VOLUME 33 · ISSUE 9 · September 2021
Visit AAN.com/Covid19 for the latest pandemic information and resources to support you and your crucial work.
2022 ANNUAL MEETING ABSTRACT SUBMISSIONS OPEN THIS MONTH The 2022 Annual Meeting is kicking off with a call for abstracts and you’re invited to submit your breakthrough research for the opportunity to present in-person and receive feedback from your neurology peers from around the world! Abstract submission opens in early September and runs until October 11. Submissions will be accepted in all subspecialties and career levels. The submission fee is $100 for AAN members, $200 for nonmembers, and free for residents and medical students. Learn more and submit at AAN.com/22Abstracts, or contact science@aan.com for questions.
April 2 –7 • Seattle In-person and Virtual
October 1 Application Deadline Nears: 2022 AAN Research Program The AAN is committed to supporting researchers—because when you make a profound difference in the lives of researchers, you ultimately make a profound difference in the lives of patients with brain disease. Valuable funding opportunities are now available through the 2022 American Academy of Neurology Research Program, and the application deadline is fast approaching.
OCTOBER
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Check out New Aducanumab Resources Page
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AAN Updates COVID-19 Vaccination Position Statement Recently, the AAN issued the following updated position statement on COVID-19 vaccination as the delta variant compels us to once again rethink how we keep ourselves, our communities, and our patients safe. Continued on page 15
12 CMS Proposes Regulatory Changes
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and Updates Physician Payment System
28 Applications Now Open for 2022 AAN Awards
Thank you to the supporters of the 2020–2021 Leadership Program “These programs provide unique opportunities to build critical leadership skills at a time when we are facing an increased demand for great leaders in today’s challenging health care environment. The AAN sincerely thanks the supporters who help make these programs possible.” ~Terrence L. Cascino, MD, FAAN Chair, Leadership Development Committee
Advocate—$100,000 to $249,999
Benefactor—$50,000 to $99,999
Associate—$25,000 to $49,999 The Allergan Foundation Amgen
Genentech, a member of the Roche group Greenwich BioSciences
Lundbeck Novartis Pharmaceuticals
Friend—$10,000 to $24,999 Adamas Pharmaceuticals, Inc.
Alnylam Pharmaceuticals, Inc.
Eisai, Inc.
Alexion Pharmaceuticals, Inc.
Bristol Myers Squibb
Supernus Pharmaceuticals Inc.
AANnews · September 2021
September Highlights The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction.
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The Vision of the AAN is to be indispensable to our members.
The new editor of Neurology ® Clinical Practice is Luca Bartolini, MD, and he will begin his 10-year term on October 1, 2021. His editorship follows the journal’s founding editor, John R. Corboy, MD, FAAN.
Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415
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Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
Bartolini Named New Editor of Neurology: Clinical Practice
AAN Advocating to Increase Neurology Workforce
memberservices@aan.com
Website: AAN.com
A recent report released by the Association of American Medical Colleges (AAMC) found the United States could see an estimated shortage of between 37,800 and 124,000 physicians by 2034.
For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone: (732) 778-2261
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Email: Eileen.Henry@wolterskluwer.com
Leadership Program Graduate Honored with National MS Society’s Woman of Spirit Award
Dina Jacobs, MD, is being honored this month with the Delaware Valley Chapter of the National MS Society’s Woman of Spirit award for the significant mark she’s made treating patients with MS.
AAN Chief Executive Officer: Mary E. Post, MBA, CAE
Editor-in-Chief: Melissa W. Ko, MD, FAAN, CPE Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com AANnews® is published monthly by the American Academy of Neurology for its 36,000 members worldwide. Access this magazine and other AAN publications online at AAN.com. 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.
News Briefs Media Coverage A Neurology® study about the possible role of flavonoids in slowing cognitive decline got hundreds of media mentions, including on CNN, The Daily Mail, and on TV stations around the country. Another study suggesting that activities like puzzles, reading, and writing letters may delay Alzheimer’s by five years was covered by The Washington Post, New York Post, and many other outlets. And a Sports Concussion Conference abstract about head impacts during soccer drills vs. soccer games was picked up by HealthDay and U.S. News & World Report.
Sports Concussion Conference The virtual 2021 Sports Concussion Conference drew more than 450 registered attendees, with strong engagement during live Q&A sessions. One new addition was the guided poster tour highlighting important research.
