VOLUME 31 · ISSUE 5 · MAY 2017
Y O U R M O N T H LY A A N M E M B E R S H I P M A G A Z I N E
Early Registration Savings to Sports Concussion Conference End June 15 June 15 is your last chance to save with deep discounts on registration to the 2017 AAN Sports Concussion Conference, set for July 14 through 16, in beautiful Jacksonville, FL, at the Hyatt Regency Jacksonville-Riverfront. Each year, 1.6 to 3.8 million concussions result from sports/recreation injuries in the United States, with the issue attracting significant media attention in recent years. New science is emerging quickly and breakthrough therapies are helping athletes recover from injuries previously thought untreatable. The Sports Concussion Conference will help you stay up-to-date, and discover the latest information on the prevention, diagnosis, and treatment of sports concussion through interactive hands-on workshops, debates, and other engaging formats.
Abstract Submission Deadline: May 8 The Sports Concussion Conference is accepting scientific abstract submissions on topics related to sports concussion until May 8. Submission of previously presented work is encouraged if it is of interest to the field. Submit online at AAN.com/view/ConcussionConference. •
You can expect to: nn Apply your knowledge to the diagnosis and treatment of concussion at the youth, high school, collegiate, or professional levels nn Understand post-concussion syndrome and how the field is moving beyond complete rest and toward more active rehab nn Better understand the continuum of the concussion model from prevention to monitoring to recovery nn Earn up to 20 CME credits
Hotel Reservation Deadline Is Also June 15 July 14 –16 • Jacksonville, FL
The AAN has negotiated a discounted room rate for conference attendees at the Hyatt Regency Jacksonville-Riverfront. Participants must identify themselves as being with the 2017 Sports Concussion Conference to receive the special rate, and book by the June 15 reservation deadline. Visit AAN.com/view/ConcussionConference to secure your spot today. •
THIS ISSUE 13 23 25 25
New ALS Book Available for Patients, Caregivers AAN Publishes Guideline on SUDEP Incidence Rates and Risks NeuroLearn Editorin-Chief Position: Call for Applications Seeking Applications for New NeuroSAE Editor-in-Chief
New Leadership Program to Empower Neurologists, Reduce and Prevent Burnout Neurology is the only medical specialty that has both one of the highest rates of burnout and the lowest rates of work-life balance. To help reduce and prevent burnout and improve well-being, the AAN is offering a new leadership program designed to empower neurologists to cultivate well-being and resilience in their lives; increase engagement at work; and develop strong, lasting leadership skills. Continued on page 28
Use Webinar to Update Your Coding Skills Correct coding is essential to document your services for reimbursement. Attend this important practice management webinar to help ensure you are in sync with the latest neurology-specific codes. Break the Code, or It Will Break Your Practice: Coding for Neurodiagnostic Procedures June 6, 2017 • 12:00 p.m.–1:00 p.m. ET Deadline to Register: June 5 Directors: Neil A. Busis, MD, FAAN, and Todd Barnes, MBA Continued on page 10
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Table of Contents
Official Publication of the American Academy of Neurology
PUBLICATION COVER Early Registration Savings to Sports Concussion Conference End June 15 New Leadership Program to Empower Neurologists, Reduce and Prevent Burnout Use Webinar to Update Your Coding Skills
5 The Goals and Priorities for My Term as President
MEET YOUR LEADERS
6 2017–2019 AAN and AAN
Institute Boards of Directors and Committee Chairs
8 AAN Sets Reform Criteria with
Health Care Delivery Principles
9 Capitol Hill Report
10 AAN Position Statement Takes
Aim at Prescription Drug Prices
11 Understand MIPS Advancing Care Information and Improvement Activities
12 Academy Honors Members for
Quality Improvement Innovations
12 Axon Registry Receives Grant
13 New ALS Book Available for Patients, Caregivers
14 Podcast Central
23 AAN Publishes Guideline on
SUDEP Incidence Rates and Risks
CME & MOC
24 Continuum Audio Series
25 NeuroLearn Editor-in-Chief
Phone: (800) 879-1960 (toll free) (612) 928-6000 (international)
25 Seeking Applications for New
Examines Systemic Disease Position: Call for Applications NeuroSAE Editor-in-Chief
26 Reminder: May 8 Is Deadline to Submit Online Evaluations for Annual Meeting CME
26 Subspecialty Fellowship
Training Program Accreditation Applications Due June 1
28 June 5 Application Deadline Approaching for Valuable Leadership Programs
CAREERS | 29 AMERICAN BRAIN FOUNDATION
30 New Crowdfunding Platform for Research Launches
DATES AND DEADLINES | 31
AAN member Greg Barkley, MD, was invited to serve on the National Committee for Quality Assurance’s Patient-Centered Specialty Practice (PCSP) Advisory Committee. The committee provides strategic direction and guidance in updating PCSP standards and guidelines, which would be used by neurologists interested in achieving a PCSP designation. The new Career Development Award, the largest research award offered by the AAN to date, has been presented to Lidia M.V.R. Moura, MD, MPH, of Harvard Medical School. Moura was presented the $450,000 award for her research project, “Epilepsy in the Elderly: Predictors of Treatment Adherence and Outcomes.” The new award was created to reflect the AAN’s dedication to promoting neurology and neuroscience research and training. • AANnews • May 2017
The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415
The Vision of the AAN is to be indispensable to our members.
Website: AAN.com For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone:
AAN Executive Director Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee and Jim Hopwood Email: aannews@AAN.com AANnews is published monthly by the American Academy of Neurology for its 32,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary. The American Academy of Neurology’s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
The Goals and Priorities for My Term as President In writing my first President’s Column for AANnews, I cannot help but reflect on how far we have come as a professional organization and how much work we still need to do. The last two years as president elect have zipped by so quickly, and I am grateful for the experience and time to learn, listen, and work with the many volunteers and outstanding staff of the AAN. Working closely with our Past President Terry Cascino, the AAN Board, and the executive team over the last two years, I can fully vouch for the great team we have in place to help guide us. As we get ready to celebrate our 70th year, I am humbled to start my term as the 35th president of the AAN and plan to emphasize teamwork, distributed leadership, and strategic continuity, as we chart a course for a brighter future. The founders of the AAN had the wisdom to create a twoyear position of president elect so that the person in this role would be intimately familiar with the wide range of issues faced by neurologists and how the Academy was addressing them. Gone are the days when the new president would chart a new path sometimes in different directions. Transitions are so critical and the AAN Board has helped ensure that we have strategic continuity between leadership teams. The recommendations from a variety of taskforces are just getting started, including Solo and Small Practices, International, Wellness and Burnout, and Gender Disparities. Terry Cascino’s presidential priorities will continue to be emphasized as we move some of these initiatives into the implementation phase and develop next steps in other priorities. For 2017, the goals of the AAN remain: nn Ensure the ongoing health of the profession and the
organization to support the unique needs of all members
nn Personalize member communication and the
nn Educate and assist members
in providing high-value, quality clinical care in the evolving health care environment
nn Advocate for members and their
patients on issues of importance to neurology, including access to high-quality, cost-effective care; research; and fair payment
nn Enhance member satisfaction,
well-being, and resiliency with resources that support members throughout their careers
Ralph L. Sacco, MD, MS, FAHA, FAAN
nn Promote neurology and neuroscience research and training
We made great strides in 2016 accomplishing objectives for many of these goals, and they remain very relevant. They will continue to be part of our strategic plan, but the tactics to fulfill them will likely evolve. We also are continuing our “Wildly Important Goal,” designed to execute a critical Academy-wide strategy during the day-to-day functions or “whirlwind” of what needs to be done:
To demonstrate the value of neurology, neurologists, and neuroscientists At the same time, each new president has brought to the table issues he or she strongly believes deserve attention for the good of our members and profession. So, I wish to take this opportunity to share my platform for the next two years.
Meeting the Future Demands for High-quality Neurologic Care Over many years and AAN presidencies, the Academy has recognized the growing chasm between the supply and demand for neurological care and has taken significant steps to address this. I, too, deeply share this concern. One in six has some neurological issue and this is likely to rise as our population ages. The supply of neurologists will fall 20 percent below demand by 2020. The urgency to expand the neurology workforce pipeline will continue as one of my top priorities. It is a massive and complex task to not only encourage medical students to enter the profession of neurology, but to reach down to our nation’s youth and excite them to pursue careers in neurology and neuroscience. We seek to spark in them the same inspiration that led us to become engaged in neurology and neuroscience. We are being helped in this effort by a generous grant from the Conrad N. Hilton Foundation to study this specific issue. Continued on page 22
AANnews • May 2017
Meet Your Leaders
2017–2019 AAN and AAN Institute Boards of Directors and Committee Chairs With the approval of voting members at the Business Meeting at the Annual Meeting, these AAN members will serve on the boards of directors of the AAN and the AAN Institute for the 2017–2019 term. Prior to the Business Meeting, Lisa M. DeAngelis, MD, FAAN, withdrew her nomination for president elect of the AAN due to a family health issue. When a member withdraws her or his candidacy for a position on the AAN Board of Directors, our AAN bylaws require the Board of Directors to designate substitute nominees. As a result, a revised slate of nominees was presented to the voting membership for approval during the AAN’s 2017 Business Meeting on April 22 during the AAN Annual Meeting in Boston. The Board of Directors designated then-Vice President James C. Stevens, MD, FAAN, as the 2017–2019 president elect. Ann H. Tilton, MD, FAAN, who at the time served as the secretary-treasurer of the AAN Institute, was designated as the 2017–2019 vice president. Charles C. Flippen II, MD, FAAN, who served as an AAN director, was elected by the AAN Institute Board of Directors as secretarytreasurer of the AAN Institute. James N. Goldenberg, MD, FAAN, was designated as substitute nominee for AAN director. The Academy is comprised of two legal entities, the AAN and the AAN Institute. Several AAN and AAN Instit ute Board members serve ex officio based on their positions as chairs of major committees. Most of the elected members of the AAN Board of Directors also serve ex officio on the Board of Directors of the AAN Institute, which includes an independent secretary-treasurer and additional members who serve in ex officio capacities. Dr. Ralph Sacco serves as the president of AAN based on his 2015 election as president elect, and Dr. Terrence Cascino serves as immediate past president based on his 2015–2017 service as president.
2017–2019 AAN Board of Directors Officers
President Ralph L. Sacco, MD, MS, FAHA, FAAN
President Elect James C. Stevens, MD, FAAN
Vice President Ann H. Tilton, MD, FAAN
Secretary Carlayne E. Jackson, MD, FAAN
Treasurer Janis M. Miyasaki, MD, MEd, FRCPC
Brenda Banwell, MD, FAAN*
Sarah M. Benish, MD, FAAN
Charlene Gamaldo, MD, FAAN*
James N. Goldenberg, MD, FAAN, CPI*
Jonathan P. Hosey, MD, FAAN*
Elaine C. Jones, MD, FAAN
Brett M. Kissela, MD, MS, FAAN*
John C. Morris, MD, FAAN
Thomas R. Vidic, MD, FAAN
Immediate Past President Terrence L. Cascino, MD, FAAN
Ex Officio (AAN voting)
Orly Avitzur, MD, MBA, FAAN, Chair, Medical Economics and Management Committee
Gregory D. Cascino, MD, FAAN Chair, Member Engagement Committee
Ex Officio (non-voting)
Robert A. Gross, MD, PhD, FAAN Editor-in-Chief of Neurology ®
Nicholas E. Johnson, MD Chair, Government Relations Committee
Catherine M. Rydell, CAE, Executive Director/CEO
2017–2019 AAN Institute Board of Directors The following are additional members of the AAN Institute Board of Directors who do not serve on the AAN Board of Directors.
