The following letter sent to CMS Administrator Dr. Mark McClellan expresses the Epilepsy Foundation's continuing concerns regarding issues related to the Medicare Prescription Drug Benefit.

Delivered: December 22, 2005

Mark McClellan, MD, PhD
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
C5-25-25
Baltimore , Maryland 21244-1800

Dear Dr. McClellan:

On behalf of the Epilepsy Foundation and the more than 2.7 million Americans living with epilepsy, we would like to share with you our concerns with the implementation of the new Medicare Prescription Drug Benefit. First, you and your staff deserve to be recognized for your skill, dedication and hard work in rolling out this new benefit under what are surely incredibly difficult time frames and complex circumstances. We also appreciate your willingness to work with our government relations team, and in particular, thank David Chatel for his ongoing commitment to outreach, Julie Goon for speaking at our Public Policy Institute, and Leah Kegler for arranging advocacy meetings and briefings with our members. The Epilepsy Foundation believes that our voice does matter to CMS, and in that spirit we would like to bring to your attention some serious concerns coming from the field and from our review of the plans and current implementation.

1. Failure to cover epilepsy medications.

   Almost uniformly, two anti-epileptic medications are not being covered by the plans even though they are in protected classes. These are:

   1. Mysoline (primidone) - This is an older drug that is not frequently prescribed; however, most neurologists report having a handful of patients on this anti-convulsant.

   2. Lyrica (pregabalin)- This is a newly approved FDA drug that has been on the market for over 6 months. Neurologists are using this as a new treatment option for seizures; it does not appear on any of the plans as of the date of this letter.
      
      
2. Failure to cover any brand name or new epilepsy medications at the lowest tier cost.

   Almost without exception, newer and/or brand name anti-epileptic medications are included in the plans only at the highest tiers. Many of these brand name drugs do not have a generic alternative yet available, and represent real advances for people with epilepsy particularly in terms of their side effect profiles as compared to older medications.¹ In some cases, the individual is well controlled only on the brand name product, and to be forced to switch because of cost may result in a breakthrough seizure.² In any event, it is simply bad medicine for a drug plan to presume that the older drugs and/or all those that have generic versions are preferred on the basis of cost alone, without taking into account the consequences of either break through seizures or the side effects that can accompany antiepileptic medications, particularly the older ones. Having seizures is a damaging, potentially life threatening event, and can be disastrous to the individual as well as to those around him. In addition, the side effects of many of the older drugs can be harmful medically, cognitively, and in terms of one's quality of life.³ Given the unique nature of seizures and the fact that no treatments are clearly optimal, it is the firm opinion of the Epilepsy Foundation and its medical advisers that all epilepsy medications, whether brand name or new products, should be available to treat seizures at the lowest possible cost, and not subject to tiering, prior authorization, or other restrictions. The expert in the treatment of the individual's seizures should be making medical care decisions based upon optimal medicines to treat the condition.

3. Adverse and discriminatory treatment of people who have epilepsy on the basis of their medical condition.

   The failure to offer brand name or new epilepsy medications at the lowest tier means that anyone with epilepsy, but particularly those with difficult to control seizures, who need to try various treatments to find one that works best in terms of fewest seizures and least side effects, will have to pay significantly more for their medical care than will someone who does not have epilepsy. In addition, since many people with epilepsy are on multiple medications due to the nature of the condition, including different antiepileptic treatments, placing their medications at the higher tiers because of issues like brand name and cost, is discriminatory and unfair to the individual, as it creates more financial burden to the person who has a chronic condition, who has no choice but to take the medicines required to optimally control their seizures and related health needs. The presumption inherent in the Medicare plans is that older, less expensive generic medications are always better is one that is completely wrong for the treatment of seizures and epilepsy, and adversely impacts this category of individuals, as well as anyone with chronic complex medical conditions.

4. Misinformation or inconsistent information provided by the CMS website and the plans about coverage of medications.

   a. There appear to be discrepancies between how plans are shown to cover epilepsy medications on the CMS website www.medicare.gov versus that of the actual plan's website. For example, on November 21, 2005, Medicare.gov showed that United Medicare Advance covered 1 mg tablet of Ativan at $41.46. After reviewing United's formulary on their website, and calling their 800 number, our staff was told by the United's customer service representative that Ativan is not covered by the plan. This confusion will be very problematic for individuals who sign up based upon what they see on the government's site, and then discover that actual coverage differs.