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AANnews • September 2021 3
PRESIDENT'S COLUMN Neurology in the Time of COVID-19 After 10 years of working at Consumer Reports, first as a medical advisor and later as medical director, I acquired advocacy in my blood. Campaigning on behalf of consumers to ensure access, safety, and equity in health was infinitely rewarding. So, when my division at Consumer Reports was sunsetted in 2018, and I began contemplating the next steps in my professional career, I was drawn to our mission-driven organization, the AAN, and the opportunity to serve in its leadership. For two decades, I had worked as a volunteer in the Medical Economics and Management Committee and witnessed firsthand how members could harness the power of their knowledge and experience to influence regulatory and legislative changes that preserved and enhanced the professional lives of our members and ensured quality care to our patients. My journey as an advocate is far from unique in our field. The more than 700 volunteers who work on AAN committees— not just Advocacy, but Education, Science, Quality, Medical Economics and Practice, and more—do so because they too have a desire to effect change. They ask not what others can do for them but what they can do for others. They rise up in crisis and meet it head on. They spend their free time on initiatives, programs, and efforts, together with staff, to enhance your career well-being and to promote the highest quality care for your patients. They take on issues such as fair reimbursement, administrative burdens like prior authorization and step therapy requirements, telemedicine, drug affordability, neurologic research dollars, and health care disparities, among others. Although every specialty has its advocates, in neurology, they are so dedicated, so tenacious, and so impactful that a tiny organization like ours is often recognized as the leader on national as well as local platforms. It came as no surprise that as the sudden and horrific appearance of COVID-19 shut down our practices, closed research labs, cancelled our educational and scientific meetings, and threatened our future, neurologists were at the forefront of advocacy. Health care disparities present in our society became increasingly glaring, so as the pandemic unfolded and later, as vaccines became available, a cadre of neurologists went to work. They created informational videos, spoke in their communities, gave vaccines, and answered countless questions from people with doubts. Kiran T. Thakur, MD, who is the Winifred Mercer Pitkin, MD, Assistant Professor in the department of neurology at Columbia University and inpatient neurologist and director of the program in neuroinfectious diseases, was concerned about the hospital's predominantly Latino community in Washington Heights and Inwood, which has been hit hard by the pandemic. When vaccines were offered at the Armory Track & Field Center, she joined others from New York-Presbyterian Hospital in administering them and lent her voice to the “Roll Up Your Sleeves New York” campaign by video. In her department, she pushed for routine vaccine histories so inpatients could get vaccinated prior to discharge, and she volunteered with others to receive professional training in effective dialogue methods to combat vaccine misinformation. Charles C. Flippen II, MD, FAAN, vice chair for education in the department of neurology at the David Geffen School of Medicine at UCLA, who joined the Los Angeles department of
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AANnews • September 2021
Avitzur
public health community ambassador program earlier this year, was recruited by his high school friend Kerry Neal, founder of KeepingIt100. The organization, which had held programs discussing relationship challenges within the Black community, pivoted to holding webinars about COVID-19 and vaccination hesitancy last summer. Dr. Flippen, who serves as treasurer for the AAN, answered questions about the vaccine along with other panelists, addressed the disparity in infection rates, and tried to motivate the audience to engage with their primary care physicians and adhere to public health guidelines. Los Angeles, which is currently undergoing another surge due to the delta variant, is in crisis. “We can’t stop trying because the stakes are too high and the responsibility for getting the word out is still there,” he explained. Omar A. Danoun, MD, a senior staff neurologist and epileptologist at Henry Ford Hospital in Detroit, took to social media to answer questions about the vaccine. He created a series of videos for YouTube in both Arabic and English covering vaccine designs and safety that have garnered over 300K views, and gives lectures to people in Detroit, which has large Black and Arab American communities, promoting vaccines. A PGY-3 at NYU Langone Medical Center when the pandemic hit, Amadou Camara, MD, contacted the Senegalese association in New York to ask if he could be of help. He took part in radio shows presenting updates on the status of COVID-19 and answered questions on prevention and treatment. More recently, he attended meetings to discuss the safety and efficacy of the vaccine by another association which gathered representatives of several West African countries, as dissenting opinions were voiced about whether the vaccine is permissible in Muslim and other communities. Now a clinical neurophysiology-EEG fellow at Duke University Medical Center in Durham, NC, Dr. Camara said, “I understand that representation matters, and that was my biggest factor in reaching out. I presented myself to them as a member of the health care community and spoke with them in our native language, which helped established good rapport.” Olajide A. Williams, MD, professor of neurology and associate dean of community research and engagement at Columbia University, is founder and board chair of Hip Hop Public Health, an organization that works with iconic hip-hop influencers and uses art, music, and science to promote healthy behaviors, health literacy, and health equity. “During the pandemic, mistrust in communities of color was energized by misinformation in social media,” he said. Striving to improve vaccine literacy,
he helped organize Community Immunity, a collection of five animated rap songs, with veteran producer Artie Green, singersongwriter Gerry Gunn, and hip-hop legend Darryl McDaniels, better known as DMC. A vaccinologist ensured the scientific accuracy of the lyrics and each verse addressed specific questions—what are vaccines; how do they work; are they safe; what to expect, and more. The results? Half a billion media impressions across the globe, including “PBS NewsHour,” “Entertainment Tonight,” and Vanity Fair. As variants continue to rise and cases of breakthrough infection become more prevalent, many of us are considering the
existential question of what it means to be a neurologist in the time of COVID. These five neurologists, and others like them, have already found the answer.
Orly Avitzur, MD, MBA, FAAN President, AAN oavitzur@aan.com @OrlyA on Twitter
BOARD SPOTLIGHT Meet Your New Board Member: Bruce Ovbiagele, MD, MSc, MAS, MBA, FAAN Bruce Ovbiagele, MD, MSc, MAS, MBA, FAAN, is professor of neurology and associate dean at the University of California, San Francisco as well as chief of staff at the San Francisco Veterans Affairs Health Care System. Prior to these roles, he served for six years as professor of neurology and chair of the department of neurology at the Medical University of South Carolina. His primary research involves the translation of evidence-based interventions into clinical practice and community settings, to improve stroke outcomes for underserved and vulnerable populations in the United States and around the world. How did you first get involved as a volunteer on committees/ subcommittees and what moved you to participate? All the academic neurologists I looked up to at my local institution, and nationally, were active volunteers and leaders in the AAN, and I noticed that they began their relationships with the AAN relatively early in their highly successful careers. I suspected that was not just a coincidence. I became a junior member in 1998 very early during my general neurology residency, joined the Stroke and Vascular Neurology Section in 2005, and then joined the Clinical Research Subcommittee in 2007. Beyond the aforementioned, I have been privileged so far to serve in a variety of roles—including being a member of the Minority Scholars Subcommittee and Education Committee. I was a Neurology on the Hill participant in 2008, Palatucci Advocacy Leadership Forum Fellow in 2009, and Minority Scholars Visiting Professor to Morehouse School of Medicine in 2011. I have directed stroke courses and health equity courses at the Annual Meeting and Fall Conference, been faculty chair/ guest editor for a Continuum® issue, an abstracts reviewer for the Annual Meeting, and a member of the Media Expert Panel. Why did you wish to be on the Board of Directors? It provides a profound opportunity to learn more and to serve our neurology community much better. It’s also a high-profile avenue with which to inspire underrepresented in medicine scholars in the US foreign medical graduates, and people of African ancestry generally.