Ex Officio (AAN Institute voting)
Secretary-Treasurer Charles C. Flippen II, MD, FAAN
Natalia S. Rost, MD, MPH, FAAN, FAHA, Chair, Science Committee*
James N. Goldenberg, MD, FAAN, CPI—AAN Board of Directors
Heidi B. Schwarz, MD, FAAN Chair, Practice Committee
James N. Goldenberg, MD, FAAN, CPI, currently serves in private practice at the Medical Specialists of the Palm Beaches Neurology in Atlantis, FL, where he served as president and chairman of the board of directors. He is also a principal investigator at JEM Research, also in Atlantis. He is affiliated assistant professor of neurology at the Leonard M. Miller School of Medicine at the University of Miami, and serves as Alumni Association founding president and on the advisory council for the University of Miami Department of Neurology. Goldenberg studied psychology at the University of Florida in Gainesville followed by the study of medicine and an internship at the University of South Florida College of Medicine in Gainesville, FL. He completed his residency and fellowship at the University of Miami School of Medicine. He has been a member of the AAN since 1991, and became a Fellow of the AAN (FAAN) in 2015. He has served in numerous leadership roles with the
A. Gordon Smith, MD, FAAN Chair, Education Committee
AAN, including his current position as vice chair of the Government Relations Committee; member of the Registry Committee; Payment Alternatives Team member; advocate, advisor, faculty, and moderator for the Palatucci Advocacy Leadership Forum; and a Neurology on the Hill participant for several years. He is immediate past president of the Palm Beach County Medical Society, and he established the Physicians’ Leadership Academy of South Florida. He also serves on the Florida Medical Association Board of Governors. Goldenberg has authored more than a dozen published articles and scientific studies, and has received numerous honors including South Florida Super Doctors, Consumer Research Council of America’s Guide to America’s Top Physicians, Doctors Across American Top Doctors; and been named to the Best Doctors in America five years in a row beginning in 2013. • Continued on page 8 AANnews • May 2017
Meet Your Leaders
2017–2019 AAN and AAN Institute Boards of Directors and Committee Chairs Continued from page 7
The following members have been appointed by President Sacco to chair these AAN committees. BrainPAC Executive Committee Glen R. Finney, MD
Practice Committee Heidi B. Schwarz, MD, FAAN
Executive Committee; No chair—led by Ralph L. Sacco, MD, MS, FAHA, FAAN
Education Committee A. Gordon Smith, MD, FAAN
Publications Committee Robert A. Gross, MD, PhD, FAAN
Fair Hearing Panel Committee Glenn A. Mackin, MD, FAAN, FACP
Government Relations Committee Nicholas E. Johnson, MD
Registry Committee Lyell K. Jones, MD, FAAN
Grievance Committee William P. Cheshire, Jr., MD, FAAN
Leadership Development Committee Terrence L. Cascino, MD, FAAN
Science Committee Natalia Sana Rost, MD, FAAN
Joint Audit Committee George K. York III, MD, FAAN
Medical Economics and Management Committee Orly Avitzur, MD, MBA, FAAN
Board Planning Committee Carlayne E. Jackson, MD, FAAN
Joint Investment Committee Ralph F. Józefowicz, MD, FAAN
Bylaws Committee Ralph L. Sacco, MD, MS, FAHA, FAAN
Nominations Committee Timothy A. Pedley, MD, FAAN •
Member Engagement Committee Gregory D. Cascino, MD, FAAN Meeting Management Committee Stefan M. Pulst, MD, FAAN
Ethics, Law, and Humanities Committee James A. Russell, DO, FAAN
AAN Sets Reform Criteria with Health Care Delivery Principles The AAN established a set of Health Care Delivery Principles to share with Congress as it debated proposed changes to the Affordable Care Act. While Republicans in the House of Representatives pulled their American Health Care Act before it could come to a vote, Congress may revisit the issue down the road. These principles were drafted by the AAN Government Relations Committee (GRC) after a significant outreach campaign to AAN members, and have been approved by the AAN Board of Directors. The AAN will support health care policies that follow these principles: nn Access to high-quality health care and preventative
care through insurance coverage for all, including those most vulnerable to health care disparities, regardless of pre-existing conditions
nn Appropriately value cognitive care services nn Limit administrative requirements and advocate for EHR
functionality to ensure that physicians spend as little time as possible on low-value clerical work, and as much time as possible engaged in direct patient care
nn Continue efforts to streamline EHR interoperability and
reduce data blocking to allow any willing provider to participate in a qualified clinical data registry
nn Improved valuation of patient-centered care setting
alternatives including telemedicine and other innovative care models
nn Improve efforts to reduce spending on pharmaceuticals
and other key drivers of health care expense through cost transparency and permit the negotiation of drug costs by Medicare
AANnews • May 2017
nn Medical liability reforms to reduce the cost of premiums
and defensive medicine
nn Preservation of the physician-patient relationship including
independent medical decision-making and patient access to needed treatments and education
nn Protect access to neurology care in all settings, including
small and solo practices
The Academy’s advocacy staff in Washington, DC, began educating Congress on these principles in February, beginning with several members of the House Doctors Caucus who made it clear that they planned to follow several of the positions important to the AAN, like ensuring access to those with pre-existing conditions. Academy members also shared the principles with their legislators during the AAN’s recordbreaking Neurology on the Hill. The AAN staff and GRC members will continue to review any health care reform proposals with an eye toward how well they conform to the AAN’s health care delivery principles. •
Capitol Hill Report Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport. Below are some recent highlights.
AAN Continues Regulatory Advocacy for Relief from Burdensome Hurdles on Neurology Practices
Fortunately, the president’s proposal is just that, a proposal. Congress is free to ignore the presidential proposal. Senior Legislative Counsel Mike Amery is hearing that Congress intends to do just that, ignore it.
A major priority of the AAN is to reduce regulatory hassles. We recently joined the American Medical Association and state medical societies from across the United States to call upon the federal government to reduce the burden and penalties associated with electronic health records, the Physician Quality Reporting System, and the Value-based Modifier. We strongly encourage leadership in the administration and at the Department of Health and Human Services to consider further reductions in regulatory burdens on neurologists, especially as they work to comply with MACRA. Learn more about MACRA at AAN.com/practice/MACRA.
One key player on NIH funding will be Rep. Fred Upton (R-MI), past chair of the House Energy & Commerce Committee. His crowning achievement in this position was the passage of the 21st Century Cures Act last year after a lengthy two-year campaign to sell the bill in both the House and Senate. This legislation included an increase of $4.8 billion for NIH. Upton’s comment on NIH cuts was, “Not on my watch!”
We also joined a large coalition calling upon the federal government to defer the implementation of 2015 Edition of Certified Electronic Health Record Technology (CEHRT) until such technology is widely available, and in any event, no sooner than January 2019. We do not believe the technology will be readily available to neurologists across a wide array of practice venues and that the use of 2015 Edition of CEHRT should remain voluntary. Finally, the AAN signed on to principles to reform the prior authorization process. The goal is to reduce the administrative burdens and barriers to timely patient care associated with prior authorization and other utilization management programs. The AAN will continue to seek out every legal and regulatory avenue possible to reduce burdens on our physicians, and in turn, increase the joy of practice for neurologists across the United States.
Congress Stands Strong in Support of NIH, BRAIN Initiative Funding A few weeks ago, President Trump proposed his 2018 budget and included a staggering $5.9 billion cut to the National Institutes of Health (NIH). A cut of this magnitude would represent a reduction of almost 20 percent from 2017 funding levels. Support for the NIH has been a hallmark of AAN advocacy for decades. For the last three years, we have prioritized funding for the BRAIN Initiative at the NIH through Neurology on the Hill and as a part of our year-round advocacy based in Washington. The results of these efforts have been profound, the BRAIN Initiative is slated to receive $160 million in 2017, and in each of the last four years since this program was created, funding levels have increased by significant margins. This is not the time to turn back on funding for research.
On the other side of the Capitol, Amery spoke with Sen. Roy Blunt (R-MO), a major champion of medical research who serves as chair of the Senate Appropriations Committee. Blunt, who has led recent efforts to substantially increase the federal commitment to funding research on Alzheimer’s (which the AAN has also strongly advocated for) said that the president’s budget was the wrong way to go and that cuts wouldn’t be coming through his committee. Sen. Bill Cassidy, MD, (R-LA) confidently said, “NIH cuts aren’t going to happen” at a meeting Amery attended with other physician specialty lobbyists. Thank you to the hundreds of AAN members who reached out to their members of Congress in response to the AAN’s action alert supporting the NIH and the BRAIN Initiative. The result of this effort was that 64 members of the House signed a “Dear Colleague” letter to the House Appropriations Committee in support of robust funding for the BRAIN Initiative. A special thank you from the AAN goes out to Reps. Earl Blumenauer (D-OR), Cathy McMorris Rodgers (R-WA), Bill Pascrell, Jr. (D-NJ), and Tim Murphy (R-PA) for leading this critical letter. The list of supporters can be found at AAN. com/view/HillReport. •
AANnews • May 2017
AAN Position Statement Takes Aim at Prescription Drug Prices “Action must be taken to ensure that prescription medications are accessible for patients with complex, chronic neurologic conditions.” So begins the AAN’s recently published position statement on prescription drug prices, the costs for which have escalated well beyond the means of many patients with neurologic disease. The AAN is calling for potential solutions that “should be affordable, simple, and transparent. Cost-containment efforts must also address the burden on the entire health care system as high prescription drug prices may be shifted and absorbed in ways that negatively impact patient and prescriber access to important medications.” The statement addresses three specific areas of concern, as excerpted here:
Price Negotiation The AAN supports proposals that would give federal agencies the authority to negotiate contracts with manufacturers of covered Part D drugs. Price negotiation would allow the government to leverage its purchasing power in an effort to obtain prescription drugs at a lower price, bringing savings to the health care system and consumers. The AAN would especially support proposals that increase competition among drug manufacturers and ultimately promote access to more affordable medications.
Transparency The AAN supports proposals that promote transparency in prescription drug pricing. Disclosure of pricing information, including how drugs are priced, the prices paid by insurers, and the prices paid by consumers, would provide important information that could lower costs for patients and for the entire health care system. The AAN would also support proposals that prohibit direct-to-consumer advertising of prescription drugs, as passed by the American Medical Association House of Delegates.
Importation The AAN supports proposals that allow for the re-importation of the same high-quality prescription drugs from Canada when prices for those prescriptions are less expensive than in the United States. Many specialty drugs are priced significantly higher in the United States than in other countries. The statement was approved by Government Relations Committee, Medical Economics and Management Committee, and the AAN Board of Directors. Read the complete position statement at AAN.com/public-policy/position-statements. •
Use Webinar to Update Your Coding Skills
Continued from cover
Upon completion, you should be able to: nn Learn to code appropriately for neurodiagnostic procedures including
EMG and nerve conduction studies, and EEG procedures
nn Use code modifiers appropriately nn Understand use of Appendix J in counting the appropriate number of
studies used to diagnose common neuromuscular conditions
AAN practice management webinars provide the valuable insights and tools you need to navigate through the ever-changing health care landscape. Single webinars are $99 but AAN members get the greatest value with the $189 subscription to all 10 live one-hour webinars. All webinars include access to presentation slides and recordings if you miss the live event. Physicians receive 1 AMA PRA Category 1 Credit™ per webinar; non-physicians receive a certificate of completion. Visit AAN.com/view/pmw17 to learn more and register. •
AANnews • May 2017
Neil A. Busis, MD, FAAN
Todd Barnes, MBA
Understand MIPS Advancing Care Information and Improvement Activities The Merit-based Incentive Payment System (MIPS) ties Medicare payments to performance through four categories. For full participation in MIPS, eligible clinicians must submit a complete year of 2017 data to possibly earn a positive payment adjustment, which is based on performance data on the information submitted (not the amount of information or length of time submitted). The best way to earn the largest payment adjustment is to submit data on the three MIPS performance categories: Quality, Advancing Care Information, and Improvement Activities. Advancing Care Information (ACI) and Improvement Activities (IA) are two MIPS performance categories that have some overlap between them. There are several IA measures that are more relevant to neurology or are easier to implement. Important note: AAN members who participate in the Axon Registry® will find it easier to meet the requirements in these two MIPS categories.
