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2 Federal Engagement Since the beginning of the 115 th Congress on January 3, 2017, the Epilepsy Foundation has been continuously engaged in advocacy with Congress and the Administration on behalf of people with epilepsy. Our federal advocacy focuses on four main policy priorities: Securing federal funding for epilepsy research & programs Ensuring access to affordable, quality health care Promoting research & innovation Protecting disability rights & ending discrimination The following is a report on the Epilepsy Foundation s federal public policy engagement. The report is not exhaustive, but outlines our most prominent areas of involvement, especially in the ongoing conversation regarding health care reform. Federal Public Policy & Grassroots Engagement by the Numbers: Since January 2017, the Epilepsy Foundation has sent 160 advocacy letters to the Administration and Congress and eight policy alerts to our national network of 53,000 grassroots advocates. Driven to action by our policy alerts, grassroots advocates have sent nearly 10,000 s and made more than one hundred calls to members of Congress Federal Priority Issues Federal Funding for Epilepsy Research & Programs Federal funding supports research and programs that bring us closer to a cure and helps people with epilepsy live well in their communities. The Epilepsy Foundation supports increases in federal funding for epilepsy research at the National Institutes of Health (NIH), epilepsy programs at the Centers for Disease Control and Prevention (CDC), and research into ensuring safe and effective treatments at the Food and Drug Administration (FDA). This year, the Epilepsy Foundation sent 14 letters to Congressional leaders urging increases in federal spending on epilepsy research and programs for Fiscal Year To amplify the impact of our advocacy, we also sent out an alert to our grassroots network, urging advocates to write to their members of Congress about increasing federal funding for epilepsy. We also drove to the alert through a targeted social media campaign. In response, advocates sent more than 4,000 e- mails to the House and Senate. As a result of the work of the Epilepsy Foundation, our grassroots advocates, and other stakeholders, Congress passed and the President signed a $1.07 trillion FY17 spending bill that includes a $2 billion funding increase for the NIH and a $22 million funding increase for the CDC. Several programs at the NIH and CDC that directly benefit the epilepsy community also

3 received funding increases, including the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative and the CDC Epilepsy Program. As Congress considers 2018 spending levels, the Epilepsy Foundation will continue to advocate for sufficient funding to support programs that serve the epilepsy community. On April 18, the Epilepsy Foundation joined a coalition letter to Congressional leaders opposing any cuts to the CDC budget and supporting continued funding increases for the CDC programs. Access to Affordable, Quality Health Care in the ACA Marketplace and Medicaid As Congress considers the repeal and replacement of the Affordable Care Act (ACA), the Epilepsy Foundation continues to raise awareness about the important role that the ACA s patient protections and Marketplace play in ensuring that people with epilepsy have access to affordable, quality care. On January 11, the Epilepsy Foundation sent a letter to President-elect Trump and 12 Congressional leaders. The letter expressed the Epilepsy Foundation s continued support for the ACA and highlighted the law s provisions that have been important for the epilepsy community. Since January, we have sent 46 additional letters to Congress and the Administration detailing how the House and Senate proposals to repeal and replace the ACA would impact our community. Several of these communications were sent on behalf of the I Am Essential coalition a coalition of patient advocacy organization focused on encouraging access to health care for individuals on the ACA Marketplace. The Epilepsy Foundation leads the I Am Essential coalition with the AIDS Institute and the National Alliance on Mental Illness. The coalition sent a letter to HHS Secretary Price after his confirmation outlining the principles of the ACA that must be preserved in the new Administration; it also submitted comments to proposed rules and a response to a Request for Information (RFI) related to the ACA Marketplace regulations. In the Epilepsy Foundation s health care reform communications with Congress and the Administration, we have stressed three key messages: The current structure of Medicaid must be maintained. Medicaid provides health insurance to more than one-third of people with epilepsy, ensuring they can access the care they need to live well. Federal funding to the Medicaid program must not be weakened with per-capita caps or block grants. Essential Health Benefits must remain mandatory. Essential Health Benefits (EHB) requirements ensure that basic services like prescription drugs, hospitalizations, and emergency services are covered by plans offered in the ACA Marketplace and Medicaid expansion plans. Without the EHB requirement, insurers would be allowed to drop coverage for essential services. As a result, premiums and out-of-pocket costs for comprehensive plans that include coverage for the full host of basic health care services would skyrocket. People with pre-existing conditions must be able to access affordable care. Prior to the enactment of the Affordable Care Act, many people with pre-existing conditions were faced with unaffordable premiums or denied coverage completely. Any plan for health care reform must allow people with pre-existing conditions like epilepsy to continue to receive affordable care. 2

