Research shows that FDA-cleared non-invasive neuromodulation devices are safe and effective for reducing migraine head pain, attack frequency, and associated symptoms. Neuromodulation treats migraine by stimulating or inhibiting neural activity, via electrical or mechanical means. Frequent users of these devices, made for home use, report fewer migraine days a month and less dependence on abortive or preventive medications.
Recognizing the benefits of neuromodulation migraine therapy, the Department of Veterans Affairs approved coverage for FDA-cleared, non-invasive neuromodulation devices for the treatment of chronic migraine in veterans.
However, despite numerous studies on the efficacy and safety of neuromodulation as a treatment for migraine — and the precedent of VA medical coverage for these devices — patients with private and other government-funded insurance plans experience considerable obstacles to obtaining coverage for neuromodulation treatments.
“The biggest barrier to the use of non-invasive neuromodulation devices for the treatment of migraine is access, cost and insurance coverage,” said Amaal J. Starling, MD, an associate professor of neurology at the Mayo Clinic. “I’m hoping that with continued advocacy, this barrier will be reduced.”
Why is health insurance coverage limited for neuromodulation treatments for migraine?
Despite increasing data on the efficacy and safety of neuromodulation, growing demand from patient advocates, and FDA clearance for these devices, few insurance companies cover non-invasive neuromodulation treatments for migraine.
“With only a few very recent exceptions, devices are generally considered investigational or experimental and are not covered by conventional insurance plans,” according to a review of advances in non-invasive devices for migraine published in Current Pain and Headache Reports.
Physicians are frequently required to send prior authorization letters, or letters of medical necessity, to insurers to prove that non-invasive neuromodulation is a medically necessary treatment for their patients.
Another hurdle to obtaining coverage is the step therapy process, which requires that other treatments are tried for a fixed period before a new prescription, such as a non-invasive device, is approved. For patients with Medicaid and Medicare, coverage for non-invasive neuromodulation is also extremely limited.
How providers can help patients seeking insurance coverage
Prior authorization letters and insurance appeals
If a treatment is not listed on an insurance company’s formulary, which is most often the case for neuromodulation devices, prescription coverage could be denied. To appeal the denial, the provider may send a prior authorization letter on the patient’s behalf.
A well-written, detailed prior authorization letter is an important patient advocacy tool. Start your letter by detailing your relationship with the patient. “Simply stating that he or she is a patient of yours is not enough,” advises the Patient Advocate Foundation. “Think more along the lines of: “My name is John Doe, and I have been Susie Smith’s neurologist treating her for chronic migraine for eight years.”
Using language that emphasizes your relationship with the patient shows “that the treatment you’re recommending is exclusive to them,” the foundation adds.
Next, provide a detailed medical history of treatments that were ineffective for your patient, the results, and why you decided to prescribe another medication. If the insurer has suggested alternatives, explain why these medications would not be a good fit for your patient. If any of the suggested medications would be an effective second or third option in comparison to the preferred treatment, explain your reasoning.
Include applicable lab tests, scans, or notes as evidence for your claim and mention these documents in the letter. Include studies that demonstrate the efficacy of non-invasive neuromodulation. If you have other patients who have used the treatment to manage chronic migraine with positive results, mention this, too.
Explain the consequences of your patient not receiving the treatment and conclude by restating why neuromodulation would be beneficial for your patient. Before sending your letter, find out if the insurer requires patient permission for third-party appeals from providers.
Step Therapy
Many insurers practice step therapy by requiring patients to try additional medications before certain prescriptions are approved for coverage. The practice may help keep down healthcare costs for patients across the board, but it can lead to delays in treatment that greatly reduce quality of life, according to patient advocates.
Sending insurers detailed authorization letters documenting treatments your patients have tried can prove that you have met an insurer’s step therapy requirements.
More ways providers can help patients with insurance coverage
Coverage for durable medical equipment
Durable medical equipment is medical equipment used repeatedly, typically at home, such as hospital beds, wheelchairs and oxygen equipment. Some patients have successfully obtained coverage for non-invasive neuromodulation devices for migraine under the DME provisions of their insurance. For instance, some insurance providers offer reimbursement for the CEFALY device under HCPCS Code E0733.
Copay assistance and savings programs
If the insurer denies coverage, direct your patient to look into co-pay and savings programs to offset the cost of neuromodulation devices. For instance, gammaCore offers cost-savings plans for eligible patients with private insurance. Health Savings Accounts or Flexible Spending Accounts may also be used to pay for neuromodulation devices.
Medicaid coverage
Recently, Medicaid programs in DC, Colorado, North Dakota, Virginia, Arizona, New Jersey and Ohio approved coverage of the Nerivio neuromodulation device by Theranica.
As patients, providers, and advocates work to expand coverage for neuromodulation devices, the insurance landscape — and the treatment options offered for migraine patients — will undoubtedly shift.