Advancing Care Information ACI accounts for 25 percent of the final MIPS score. In 2017, there are two measure sets for reporting based on the eligible clinician’s EHR edition. You can report the Advancing Care Information Objectives and Measures: nn If you have technology certified to the 2015 Edition; or nn If you have a combination of technologies from 2014 and 2015 Editions that support these measures.
a base score, a performance score, and a bonus score. Eligible clinicians need to report four to five base score measures, depending on the edition to which their EHR technology is certified. However, the ACI base score is all or nothing. If all four to five measures are not met, eligible clinicians will receive an overall ACI score of zero. For the bonus score, there are 18 Improvement Activities that are eligible for Advancing Care Information. The AAN has developed resources to help members explore measures and scoring in this category. It can be found online at AAN.com/practice/macra/advancing-care-information.
Improvement Activities IA account for 15 percent of the final MIPS score in 2017. There is a total of 40 points in this category. For partial or full participation, eligible providers need to choose a combination of the following: nn Two high-weighted activities nn One high-weighted and two medium-weighted activities nn At least four medium-weighted activities; for physicians in groups of 15 or fewer clinicians, activity points are doubled, so they only need to attest to 1 or 2 activities.
You can report the 2017 Advancing Care Information Transition Objectives and Measures: nn If you have technology certified to the 2015 Edition; or nn If you have technology certified to the 2014 Edition; or nn If you have a combination of technologies from 2014 and 2015 Editions.
Clinicians can choose from more than 90 activities under these nine subcategories: nn Expanded practice access nn Population management nn Care coordination nn Beneficiary engagement nn Patient safety and practice assessment nn Participation in an Alternative Payment Model (APM) nn Achieving health equity nn Integrating behavioral and mental health nn Emergency preparedness and response
The overall ACI score offers the possibility of a total of 100 percentage points to be earned across three components:
For more information on ACI, IA, and MIPS, visit AAN.com/practice/MACRA. •
2017 Performance Category Weights for MIPS Scoring in the four areas leads to one composite performance score. For the first year of MIPS, the categories are proposed to be weighted as follows:
Cost 0% Improvement Activities 15%
Advancing Care Information (MU) 25%
Quality (PQRS) 60%
Academy Honors Members for Quality Improvement Innovations Innovative approaches to improving quality in practice were recognized by the AAN Quality and Safety Subcommittee at the Annual Meeting in Boston, with four projects receiving Safety and Quality Awards. David Do, MD, from the University of Pennsylvania, was recognized for his work on automated solutions to improve nutrition in the critically ill. An automated system leveraged electronic data to assess nutritional needs, prompting providers to improve feeding, and thereby reducing underfeeding and subsequent muscle breakdown, infections, and mortality. Preston Douglas, MD, accepted on behalf of a Loyola University treatment team using simulation-based training to improve brain death determination and communication to family members. The team taught incoming residents how to diagnose brain death and communicate effectively with family members in an empathetic and professional manner.
David Do, MD
Preston Douglas, MD
Raghav Govindarajan, MD, FISQua, FACSc, FCPP
James Siegler, MD
Raghav Govindarajan, MD, FISQua, FACSc, FCPP, at the University of Missouri was recognized for his work teaching other health care providers to identify myasthenia gravis exacerbation through telephone and telemedicine encounters. This work further developed a multidisciplinary team approach to intervene rapidly using non-traditional patient encounters during a time of patient crisis. James Siegler, MD, from the Hospital of the University of Pennsylvania, received the award for his work using Scheduled Provider Alert-Response Communication System (SPARCS) to improve nurse and resident communication improving quality of life among treatment team members. For information about applying for Safety and Quality Awards for 2018, contact Amy Bennett at email@example.com. •
Axon Registry Receives Grant The AAN Institute has accepted a grant from the American Board of Psychiatry and Neurology (ABPN) to support the continued development and operation of the Axon Registry ®, the AAN’s quality improvement registry that collects data on patients and tracks practice performance and patient outcomes on quality measures.
Registry will be of significant benefit to ABPN diplomates in ABPN’s efforts to improve and document quality patient care.
“The Axon Registry is a game changer for AAN members and is central to the Academy’s mission of quality improvement in the delivery of neurologic care. Lyell K. Jones, Axon participation helps MD, FAAN participating members The ultimate goal of the meet federal reporting registry is to improve patient care. requirements while simultaneously Participating in the Axon Registry helps meeting the ABPN’s MOC Part AAN members meet federal reporting IV requirements. It’s important to requirements such as MACRA/QPP remember that the Axon Registry is and MIPS, easing the transition to the AAN’s single largest investment in value-based Medicare reimbursement its members and will require innovation for members. The ABPN offered the $1 million dollar grant to the AAN Institute since the Axon
AANnews • May 2017
in terms of continued financial support from a number of sources,” said Lyell K. Jones, MD, FAAN, chair of the AAN’s Axon Registry Committee. Participation in the Axon Registry is free for all AAN members regardless of ABPN certification status. Under the terms of the grant, ABPN diplomats who are not AAN members will be able to participate in the Axon Registry for a fee which will cover AAN costs. The grant is consistent with the AAN/AAN Institute’s Principles Governing Academy Relationships with External Sources of Support. Nearly 1,000 AAN members are now participating in the Axon Registry and more than 1 million patient records are now included in its database. •
New ALS Book Available for Patients, Caregivers A new resource is available for your patients with ALS with the publication of Navigating Life with Amyotrophic Lateral Sclerosis by Mark B. Bromberg, MD, PhD, FAAN, and Diane Banks Bromberg, JD. The title is the latest in the AAN’s Neurology Now™ Books series. Navigating Life with Amyotrophic Lateral Sclerosis is unique because it covers two perspectives of these married authors: One is a neurologist with 30 years of experience treating ALS patients, and the other experienced firsthand the issues in providing care for a parent with ALS. “I have worked with patients with amyotrophic lateral sclerosis and followed research for the disease for over 30 years,” said Mark Bromberg. “This experience has been rewarding as I have come to understand how patients and their families manage a most challenging disease. The experience is also frustrating as an understanding of underlying causes and a cure remain elusive. Together with my wife, whose mother had ALS, we have written Navigating Life with Amyotrophic Lateral Sclerosis to communicate to affected families what we have learned about managing the disease.” Patients, family members, and caregivers will value this book for the accessible, comprehensive, and up-to-date information about the challenges they face when confronted by ALS. This guide covers all aspects of managing ALS, from the onset of symptoms, diagnosis, treatments, and coping strategies, to the use of home health care or hospice, and new research in the field. The book also sheds lights on difficult topics, such as end-of-life care and managing legal affairs. Formatted in a question-and-answer style, peppered throughout with patient stories, and with sections devoted to family members and caregivers, this compassionate resource provides guidance to those seeking to understand how to live with this disease. “Even in today’s fast-paced digital world, there’s no replacement for a trustworthy and authoritative reference book,” said Editor-in-Chief Lisa M. Shulman, MD, FAAN. “Neurology Now Books fill that need for the many patients and families who are managing neurologic conditions. As editorin-chief of the book series, it’s particularly rewarding to add a patient book focused on ALS to our many previous volumes, including epilepsy, MS, and Parkinson disease. When patients experience unfamiliar
symptoms, manage functional limitations, and weigh the pros and cons of difficult treatment decisions, this new book will foster patient self-management skills and enhance their self-efficacy to manage their condition.” Navigating Life with Amyotrophic Lateral Sclerosis is available from all major booksellers or order online at AAN.com/view/NeurologyNowBooks. Both the Neurology Now Books series and Neurology Now ® magazine focus on the needs of people with neurologic disorders. The goal is to provide patients and their families and caregivers with the information they need to confront the day-to-day challenges of living with a neurologic condition. •
Steer Your Patients to These Other Neurology Now Books Navigating Life with Parkinson’s Disease Sortirios A. Parashos, MD, PhD; Rose Wichmann, PT; and Todd Melby Navigating Life with a Brain Tumor Lynne P. Taylor, MD, FAAN; Alyx B. Porter Umphrey, MD; and Diane Richard Navigating the Complexities of Stroke Louis R. Caplan, MD, FAAN Navigating Life with Multiple Sclerosis Kathleen Costello, MS, ANP-BC, MSCN; Ben W. Thrower, MD; and Barbara S. Giesser, MD Navigating Life with Epilepsy David C. Spencer, MD, FAAN
UPCOMING BOOKS Navigating Life with Migraine and Other Headaches William B. Young, MD, FAHS, FAAN, and Stephen D. Silberstein, MD, FACP, FAHS, FAAN
New Edition Navigating Life with Parkinson’s Disease •
AANnews • May 2017
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AANnews • May 2017
QUIETING MS Quietly for your patients with relapsing MS
*AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.1,2
INDICATION AUBAGIO® (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY • Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for 6 months after starting AUBAGIO. If drug-induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or activated charcoal. AUBAGIO is contraindicated in patients with severe hepatic impairment. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposure lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant. Please see additional Important Safety Information and Brief Summary of Full Prescribing Information, including boxed WARNING, on the following pages.
THINK BEYOND RELAPSES IN THE MANAGEMENT OF RMS
MAKE AN IMPACT ON DISABILITY PROGRESSION NOW TRE
IMPORTANT SAFETY INFORMATION (continued) CONTRAINDICATIONS • Patients with severe hepatic impairment. • Pregnant women and females of reproductive potential not using effective contraception. • Patients with a history of hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. • Co-administration with leflunomide. WARNINGS AND PRECAUTIONS • Hepatotoxicity: Patients with pre-existing acute or chronic liver disease, or those with serum ALT >2 times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. In clinical trials, if ALT elevation was >3 times the ULN on 2 consecutive tests, patients discontinued AUBAGIO and underwent accelerated elimination. Consider additional monitoring if co-administering AUBAGIO with other potentially hepatotoxic drugs; monitor patients who develop symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine). • Teratogenicity: AUBAGIO may cause fetal harm when administered in pregnant women. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose of 14 mg/day. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception. Women who become pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy registry by calling 1-800-745-4447, option 2. • Procedure for Accelerated Elimination of Teriflunomide: Teriflunomide is eliminated slowly from the plasma—it takes an average of 8 months, or up to 2 years, to reach plasma concentrations <0.02 mcg/mL. Elimination may be accelerated by administration of cholestyramine or activated charcoal, but this may cause disease activity to return in patients who were responding to AUBAGIO.
Please see additional Important Safety Information and Brief Summary of Full Prescribing Information, including boxed WARNING regarding hepatotoxicity and use in pregnancy, on the following pages.