Ovbiagele What experiences and viewpoints do you bring to this role? From a professional standpoint, I bring my medical organization leadership experiences from serving as chair of an academic neurology department, chief medical officer for a veterans’ affairs health care system, and associate dean of a medical school. I have scientific journal experience from serving as an editor on several medical journals in neurology and stroke, and research program leadership experience from overseeing several NIHfunded research programs. My academic conference leadership experience comes from directing several scientific conferences and educational courses. I have been involved in the professional pipeline building experience, from conceiving and implementing national career development programs to expanding diversity in neurology. My work in local and global health equity research and practice experience in stroke and vascular neurology should be of benefit as well. I also bring the perspective of someone who has received formal education in business and law. Finally, on a personal note, having originated from a low-income country, I have great interest in nurturing the careers of individuals who are underrepresented in medicine or come from underprivileged backgrounds.
In your view, how does the AAN benefit the field of neurology most? The Academy fosters an enduring professional network of highly motivated and capable volunteers committed to the optimal prevention and treatment of neurological diseases.
AANnews • September 2021 5
#NeurologyProud and proud to call the AAN my home. Share why you are #NeurologyProud on social media.
Christina Kelly Vest, NP
EVENTS There’s Still Time to Register for the APP Neurology Education Series Starting September 6 There’s still time to attend this year’s Advanced Practice Provider Neurology Education Series taking place September 6 through November 23. Visit AAN.com/APP to register, and consider purchasing Gold Registration to extend access to content, including Q&As. This is the perfect opportunity for advanced practice providers looking for the latest overviews, updates, and resources on a variety of core topics in both the clinical and business side of neurology, up to 12 CME, and excellent networking opportunities—all in a convenient, online format accessible anywhere there’s an internet connection. The series includes all new content covering clinical updates on a variety of topics such as mild cognitive impairment, anatomy, and neuroimaging as well as APP productivity. While programming was designed by neurologists and APPs specifically for APPs, the series is also relevant to students and trainees looking to deepen their understanding of neurology. Registered attendees will receive weekly emails with resources and access to that week’s course. Six of the talks will feature a live Q&A component, giving attendees the opportunity to network and ask questions of the speakers in real time. Course topics and presenters include:
AAN Advanced Practice Provider Neurology Education Series 2021 A Virtual Experience
Neurological Exam (LIVE) Calli Leighann Cook, DNP, FNP-C, FAANP Neuromyelitis Optica Spectrum Disorders Bryan D. Walker, PA Neeta Garg, MD Mild Cognitive Impairment/Common Dementias (LIVE) Vijay K. Ramanan, MD, PhD Laura Andelman Allen Clinical Anatomy/Localization (LIVE) Jaffar Khan, MD, FAAN Neuro-ophthalmology: Diplopia Suma Shah, MD Neuromuscular Disorders: Myopathies and Motor Neuron Disease Ericka P. Greene, MD, FAAN Margaret Naclerio, PA APP Productivity: The Business of APPs (LIVE) David A. Evans, MBA Evaluation of TIA/Ischemic Stroke and Secondary Prevention (LIVE) Andrew Mebane Southerland, MD Jessica Erfan, PA-C Dizziness Jaffar Khan, MD, FAAN Neuroimaging: Spine Ryan Hakimi, DO Movement Disorders: Tremor Shannon Donovan Anderson, PA
Look What Past Participants Are Saying! Love this! All neurology APPs should see these lectures. So helpful.” I wish I had this training years ago. Makes it look simple. Basics matter.”
Additionally, the AAN’s Consortium of Neurology Advanced Practice Providers will host a special networking session for APPs at 4:00 p.m. ET on Wednesday, September 22. Celia McIntosh, DNP, and Amber Ebert, PysD, will lead a discussion on APP Burnout/Sustaining a Career in Neurology, which will focus on how to balance the unique professional and personal demands of a neurology APP.
Peripheral Neuropathy (LIVE) Michelle L. Mauermann, MD, FAAN
AANnews • September 2021 7
PRACTICE AAN Continues Aducanumab Advocacy Efforts The AAN continues its multi-pronged work efforts in addressing aducanumab concerns, including the approval process and drug efficacy, as well as addressing burdens such as costs to the health care system and patients. Visit AAN.com/aducanumab for more details about the following highlights.
AAN Advocacy The AAN submitted comments in August on CMS’s plans for a national coverage determination (NCD) for monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease, addressing important health outcomes for the treatments, characteristics of patients, and issues of equity and inclusion. The AAN joined the American Geriatrics Society and the Society for Nuclear Medicine and Molecular Imaging in calling for the immediate retirement by CMS of its NCD limiting coverage of beta amyloid PET to CMS-approved clinical trials. Brian Callaghan, MD, MS, FAAN, spoke on behalf of the AAN at the July meeting by the Institute for Clinical and Economic Review about its recently released evidence report “Aducanumab for Alzheimer’s Disease: Effectiveness and Value.” In his comments, Callaghan emphasized the challenges faced by neurologists in prescribing given the uncertainties surrounding efficacy and the lack of racial and ethnic diversity in the clinical trials.