4 The Epilepsy Foundation Public Policy team has also launched a public education campaign to publicize the importance of ACA patient protections and the current structure of the Medicaid program. In June, we published a blog on the Epilepsy Foundation main page that detailed the current health care debate and proposals. This blog was also featured in the Epilepsy Foundation s weekly newsletter. Additionally, our advocacy website (advocacy.epilepsy.com) hosts in-depth articles about the ACA and Medicaid and tells the stories of families with epilepsy who would be devastated by Medicaid cuts. We constantly update these pages with new resources and stories as the debate continues. We also communicate updates regularly with affiliate and chapter leadership and provide them with opportunities and tools to engage. To further amplify our efforts, we have leveraged the power of social media and our grassroots network, ensuring that members of Congress hear the voices of their constituents. Since January, we have sent four nationwide alerts to our 53,000 grassroots advocates, urging them to write to their members of Congress about protecting access to health care. We promoted these alerts and the issue generally through the Epilepsy Foundation social media profiles. After receiving our alerts, advocates have sent more than 5,000 s to members of the House and Senate. The Children s Health Insurance Program For two decades, the Children s Health Insurance Program (CHIP) has been an essential source of health care coverage for nearly 9 million American children, including many with epilepsy. CHIP provides access to affordable, quality health care for children in working families whose parents earn too much to qualify for Medicaid but too little to purchase private health insurance on their own. CHIP funding is set to expire on September 30, 2017 and swift Congressional action is needed to ensure that this successful program continues, especially while the future of the ACA remains unresolved. The Epilepsy Foundation strongly supports CHIP. In June, we sent a letter to eight key Congressional leaders urging a prompt long-term funding extension for CHIP. Protecting and Strengthening Medicare Medicare provides health insurance for Americans age 65 and older, and to younger people with disabilities. More than 570,000 adults age 65 and older live with epilepsy, and that number is rapidly rising as the baby boomer generation enters retirement age. Additionally, many individuals under age 65 living with epilepsy are Medicare beneficiaries due to their disability status. The Centers for Medicare and Medicaid Services (CMS) is currently exploring ways to enhance Medicare Part D, the program s prescription drug benefit. As CMS considers changes to Medicare Part D, the Epilepsy Foundation is urging the agency to make continued access to physician-directed care a policymaking priority. We support the existing Medicare Part D Six Protected Classes policy, which ensures greater protections for six classes of medications, including anticonvulsants for epilepsy. Despite the Six Protected Classes policy, Medicare Part D plans currently provide lower levels of coverage for anticonvulsants than many commercial health care plans, and we have urged CMS to address this deficit. 3

5 This year, the Epilepsy Foundation has submitted three comments and sent one letter to CMS urging the agency to address high cost-sharing, formulary restrictions, and other barriers to epilepsy care in the Medicare program. Further, we are also supporting the CHRONIC Care Act, a bill that would implement Medicare payment policies designed to improve the management of chronic disease. The bill resulted from extensive discussions between the patient community and lawmakers, and demonstrates the positive results of patient involvement in policymaking. Improving Access to Medical Cannabis For many living with intractable seizures or rare epilepsies, therapies derived from cannabidiol (CBD) and medical cannabis show great promise to decrease seizure frequency or eliminate seizures. While not everyone with epilepsy should or would consider these potential treatment options and more research is needed, the Epilepsy Foundation is committed to supporting safe, legal access to medical cannabis and CBD if a patient and their health care providers feel that the potential benefits outweigh the risks. In 2017, the Epilepsy Foundation is supporting several bills that would advance access to medical cannabis and/or CBD and protect existing state medical cannabis and/or CBD programs. We support the Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017; the