Start or switch to AUBAGIO (teriflunomide) 14 mg—the only oral DMT with a proven impact on disability progression in 2 Phase III trials ®
The majority of patients remained free from disability progression* with AUBAGIO 14 mg1
80 84 AN ESTIMATED
OVER 108 WEEKS (P =0.03)1†
OVER 108 WEEKS (P <0.05)1†
DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; RMS=relapsing forms of MS. *Disability progression was a secondary endpoint in TEMSO and TOWER.6,7 † Based on Kaplan-Meier estimates.1 TEMSO: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1088). Patients were randomized to receive AUBAGIO 14 mg (n=359), AUBAGIO 7 mg (n=366), or placebo (n=363) once daily for 108 weeks.6 TOWER: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1169). Patients were randomized to receive AUBAGIO 14 mg (n=372), AUBAGIO 7 mg (n=408), or placebo (n=389) once daily with results for up to 40 months of treatment.7
• The estimated proportion of patients with sustained disability progression: —TEMSO: 20.2%, 21.7%, and 27.3% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 —TOWER: 15.8%, 21.1%, and 19.7% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 • AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression versus placebo in either trial1 • Sustained disability progression was defined as at least a 1-point increase from baseline EDSS score ≤5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks1 • AUBAGIO 14 mg and 7 mg achieved a significant relative reduction in risk of relapse in TEMSO (31% for both doses; P<0.05) and TOWER (36% and 22%, respectively; P<0.05)1
• Bone Marrow Effects/Immunosuppression Potential/Infections: Decreases in white blood cell counts, mainly of neutrophils and lymphocytes, and platelets have been reported with AUBAGIO. Thrombocytopenia, including rare cases with platelet counts less than 50,000/mm3, has been reported in the postmarketing setting. Obtain a complete blood cell count within 6 months before starting treatment, with further monitoring based on signs and symptoms of bone marrow suppression. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe uncontrolled infections. Tuberculosis (TB) has been observed in clinical studies of AUBAGIO. Before starting treatment, screen patients for latent TB infection with a tuberculin test. Treatment in patients with acute or chronic infections should not be started until the infection(s) is resolved. Administration of live vaccines is not recommended. The risk of malignancy, particularly lymphoproliferative disorders, or infection may be increased with the use of some medications with immunosuppressive potential, including teriflunomide. • Hypersensitivity and Serious Skin Reactions: AUBAGIO can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including Stevens-Johnson syndrome and a fatal case of toxic epidermal necrolysis, have been reported with AUBAGIO. Very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms have also been reported with leflunomide. If a severe skin reaction develops with AUBAGIO, stop treatment and begin accelerated elimination. In such cases, patients should not be re-exposed to teriflunomide. • Peripheral Neuropathy: Peripheral neuropathy, including polyneuropathy and mononeuropathy, has been reported with AUBAGIO. Age >60 years, concomitant neurotoxic medications, and diabetes may increase the risk. If peripheral neuropathy is suspected, consider discontinuing treatment and performing accelerated elimination. • Increased Blood Pressure: Blood pressure increases and hypertension have occurred with AUBAGIO. Measure blood pressure at treatment initiation and manage any elevations during treatment. • Respiratory Effects: Interstitial lung disease (ILD), including acute interstitial pneumonitis, has been reported with AUBAGIO. ILD may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure. (continued on back)
MAKE AN IMPACT ON DISABILITY PROGRESSION—START OR SWITCH TO AUBAGIO 1
The only oral DMT with a proven impact on disability progression in 2 Phase III trials1,4,5 • An estimated 80% of patients in TEMSO and 84% of patients in TOWER remained free from disability progression over 108 weeks with AUBAGIO® (teriflunomide) 14 mg1 • AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression versus placebo in either trial1 • Sustained disability progression was defined as at least a 1-point increase from baseline EDSS score ≤5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks1
AUBAGIO kept a range of RMS patients free from relapse1 • AUBAGIO 14 mg and 7 mg achieved a significant relative reduction in risk of relapse in TEMSO (31% for both doses; P<0.05) and TOWER (36% and 22%, respectively; P<0.05)
One pill, once a day, taken with or without food1
• Health care professionals should run certain tests before prescribing AUBAGIO and should monitor patient liver enzyme levels monthly for the first 6 months
AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.1,2
IMPORTANT SAFETY INFORMATION (continued) Adverse Reactions: The most frequent adverse reactions (≥10% and ≥2% greater than placebo) with AUBAGIO 7 mg and 14 mg and placebo, respectively, were headache (18% and 16% vs 15%), ALT increased (13% and 15% vs 9%), diarrhea (13% and 14% vs 8%), alopecia (10% and 13% vs 5%), and nausea (8% and 11% vs 7%). Drug Interactions: Monitor patients when teriflunomide is coadministered with warfarin, or with drugs metabolized by CYP1A2, CYP2C8, substrates of OAT3 transporters, substrates of BCRP, or OATP1B1/1B3 transporters. Use in Specific Populations: Women who wish to become pregnant should discontinue AUBAGIO and undergo an accelerated elimination procedure. Use of effective contraception should be continued until plasma concentrations of teriflunomide are <0.02 mcg/mL. Nursing mothers should not use AUBAGIO. AUBAGIO is detected in human semen. To minimize any possible fetal risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue therapy and either undergo accelerated elimination or verify plasma teriflunomide concentration is <0.02 mcg/mL. Please see additional Important Safety Information on the previous pages and Brief Summary of Full Prescribing Information, including boxed WARNING regarding hepatotoxicity and use in pregnancy, on the following pages. References: 1. AUBAGIO (teriflunomide) [package insert]. Cambridge, MA: Genzyme Corporation; November 2016. 2. Data on file, Sanofi/Genzyme. Summary of safety HMR1726teriflunomide. December 5, 2013. 3. Ziemssen T, De Stefano N, Pia Sormani M, Van Wijmeersch B, Wiendl H, Kieseier BC. Optimizing therapy early in multiple sclerosis: An evidence-based view. Mult Scler Relat Disord. 2015;4(5):460-469. 4. Tecfidera (dimethyl fumarate) [package insert]. Cambridge, MA: Biogen Inc.; February 2016. 5. Gilenya (fingolimod) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2016. 6. O’Connor P, Wolinsky JS, Confavreux C, et al; for the TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. 7. Confavreux C, O’Connor P, Comi G, et al; for the TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247-256.
©2016 Genzyme Corporation. All rights reserved. AUBAGIO, Sanofi, and Genzyme registered in U.S. Patent and Trademark Office. GZUS.AUBA.15.01.0246(3) December 2016
AUBAGIO® (teriflunomide) tablets, for oral use
Brief Summary of Prescribing Information WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY • Hepatotoxicity Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3)]. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • Risk of Teratogenicity AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1), and Clinical Pharmacology (12.3) in the full prescribing information].
1 INDICATIONS AND USAGE AUBAGIO® is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 2 DOSAGE AND ADMINISTRATION The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food. Monitoring to assess safety • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. • Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4)]. • Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4)]. • Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential [see Warnings and Precautions (5.2)]. • Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see Warnings and Precautions (5.7)]. 4 CONTRAINDICATIONS AUBAGIO is contraindicated in/with: • Patients with severe hepatic impairment [see Warnings and Precautions (5.1)]. • Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm [see Warnings and Precautions (5.2 and 5.3) and Use in Specific Populations (8.1)]. • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. • Coadministration with leflunomide [see Clinical Pharmacology (12.3) in the full prescribing information]. 5 WARNINGS AND PRECAUTIONS 5.1 Hepatotoxicity Severe liver injury including fatal liver failure and dysfunction has been reported in some patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. In placebo-controlled trials, ALT greater than three times the ULN occurred in 61/1045 (5.8%) and 62/1002 (6.2%) of patients receiving AUBAGIO 7 mg and 14 mg, respectively, and 38/997 (3.8%) of patients receiving placebo, during the treatment period. These elevations occurred mostly within the first year of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, if ALT elevation was greater than three times the ULN on two consecutive tests, AUBAGIO was discontinued and patients underwent an accelerated elimi-
nation procedure [see Warnings and Precautions (5.3)]. Of the patients who underwent discontinuation and accelerated elimination in controlled trials, half returned to normal or near normal values within 2 months. One patient in the controlled trials developed ALT 32 times the ULN and jaundice 5 months after initiation of AUBAGIO 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure. AUBAGIO-induced liver injury in this patient could not be ruled out. Obtain serum transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO. Consider additional monitoring when AUBAGIO is given with other potentially hepatotoxic drugs. Consider discontinuing AUBAGIO if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on AUBAGIO therapy, particularly in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. If liver injury is suspected to be AUBAGIO-induced, discontinue AUBAGIO and start an accelerated elimination procedure [see Warnings and Precautions (5.3)] and monitor liver tests weekly until normalized. If AUBAGIO-induced liver injury is unlikely because some other probable cause has been found, resumption of AUBAGIO therapy may be considered. 5.2 Teratogenicity AUBAGIO may cause fetal harm when administered to a pregnant woman. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose (MHRD) of 14 mg/day [see Use in Specific Populations (8.1)]. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception [see Contraindications (4) and Warnings and Precautions (5.3)]. 5.3 Procedure for Accelerated Elimination of Teriflunomide Teriflunomide is eliminated slowly from the plasma [see Clinical Pharmacology (12.3) in the full prescribing information]. Without an accelerated elimination procedure, it takes on average 8 months to reach plasma concentrations less than 0.02 mg/L, although because of individual variations in drug clearance it may take as long as 2 years. An accelerated elimination procedure could be used at any time after discontinuation of AUBAGIO. Elimination can be accelerated by either of the following procedures: • Administration of cholestyramine 8 g every 8 hours for 11 days. If cholestyramine 8 g three times a day is not well tolerated, cholestyramine 4 g three times a day can be used. • Administration of 50 g oral activated charcoal powder every 12 hours for 11 days. If either elimination procedure is poorly tolerated, treatment days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly. At the end of 11 days, both regimens successfully accelerated teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations. Use of the accelerated elimination procedure may potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment. 5.4 Bone Marrow Effects/Immunosuppression Potential/Infections Bone Marrow Effects A mean decrease compared to baseline in white blood cell (WBC) count of approximately 15% (mainly neutrophils and lymphocytes) and in platelet count of approximately 10% was observed in placebo-controlled trials with 7 mg and 14 mg of AUBAGIO. The decrease in mean WBC count occurred during the first 6 weeks and WBC count remained low during treatment. In placebo-controlled studies, neutrophil count <1.5×109/L was observed in 12% and 16% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 7% of patients receiving placebo; lymphocyte count <0.8× 109/L was observed in 10% and 12% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 6% of patients receiving placebo. No cases of serious pancytopenia were reported in premarketing clinical trials of AUBAGIO but rare cases of pancytopenia and agranulocytosis have been reported in the postmarketing setting with leflunomide. A similar risk would be expected for AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Cases of thrombocytopenia with AUBAGIO, including rare cases with platelet counts less than 50,000/mm3, have been reported in the postmarketing setting. Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms suggestive of bone marrow suppression. Risk of Infection / Tuberculosis Screening Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved. If a patient develops a serious infection consider suspending treatment with AUBAGIO and using an accelerated elimination procedure. Reassess the benefits and risks prior to resumption of therapy. Instruct patients receiving AUBAGIO to report symptoms of infections to a physician. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections. Medications like AUBAGIO that have immunosuppression potential may cause patients to be more susceptible to infections, including opportunistic infections. In placebo-controlled studies of AUBAGIO, no overall increase in the risk of serious infections was observed with AUBAGIO 7 mg (2.2%) or 14 mg (2.7%) compared to placebo (2.2%). However, one fatal case of klebsiella pneumonia sepsis occurred in a patient taking AUBAGIO 14 mg for 1.7 years. Fatal infections have been reported in the postmarketing setting in patients receiving leflunomide, especially Pneumocystis jiroveci pneumonia and aspergillosis. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness which, in addition to rheumatoid disease, may predispose patients to infection. In clinical studies with AUBAGIO, cytomegalovirus hepatitis reactivation has been observed. In clinical studies with AUBAGIO, cases of tuberculosis have been observed. Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or with a blood test for mycobacterium tuberculosis infection. AUBAGIO has not been studied in patients with a positive tuberculosis screen, and the safety of AUBAGIO in individuals with latent tuberculosis infection is unknown. For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Vaccination No clinical data are available on the efficacy and safety of live vaccinations in patients taking AUBAGIO. Vaccination with live vaccines is not recommended. The long half-life of AUBAGIO should be considered when contemplating administration of a live vaccine after stopping AUBAGIO. Malignancy The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppressive medications. There is a potential for immunosuppression with AUBAGIO. No apparent increase in the incidence of malignancies and lymphoproliferative disorders was reported in the AUBAGIO clinical trials, but larger and longer-term studies would be needed to determine whether there is an increased risk of malignancy or lymphoproliferative disorders with AUBAGIO. 