Epilepsy Foundation Mobilizes Opposition to CMS’s Proposed Rule that Would Weaken Medicare Part D’s Six Protected Classes

Wednesday, January 30, 2019

LANDOVER, Md. — The Epilepsy Foundation has mobilized to oppose the proposed rule from the Centers for Medicare & Medicaid Services (CMS) that would weaken Medicare Part D’s Six Protected Classes (CMS-4180-P). Last week, the Foundation submitted comments to CMS urging the Administration to rescind all aspects of its Six Protected Classes proposal, which pose grave risks for people living with epilepsy and seizure disorders. Today, the Epilepsy Foundation joined a group of other impacted advocacy organizations on a roundtable expressing collective concerns with the proposed Medicare Part D changes.

“We are very concerned about giving plans the flexibility to impose more barriers on vulnerable populations,” said Philip M. Gattone, M.Ed., president and chief executive officer of the Epilepsy Foundation. “While the Foundation recognizes the need to cut healthcare and medication spending costs, it should not be done at the detriment of these populations who have a clear clinical, life-saving need to access the full range of certain medications. This is, after all, why CMS created — and Congress has since confirmed — the Six Protected Classes policy and included anticonvulsants as one of the protected classes.”

CMS established the Six Protected Classes policy to ensure that Medicare Part D beneficiaries living with chronic conditions — such as epilepsy, HIV, mental illness, cancer, and organ transplants — have meaningful and timely access to medications necessary to control their condition and maintain their quality of life. Rather than the statutory minimum of two drugs per therapeutic class, Medicare Part D plans must cover “all or substantially all” drugs for these six classes of medications.

While the Foundation did support another component of the proposed rule that will allow pharmacists to let Medicare beneficiaries know if it’s cheaper to pay for their prescription outside of their healthcare plan, the Foundation opposes the Six Protected Classes provisions of the proposed rule. The Foundation particularly opposes allowing plans to require people who are already stable on an anticonvulsant to go through prior authorization or fail on another medication first (called “step therapy”) when enrolling in Part D for the first time or switching between Part D plans. For people living with epilepsy and seizures, there is no “one size fits all” anticonvulsant, and the response to anticonvulsants can differ between seizure type and be different from person to person. It can take months to identify the anticonvulsant that helps each individual maintain seizure control with minimal side effects. Once an appropriate regimen has been determined, it can be very destabilizing to switch to any alternative regimen. Studies have demonstrated that people with epilepsy are at greater risk of seizure after a switch and breakthrough seizures can lead to injury, disability, loss of mobility or employment, and even death.

Since CMS released the proposed ruling in November 2018, the Foundation embarked on a multi-faceted and targeted advocacy effort to voice opposition to the Six Protected Classes components. In addition to submitting its own comments to CMS, the Foundation:

  • Activated its Speak Up Speak Out grassroots advocacy network, national Professional Advisory Board, Epilepsy Foundation staff and social media base whereby more than 870 people submitted personal comments to CMS.
  • Helped organize group comments to CMS from more than 30 epilepsy organizations through the Epilepsy Leadership Council.
  • Worked with coalition partners and signed on to group comments organized by the American Cancer Society Cancer Action Network, the Consortium for Citizens with Disabilities, the Partnership for Part D Access, and MapRx.
  • Joined nearly 60 patient and provider organizations in an ad campaign emphasizing the dangerous impact of the proposed rule on the patient community and asking Secretary Azar and Congress to stop the proposed changes. The campaign will run in print and digital national and Capitol Hill publications through the first week of February.
  • Participated in a Twitter day of action on January 23, 2019, using the coordinated hashtags #DontDelayAccess and #ProtectMedicareRx.

“As an organization representing people with epilepsy and seizure disorders who rely on anticonvulsants, we sincerely hope that the Administration listens to our concerns and rescinds the Six Protected Classes components of its proposal,” said Gattone.

Since this is a proposed federal rule, CMS will review the public comments and at some point, issue a final rule. The Foundation will continue to educate Capitol Hill and try to activate members of Congress to protect the Six Protected Classes, as the policy has a significant history of bipartisan congressional support. For more information please visit http://advocacy.epilepsy.com/ProtectedClasses.

About Epilepsy

According to the World Health Organization, epilepsy is the most common serious brain disorder worldwide with no age, racial, social class, national or geographic boundaries. The U.S. Centers for Disease Control & Prevention (CDC) estimates that 3.4 million people in the United States are affected by epilepsy. It is the underlying tendency of the brain to produce seizures which are sudden abnormal bursts of electrical energy that disrupt brain functions.

About the Epilepsy Foundation

With a network of nearly 50 partners throughout the United States, the Foundation connects people to treatment, support and resources; leads advocacy efforts; funds innovative research and the training of specialists; and educates the public about epilepsy and seizure first aid. For more than five decades, the Epilepsy Foundation has shone a light on epilepsy to promote awareness and understanding, and to advocate for laws that matter to people with epilepsy, while also funding $65 million for epilepsy research and supporting 3,076 epilepsy investigators and specialists in their early careers. Over the past 17 years, in partnership with the CDC, the Epilepsy Foundation has helped to improve access to care for people with epilepsy, expanded its digital reach and online resources in homes across the country, and trained more than 500,000 school and community personnel in how to recognize seizures and administer Seizure First Aid. The Foundation has also assisted more than 108,000 people through its 24/7 Helpline in the past five years, and continues to focus on innovation, new therapies, community services, advocacy and education as key priorities. To learn more visit epilepsy.com or call 1.800.332.1000. Follow us on Facebook and Twitter.

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The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

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