Description of Procedure or Service

Migraine is a neurologic disease characterized by recurrent moderate to severe headaches with associated symptoms that can include aura, photophobia, nausea, and/or vomiting.

Migraine attacks due to episodic or chronic migraine require acute management. Some individuals may also require preventive migraine therapy. Current first-line therapy for treatment and prevention 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.

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. Specific International Classification of Headache Disorders diagnostic criteria are as follows:

• Episodic migraine:
  1. Untreated or unsuccessfully treated headache lasting 4 to 72 hours
  2. Headache has at least 2 of the following characteristics:
     1. Unilateral location
     2. Pulsating quality
     3. Moderate or severe pain intensity
     4. Aggravation by or causing avoidance of routine physical activity
  3. At least 1 of the following during headache:
     1. Nausea and/or vomiting
     2. Photophobia or phonophobia.
• Chronic migraine:
  1. Migraine-like or tension-type headache on 15 or more days per month for more than 3 months
  2. At least 5 headache attacks without aura meet episodic migraine criteria 1 to 3, and/or at least 5 headache attacks with aura meet episodic migraine criteria 2 to 3
  3. On more than 8 days per month for more than 3 months, fulfilling any of the following criteria:
     1. For migraine without aura, episodic migraine criteria 2 and 3
     2. For migraine with aura, episodic migraine criteria 1 and 2
     3. Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative.

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.In February 2023, Nerivio's indication was expanded to include preventive treatment of migraine with or without aura in individuals 12 years and age or older and was cleared for marketing through the 510(k) process (K223169).

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

Remote Electrical Neuromodulation for Migraines is considered investigational for all applications.  BCBSNC does not provide coverage for investigational services or procedures.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore, member benefit language should be reviewed before applying the terms of this medical policy. 

When Remote Electrical Neuromodulation for Migraines is covered

Not Applicable.

When Remote Electrical Neuromodulation for Migraines is not covered

Remote electrical neuromodulation for acute migraine or prevention of migraine is considered investigational.

Policy Guidelines

For individuals with acute migraine due to episodic or chronic migraine who receive remote electrical neuromodulation (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.

For individuals who may benefit from preventive migraine therapy, including those with frequent or long-lasting episodic or chronic migraines, migraine attacks that diminish quality of life or cause significant disability despite acute treatment, contraindications to or failure of acute therapies, and risk of medication overuse headache, who receive REN, the evidence includes 1 RCT and 1 prospective, observational study. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Use of an active REN device resulted in more adults with decreased migraine days per month, regardless of episodic or chronic subtype, when used every other day for 8 weeks compared with a sham device based on 1 small (N=248) RCT with numerous relevance limitations. Prospective, observational data in 2 real world evidence studies using the device for acute treatment of migraine demonstrated a significant reduction in migraine headache days from baseline to months 2 and 3 with device use in adolescent patients. Based on the existing evidence, it is unclear how Nerivio would fit into the current migraine prevention pathway, although it could provide benefit for those who do not receive adequate benefit from pharmacologic first- or second-line therapies, or who may have a contraindication to pharmacologic therapies. The specific intended use and associated empirically documented recommended regimen(s) must be specified in order to adequately evaluate the net health benefit. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: A4540

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

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

Singh RBH, VanderPluym JH, Morrow AS, et al. Acute Treatments for Episodic Migraine. Rockville (MD): Agency for Healthcare Research and Quality (US); December 2020.

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 U.S. Food and Drug Administration. De Novo Classification Request for Nerivio Migra.

U.S. Food and Drug Administration. 501(k) Summary: Theranica Bio-Electronics LTDs Nerivio.

U.S. Food and Drug Administration. 510(k) Summary: Nerivio Approval in Adolescents. Accessed

U.S. Food and Drug Administration. 510(k) Summary (K223169): Nerivio Approval for Preventative Treatment.

Specialty Matched Consultant Review 5/2025

Medical Director Review 5/2025

Policy Implementation/Update Information

5/14/25 New policy developed. Remote Electrical Neuromodulation for Migraines is considered investigational for all applications.  BCBSNC does not provide coverage for investigational services or procedures. Specialty Matched Consultant Review 5/2025. Medical Director Review 5/2025. Notification given 5/14/2025 for effective date 7/16/2025. (tt)