5.5 Hypersensitivity and Serious Skin Reactions AUBAGIO can cause anaphylaxis and severe allergic reactions [see Contraindications (4)]. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including cases of Stevens-Johnson syndrome (SJS) and a fatal case of toxic epidermal necrolysis (TEN), have been reported with AUBAGIO. In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Inform patients of the signs and symptoms of anaphylaxis and angioedema and signs and symptoms that may signal a serious skin reaction. Inform patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, or hepatic dysfunction) may be drug-related. Instruct patients to discontinue AUBAGIO and seek immediate medical care should these signs and symptoms occur. Discontinue AUBAGIO, unless the reactions are clearly not drug-related, and begin an accelerated elimination procedure immediately [see Warnings and Precautions (5.3)]. In such cases, patients should not be re-exposed to teriflunomide [see Contraindications (4)]. 5.6 Peripheral Neuropathy In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), occurred more frequently in patients taking AUBAGIO than in patients taking placebo. The incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.4% (13 patients) and 1.9% (17 patients) of patients receiving 7 mg and 14 mg of AUBAGIO, respectively, compared with 0.4% receiving placebo (4 patients). Treatment was discontinued in 0.7% (8 patients) with confirmed peripheral neuropathy (3 patients receiving AUBAGIO 7 mg and 5 patients receiving AUBAGIO 14 mg). Five of them recovered following treatment discontinuation. Not all cases of peripheral neuropathy resolved with continued treatment. Peripheral neuropathy also occurred in patients receiving leflunomide. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. If a patient taking AUBAGIO develops symptoms consistent with peripheral neuropathy, such as bilateral numbness or tingling of hands or feet, consider discontinuing AUBAGIO therapy and performing an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.7 Increased Blood Pressure In placebo-controlled studies, the mean change from baseline to the end of study in systolic blood pressure was +2.3 mmHg and +2.7 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.6 mmHg for placebo. The change from baseline in diastolic blood pressure was +1.4 mmHg and +1.9 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.3 mmHg for placebo. Hypertension was an adverse reaction in 3.1% and 4.3% of patients treated with 7 mg or 14 mg of AUBAGIO compared with 1.8% for placebo. Check blood pressure before start of AUBAGIO treatment and periodically thereafter. Elevated blood pressure should be appropriately managed during treatment with AUBAGIO. 5.8 Respiratory Effects Interstitial lung disease, including acute interstitial pneumonitis, has been reported with AUBAGIO in the postmarketing setting. Interstitial lung disease and worsening of pre-existing interstitial lung disease have been reported during treatment with leflunomide. Interstitial lung disease may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. New onset or worsening pulmonary symptoms, such as cough and dyspnea, with or without associated fever, may be a reason for discontinuation of therapy and for further investigation as appropriate. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.9 Concomitant Use with Immunosuppressive or Immunomodulating Therapies Coadministration with antineoplastic, or immunosuppressive therapies used for treatment of multiple sclerosis has not been evaluated. Safety studies in which AUBAGIO was concomitantly administered with other immune modulating therapies for up to one year (interferon beta, glatiramer acetate) did not reveal any specific safety concerns. The long term safety of these combinations in the treatment of multiple sclerosis has not been established. In any situation in which the decision is made to switch from AUBAGIO to another agent with a known potential for hematologic suppression, it would be prudent to monitor for hematologic toxicity, because there will be overlap of systemic exposure to both compounds. Use of an accelerated elimination procedure may decrease this risk, but may also potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment [see Warnings and Precautions (5.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1)] • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4)] • Hypersensitivity and Serious Skin Reactions [see Contraindications (4) and Warnings and Precautions (5.5)] • Peripheral Neuropathy [see Warnings and Precautions (5.6)] • Increased Blood Pressure [see Warnings and Precautions (5.7)]
AUBAGIO® (teriflunomide) tablets, for oral use • Respiratory Effects [see Warnings and Precautions (5.8)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years. Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively). Table 1. Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis AUBAGIO AUBAGIO 7 mg 14 mg Placebo Adverse Reaction (N=1045) (N=1002) (N=997) Headache 18% 16% 15% Increase in Alanine aminotransferase 13% 15% 9% Diarrhea 13% 14% 8% Alopecia 10% 13% 5% Nausea 8% 11% 7% Paresthesia 8% 9% 7% Arthralgia 8% 6% 5% Neutropenia 4% 6% 2% Hypertension 3% 4% 2% Cardiovascular Deaths Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2600 patients exposed to AUBAGIO in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between AUBAGIO and cardiovascular death has not been established. Acute Renal Failure In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1045 (0.8%) patients in the 7 mg AUBAGIO group and 6/1002 (0.6%) patients in the 14 mg AUBAGIO group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. AUBAGIO may cause acute uric acid nephropathy with transient acute renal failure because AUBAGIO increases renal uric acid clearance. Hypophosphatemia In clinical trials, 18% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of AUBAGIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see Warnings and Precautions (5.5)] • Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see Warnings and Precautions (5.5)] • Thrombocytopenia [see Warnings and Precautions (5.4)] • Interstitial lung disease [see Warnings and Precautions (5.8)] • Pancreatitis 7 DRUG INTERACTIONS Effect of AUBAGIO on CYP2C8 substrates Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on warfarin Coadministration of AUBAGIO with warfarin requires close monitoring of the international normalized ratio (INR) because AUBAGIO may decrease peak INR by approximately 25%. Effect of AUBAGIO on oral contraceptives AUBAGIO may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on CYP1A2 substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3) in the full prescribing information].
Effect of AUBAGIO on organic anion transporter 3 (OAT3) substrates Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking AUBAGIO, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on BCRP and organic anion transporting polypeptide B1 and B3 (OATP1B1/ 1B3) substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking AUBAGIO, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AUBAGIO during pregnancy. Healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2 Risk Summary AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data. Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of AUBAGIO during pregnancy. In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day [see Data]. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. The background risk of major birth defects and miscarriage in the indicated population is unknown. Clinical Considerations Women who wish to become pregnant should discontinue use of AUBAGIO and undergo an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L (0.02 mcg/mL). Effective contraception should be used until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Human plasma concentrations of teriflunomide less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryofetal risk [see Contraindications (4) and Warnings and Precautions (5.3)]. If the patient becomes pregnant while taking this drug, stop treatment with AUBAGIO, inform the patient of the potential risk to the fetus, and perform the accelerated drug elimination procedure to achieve plasma concentrations of less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) in the full prescribing information]. Refer the patient to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling [see Warnings and Precautions (5.2, 5.3)]. Data Animal Data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death were observed at doses not associated with maternal toxicity. Adverse effects on embryofetal development were observed following dosing at various stages throughout organogenesis. Maternal plasma exposure at the no-effect level (1.0 mg/kg/day) for embryofetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg /day). Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death at doses associated with minimal maternal toxicity. Maternal plasma exposure at the no-effect dose (1.0 mg/kg/day) for embryofetal developmental toxicity in rabbits was less than that in humans at the MRHD. In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1.0 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high incidences of malformation (limb defects) and postnatal death were observed in the offspring at doses not associated with maternal toxicity. Maternal plasma exposure at the no-effect dose for pre- and postnatal developmental toxicity in rats (0.10 mg/kg/day) was less than that in humans at the MRHD. In animal reproduction studies of leflunomide, embryolethality and teratogenic effects were observed in pregnant rat and rabbit at or below clinically relevant plasma teriflunomide exposures (AUC). In published reproduction studies in pregnant mice, leflunomide was embryolethal and increased the incidence of malformations (craniofacial, axial skeletal, heart and great vessel). Supplementation with exogenous uridine reduced the teratogenic effects in pregnant mice, suggesting that the mode of action (inhibition of mitochondrial enzyme dihydroorotate dehydrogenase) is the same for therapeutic efficacy and developmental toxicity. At recommended doses in humans, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. 8.2 Lactation Risk Summary It is not known whether this drug is excreted in human milk. Teriflunomide was detected in rat milk following a single oral dose. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AUBAGIO and any potential adverse effects on the breastfed infant from AUBAGIO or from the underlying maternal condition.
AUBAGIO® (teriflunomide) tablets, for oral use 8.3 Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential. Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)]. Contraception Females Females of reproductive potential should use effective contraception while taking AUBAGIO. If AUBAGIO is discontinued, use of contraception should be continued until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL). Females of reproductive potential who wish to become pregnant should undergo an accelerated elimination procedure. Effective contraception should be used until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Males AUBAGIO is detected in human semen. Animal studies to specifically evaluate the risk of male-mediated fetal toxicity have not been conducted. To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue use of AUBAGIO and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Infertility Administration of teriflunomide to male rats resulted in no adverse effects on fertility. However, reduced epididymal sperm count was observed [see Nonclinical Toxicology (13.1) in the full prescribing information]. Effects of AUBAGIO on fertility in humans have not been evaluated. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AUBAGIO did not include patients over 65 years old. 8.6 Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. The pharmacokinetics of teriflunomide in severe hepatic impairment have not been evaluated. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3) in the full prescribing information]. 8.7 Renal Impairment No dosage adjustment is necessary for patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. 10 OVERDOSAGE There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects. In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3)].
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The Goals and Priorities for My Term as President The goal of the grant is to increase the number of medical students entering neurology by 25 percent over three years. We also need to increase the diversity of our neurology workforce and leadership to more adequately address health care disparities. The AAN will also continue to invest in leadership training through our Leadership University across a variety of constituents. At the same time, we will continue to enhance the multi-disciplinary neurology patient care team of tomorrow, building on our successful campaign to bring advanced practice providers into our membership so they can improve their skills and working relationships with neurologists and provide high-quality patient care. They are essential to helping to meet the future neurological care demands. Moreover, our advocacy team will continue its efforts to increase patient access through innovative technologies including reducing the barriers to teleneurology.
Enhancing Value and Quality of Neurologic Care One of the AAN’s largest and most ambitious undertakings has been the Axon Registry®, which successfully completed its pilot phase last year. With nearly 1,000 providers from clinics and hospitals now participating, and more being added on a quarterly basis, the Axon Registry will move into phase two and evolve to an essential quality improvement tool. What has been classified as the learning health system, we need to harness the power of this registry to improve the lives of our patients. The registry makes it possible to harness and analyze patient data that neurologists can then use to measure, track and benchmark performance, share best practices and efficiencies, and improve the quality of care. The Axon Registry also provides members an easy way to submit quality data to the Centers for Medicare & Medicaid Services for quality reporting, and it is approved by the American Board of Psychiatry and Neurology as an MOC Part IV PIP Clinical Module activity. The AAN will continue to grow its quality improvement programs and neurologyspecific measurement sets.
Expanding Neurologic Research Understanding the complexity of the brain and the hundreds of disorders that can affect it requires a herculean research effort. While we had great success last year advocating for increases for the National Institutes of Health, the 21st Century Cures Act, and the BRAIN Initiative, those efforts are endangered as Congress wrestles with drastic cuts in the new administration’s proposed budget. We will fight those cuts, working in tandem with other associations when suitable. We must unify the many voices of neurology and speak loudly to continue the investment in neurological research. Our annual Neurology on the Hill will continue to be a highlight, but our members must be willing to advocate daily for causes that are important to our profession and patients. We will continue to leverage the power of our political action committee BrainPAC to access members of Congress and educate them on our issues.