Compassionate Access Act; the Therapeutic Hemp Medical Access Act. Further, we also support and appreciate the research opportunities promised by the Cannabidiol Research Expansion Act, which would require the Attorney General to determine whether CBD should be a controlled substance and expand research on the possible medical benefits of CBD and other marijuana components. We will continue to support these bills and others with similar objectives as they are debated by Congress. Reducing Step Therapy and Barriers to Care Step therapy, or fail first, is a process used by insurance companies that requires individuals to try and fail one or more medications preferred by the insurer before receiving coverage for the treatment their physician originally prescribed. Step therapy requirements delay access to the medication physician-directed care, prolong ineffective treatment, and can lead to interruptions in regimes that work; thus endangering patients well-being and leading to higher overall health care costs. Step therapy is a common utilization management technique used by insurers in the epilepsy space. In 2017, the Epilepsy Foundation is supporting the Restoring the Patient s Voice Act, which would require employer-based group health plans to provide a clear exemption process for any step therapy protocol. In May 2017, we signed on to a group letter thanking the bill s sponsors for introducing the legislation, and we will continue to advocate for this bill throughout the year. Access to Emergency Medication People living with epilepsy can experience seizures that require emergency medical attention with controlled substances by first responders. Delays can be life-threatening and prolonged, cluster, or status seizures may cause serious injury and even death. 4

6 On January 9, 2017, the House unanimously passed the Emergency Medications Act, which would make changes to the Drug Enforcement Agency s registration process for emergency medical services (EMS) agencies, and clarify that EMS personnel can administer certain approved medications to their patients. The Epilepsy Foundation advocated for the passage of the Emergency Medications Act, sending a letter to the chair and ranking member of the House Energy & Commerce Committee in We will continue to advocate for this bill to pass the Senate and be signed by the President. Accelerating Drug and Device Development and Approval at the Food and Drug Administration For many people with drug-resistant epilepsy or who suffer from debilitating medication side effects, the hope of timely approval for new epilepsy treatments lies with the Food and Drug Administration (FDA). The FDA is currently partially funded by industry user fees, which support a personnel level that allows the agency to approve new treatments in a timely and more efficient manner. The FDA user fee agreements must be re-authorized in 2017 or the FDA will not be able to continue its important work. There is bipartisan consensus that the FDA user fees should be reauthorized. The Epilepsy Foundation strongly supports the FDA user fee agreements. The Epilepsy Foundation is committed to accelerating the development and approval of new therapies. We support a strong FDA that is responsive to the needs of the patient community and the innovations of scientific research and health care delivery. This year, we have sent 71 letters to members of Congress on key committees in support of prompt reauthorization of the FDA user fee agreements, which include several new FDA initiatives that would support increased patient involvement at the agency. Our grassroots advocates amplified our message by sending an additional 1,355 s to members of Congress. On May 11, 2017, the FDA Reauthorization Act passed the Senate Health, Education, Labor & Pensions (HELP) Committee. On June 7, 2017, the bill also passed the House Energy & Commerce Committee. We will continue to advocate for reauthorization. Including the Patient Prescriptive in Conversations about Value-Based Approach to Health Care Delivery Reform As policymakers consider reforms intended to improve the delivery of quality and bend the evergrowing cost curve, the Epilepsy Foundation advocates for the patient voice to be included in these conversations whether this be at the FDA as part of their review process or as CMS considers outcomes-based payment reforms. As health care stakeholders work towards a transition to a value-based approach for decisions about access and coverage of therapies, providers, and services, we must be actively involved in these discussions. We will continue to participate in the dialog around value and advocate for including the patient perspective as a critical stakeholder for successful reforms. 5

