Medicaid Commission Hears Epilepsy Foundation Testimony

Prepared Comments for Medicaid Commission Hearing on November 16, 2006

Health and Human Services Medicaid Commission
200 Independence Ave., SW, Suite 450G
Washington, DC 20201

Good afternoon. Thank you for the opportunity to provide comments regarding the Commission's recommendations. I am a Neurologist and Medical Director of the Epilepsy Program at Henry Ford Hospital in Detroit. I also serve on the National Board of Directors and Chair the Legal and Government Affairs Committee of the Epilepsy Foundation. I am aware that the Commission is in the final stages of making its recommendations. I hope that you will consider the feedback I have received from others around the country concerning the Medicaid appeal process when attempting to obtain anti-epileptic drugs, (also known as AEDs) for patients with epilepsy.

I come to you as a physician who treats many persons with epilepsy, a chronic disorder characterized by recurrent, unprovoked seizures. I also come to you as a previous patient with epilepsy who is quite aware of the ramifications when appropriate seizure medications are not available in a timely manner. My personal experience with epilepsy includes a harder seizure when I did not get my seizure medication resulting in a fracture of my spine in three places. Fortunately, approximately two-thirds of the 3 million people with epilepsy can be well controlled on anti-epileptic medications and other treatments. Acute changes in their medical therapy, however, including not getting their scheduled medication or substitution of generic medication for brand name or switching among different generic versions, may result in unexpected seizures, even if the patient has been free of seizures for years. Every brain is different, and how epileptic seizures are expressed and the potential ramifications of them occurring may be mild or severe. We know that the severity of seizures and the propensity for secondary injury (such as pneumonia, compression fractures, and status epilepticus) tends to be higher when the cause is missed seizure medication. This is a major reason the appeal process to obtain AEDs through Medicaid needs to be completed in an efficient and timely manner.

I surveyed a number of colleagues around the country concerning their experience with the Medicaid appeal process to understand their concerns. Although their responses were somewhat variable from state to state, there did appear to be some significant concerns with the process.

An epilepsy nurse responded, "the process has been VERY frustrating, not only for physician's offices, but also on the patients and pharmacies.  They do not want to cover any controlled substances, so for anyone on phenobarbital, klonopin, or ativan, it has been a fight to get any approval, if approved at all. They are very picky regarding 'Dispense as Written' and want specific information regarding past anti-epileptic medicines when taken, and why stopped.  If for example, we are requesting dispense as written for Dilantin, it will not be approved unless the patient has been tried on generic, and up to a specific dosage. It seems as though they have more say than the doctor."  

Another stated, "The appeal process is very time consuming, sometimes we would fill out forms and still not be approved. They would request that another drug be tried first. Who has time to look at a patient's chart and long notes of when they tried the other requested drug, how long they tried it, and why it didn't work.  Yes a pain, however I do think lately things have gotten a little better, in that I have not seen as many requests."

Concerning the need for a brand name drug, and the ability for the patient to have access to what the doctor believes is the appropriate drug within 24 hours was a frequent complaint. Many noted it was more commonly a 24-72 hour process, if not longer. If the proper forms are in the office it can be completed in about 5 minutes, but this takes longer if we need to make a phone call to the Medicaid provider to request the proper form. Phone time can be anywhere from 10-30 minutes.

If patients don't have access to their medication for several days, problems including breakthrough seizures, ER visits, admission to hospital, seizure related injuries, and even death can result. As you can see, the costs of these occurrences could be monumental (both at a financial and personal level).

I do not hesitate to suggest a solution to this problem would be access to all AEDs without prior authorization. This is a population for which the ramifications from lack of drug access or inappropriate transition to a generic far outweigh any specific benefit. Physicians are aware of the potential risks and have the knowledge to identify the appropriate situations in epilepsy where generic medications or less expensive alternatives are appropriate. If this is not the process for the epilepsy population, then a more realistic analysis of the AEDs on the list should be considered.

Formularies continue to exclude some of the most valuable anti-epileptic drugs which were introduced over the last 10 years.  These agents have provided many patients with effective seizure control with limited side effects compared to the older AEDs.  Their unique anatomical structure, mechanism(s) of action, and tolerability have made them extremely valuable weapons in the care of epilepsy patients.  Casual substitution of older agents or transition to generics can't be justified with the potential risks to these patients.

In conclusion, I would like the Commission to consider the life-threatening and costly risks to individuals with epilepsy – and the general public - in not having access to all of the anti-epileptic drugs as prescribed by the individual's physician. It is the Epilepsy Foundation's position, as well as my own, that the physician should have the freedom to prescribe what will work best for the patient with epilepsy without fighting barriers such as limited formularies and the appeals process.

I look forward to answering your questions on how Medicaid can work with physicians to better serve and treat the nearly 3 million Americans with epilepsy.

Thank you.

Brien J. Smith, M.D.