The AAN continues to support the growth of the American Brain Foundation with a mission of bringing researchers and donors together to defeat brain disease. We have and will continue to invest our own funds into the best and brightest among our colleagues to develop the Clinical Research Training Scholars and our new Translational Research awards. We need to accelerate cures for neurological disorders and more rapidly translate advances in research from the bench to the bedside.
Expand the Scope of Neurology Practice to Enhance Brain Health Across the Lifespan Over the last decade, we have made many strides in our mission to treat and prevent neurological disorders. The time is right for us to more effectively expand the scope of neurology practice to include interventional, preventative, and regenerative neurology. The “new neurologist” of the 21st century has many more opportunities to improve the health of individual patients, those at-risk, and take a leading role in caring for populations. We need to inspire young people to enter the field to intervene, treat, and prevent neurologic disease. This neurologist should be equipped with cures for stroke and epilepsy; the ability to modify disease with interventions like deep brain stimulation for Parkinson’s; and use of early aggressive treatments that could prevent advancement of such progressive diseases like Alzheimer’s disease and multiple sclerosis. And we must emphasize regeneration and recovery following intervention, so our patients can resume a life as normal as is possible. We must promote preventive neurology that may help keep chronic, debilitating diseases like stroke, traumatic brain injury, migraine, Alzheimer’s and Parkinson’s at bay. The new neurologist would care for those who are “at-risk” of neurological conditions across the lifespan. If we can detect conditions earlier, we may be able to modify transitions from wellness to illness, delaying the disease and even compressing morbidity. Our role should emphasize successful aging, quality of life, and maintenance of brain health. This is an ambitious platform, but I believe our reach should always exceed our grasp. I will revisit these topics as we make progress over the next two years. Your input is always welcome and you can feel free to email me at the address below with your thoughts and concerns. We can only advance as a profession if we work together, openly communicate, and take control of our future. I look forward to working with you, the countless colleagues that volunteer in leadership capacities, and our terrific AAN staff to strengthen our profession and the value that we provide to our patients. •
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN firstname.lastname@example.org
AANnews • May 2017
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AAN Publishes Guideline on SUDEP Incidence Rates and Risks The AAN’s “Practice Guideline: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors” was published online in Neurology ® on April 24, 2017, and in print in Neurology on April 25, 2017. The guideline was co-developed with the American Epilepsy Society and endorsed by the International Child Neurology Association. Sudden unexpected death in epilepsy Cynthia L. Harden, MD (SUDEP) is an uncommon but known complication of epilepsy. SUDEP is the sudden, unexpected death of a person with epilepsy who is otherwise healthy. There is evidence that SUDEP is rare in children. Each year, 1 in 4,500 children with epilepsy will die of SUDEP. In adults, 1 in 1,000 with epilepsy will die each year of SUDEP. The cause of death in SUDEP is unknown, but evidence does indicate certain risk factors. The occurrence of generalized tonic-clonic seizures (GTCS) is the most important risk factor for SUDEP. The greater the frequency of GTCS, the greater the risk of SUDEP. “Clinicians should counsel patients accurately on the incidence rates of SUDEP in different populations and address treatment of generalized tonic-clonic seizures to reduce the risk of SUDEP in patients with epilepsy,” said lead guideline author Cynthia L. Harden, MD. “For persons with epilepsy who continue to experience GTCS, clinicians should continue to actively manage epilepsy therapies to potentially reduce seizures, while incorporating patient preferences and weighing the risks and benefits of any new approach. Other risk factors with less strong evidence for their effect on SUDEP occurrence are covered in the guideline and can inform a more detailed discussion between the patient and the treating clinician.”
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Read the guideline and access PDF summaries for clinicians and patients, and a slide presentation set on AAN.com. For more information, contact Jon Dittman at email@example.com or (612) 928-6056. • Summary of Practice Guideline for Clinicians
Practice Guideline: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors
This is a summary of the American Academy of Neurology (AAN) and American Epilepsy Society (AES) practice guideline, “Sudden unexpected death in epilepsy incidence rates and risk factors,” which was published in Neurology ® online on April 24, 2017, and in the April 25, 2017, print issue.
PleaseGuideline refer to the guideline AAN.com/guidelines for more information, including descriptions of the processes for classifying AAN Summary of Practice for full Patients and at their Families evidence, deriving conclusions, and making recommendations.
Sudden Unexpected Death in Epilepsy Incidence is the incidence rate of SUDEP in different epilepsy populations? Rates and RiskWhat Factors Rationale systematic review found that the [sudden death in epilepsy] SUDEP This information sheet is provided to help you understand the evidenceOur regarding the number of occurrences and riskunexpected factors for sudden unexpected death inrisk in children with epilepsy is 0.22/1,000 patient-years (95% CI 0.16–0.31). The (AAN). SUDEP risk increases in adults to 1.2/1,000 patient-years (95% CI 0.64–2.32). There is considerable uncertainty regarding the estimates of epilepsy (SUDEP). This document is a service of the American Academy of Neurology the adult risk. The AAN is the world’s largest association of neurologists and neuroscience professionals. Neurologists are doctors who identify and treat diseases of the brain and nervous system. The AAN is dedicated to promoting the highest quality care.prefer to be informed of the individual’s risk for a catastrophic event such as SUDEP, even when the probability of Peoplepatient-centered with epilepsy andneurologic their families e39 This preference is subject to cultural influences. After beingisinformed thereviewed event is low. Experts from the AAN and the American Epilepsy Society (AES) carefully the available scientific studies on SUDEP. The following information based on of an adverse event, people commonly overestimate the risk of e40 unduly increases anxiety related to an adverse event. Overestimation can be lessened by adverse event happening evidence from those studies and other key information. The informationthat summarizes the main findings to of them. the 2017Such AANoverestimation and AES guideline on SUDEP. presenting the risk as the probability of both having and not having the event,e41 and by using numbers in addition to wordse40 and frequencies rather than To read the full guideline, visit AAN.com/guidelines. percentages to convey the risk.e42
What is the incidence of SUDEP in childhood?
Sudden unexpected death in epilepsy (SUDEP) is a poorly understood and catastrophic risk of epilepsy. The sensitive nature this infrequent but important risk the children’s parents or guardians that: Clinicians caring for of children with epilepsy should inform with patients and families prompted the need for evidence-based information about SUDEP. The goal of•this practice guideline to examine how often SUDEP There is a rare risk ofisSUDEP Level B occurs and what factors increase the risk of SUDEP. • In 1 year, SUDEP typically affects 1 in 4,500 children with epilepsy; in other words, annually, 4,499 of 4,500 children will not be affected by SUDEP What is SUDEP? SUDEP is an uncommon but known complication of epilepsy. SUDEP is the sudden, unexpected death of a person with epilepsy who is otherwise healthy. The What is the incidence of SUDEP in childhood? cause of death in SUDEP is unknown, but evidence discussed below does indicate certain risk factors. Clinicians should inform their adult persons with epilepsy that How often does SUDEP happen each year? • There is a small risk of SUDEP Occurrence rate in children Level B • In 1 year, SUDEP typically affects 1 in 1,000 adults with epilepsy; in other words, annually, 999 of 1,000 adults SUDEP is rare in children. Each year, 1 in 4,500 children with epilepsy will die of SUDEP. will not be affected by SUDEP Occurrence rate in adults SUDEP is uncommon in adults. Each year, 1 in 1,000 adults with epilepsy will die of SUDEP.
What are the risk factors for SUDEP?
Are there any risk factors for SUDEP?
Generalized tonic-clonic seizures (GTCS) Generalized tonic-clonic seizures The occurrence of generalized tonic-clonic seizures (GTCS), is a risk factor for SUDEP. GTCS is a type of seizure that involves the entire body with convulsions Rationale and loss of consciousness. The greater the frequency of GTCS, the greater the risk of SUDEP. Reducing the number of GTCSs (e.g., with effective treatment), may reduce the risk of SUDEP. Seizure freedom from GTCS is strongly associated with a decreased SUDEP risk. Our systematic review found that a major risk factor for SUDEP is the presence and frequency of [generalized tonic-clonic seizures] GTCS. For example, Other risks people with 3 or more GTCS per year have a 15-fold increased risk of SUDEP. This relative risk increase translates to an absolute risk of up to 18 deaths Other risks with low evidence exist and should be discussed in more detail with patient-years your treating e20 clinician. for people with frequent GTCS. per 1,000
The Society large SUDEP increaseby from coupled with epilepsy monitoring unit evidence demonstrating that a GTCS was always the precipitating event This guideline was co-developed with the American Epilepsy andrisk endorsed theGTCS, International Child Neurology Association. of SUDEP, strongly suggests that GTCS are not just associated with SUDEP but, rather, are in the causal path to SUDEP. From this, it seems reasonable to e43
infer that improved control of an individual’s GTCS will result in a reduced risk of SUDEP. Thus, a reduction in SUDEP risk is an additional benefit to the many benefits resulting from improved seizure control. As with all benefits associated with improved seizure control, the potential benefit of SUDEP risk reduction needs to be balanced with the risks and burdens associated with antiseizure therapies. Recommendation Level B
For persons with epilepsy who continue to experience GTCS, clinicians should continue to actively manage epilepsy therapies to reduce seizure occurrences and the risk of SUDEP while incorporating patient preferences and weighing the risks and benefits of any new approach.
©2017 American of Neurology This statement is provided as an educational service of the American Academy of Neurology. It is based on anAcademy assessment of current scientific and clinical information. It is not intended to include all possible proper methods of care for a particular neurologic problem or all legitimate criteria for choosing to use a specific procedure. Neither is it intended to exclude any reasonable alternative methodologies. The AAN recognizes that specific patient care decisions are the prerogative of the patient and the physician caring for the patient, based on all of the circumstances involved.
The AAN develops these summaries as educational tools for neurologists, patients, family members, caregivers, and the public. You may download and retain a single copy for your personal use. Please contact firstname.lastname@example.org to learn about options for sharing this content beyond your personal use.
American Academy of Neurology, 201 Chicago Avenue, Minneapolis, MN 55415 Copies of this summary and additional companion tools are available at AAN.com or through AAN Member Services at (800) 879-1960. ©2017 American Academy of Neurology
AANnews • May 2017
CME & MOC
Continuum Audio Series Examines Systemic Disease Neurologic complications from systemic disease are reviewed in the latest Continuum® Audio series. “Neurologists are often asked to consult on patients with neurologic complications of systemic disease,” said Ralph F. Józefowicz, MD, FAAN, associate editor and host of the Systemic Disease issue. “This Continuum Audio issue will cover the most important neurologic complications of systemic disorders seen by neurologists in practice. Specific topics include neurologic complications of cardiac disease, endocrine disorders, gastrointestinal and liver diseases, renal diseases, hematologic disorders and rheumatologic and immunologic disorders. Special consideration will be given to the neurology of transplantation, nutritional deficiency, and physical and environmental injuries.” The first two hours of the series are currently available; the second two hours will be available in June.