Payer Perspectives The AAN has held several meetings with national payers such as UHC, Anthem, and Humana. Discussions with payers have been productive, with payers asking questions about who should receive this drug. They have also requested information on which patient populations should be eligible and what
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modalities should be used for determining amyloid-beta positivity. Other areas of interest for payers are when to stop aducanumab, monitoring for ARIA, and care coordination. The AAN continues to monitor announcements of payers' decisions in relation to coverage for aducanumab.
Member Tools and Resources The Aducanumab Resource Center webpage on AAN.com/ aducanumab continues to be updated as new tools and resources become available. You can read the full comment letters sent to CMS, the ICER report, and AAN comments provided by Callaghan on this resource center. The recording of the August 16 webinar featuring AAN members answering questions about their practices' protocols for aducanumab is featured on this resource page. New resources are being produced and placed on the website as soon as they are available. Members are encouraged to check back often for updates and contact practice@aan.com with any questions.
Use New Concussion Quality Measures to Improve Outcomes
Use Updated Parkinson’s Disease Measure Set to Improve Outcomes
The AAN published “Quality Improvement in Neurology: Concussion Quality Measurement Set” on July 28, 2021, in the online issue of Neurology ® at n.Neurology.org. The measurement set is scheduled to appear in the print edition on September 14.
The AAN has published “Quality Improvement in Neurology: 2020 Parkinson Disease Quality Measurement Set Update” in the August 2, 2021, issue of Neurology at n.Neurology.org. This is an update of the 2015 Parkinson’s disease measurement set.
Three measures were created for the management of concussion: concussion symptoms evaluation, appropriate neurological exam, and documentation of a return to play strategy or protocol.
Nine measures have been retained and updated, and one new measure―Assessment of Impulse Control Disorders― was created. Two measures were retired and replaced with existing cross-cutting measures on these topics: Fall Rate and Advanced Care Planning.
The measures will be reviewed every three years to monitor implementation efforts.
The measures will be reviewed in six months to monitor implementation efforts.
View the executive summary and the full measure set and tools at AAN.com/ConcussionMeasures.
View the executive summary and the full measure set and tools at AAN.com/MDMeasures.
AANnews • September 2021
New Tools Help Monitor Patients with MS, Parkinson’s, Concussion The AAN recently released three quality measurement sets for patients with multiple sclerosis, Parkinson’s disease, and concussion. Quality measures are intended to help drive quality improvement in practice. Physicians, neurology providers, and care teams may find it helpful to implement one or two of these measures to drive improved outcomes for patients. The new and updated measures use patient reported outcome measure (PROM) tools and scales to assist in monitoring outcomes for your patients. Collecting PROM data can occur during the visit with a treatment team member or can be collected in advance of the visit to help the treatment team better plan for an upcoming visit. Implementation of PROM data can help better define patient outcomes over time. The multiple sclerosis and Parkinson’s disease quality measurement set updates include multiple measures that use PROM collection to monitor adherence to guideline recommended treatment. For example, there is a new measure that calculates the percentage of patients with multiple sclerosis who were screened for cognitive impairment in the past 12 months and if screening positive, patient was referred appropriately for further evaluation and management. The measure requires screening via a standardized tool: Brief International Assessment of Cognition for MS (BICAMS) Symbol Digit, Modalities Test (SDMT) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) Computerized Speed Cognitive Test (CST) Processing Speed Test (PST) Verbal fluency, Paced Auditory Serial Addition Test (PASAT) Roa Brief Repeatable Neuropsychological Battery (BRNB) Minimal Assessment of Cognitive Function in MS (MACFIMS) PROMIS® (Patient-Reported Outcomes Measurement Information System) Montreal Cognitive Assessment (MoCA) The Parkinson’s disease quality measurement update includes a similar measure that captures the percentage of patients who were assessed for cognitive impairment or dysfunction once in the past 12 months with a similar list of recommended tools. A practice may opt to implement and collect PROMIS data for both patient populations to capture cognitive impairment screening uniformly across patient populations. The practice can then use this data to capture two quality improvement measures: one for multiple sclerosis and one for Parkinson’s disease. The quality measures will provide an individual
PODCAST
benchmark of how many screenings were completed and the practice can use this benchmark to establish goals to improve upon in future years. Physicians and neurology providers can track individual patient data over time to determine if cognitive impairments are occurring to identify opportunities for earlier intervention. There may also be opportunity for practices to dive into their data to determine which interventions were most successful over time for their individual patients. Practices will want to evaluate which PROM will meet their patient and organizational goals. For example, the concussion quality measurement set includes as measure that assesses the percentage of patients five years and older diagnosed with concussion who had a symptom evaluation completed at their initial visit. The evaluation can be done using one of the currently approved tools: Child Sport Concussion Assessment Tool (Child-SCAT) Health and Behavior Inventory (HBI) Post-Concussion Symptom Inventory (PCSI) Post-Concussion Symptom Scale (PCSS) Rivermead Postconcussive Symptom Questionnaire A practice may opt to use the HBI as this PROM could be sent via patient portal for the patient to complete in advance of the visit. In comparison, practices may opt to use Child-SCAT to collect data from the patient or guardian which supplements the examination done during the initial evaluation. Opportunities to use PROM data will continue to grow over time. By initiating collection of PROM data now, practices will be better poised to understand individual patient trends and grow a data set that can help capture long-term outcomes for their patient populations. The new and updated measurement sets are available for free at AAN.com/policy-and-guidelines/quality.