7 Supporting the Americans with Disabilities Act Epilepsy Foundation Public Policy Engagement Since 1990, the Americans with Disabilities (ADA) has guaranteed millions of individuals with disabilities the right to participate meaningfully in their communities. The Epilepsy Foundation is committed to supporting the ADA and opposing any attempts to limit the rights of people with disabilities. In 2017, the Epilepsy Foundation is opposing the ADA Education and Reform Act, which would shift the burden of ADA compliance from business owners to people with disabilities. Together with other patient advocacy groups in the disability community, we have written two letters to Congressional leaders in opposition to the bill. In response to our call for grassroots advocacy, our epilepsy advocates sent 863 s to members of the House of Representatives expressing opposition to the bill. Including the Epilepsy Community in Autonomous Car Development and Policy As automobile manufacturers and technology companies move closer to the development of fully autonomous vehicles or self-driving cars, the Epilepsy Foundation is focused on the possible benefits of these vehicles for people with epilepsy, especially for those who cannot legally drive due to seizures. Autonomous vehicles could expand mobility for members of the epilepsy community who cannot safely operate a traditional motor vehicle. We urge federal, state, and local policymakers to encourage innovation related to autonomous vehicles, and oppose unnecessarily restricting manufacture and use of such vehicles. Policies requiring riders of fully autonomous vehicles to hold drivers licenses would needlessly restrict some people with epilepsy from realizing the full benefits of this new technology. On June 15, we attended a roundtable organized by the Senate Commerce Committee and shared our involvement in the field and our concerns about licensing to help inform the development of legislation. riders Looking Ahead Over the next six months of 2017, the Epilepsy Foundation will continue to advocate before Congress and the Administration for our main policy priorities. We will remain especially focused on preserving access to affordable, quality health care for people with epilepsy, reauthorizing the FDA user fee agreements and CHIP, securing appropriate funding for epilepsy research and programs in Fiscal Year 2018, ensuring the patient perspective is considered in conversations around the value of care and in reforms to the structure of health care system to account for value, and preventing disability discrimination. State Engagement During the first six months of 2017, 40 state legislatures began and concluded their regular sessions. During these sessions, legislators considered hundreds of bills of importance to the epilepsy community and passed 17 into law. Our primary policy priority in the states is ensuring access to care mainly epilepsy medications across a variety of payers as this is the policy priority that states have some control over. 6

8 The following is a report on the Epilepsy Foundation s public policy engagement in the states. The report is not exhaustive, but outlines our most significant areas of involvement and victory. On several issues including step therapy and medical cannabis, the Epilepsy Foundation supported model bills that used similar language to accomplish comparable policy outcomes in different states. State Public Policy & Grassroots Engagement by the Numbers: Since January 2017, the Epilepsy Foundation has sent 690 advocacy letters to state legislators and policymakers and 34 policy alerts to grassroots advocates across the country. Driven to action by our policy alerts, 1,000 grassroots advocates from 15 states have sent 1,384 letters and made 62 calls to state officials. Step Therapy 2017 State Priority Issues Step therapy, or fail first, is a process used by insurance companies that requires individuals to try and fail one or more medications preferred by the insurer before receiving coverage for the treatment their physician originally prescribed. Step therapy requirements can delay access to the medication physician-directed care, prolong ineffective treatment, and can lead to interruptions in regimes that work; thus endangering patients well-being and leading to higher overall health care costs. Step therapy is a common utilization management technique used by insurers in the epilepsy space. In 2017, the Epilepsy Foundation, along with several other patient advocacy groups, is promoting model legislation that would require a clear appeals process and provide certain circumstances in which a health care provider and patient can override an insurer s step therapy requirements when medically necessary. We are also supportive of any legislation that restricts the number of steps insurers can impose and provides patients with direct access to the care their physicians think is best. This year, the Epilepsy Foundation has sent letters advocating for step therapy override protocols to 225 legislators in 16 states. Grassroots epilepsy advocates have amplified our message with 361 additional calls and s to policymakers. Five states have passed step therapy protections into law this year: Arkansas (Senate Bill 665, signed into law on April 4, 2017) Colorado (Senate Bill 203, signed into law on June 2, 2017) Iowa (House File 233, signed into law on May 10, 2017) Texas (Senate Bill 680, signed into law on May 23, 2017) West Virginia (House Bill 2300, signed into law on March 30, 2017) 7