Neurologic Complications of Cardiac Disease and Aortic Disease / James P. Klaas, MD
Neurologic Complications of Lymphoma, Leukemia, and Paraproteinemias / Michelle L. Mauermann, MD, FAAN
Environmental Neurologic Injuries / Rodolfo Savica, MD, PhD
Renal Disease and Neurology / Sara E. Hocker, MD
Endocrine Emergencies with Neurologic Manifestations / Makoto Ishii, MD, PhD
Safety Considerations During Transitions of Care from Inpatient to Outpatient Settings / Marcus Ponce de Leon, MD, FAAN
Continuum Audio is a biweekly audio CME program based on discussions with the authors of articles published in Continuum: Lifelong Learning in Neurology ®, the official CME journal of the AAN. Continuum Audio is available in multiple formats, including apps for iOS and Android devices. This program may be used to meet self-assessment and CME requirements for maintenance of certification as mandated by the American Board of Psychiatry and Neurology. To learn more and subscribe, visit Audio-digest.org/Continuum. •
Gastroenterology and Neurology / Ronald F. Pfeiffer, MD, FAAN Liver Disease and Neurology / Alireza Minagar, MD, FAAN Nutrients and Neurology / Neeraj Kumar, MD
Hour 3: Rheumatology and Neurology / Elliot L. Dimberg, MD, FAAN Autoimmune Neurology of the Central Nervous System / W. Oliver Tobin, MBBCh, BAO, PhD Neurologic Complications of Transplantation / Amy A. Pruitt, MD
Ralph F. Józefowicz, MD, FAAN
AANnews • May 2017
NeuroLearn Editor-in-Chief Position: Call for Applications May 30 Deadline Online applications are open for a NeuroLearnSM editor-in-chief. The position will be responsible for leading and advising on program strategy, innovation, and content for the AAN’s suite of exclusive online education courses designed to address relevant clinical and practice topics.
The initial one-year appointment begins July 2017. “Serving as editor for NeuroLearn has been one of the highlights of my career,” said current Editor-in-Chief A. Gordon Smith, MD, FAAN. “Working closely with experts in eLearning design, AAN instructional designers, and neurology faculty we have created an extremely valuable and innovate online learning tool for practicing neurologists, residents and fellows.” Visit AAN.com/view/NeuroLearn for a detailed position description and desired qualifications, and to apply by the May 30 deadline. •
Seeking Applications for New NeuroSAE Editor-in-Chief June 30 Deadline
Join Neurology’s Global Conversation! Connect with neurologists and neuroscience professionals in your area of interest. Get started at AAN.com/Synapse
The AAN is currently accepting applications for a newly created editor-in-chief position for NeuroSAE®, the AAN’s popular online self-assessment program designed to help neurologists meet the American Board of Psychiatry and Neurology (ABPN) self-assessment and lifelong learning component (Part 2) for Maintenance of Certification (MOC). The editor-in-chief position will have an initial appointment term of one year, beginning August 2017. The selected candidate will be responsible for leading and advising on program direction and content, as well as on updates or changes to current content. For a detailed position description, desired qualifications, and to apply, visit AAN.com/view/NeuroSAE. The deadline to apply is June 30. •
AANnews • May 2017
CME & MOC
Reminder: May 8 Is Deadline to Submit Online Evaluations for Annual Meeting CME May 8 is the deadline to submit your evaluation forms to receive CME for the 2017 Annual Meeting. Forms may be completed online at AAN.com/view/CME or through the Annual Meeting mobile app at AAN.com/view/app. •
Subspecialty Fellowship Training Program Accreditation Applications Due June 1 Neurologic subspecialty fellowship training programs may apply to accredit their programs through the United Council for Neurologic Subspecialties (UCNS). Accredited programs are those which have demonstrated they meet specific peer-reviewed program quality standards. There are currently 176 UCNS-accredited training programs in the UCNS-recognized subspecialty areas including Autonomic Disorders, Behavioral Neurology & Neuropsychiatry, Clinical Neuromuscular Pathology Geriatric Medicine, Headache Medicine, Neurocritical Care, Neural Repair and Rehabilitation, Neuroimaging, and Neuro-oncology. All accredited programs are listed in the UCNS Fellowship Directory at UCNS.org/apps/directory. Training program applications must be submitted by June 1, 2017, through the online Accreditation Interface at http://tools.ucns.org/ai/request/accreditationrequest.
AANnews • May 2017
For more information, visit UCNS.org or contact Amanda Carpenter at (612) 928-6065 or email@example.com. The United Council for Neurologic Subspecialties is a nonprofit medical organization that accredits neurologic subspecialty training programs and awards certification to physicians who demonstrate their knowledge in these subspecialties with the goal of enhancing the quality of training for physicians and the quality of patient care. •
EARN up to
July 14 –16 • Jacksonville, FL
Your Ticket for the Latest in Diagnosis, Treatment, and Prevention July 14-16
Learn about the latest science and research advances in the rapidly evolving field of sports concussion!
Register Now! AAN.com/view/ConcussionConference
AANnews • May 2017
June 5 Application Deadline Approaching for Valuable Leadership Programs Today’s challenging health care environment creates a special need for great leadership, and the AAN is committed to helping its members expand their leadership potential and building the next generation of neurology leaders. The June 5 application deadline is quickly approaching for these intensive programs: Transforming Leaders Program
NEW! Women Leading in Neurology
NEW! Live Well, Lead Well Program
An elite, 10-month leadership training program for US member neurologists who are 10 or more years out of residency. Lean more and apply at AAN.com/view/TL.
A 10-month program for US female AAN member neurologists 10 or more years out of neurology training. Learn more and apply at AAN.com/view/WL.
A nine-month program designed for US neurologists to learn how to cultivate well-being and resilience in their lives, increase engagement at work, and develop strong, lasting leadership skills. Learn more and apply at AAN.com/view/LWLW. •
New Leadership Program Designed to Empower Neurologists, Reduce and Prevent Burnout Continued from cover Live Well, Lead Well: A Well-being and Resiliency Program for Neurologists will kick off the weekend of September 8 through 10, 2017, in Minneapolis, MN, and offer a unique and powerful opportunity for participants to: nn Understand burnout in neurology at the individual,
work-unit, and national levels
nn Identify and implement strategies to promote personal
well-being and resiliency-related improvement in the culture of one’s local organization, clinic, or institution
nn Create a network of support to share ideas about
promoting engagement in neurology
“As neurologists, we deal with diseases that are extremely complex, and most of these disorders are chronic and severely debilitating,” said Neil A. Busis, MD, FAAN, co-chair of the AAN’s Neurologist Burnout Taskforce. “At the same time, we are faced with excessive workloads, loss of autonomy, clerical burden, and inadequate support staff—issues that are associated with the high prevalence of burnout and low rates of satisfaction with career and work-life integration.” The program is open to all US AAN member neurologists from resident through late career. Up to 18 applicants will be selected, and over the nine-month duration be expected to: nn Develop and implement a project that will increase
well-being and resilience in their respective workplaces
nn Share an outline of their proposed project as part of the
nn Team up with two other participants and a neurologist
coach, who will provide project-related guidance and hold the participants accountable for completing their project
Live Well 28
AANnews • May 2017
nn Take part in: §§ Weekend immersion §§ In-person half-day session during
the 2018 AAN Annual Meeting
§§ Scheduled teleconferences
The application deadline is June 5, 2017. Visit AAN.com/view/LWLW for more information and to apply. •
AAN.com/careers Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added.
Maine Central Maine Medical Group is seeking a BE/BC neurologist to join an established adult neurology practice primarily associated with Central Maine Medical Center. A focused interest in stroke, muscle disease, headache/migraine, epilepsy, or movement disorder would be a welcome addition, but is not required. Our diagnostic capabilities include: 1.5 T MRI, CT angio, EMG, Evoked Potentials, EEG, and 24-72 Hour Ambulatory EEG. We also have an active Teleneurology service that is affiliated with Massachusetts General Hospital. Central Maine Medical Center is the flagship hospital of Central Maine Healthcare. The medical center has 250 inpatient beds and offers a broad range of services that include, among many, neurosurgery, a Level II trauma center, cardiovascular medicine, vascular and cardiac surgery, and medical and radiation oncology. The Central Maine Medical Group comprises of approximately 350 providers, approximately half of which are in primary care. The group delivers care across almost 2500 square miles at numerous outpatient sites and four hospitals. A competitive salary and attractive benefits package are enhanced by the scenic beauty and abundant outdoor adventure found in Maine. Interested candidates, please send CV to Gina Mallozzi, Central Maine Medical Center, 300 Main Street, Lewiston, ME 04240. Fax: (207) 795-5696, email: MallozGi@cmhc.org, or call: (800) 445-7431. Not a J1 Opportunity. Neuroscience Institute at Mercy Health—St Vincent Medical Center in Toledo, Ohio Seeking Neurohospitalists Mercy Health northern Ohio (Toledo Ohio) market is a seven-hospital market and a preferred provider of healthcare services for a 20-county area in Northwest Ohio and Southeast Michigan. As a faith-based healthcare system, Mercy Health continues to honor its long-standing Mission to extend the healing ministry of Jesus by improving the health of our communities, with an emphasis on the underserved. Mercy demonstrates behaviors reflecting its core values of compassion, excellence, human dignity, justice, service, and sacredness of life. Mercy Health based in Cincinnati, the largest healthcare system in Ohio and ranked nationally in the top 20% of health systems for clinical quality and efficiency. As the only Joint Commission Designated Comprehensive Stroke Center within Mercy Health, St. Vincent Medical Center provides an excellent opportunity for an energetic Neurologist to work with the Neuroscience Institute team led by Osama O. Zaidat, MD, MS. Our Services: Dedicated team of employed neurosurgeons with experience in the full aspects of neurosurgical care and procedures including clipping and hemi-craniotomy for large hemispheric strokes and intracranial bleeds. Dedicated Endovascular Neurosurgery service provided by two experienced full time interventional and stroke neurologists. Great support, relationship and interaction with Pulmonary and surgical/trauma critical care teams with moving toward 24/7 block models. Tele-NeuroICU robot in the neurocritical care unit for 24/7 communication via your smart device. Dedicated Neocritical Care nurse practitioners. Academic pursuit with resident’s rotation from emergency medicine, preliminary medicine, family practice, internal medicine and surgical residents and fellows. 24 hours EEG monitoring. Video EEG monitoring. 24/7 TCD transcranial ultrasound. Clinical research infra-structure support. EPIC electronic medical record with access on your smart device. Mercy Health is a recognized leader in providing quality, cost-effective healthcare and is a regional leader in collaboration with other community organizations to meet community needs. Mercy is a preferred provider in the majority of health insurance plans, we actively work to control healthcare costs through managed care contracts and insurance initiatives. We offer highly competitive compensation, with excellent sign-on bonuses and starting salaries, plus unparalleled benefits. A culturally prosperous city, Toledo is home to a nationally renowned art museum and zoo, the Toledo Symphony, as well as the newly renovated Valentine Theater. The community is home to the Toledo Mud Hens, the Triple A affiliate of the Detroit Tigers. The Mud Hens play in their downtown stadium, Fifth Third Field, which was named as one of the top minor league baseball stadiums in the country. Toledo also offers an ECHL hockey team, NCAA sports at the University of Toledo, and an annual LPGA golf tournament. Nature and outdoor enthusiast enjoy the close proximity to Lake Erie. Outstanding schools coupled with affordable housing give northwest Ohio families a great lifestyle. Toledo boasts of having 33 colleges and universities within a 60-mile radius, including a medical