Neurology ® Podcast:
20 Minutes Pack a Punch! Subscribe and download the latest podcast at Neurology.org/podcast
AANnews • September 2021 9
PRACTICE Take Advantage of Axon Registry Benefits One of the many ways the AAN is invested in your success is the Axon Registry ®, a clinical data registry that aims to improve patient care. The registry collects, reports, and analyzes patient electronic health record (EHR) data to identify gaps in care and provides a roadmap for neurologists on where they can improve. The Axon Registry is a free AAN member benefit with over 150 practices nationwide using over 30 EHRs, including Allscripts, Cerner, and EPIC. Over the last few years, the Axon Registry has integrated with large health systems and academic medical centers, providing accurate data that can be used for internal quality improvement projects, continuing certification credits, and the de-identified data will inform new treatments and therapies for neurologic disease. What can the Axon Registry do for institutions? Demonstrate value: Your data is evidence of your skills and can support higher reimbursement rates. Maximize financial potential: Use data to improve department inefficiencies and build on quality to provide the best possible patient care and maximize its financial potential. Deliver timely, accurate insights: Using neurology-specific data in the Axon Registry instead of generic, non-specialty specific measures provides better guidance to help your department improve patient outcomes and manage resources.
Join your colleagues in driving the quality-of-care conversation while sharing best practices to improve patient care. Participation in the Axon Registry allows you to collect realworld clinical data that helps you better negotiate higher reimbursement rates from private payers and CMS in riskbearing contracts. You will be able to participate and lead this important discussion on real clinical value vs. being told what metrics determine the best quality of care.
Increase your stature: Demonstrate the value of your neurology department within your organization so you can secure the resources needed to fund growth.
Take the first step to learn more about the Axon Registry today by visiting AAN.com or contacting the AAN registry staff at registry@aan.com for assistance and answers to your questions.
Axon Registry Quality Measure Performance Examined “Quality of Neurologic Care in the United States: Initial Report from the Axon Registry” was published in Neurology at n.Neurology.org on June 18, 2021. This cross-sectional assessment of quality measure performance in 2019 Axon Registry ® data demonstrates modest performance scores and considerable variability across measures and providers. More complex measures were associated with lower performance. These findings serve as a baseline assessment of quality of ambulatory neurologic care in the US and provide insights into future measure design.
Bartolini Named New Editor of Neurology: Clinical Practice The new editor of Neurology ® Clinical Practice is Luca Bartolini, MD, and he will begin his 10-year term on October 1, 2021. Bartolini is the second editor of Neurology: Clinical Practice since the journal first published in 2011. His editorship follows the journal’s founding editor, John R. Corboy, MD, FAAN. Bartolini has been a section editor for Neurology: Clinical Practice since 2015, editing the section he initiated, Practice Current: An Interactive Exchange on Controversial Topics, and its new subsection, Practice Buzz: Giving Voice to Neurology Professionals Worldwide.
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AANnews • September 2021
Bartolini is director of the Pediatric Epilepsy Program at Hasbro Children’s Hospital and assistant professor of pediatrics, assistant professor of neurology, and assistant professor of neurosurgery at the Warren Alpert Medical School of Brown University.
Bartolini
Academy Publications Honored Neurology Today® and Brain & Life® won editorial awards again this year in the recent APEX 2021 annual competition for publication excellence.
Neurology Today also won an Award of Excellence in the category, WritingRegular Departments & Columns, for the Society and Brain Section featuring articles on the impact of social determinants on brain health.
Brain & Life was awarded an Award of Excellence in the category, Feature Writing/ Profiles, for the story in the April/May 2020 issue, “Inside Nancy Ryder’s Battle with ALS: Friends Renée Zellweger and Courteney Cox help the Hollywood publicist in her fight against amyotrophic lateral sclerosis.”
more changes and challenges as neurologists face another surge of coVid-19 Page 10
the official ne ws source of the a merican academy of neurology | neurology today.com January 7, 2021 | Volume 21 | issue 1
what neurologists should Know about the 3 coVid-19 Vaccines richard robinson
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accines for COVID-19 are on the way, promising to surely, if only slowly, reduce the rates of infection and death from the world’s worst pandemic in a century. But questions remain, pending more publication of the results in peer-reviewed journal, about how long immunity will last and the best ways to distribute and administer the vaccine. Neurology Today spoke with three experts in neurovirology about what neurologists
Vaccines Are Safe and Effective Among the many vaccines being developed worldwide, three have announced early results that are highly promising; one or more may be available in the next
few months. The first and most important message from all three experts is that these three vaccines—from Pfizer, Moderna, and AstraZeneca—appear to be safe for neurology patients across the spectrum. “These are not vaccines made from a live or attenuated virus, and there is no evidence that I’ve seen that they will be contraindicated in any patient with a neurologic disorder,” said Joseph R. Berger, MD, FAAN, professor of neurology at the Hospital of the University of Pennsylvania. “We have immunized our patients for years, and we Continued on page 21
outpatient evaluation-and-management (E/M) codes significantly. Indeed, the Centers for Medicare & Medicaid Services (CMS) forecasts that payments across the neurology specialty will increase by 6 percent this year. “For those who are involved in cognitive work, like a lot of neurologists, this is a long overdue recognition for the work they do,” said Korwyn Williams, MD, PhD, FAAN, a pediatric epileptologist at Phoenix Children’s Hospital.