   1. People who are dual-eligible for Medicare and Medicaid have been sent a letter from CMS stating that they will not be auto-enrolled into a plan until December 31, 2005. However, some individuals are also receiving letters indicating that they have been auto-enrolled in plans as of October 31, 2005. We have individuals who have only this week received their letter from CMS telling them which plan they are auto-enrolled in. We have complaints from some individuals that the plan in which they have been auto-enrolled is not covering their epilepsy or seizure medication.
   2. Some of the Plan sites, e.g., www.meds4medicare.com, do not have current information about their formularies and terms of coverage; that information is "coming soon." When beneficiaries call CMS to ask questions about their coverage, based upon these letters from various sources, they have been told by the Medicare customer service representative that it will take at least 30 days to make a change from the auto enrolled plan. While we have heard that CMS is also assuring some dual-eligible individuals that they will be covered on all their current medications for one month starting January 1, no matter what the terms of the plan in which they have been auto-enrolled, all of this is extremely confusing and time consuming for the individual and his or her caretakers. In short, they are trying to sign up for plans for which they have inadequate and conflicting information.
   3. Some beneficiaries are being told by the plans that they cannot enroll in a plan by phone; instead they must enroll in person at a participating store. (For example, on December 6, 2005, according to one complainant, Humana told a Massachusetts dual-eligible individual that she would have to go to the nearest Wal-Mart and speak with an agent to enroll).
      
5. Physician charges for appeals or prior authorization requests in plans.

   The Foundation has been receiving complaints from beneficiaries that their physicians are charging $5 per page to file an appeal or a prior authorization request. As stated above, individuals with epilepsy are often on multiple drugs and facing enormous medical expenses; they cannot afford this added expense. This potentially unforeseen consequence means that individuals will bear additional burdens because they have a chronic medical condition like epilepsy – or they will receive less than adequate care because they cannot afford the additional expense.

6. Failure of plans to know how to transition people who are dual-eligible.

   Ten out of the ten plans the Epilepsy Foundation called did not know what a transition plan was for dual eligibles.

As you and your colleagues work to implement the new benefit, we feel that it is essential for CMS to ensure that the most vulnerable Medicare beneficiaries – individuals with epilepsy and other serious, life-threatening, disabling, or chronic conditions – have access to the prescription drugs they need without undue burdens and barriers. Moreover, ensuring that individuals with epilepsy have access to the care and therapies they need will help preserve and protect their health and well-being, and work to reduce costs to the Medicare program, affected individuals and families, and the nation.

Please know that we very much appreciate the hard work of you and your staff as you take on the challenging endeavor of implementing the MMA. We look forward to hearing from you regarding the above issues, and would be happy to provide additional information on any of the topics noted above. We would also appreciate the opportunity to meet with you and hear from you how you think these matters could be resolved. Please feel free to contact me, Donna Meltzer, Senior Director of Government Affairs, at (301) 918-3764 or Julie Venners Yannes, Director of Federal Relations, at (301) 918-3766 at your earliest convenience.

With best wishes for the Holidays,

Very truly yours,

Alexandra K. Finucane, Esq.

Vice President, Legal & Government Affairs

cc: David Chatel
Julie Goon
Leah Kegler
Greg Barkley, M.D.
Brien Smith, M.D.
Jackie French, M.D.
Medicare Access for Patients-RX (MAPRx) Coalition Members

1 French JA, Kanner AM, Bautista J, Abou-Khalis B, et al. Efficacy and tolerability of the new antiepileptic drugs I: Treatment of the new onset epilepsy. Neurology 2004; 62(8): 1252-60.

French JA, Kanner AM, Bautista J, Abou-Khalis B, et al. Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy. Neurology 2004; 62(8): 1261-73.

2 Burkhardt RT, Leppik IE, Blesi K, et al. Lower phenytoin serum levels in persons switched from brand to generic phenytoin. Neurology 2004; 63:1494-1496.

Birnbaum A, Hardie NA, Leppik IE, et al. Variability of total phenytoin serum concentrations within elderly nursing home residents. Neurology 2003; 60:555-559.

3 Leppik I. Choosing an antiepileptic. Selecting drugs for older patients with epilepsy. Geriatrics 2005; 60(Nov):42-47.