 (23), 2357-2369. (Level 1 evidence)

ORIGINAL EFFECTIVE DATE: 3/3/2026

MOST RECENT REVIEW DATE: 3/3/2026

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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