The increased reimbursement for E/M clinicians see reimbursement cuts for procodes, however, will come expense “We are supportive of efforts to — RatEthe NÉE Z E L LW Ecedures. GER of neurologists whose practices budget neutrality to offset cuts to A N Drely C Omore U R TE Nwaive E Y C OX heavily on EEG, EMG, and other proce- reimbursement for non-E/M services proO N By N Alaw, N Cthe I RY Dvided E R ’S that it would not result in a delay or dures than on E/M services. B AT E W ITH AinL S physician fee schedule must beTLbudgetany way undermine CMS’s decision to neutral, meaning that increased reim- fully implement the new E/M payment bursements for certain codes must be structure on January 1,” the AAN said in offset by decreases for others. its summary of the new fee schedule. The AAN, the American Medical Also new in 2021: CMS has created an Association (AMA) and others have been add-on code—G2211—to account for the Continued on page 19 trying to get Congress to intervene before additional
and their patients should know about the vaccines and how they may advise their patients about getting vaccinated. “The widespread availability and administration of the vaccines is going to be a game-changer,” said Kenneth L. Tyler, MD, FAAN, the Louise Baum endowed chair of neurology at University of Colorado School of Medicine. “The tunnel we are in is still long, but there is a light at the end.”
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We hope that by showing up, Nanci the medicare 2021 Physician fee schedule: the upshot for neurology e/m this year knows we love her.” lola butcher
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eurologists won big—higher pay rates, reduced documentation and recognition of the complexity of their work—in the federal government’s new fee schedule that went into effect January 1. The Medicare Physician Fee Schedule for 2021 raises the reimbursement for
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Neurology Today won the Grand Award, the highest award level, in the category, COVID-19 Media, for coverage of COVID-19 and neurology with more than 130 stories published from March 2020 through April 2021.
what you should Know about those Palliative noncompete Care clauses When Is It Page 12 Appropriate? PerIODICAlS
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Music Therapy A Choir for All Voices
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Take time for yourself. We can help with wellness resources to help you improve your physical, emotional, and mental health. Learn more at AAN.com/LiveWell
ADVOCACY CMS Proposes Regulatory Changes and Updates Physician Payment System Each year, the Centers for Medicare & Medicaid Services (CMS) proposes regulations that impact the reimbursement of physicians. On July 13, 2021, CMS issued a proposed rule updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule in 2022. The proposed rule illustrates the importance of the AAN’s regulatory advocacy efforts on behalf of neurologists and their patients. Despite a difficult economic year, CMS expects payments across the specialty of neurology to increase in 2022 by one percent with variations depending on the individual provider’s practice.
Evaluation and Management (E/M) Visits Like in previous years, CMS continues its ongoing review of E/M code sets. The AAN remains highly supportive of the new coding and payment structure implemented on January 1, 2021, and lauds the agency for moving forward with implementation. For 2022, the agency is making several proposals to align with the revised E/M visit codes guidelines that took effect January 1, 2021. CMS is proposing to refine its policies for split or shared E/M visits to reflect the evolving role of advanced practice providers (APP) and changes to the practice of medicine. For 2022, CMS proposes to define split or shared E/M visits as those provided in the facility setting by a physician and an APP in the same group and expands to include new patient encounters. Additionally, CMS is proposing updated definitions related to documenting care for split or shared visits, including what constitutes a substantive portion of the visit.
Telehealth Regulations As expected, the rule indicates that the telehealth services added to the Medicare telehealth services list under the temporary “category 3” during the COVID-19 public health emergency (PHE) be removed from the list after the PHE ends. These services will have to be submitted to be made permanent under either category 1 or 2. However, CMS acknowledges that there has not been sufficient time to collect the utilization data needed on these telehealth services for submission and approval. Therefore, CMS will retain all telehealth services added due to the PHE through calendar year 2023 so that they can be analyzed and submitted for the 2023 and 2024 fee schedules for permanent inclusion. This is a welcome
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AANnews • September 2021
decision by CMS as it gives providers a clear timeframe during which they can continue to utilize these temporarily approved telehealth services and allows for the much-needed study of these services for their potential permanent inclusion. CMS is also seeking comment on adjustments to the requirement for in-person visits that must currently be conducted by the provider delivering telehealth services in the six months preceding a telehealth visit. CMS is considering changing this requirement so that another physician in the same specialty and subspecialty and in the same practice may conduct this in-person visit if the original physician is unavailable. CMS is also considering either shortening or lengthening the allowable time period (e.g., every three months or every 12 months) if it is determined that this would neither present a prohibitively burdensome travel requirement for the patient nor be detrimental to the quality of care. The rule proposes to change the requirements of telehealth provision to permanently allow audio-only telehealth services for the diagnosis, evaluation, or treatment of mental health disorders when the patient’s home is the originating site. Only providers who are set up to provide full audio/visual telehealth services can make use of audio-only services; this is to ensure that it is the patient’s aversion or inability to utilize audio/ visual services that leads to an audio-only visit. CMS is seeking comment on what if any additional restrictions should be placed on the use of audio-only telehealth services.
Appropriate Use Criteria CMS is proposing to delay the beginning of the payment penalty phase of the Appropriate Use Criteria (AUC) program to no sooner than January 1, 2023, or the January 1 that follows the declared end of the COVID-19 public health emergency. The flexibilities offered by CMS are intended to consider the impact of COVID-19 on providers and their beneficiaries. The current payment penalty phase of the AUC program was to begin at the start of 2022. This is a welcomed change. We continue to advocate for modifications to the AUC program recognizing its potential burden on neurologists.
