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Regular TENS Unit Instead of Cefaly?

Cefaly“Can I use a regular TENS unit instead of Cefaly?” I’ve been asked this questions so many times that I know others are curious and haven’t asked. I can’t give you a direct yes or no, but here’s what I’ve seen headache specialists say about it.

Writing for the American Headache Society, headache specialist Brian Plato, D.O, says, “It should be noted that “regular” TENS units should not be used in place of the Cefaly.” He does not explain why.

Headache specialist Alexander Mauskop, M.D., said in a comment on my Migraine.com post about Cefaly, “My patients haven’t had much success with Cefaly. To save them money, I suggest that they try a regular TENS unit, which can costs as little as $50. It is not as cool-looking or convenient, but it offers more options in adjusting the current, frequency of stimulation and duration.”

Dr. Mauskop wrote on his blog that he was unsure whether Cefaly has an advantage over a regular TENS unit. He speculates that Cefaly could be better because of its convenience and that the current “may have specific frequency, strength and wave shape, which provides better relief. However, an electrical engineer could easily hook up the Cefaly unit to a monitor and figure out and publicize these settings.” (To my knowledge, no one has done this.)

Many patients point out in forums that their doctors and the instructions with their TENS units say not to use them on your head. One said that a regular TENS unit may be too strong for the forehead.

That’s all I can tell you. I cannot give a direct recommendation either way. Even if I could, I don’t have enough information to form a solid opinion. My best advice is to talk to your doctor about it.

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Cefaly Insurance Coverage Update

“Is Cefaly covered by insurance?” is the question I’ve been asked most since the device was approved. The answer is probably not, but your insurance company may cover it as they would any TENS unit.

Cefaly does not currently have a procedure code (also called a CPT code), which is required for an insurance company to cover any medical device or procedure. A company representative told me FDA approval is the first step in the long process of getting a CPT code. They expect it to be one to two years before Cefaly has a code.

Hope is not lost! Some migraineurs have found that their insurance companies will cover Cefaly the way they would any TENS unit using an established code for those devices. Google tells me those are E0720 for a two-lead device and E0730 for a four-lead device. The problem? Cefaly only has one lead, which may trip up some insurance companies.

HomeCare, a magazine for the home medical equipment industry, says that to have a TENS unit covered for chronic pain, your doctor must submit a statement of medical necessity and “must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician’s records must document a reevaluation of the patient at the end of the trial period and indicate how often the patient used the TENS unit, the typical duration of use each time and the results.” Unfortunately, the article also says TENS units are rarely considered medically necessary for headache disorders. (This is general industry information. What you encounter with your insurance company may be different.)

Don’t give up without checking with your own insurance company. Enough migraineurs have received positive responses that it’s worth a try. Please let us know if you have success and, if possible, which code your insurance company is using.

Update on Cefaly availability: As of April 9, 2014, the order page of Cefaly’s U.S. website says, “Order intakes on hold for a week because of limitation in the supply chain.” This notice apparently went up today, so I hope that means you’ll be able to order from them next week. I’ll keep an eye on the site and let you know if anything changes.

April 15, 2014: Cefaly has removed the “not currently taking orders” notification from their website. They appear to now be shipping previously ordered products and taking new orders.

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Cefaly Availble in the US, Insurance Coverage

If you’re in the US, you can now order a Cefaly from Cefaly.us. The device itself is $295 (plus $29 for shipping) and a three-pack of electrodes is $25. You must send a copy of your prescription before they will send your order. Devices will be delivered beginning the first week of April.

Here’s what Cefaly’s FAQs currently say about insurance coverage:

Cefaly is not currently reimbursable via the social security system and therefore is not listed in the catalogue of approved medical devices. However it is becoming increasingly apparent that certain health insurance companies and mutual funds are partially funding this treatment and may do so on a case-by-case basis.

We therefore advise that you write to your insurer or health care in order to ask them if they will help you with the cost of Cefaly. Explain your migraine problem and the benefits that the device brings you. Make sure you to attach a prescription along with a copy of the invoice to your letter.

Translated: Your insurance company might reimburse you, but probably not. Sending your insurance company a letter with your receipt, as the Cefaly website recommends, is unlikely to work out in your favor. If insurance coverage is imperative for you, contact your insurance company before purchasing the device. They may refuse to cover it at all or they may allow you to submit an appeal for coverage. Be sure to ask if having your doctor send a letter of medical necessity will increase the chance that they’ll cover it.

April 8, 2014: Check Cefaly Insurance Coverage Update for current information.

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FDA Approves Cefaly for Migraine Prevention

Cefaly

(i can’t believe I’m posting a selfie with a Cefaly.)

The FDA has approved the Cefaly for migraine prevention in the U.S., according to an announcement from the agency yesterday. Purchasing details aren’t available yet, but it shouldn’t be too long since it is already being manufactured for other countries. It will be available by prescription, which I expect means it will also be covered by insurance. You can order one now at Cefaly.us. The device itself is $295 and a pack of three electrodes costs $25. You must send them your prescription before they will ship your order. I don’t know what this means for eventual insurance coverage.

Here’s an excerpt from the FDA’s press release that describes the studies the approval was based on:

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

Neither of these studies are new and still have the limitation of being short-term, but I’ll reiterate that it’s worth trying out. Even more so now that you won’t have the additional expense of ordering it from Canada and your insurance may pay for it. I’ll keep you posted on it’s availability.

Here’s my experience with it, including a detailed description of what it feels like:

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Cefaly for Migraine: Diminishing Returns & No Long-Term Relief

My early success with the Cefaly, the external nerve stimulator I told you about last summer, didn’t hold up. I used it for at least an hour a day for six months, over which time my relief from it decreased from three hours a day to no relief at all. None of the published studies on the Cefaly talk about this happening, but none of them studied its use for more than a few months.

The Cefaly can be used to stop migraine attacks in progress (and to stop other types of headaches, according to the manual, though all the published research is on migraine) or as a daily preventive. Since I have (had!) migraines every day, I hoped for both. Not only did I experience diminishing returns of acute relief, I never noticed a preventive effect. Stopping it did not increase my migraine frequency, severity or duration.

I’ve heard from about a dozen of you who tried the Cefaly. No one reported relief even as significant as I had early on and half couldn’t use the device because the sensation in their foreheads was unbearably painful. The Daily Headache readers tend to have chronic and/or severe chronic disorders, so we’re unlikely to be a representative sample. Maybe it’s less effective for people with more severe headache disorders or our propensity toward more significant allodynia (sensitivity to touch) makes it more painful than normal. (If you’re worried it will be painful for you, see if someone you know has a TENS unit you can try. The Cefaly is different than a standard unit in its electrode shape and preset programs, but you’ll get an idea of what it feels like.)

Do I rescind my recommendation? Somewhat surprisingly, no. As long as it’s in your budget (it is returnable, but you’ll be out shipping to and from Canada and a 20% restocking fee), I say go for it. We all respond to different treatments and several headache specialists have told me that even a 10% response rate in early research is encouraging. If you want to explore nerve stimulation without invasive surgery, want a drug-free treatment or haven’t had much luck with standard treatments, the Cefaly is, at the very least, worth a try.

I still have mine and will try it again soon. I’m hopeful that a few months without it will be a sort of reset.