Remote Electrical Neuromodulation for Migraines

POLICY NUMBER

A.7.01.171

DESCRIPTION

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

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/Alaska Natives (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. 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.

Migraine attacks, whether due to episodic or chronic migraine, require acute management. The goal of acute treatment is to provide pain and symptom relief as quickly as possible while minimizing adverse effects, with the intent of timely return to normal function. Pharmacologic interventions for treatment of acute migraine vary according to migraine severity. First-line therapy for an acute episode of mild or moderate migraine includes oral non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen. Moderate to severe migraine can be treated through the use of triptans or an NSAID-triptan combination. Antiemetics can be added for migraine accompanied by nausea or vomiting, though certain antiemetic medications used as monotherapy can also provide migraine relief. Other pharmacologic interventions used to treat acute migraine include calcitonin-gene related peptide antagonists, which can be used in patients with an insufficient response or contraindications to triptans, lasmiditan, and dihydroergotamine. Migraine can be managed at home, although acute migraine is a frequently cited reason for primary care and emergency department visits. Regular use of pharmacologic interventions can result in medication overuse, which in turn could lead to rebound headache and increased risk of progression from episodic to chronic migraine.

Many individuals who suffer from migraine may also benefit from preventive migraine therapy, including those with frequent or long-lasting 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. The main goals of preventive therapy are to reduce future attack frequency, severity, and duration, improve responsiveness to acute treatments, improve function and reduce disability, and prevent progression of episodic migraine to chronic migraine. For most adults with episodic migraines who may benefit from preventive therapy, initial therapy with an antiepileptic drug (divalproex sodium, sodium valproate, topiramate) or beta-blockers (metoprolol, propranolol, timolol) is recommended. Frovatriptan may be beneficial as initial therapy for prevention of menstrually associated migraine. Antidepressants (amitriptyline, venlafaxine), alternative beta-blockers (atenolol, nadolol), and additional triptans (naratriptan, zolmitriptan for menstrually associated migraine prevention) may be considered if initial therapy is unsuccessful. For preventive treatment of pediatric migraine, many children and adolescents who received placebo in clinical trials improved and most preventive medications were not superior to placebo. Possibly effective preventive treatment options for children and adolescents may include amitriptyline, topiramate, or propranolol.

Remote Electrical Neuromodulation

Remote electrical neuromodulation (REN) may offer an alternative to pharmacologic interventions for patients with acute migraine or it may decrease the use of abortive or preventive medications and the risk of medication overuse to treat or prevent 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. For acute treatment, at onset of migraine or aura and no later than within 1 hour of onset, the user initiates use of the device through their mobile application. When used for preventive treatment, the device should be used every other day, controlled by the individual through their smartphone or tablet application. Patient-controlled stimulation intensity ranges from 0 to 100%, corresponding to 0 to 40 milliamperes (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.

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). The 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 of age or older and was cleared for marketing through the 510(k) process (K223169). In May 2025, the Nerivio and rechargeable Nerivio Infinity devices were cleared for marketing (K241756) with an expanded indication for acute and/or preventive treatment of migraine with or without aura in patients 8 years and older.

POLICY

Preventive treatment: Initiation of Use

Remote electrical neuromodulation (REN [e.g. Nerivio]) for the prevention of migraine may be considered medically necessary in individuals when the following criteria are met:

• Individual is 18 years of age or older; AND

• Headaches meet the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura (see Policy Guidelines); AND

• The REN device will be used in the following clinical scenario:

  • For the prevention of migraine in individuals with 6 to 24 headache days (defined as a calendar day with headache regardless of severity or duration) per 28-day period in each of the 3 months preceding use of the REN device); AND

• 1 of the following additional criteria must also be met:

  • Insufficient response, contraindication, or intolerance to 2 or more guideline-recommended preventive headache medications (e.g., anticonvulsants, antihypertensives, antidepressants, CGRP inhibitors); OR

  • Pregnancy, breastfeeding, or planning to conceive; OR

  • At risk for or have a history of medication overuse headache; OR

  • At risk for drug-drug interactions with medications for comorbid conditions.

Preventive treatment: Continuation of Use

Continued use of the REN device and/or accessories for the prevention of migraine is considered medically necessary in individuals when the following criteria are met:

• Compliance with ongoing use; AND

• Documentation of clinical benefit (see Policy Guidelines).

Remote electrical neuromodulation for prevention of migraine outside of the above criteria is considered investigational (see Policy Guidelines Considerations).

Acute treatment

Remote electrical neuromodulation for acute migraine is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Remote Electrical Neuromodulation Contraindications

Nerivio is contraindicated in patients with uncontrolled epilepsy and patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device. Nerivio has not been evaluated in patients with congestive heart failure, severe cardiac or cerebrovascular disease, pregnancy, or patients under the age of 8 years.

Considerations

There is significant unmet need for migraine treatments, including lack of access. Clinical input respondents note that first-line use is especially recommended in children and adolescents due to limited alternatives with demonstrated efficacy or tolerable adverse effects. Reduction in school absenteeism is recommended in this age group to ascertain clinical benefit.

Remote electrical neuromodulation (REN [e.g. Nerivio]) for the prevention of migraine may be considered medically necessary in individuals when the following criteria are met:

• Individual is 8-17 years of age; AND

• Headaches meet the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura (see Policy Guidelines); AND

• The REN device will be used in the following clinical scenario:

  • For the prevention of migraine in individuals with 6 to 24 headache days (defined as a calendar day with headache regardless of severity or duration) per 28-day period in each of the 3 months preceding use of the REN device).

Criteria for Migraine

The International Classification of Headache Disorders ICDH-3 criteria for migraine with and without aura can be accessed at https://ichd-3.org/1-migraine/.

Clinical Benefit for Continuation of Use

Documentation of clinical benefit for continuation of use may include a clinician attestation regarding any of the following outcomes:

• Improvements in pain relief or freedom, particularly for acute use;

• Reduction in headache frequency, duration, or severity;

• Reduction in functional disability;

• Reduction in absenteeism;

• Reduction in concomitant headache medications.

Based on observed outcomes of pivotal studies of Nerivio and study duration recommendations from the International Headache Society concerning migraine neuromodulation trial designs, assessment for clinical benefit is reasonable after a minimum of 8-12 weeks for preventive treatment.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS 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.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/01/2022: New policy added. Approved by the Medical Policy Advisory Committee.

11/21/2023: Policy description updated regarding preventive migraine therapy. Policy statement updated to state that remote electrical neuromodulation for acute migraine or prevention of migraine is considered investigational.

12/21/2023: Code Reference section updated to add new 2024 HCPCS code A4540, effective 01/01/2024.

01/28/2025: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted HCPCS code K1023.

05/01/2026: Policy description updated regarding devices. Policy statement changed from investigational to medically necessary for the use of remote electrical neuromodulation for the prevention of migraine when the listed criteria are met. Policy Guidelines updated regarding remote electrical neuromodulation contraindications, considerations, migraine criteria, and clinical benefit for continuation of use. Added medically necessary definition. Code Reference section updated to change HCPCS code A4540 from investigational to medically necessary. Added the following ICD-10 diagnosis codes: G43.701 - G43.719.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.171

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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