Quality Payment Program The rule includes proposed updates to the Quality Payment Program (QPP), which includes the Merit-based Incentive Payment System (MIPS), Advanced Alternative Payment Model (APM), and MIPS Value Pathways (MVPs). For the MIPS track, CMS is proposing to increase the 2022 performance threshold to 75 points from 60 points, as well as the exceptional performance bonus to 89 points from 85 points. For the Quality and Cost components, CMS proposes decreasing the weight of the MIPS Quality component to 30 percent from 40 percent and increasing the weight of the MIPS Cost component to 30 percent from 20 percent. There are minimal changes proposed for reporting the Improvement Activities and Promoting Interoperability components. CMS is proposing to remove several bonus point opportunities, including for reporting additional outcome and high priority measures, and for meeting end-to-end electronic reporting criteria. The rule also extends various flexibilities for QPP participants and specific eligible clinicians. CMS is proposing automatically reweighting the MIPS Promoting Interoperability performance category for all clinicians in small practices. Additionally, CMS is continuing its doubled bonus point opportunities to reward caring for complex patients during the COVID-19 public health emergency.
For the APM track, CMS proposes extending the CMS Web Interface reporting option through 2023, thus delaying the plan to sunset this reporting mechanism by one year.
MIPS Value Pathway The rule proposes seven MIPS Value Pathways (MVPs), a new track of the QPP that intends to offer more cohesive sets of MIPS measures and activities related to a specialty or condition. CMS proposes voluntary reporting for MVPs to begin in 2023. CMS is proposing an MVP titled "Cultivating Care for Positive Outcomes in Stroke Patients" which features measures and activities related to caring for stroke patients and may be relevant to some neurologists. The AAN actively engaged with CMS during the development process at CMS’s invitation and provided feedback reflected in the proposed MVP. In addition to foundational population health measures and Promoting Interoperability measures, the stroke MVP features nine quality measures and nine improvement activities to choose from and one cost measure relevant to stroke care. In the rule, CMS also proposes guidance on reporting requirements and scoring for MVPs. While CMS has not indicated when MVPs would become mandatory, CMS is seeking public comment on its aim to fully sunset traditional MIPS reporting for MVPs by 2027.
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ADVOCACY AAN Advocating on Increasing Neurology Workforce A recent report released by the Association of American Medical Colleges (AAMC) found the United States could see an estimated shortage of between 37,800 and 124,000 physicians by 2034. The AAN understands the importance of supporting a strong neurology workforce, as the population is aging and needing more neurologic care. The AAN is advocating for the following: The Resident Physician Reduction Shortage Act of 2021 (S. 834/H.R. 2256), to increase the number of graduate medical education (GME) slots by at least 2,000 per year over seven years (14,000 slots) for specialties facing shortages. The Conrad State 30 and Physician Access Reauthorization Act (S. 1810/H.R. 3541), to permanently authorize the Conrad 30 Program, which allows international doctors to stay in the US after their residency if they practice in an underserved area for three years. The Healthcare Workforce Resilience Act (S. 1024/H.R.2255), to support the COVID-19 response workforce by expediting visas for international medical graduates (IMGs) to enter the US for training and patient care and provide a pathway for IMGs and their families already in the US to obtain permanent residency status. The Dr. Lorna Breen Health Care Provider Protection Act (S. 610/H.R. 1667), to address the behavioral health and well-being of physicians, including depression, suicide, and burnout. The Resident Education Deferred Interest (REDI) Act (H.R. 4122), to allow interest-free deferment on student loans for borrowers serving in a medical or dental internship or residency program. Funding for the Pediatric Subspecialty Loan Repayment Program, to provide up to $35,000 annually for a maximum of three years to pediatric subspecialists who agree to practice in an underserved area. The AAN regularly collaborates with other medical societies, including the AAMC, on these issues. As a result of many years of collective physician workforce advocacy, Congress created 1,000 new GME positions in the December 2020 Consolidated Appropriations Act. This is the first increase in GME positions in nearly 25 years, and the AAN recently joined a letter led by AAMC to the Centers for Medicare & Medicaid Services providing input on the distribution of newly created residency positions.
Member’s Efforts Help Deter Restrictive Immigration Policy Academy members often are effective advocates as they understand the ramifications of proposed legislation or regulations. A case in point is Umer Najib, MD, FAHS, who worked against a 2020 draft proposal released by US Immigration and Customs Najib Enforcement (ICE) to eliminate “duration of status” as an authorized period of stay for certain classes of nonimmigrant visas, including J-1 visas, the visa used by foreign physicians who train in the US. If implemented, this policy would set a finite expiration date for the length of an authorized stay for affected nonimmigrant visas. Given that J-1 physicians play a critical role in the US health care system and in neurology, the AAN submitted comments strongly opposing this proposal to ICE and urged the agency not to move forward with implementation of the rule. “I feel strongly about this issue because J-1 physicians contribute significantly to the neurology workforce,” Najib said in a Capitol Hill Report last October. “In 2020, about 25 percent of the neurology residency positions were filled by highly qualified non-American international medical graduates.” Najib, who lives and works in West Virginia, collaborated with the AAN to set up meetings with his members of Congress. “We discussed the potential impact of this new policy on our state, which already has a significant shortage of neurologists. As a result of my meetings, Rep. David McKinley (R-WV-01), alongside Reps. Brad Schneider (D-IL-10) and Abby Finkenauer (D-IA-01), worked together to promote a sign-on letter from members of the US House of Representatives to the Department of Homeland Security expressing concern about this new policy.” Success came on July 6, 2021, as the Biden administration withdrew the previous administration’s proposed rule. "I am immensely thankful to the Academy for constantly monitoring the legislative and regulatory landscape, identifying relevant issues, and providing the members with training and tools to be effective health care advocates. This is a great example of successful advocacy and shows that our efforts can result in a meaningful policy change."