college within the metro area. Additionally, Ann Arbor, Chicago, Cleveland, Columbus and Detroit are all within a short driving distance. Inquiries, including curriculum vitae should be addressed to: Tom Leeds, Director Medical Staff Recruitment, Mercy Health Partners, 2200 Jefferson Avenue, Toledo, Ohio 43604, or via email firstname.lastname@example.org. mercyweb.org Neurologist Androscoggin Valley Hospital is seeking a full-time (4 days/week) Neurologist to join our team in beautiful Northern NH. Employed by the hospital. Salaried position with the opportunity to earn up to an additional $15,000 annually in good citizenship incentives. a productivity inventive plan is also available. Generous vacation, CME funds, retirement account, and other benefits provided. 4 patient days and 1 administrative day per week. Usual mix: stroke, headache, dementia, seizure disorders, gait disturbance, tremor, multiple sclerosis, Parkinson’s disease, carpal tunnel syndrome, back pain with radiculopathy, neurovascular disease. Integrated ambulatory and hospital EMR with CPOE and voice recognition/templates. Relationships with multiple tertiary care facilities, including Dartmouth Hitchcock Medical Center [DHMC ] (Lebanon, NH), Catholic Medical Center [CMC ] (Manchester, NH), or Maine Medical Center [MMC ] (Portland, ME). NCS/EMG studies and the interpretation of NCS, EMG, and EEG studies. Email email@example.com Neurologist Androscoggin Valley Hospital is seeking a full-time (4 days/week) Neurologist to join our team in beautiful Northern NH. Employed by the hospital. Salaried position with the opportunity to earn up to an additional $15,000 annually in good citizenship incentives. a productivity inventive plan is also available. Generous vacation, CME funds, retirement account, and other benefits provided. 4 patient days and 1 administrative day per week. Usual mix: stroke, headache, dementia, seizure disorders, gait disturbance, tremor, multiple sclerosis, Parkinson’s disease, carpal tunnel syndrome, back pain with radiculopathy, neurovascular disease. Integrated ambulatory and hospital EMR with CPOE and voice recognition/templates. Relationships with multiple tertiary care facilities, including Dartmouth Hitchcock Medical Center [DHMC ] (Lebanon, NH), Catholic Medical Center [CMC ] (Manchester, NH), or Maine Medical Center [MMC ] (Portland, ME). NCS/EMG studies and the interpretation of NCS, EMG, and EEG studies. Email: firstname.lastname@example.org BC/BE Neurologist Mid Coast Medical Group is seeking a fulltime BC/BE Neurologist. Bring your own interests to join our four Neurologists specializing in multiple sclerosis, movement disorders, epilepsy and neuromuscular disorders. Call is a reasonable 1:4, with a Telestroke program for after-hours emergency stroke care. New graduates and experienced candidates are encouraged to apply. A department of Mid Coast Hospital, Mid Coast Medical Group provides high quality primary and specialty care with more than 100 providers. One of Maine’s newest full service hospitals, Mid Coast Hospital is a 93-bed modern facility with more than 200 providers on its active medical staff. Mid Coast is accredited by The Joint Commission, and is recognized as a Magnet™ facility by the American Nurses Credentialing Center for exceptional nursing and patient care. The hospital promotes a healing environment through the design, as well as its location on 150-acres of coastal Maine. Part of the Mid Coast–Parkview health family of services, Mid Coast Medical Group offers competitive benefits and compensation package, along with an excellent work environment. Please send CV to Melanie Crowe, Physician Recruiter, at mcrowe@midcoasthealth. com or call (207) 406-7872, for more information. Neurocritical Care Physicians New Orleans Ochsner Neuroscience Institute is actively recruiting two Neurocritical Care Specialists to join our growing department and practice at Ochsner Medical Center in New Orleans, Louisiana. Candidates must be BC/ BE in Anesthesiology or Neurology with fellowship training in Neurocritical Care. Subspecialty interest in vascular neurology can be accommodated. Practice in a collegial, patient-focused, and academic environment in a state-of-the-art unit with 30 neurological beds. Academic appointments are available at any of our affiliated institutions, including Tulane, LSU, and the University of Queensland. Both newly trained and experienced physicians are encouraged to apply. Ochsner Health System
Neurocritical Care physicians are part of a comprehensive team of physicians trained in both anesthesiology and neurology, and work closely with the departments of anesthesiology, neurology, and neurosurgery. Ochsner’s TeleStroke Program has become one of the fastest growing networks in the country with 30 active spoke hospitals. Ochsner Health System is Louisiana’s largest non-profit, academic, healthcare system with 30 owned, managed and affiliated hospitals and more than 60 health centers. Ochsner employs 17,000 employees and over 1,000 physicians in over 90 medical specialties and subspecialties, and conducts more than 600 clinical research studies. Ochsner is the only Louisiana hospital recognized by U.S. News & World Report as a “Best Hospital” across three specialty categories caring for patients from all 50 states and more than 80 countries worldwide each year. For more information, please visitwww.ochsner.org. Please email CV email@example.com or call (800) 488-2240. Ref. # NCC-2. Sorry, no J1 visa opportunities. Ochsner is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, disability status, protected veteran status, or any other characteristic protected by law. General Neurologist-Focus on Headache,General Neurologist, Neurohospitalist, Acute Inpatient Neurorehabilitation PMR, Neurobehavioralist, Neurobehavioralist with focus on Dementia We are a private practice multispecialty group in North San Diego County consisting of Twenty physicians practicing in a number of different disciplines. Our practice includes multiple fellowship trained and boarded subspecialists with expertise in neurophysiology, epilepsy monitoring, sleep medicine, headache medicine, stroke care, neuro-rehabilitation, neuropsychology and psychiatry. We have a sleep lab and four offices in the region. We practice at Scripps Memorial Hospital Encinitas-Acute Inpatient Rehab, Scripps Memorial Hospital in La Jolla, California, Palomar Pomerado Hospital in Escondido and Poway California, as well as Tri City Medical Center in Oceanside, California. We have affiliations with all the major health systems in San Diego including Scripps, UCSD, Sharp and Kaiser. This practice has been in existence since 1977 and is well positioned in the community to provide neurological services. Most partners have academic appointments at UCSD as volunteer faculty. We have a busy clinical trials practice. Our practice has grown out of a desire to combine the benefits of private practice with elements of research and academics. Our desire is to attract several BC/ BE, highly qualified, energetic and motivated physicians for our Multidisciplinary Neurology practice as we continue to grow. We are recruiting for the following positions: Neurohospitalist, Acute Inpatient General Physical Medicine and Rehabilitation specialist, General neurologist and Neurologist with focus on Headache/ Migraine as well as a Neurobehavioralist and a Neurobehavioralist with focus on Dementia. There is partnership opportunity. Our practice has had Electronic Health Records for many years, we are Joint Commission accredited you can visit our website at www. neurocenter.com. Please email CV directly to vtibbs@neurocenter. com Subject line should read: CV, your name and the position you wish you apply for. I.e. CV, John Smith MD, Acute Inpatient PM&R.
AANnews® Classified Advertising he AAN offers a complete package of print, online, T and in-person recruitment advertising opportunities. Visit AAN.com/careers for all AAN options, rates, and deadlines. d copy for the July 2017 print edition of AANnews A must be submitted by June 1, 2017. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
AANnews • May 2017
New Crowdfunding Platform for Research Launches The American Brain Foundation has launched a new online neuroscience research crowdfunding platform that allows members of the public to search for and give money to research projects addressing brain diseases. “Any neuroscience research project that contributes to the American Brain Foundation’s mission of curing brain disease is eligible for listing on the crowdfunding platform,” said Robert C. Griggs, MD, FAAN, chair of the Research Advisory Committee that developed guidelines for researcher applications and for the scientific review of applications. “We will accept a wide range of project proposals from basic neuroscience research to clinical trials.” All proposals will be reviewed by a scientific committee and must have Internal Review Board or Institutional Animal Care and Use Committee approval or exemption before posting on the site. The maximum amount that can be requested in a single campaign is $100,000. However, Griggs noted that information from other organizations’ charitable crowdfunding efforts indicates that campaigns in the $50,000 range are most likely to be fully funded.
AANnews • May 2017
Robert C. Griggs, MD, FAAN
Applications for inclusion on the site are accepted on a rolling basis. To apply, researchers must submit a letter of inquiry online. There is no charge for submitting a letter of inquiry. If the letter of inquiry is accepted, there is a $100 application fee to submit a full proposal. Projects will be posted on the crowdfunding platform for 90 days. If the project is not fully funded in 90 days, the project can be extended in 30-day increments until it is funded, with approval from the Research Advisory Committee and the investigator. Once the project is fully funded, funds will be transferred to the researcher’s institution, earmarked for the project. The platform is part of the American Brain Foundation’s new strategic plan to reach out to the public for support. The American Brain Foundation, which was founded in 1992 as the charitable arm of the AAN, has invested more than $20 million in funding for clinical research in its quest to find cures for brain and nervous system diseases affecting nearly 50 million Americans. For more information about the new crowdfunding platform, visit AmericanBrainFoundation.org or contact Suzi Sherman at grants@AmericanBrainFoundation.org or (612) 928-6315. •
Dates and Deadlines SUN
MAY 2017 WED
JUNE 2017 WED
JULY 2017 WED
Webinar: Coding for Risk: How It Impacts Payment (Register by May 1) AAN.com/view/pmw17
Deadline: UCNS Accreditation UCNS.org
Application Deadline: Emerging Leaders AAN.com/view/ELP
Application Deadline: Transforming Leaders AAN.com/view/TLP
Deadline: Neurology Compensation and Productivity Survey AAN.com/view/benchmark
Application Deadline: Women Leading In Neurology AAN.com/view/WLN
Application Deadline: NeuroLearnSM Editor-in-Chief AAN.com/view/NeuroLearn
Application Deadline: Live Well, Lead Well AAN.com/view/LWLW
SAVE THE DATES OCTOBER 20–22, 2017 Fall Conference The Cosmopolitan of Las Vegas AAN.com/view/17FC
JULY 14–16 Sports Concussion Conference Jacksonville, FL AAN.com/view/ConcussionConference
JULY 17 Application Deadline: UCNS Neurocritical Care Certification and Recertification UCNS.org/go/subspecialty/neurocritical/ certification
Webinar: Break the Code, or It Will Break Your Practice: Coding for Neurodiagnostic Procedures (Register by June 5) AAN.com/view/pmw17
JUNE 15 Early Registration Deadline: Sports Concussion Conference AAN.com/view/ConcussionConference
JUNE 30 Application Deadline: NeuroSAE® Editor-in-Chief AAN.com/view/NeuroSAE
Find Your Next Job AAN.com/careers
Fill Your Open Job The hottest jobs meet the top candidates at the AAN Neurology Career Center.
AANnews® Classified Advertising T he AAN offers a complete package of print, online, and in-person recruitment advertising opportunities. Visit AAN.com/careers for all AAN options, rates, and deadlines.
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d copy for the IssMonth+2 20XX print edition of A AANnews must be submitted by IssMonth+1 1, 20XX. The same deadline applies to changes/ cancellations.
he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
Migraine is a common and debilitating neurological disease.1-3 Uncover its true impact on the lives of patients, and see how the neuropeptide CGRP can play a key role in migraine’s complex pathophysiology. 2,4-9 References: 1. Barbanti P, Aurilia C, Egeo G, Fofi L. Future trends in drugs for migraine prophylaxis. Neurol Sci. 2012;33(suppl 1):S137-S140. 2. Edmeads J, Findlay H, Tugwell P, Pryse-Phillips W, Nelson RF, Murray TJ. Impact of migraine and tension-type headache on life-style, consulting behaviour, and medication use: a Canadian population survey. Can J Neurol Sci. 1993;20:131-137. 3. Munakata J, Hazard E, Serrano D, et al. Economic burden of transformed migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2009;49:498-508. 4. Lipton RB, Bigal ME, Diamond M, et al; for AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007;68:343-349. 5. Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States. Arch Intern Med. 1999;159:813-818. 6. Buse DC, Rupnow MFT, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422-435. 7. Russo AF. Calcitonin gene-related peptide (CGRP): a new target for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552. 8. Russell FA, King R, Smillie S-J, Kodji X, Brain SD. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014;94:1099-1142. 9. Goadsby PJ, Edvinsson L, Ekman R. Release of vasoactive peptides in the extracerebral circulation of humans and the cat during activation of the trigeminovascular system. Ann Neurol. 1988;23:193-196.
Learn more about the impact of migraine and the science behind it at
Neuroscience © 2016 Amgen Inc. All rights reserved. USA-334-033602
Published on May 3, 2017