9 State Rescheduling for FDA-Approved Therapies Derived from Cannabidiol For people living with intractable seizures or rare epilepsies, therapies derived from cannabidiol (CBD) show great promise to decrease seizure frequency or eliminate seizures altogether. However, even with FDA approval, any new therapies derived from CBD would not be available to patients unless states implement changes to existing drug schedules. These changes can be accomplished through regulatory action in some states, while others will be required the passage of legislation. A state s medical cannabis/cbd laws will not impact this status as this is an issue of prescription drug access. In 2017, the Epilepsy Foundation is promoting model legislation that would allow CBD-derived and FDA-approved prescription drugs to become available to patients. This year, we have sent letters to 81 legislators and policymakers in eight states, urging changes to state scheduling laws to allow patient access to CBD-derived, FDA-approved therapies. Grassroots epilepsy advocates have amplified our message with 143 additional s to legislators. Five states have created legislative pathways for FDA-approved, CBD-derived medications this year: Arkansas (House Bill 1402, signed into law on May 9, 2017) Arizona (Senate Bill 1377, signed into law on April 24, 2017) Kentucky (House Bill 333, signed into law on April 10, 2017) Utah (Senate Bill 219, signed into law on March 25, 2017) Wisconsin (Senate Bill 10, signed into law on April 18, 2017) State Medical Cannabis and Cannabidiol Programs 46 states and the District of Columbia have created programs allowing medical access to cannabis or cannabidiol (CBD). While not everyone with epilepsy should or would consider these potential treatment options, the Epilepsy Foundation is committed to supporting safe, legal access to medical cannabis and CBD, if an individual and their health care team feel that the potential benefits outweigh the risks. This year, the Epilepsy Foundation has sent letters of support for access to medical cannabis and CBD to 29 legislators and policymakers in three states. Grassroots epilepsy advocates have amplified our message with 316 additional s to legislators. On April 26, 2017, Indiana Governor Eric Holcomb signed House Bill 1148 into law, legalizing the use of CBS as a treatment option for epilepsy and seizures. On May 12, 2017, Iowa Governor Terry Branstad signed House File 524 into law, which expanded the existing state law related to the use of CBD. The new law allows the state to authorize up to two facilities to grow and produce CBD and five dispensaries to sell CBD. The Epilepsy Foundation Public Policy team will continue our work to educate lawmakers about the potential benefits of this treatment option in the coming year and support bills that advance 8

10 access to medical cannabis/cbd. We also continue to monitor and engage with the implementation of medical cannabis/cbd programs that were passed into law during previous legislative sessions or through voter referenda. Medication Synchronization People living with chronic conditions like epilepsy often take multiple medications to maintain their health. Having to make several trips to the pharmacy to fill prescriptions is one of the many barriers that make it difficult for people with chronic conditions to stay on their medications and maintain seizure control. The Epilepsy Foundation supports medication synchronization initiatives that allow pharmacists and patients to work together to ensure that all of a patient s medications can be refilled in one visit, and require insurers to adjust payments to facilitate this process. In 2017, the Epilepsy Foundation is supporting model medication synchronization legislation that would allow patients to pick up all their prescriptions on the same day each month and ensure that costs are appropriately prorated. The Epilepsy Foundation has sent letters in support of medication synchronization to 198 legislators and policymakers in eight states. Grassroots advocates have amplified our message by sending an additional 42 s to legislators. Three states have passed medication synchronization bills into law this year: Florida (Senate Bill 800, signed into law on June 14, 2017) Georgia (Senate Bill 200, signed into law on May 9, 2017) Oklahoma (House Bill 1824, signed into law on May 1, 2017) Medicaid Medicaid is a jointly funded state and federal program that provides health insurance coverage for lower-income adults and children, and individuals with disabilities and other significant health care needs. While the federal government has established some standard policy requirements, states have considerable freedom to structure their programs. About a third of people living with epilepsy rely on Medicaid. This year, the Epilepsy Foundation has supported a variety of state legislative and regulatory initiatives to protect the health of people with epilepsy who rely on Medicaid, and sent more than 60 letters to state legislators and policymakers in support of preserving, creating, or strengthening protections for epilepsy medication in state Medicaid programs. In Texas, the Epilepsy Foundation sent letters to Senate leaders and Governor Greg Abbott in support of House Bill 1917, a bill that would maintain open access to epilepsy medications by preserving the single formulary policy in the Texas Medicaid program. Governor Abbott signed this bill into law on June 14, In New York, the Epilepsy Foundation sent letters to 7 Senate and Assembly leaders and Governor Andrew Cuomo in support of the Prescriber Prevails policy that protects access to physician-directed care in the state Medicaid program. This policy was preserved in the annual budget. 9

11 In Michigan, Governor Rick Snyder signed a 2018 budget into law that renewed the protection for epilepsy medications in the state Medicaid program. The Epilepsy Foundation affiliate in Michigan has participated in several coalition efforts to emphasize the importance of this protection. In Indiana the Epilepsy Foundation sent letters to state legislators and administrators in support of the reinstating step therapy protections in the state Medicaid program. Eventually these discussion led to the creation of a Gold Card program that allows neurologist to have open access to epilepsy medications and only one step for all other physicians. Massachusetts and New Jersey are still in session and efforts continue in these states related to protections in the Medicaid programs. Grassroots advocates have amplified our message by sending 205 s to state legislators in support of protections for people with epilepsy in state Medicaid programs. State Prescription Drug Monitoring Programs Prescription drug monitoring programs are intended to curb prescription drug abuse by tracking the dispensing of medications with a high risk of abuse. Schedule V medications (which include some epilepsy treatments) are sometimes included in prescription drug monitoring programs, despite having a low risk of abuse. This inclusion can cause delays in access to treatment, which can be dangerous for people who rely on medication to maintain seizure control. The Epilepsy Foundation supports exempting all Schedule V non-opioid, non-narcotic medications, which are primarily epilepsy medications, from state monitoring programs. This year, the Epilepsy Foundation has sent letters to 81 state legislators and policymakers in four states urging the exclusion of Schedule V epilepsy medications from state drug monitoring programs. Grassroots advocates have amplified our message with an additional 207 s to their state legislators. On June 29, 2017, North Carolina Governor Roy Cooper signed HB 243, a bill that will require state physicians to participate in North Carolina s prescription drug monitoring program. The final bill draft exempted Schedule V medications from the highest level of monitoring ensuring that people with epilepsy who rely on Schedule V medications will not encounter additional barriers to accessing care. On March 10, 2017, the Epilepsy Foundation wrote to the sponsors of HB 243, requesting the exemption that was included in the final law. In Pennsylvania, advocacy continues and it is likely a bill to exempt Schedule V epilepsy medications from the state prescription drug monitoring program that we have supported will pass this session. The Epilepsy Foundation has continuously communicated with legislators and published an op-ed in local media outlets urging support for the bill. Mid-Year Formulary Changes For the majority of people living with epilepsy, medication is the most cost-effective treatment for controlling and/or reducing seizures. The Epilepsy Foundation supports legislation that prevents insurers from making mid-year changes to drug formularies, like removing a 10

12 medication or placing it on a higher, more expensive tier. When prescription drug benefits are changed mid-year, beneficiaries can be left with higher out-of-pocket costs, or with no coverage at all for a necessary medication. This year, the Epilepsy Foundation has sent letters in support of restrictions on mid-year formulary changes to four high-ranking legislators in two states. Patient Voice in Value of Health Care and Innovation Conversations The Epilepsy Foundation is committed to supporting patient participation in conversations on the value of health care and ensuring that any policy intended to bring transparency to and lower health care costs will not result in unintended consequences such as limiting access to medications and services or barriers to the development of innovative therapies. In Spring 2017, we sent letters to the Nevada state legislature and Governor Brian Sandoval in opposition to Senate Bill 265, a bill intended to bring transparency to the drug pricing process with the goal of reducing drug costs, but that would result in reduce involvement of patient advocacy groups in conversations about the value of health care. On June 2, Governor Sandoval vetoed the bill, noting the concerns of the Epilepsy Foundation and other groups. The Governor later signed on a similar version of the bill that will extend transparency requirements to other players in the drug supply chain, but that unfortunately places reporting burdens on patient advocacy groups. Looking Ahead Over the next six months of 2017, the Epilepsy Foundation will continue advocating in the states for our main priority issues, including: state funding for epilepsy programs and services, access to care, research and innovation, and protections against discrimination. Ten states remain in session. 11