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AAN Releases Updated COVID-19 Vaccine Position Statement Recently, the AAN issued the following updated position statement on COVID-19 vaccination as the delta variant compels us to once again rethink how we keep ourselves, our communities, and our patients safe. The American Academy of Neurology has responded to the world’s disruption and recovery from the COVID-19 pandemic by providing resources and awareness for neurology providers; engaging in efforts to mitigate the long-term health and financial impacts on patients; and publishing research as new data emerge. The AAN continues to focus on the health and safety of neurology providers, neurology care teams, and patients. We now know that the vaccines provide increased protection against severe illness, hospitalization, and death if breakthrough infections occur and that nearly all mortality as of July 2021 is among the unvaccinated population. To that end, on July 30, 2021, the AAN signed onto a joint statement calling for all health care employers to mandate employees be vaccinated against the SARS-CoV-2 virus. Unless there are medical reasons, unvaccinated patients should be encouraged by all members of the health care team to get vaccinated to prevent illness, death, long-term effects, and further spread of COVID-19. Children with neurologic diseases are among the most vulnerable of populations. For children to safely engage with their families and in their communities, vaccinations for children under the age of 12 are needed. The AAN supports continued efforts to expedite regulatory approvals and deployment of COVID-19 vaccinations for children under the age
of 12 once clinical trial data support their use. In addition, it is imperative that those eligible become vaccinated to protect this vulnerable population. While current evidence suggests the COVID-19 vaccines are still effective, booster vaccinations may be needed if immunity wanes over time or does not protect against a new developing variant. When booster vaccinations are approved and available, the AAN will advocate for immediate administration to all eligible recipients, including those with compromised immune systems and health care providers who risk contracting and spreading COVID-19 to vulnerable populations. The American Academy of Neurology is the world's largest association of neurologists and neuroscience professionals, with 36,000 members. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, stroke, migraine, multiple sclerosis, concussion, Parkinson's disease, and epilepsy. AAN members should continue to visit the AAN’s COVID-19 Resource Center at AAN.com/covid19 for the very latest resources and information.
COVID-19 Vaccine Position Statement
AANnews • September 2021 15
Not actual patients.
INDICATION MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION Contraindications • Patients with a CYP2C9*3/*3 genotype • In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure • Presence of Mobitz type II second-degree, third-degree atrioventricular block, or sick sinus syndrome, unless patient has a functioning pacemaker Infections: MAYZENT may increase risk of infections with some that are serious in nature. Life-threatening and rare fatal infections have occurred. Before starting MAYZENT, review a recent complete blood count (CBC) (ie, within 6 months or after discontinuation of prior therapy). Delay initiation of treatment in patients with severe active infections until resolved. Employ effective treatments and monitor patients with symptoms of infection while on therapy. Consider discontinuing treatment if patient develops a serious infection. Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have occurred with MAYZENT. If CM is suspected, MAYZENT should be suspended until cryptococcal
infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. No cases of progressive multifocal leukoencephalopathy (PML) were reported in MAYZENT clinical trials; however, they have been observed in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator and other multiple sclerosis (MS) therapies. If PML is suspected, MAYZENT should be discontinued. Cases of herpes viral infection, including one case of reactivation of varicella zoster virus leading to varicella zoster meningitis, have been reported. Patients without a confirmed history of varicella zoster virus (VZV) or without vaccination should be tested for antibodies before starting MAYZENT. If VZV antibodies are not present or detected, then VZV immunization is recommended and MAYZENT should be initiated 4 weeks after vaccination. Use of live vaccines should be avoided while taking MAYZENT and for 4 weeks after stopping treatment. Caution should be used when combining treatment (ie, anti-neoplastic, immune-modulating, or immunosuppressive therapies) due to additive immune system effects. Macular Edema: In most cases, macular edema occurred within 4 months of therapy. Patients with history of uveitis or diabetes are at an increased risk. Before starting treatment, an ophthalmic evaluation of the fundus, including the macula, is recommended and at any time if there is a change in vision. The use of MAYZENT in patients with macular edema has not been evaluated; the potential risks and benefits to the individual patient should be considered.
FOR PATIENTS WITH FIRST SIGNS OF PROGRESSION IN RMS AND ACTIVE SPMS1
STAY AHEAD OF
PROGRESSION WITH ® MAYZENT (siponimod) MAYZENT IS
THE
THE FIRST AND ONLY
DUAL MOA
oral DMT studied and proven to delay disability progression in a more progressed RMS population, including active SPMS1,2*
targets S1P1,5—2 key receptors thought to play a role in RMS inflammation and neurodegeneration1,3-6
OF MAYZENT
WITH INTERIM EXPLORATORY DATA
UP TO 5 YEARS
from an open-label extension study aiming to evaluate long-term safety and tolerability, as well as efficacy measures; patients who completed the core part of the study either continued on MAYZENT or switched from placebo to MAYZENT7,8†‡
*Patients in EXPAND had a mean EDSS score of 5.4.8 †From a preplanned interim analysis of an open-label extension study.8 ‡6-month CDP, ARR, and SDMT were exploratory end points and assessments of efficacy measurements, respectively, in the EXPAND extension study.9
The mechanism by which siponimod exerts therapeutic effects on MS is unknown but may involve reduction of lymphocytes in the CNS.1 ARR=annualized relapse rate; CDP=confirmed disability progression; CNS=central nervous system; DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; MOA=mechanism of action; MS=multiple sclerosis; RMS=relapsing MS; S1P=sphingosine 1-phosphate; SDMT=Symbol Digit Modalities Test; SPMS=secondary progressive MS.
DISCOVER UP TO 5 YEARS OF INTERIM DATA AT
mayzenthcp.com
IMPORTANT SAFETY INFORMATION (CONT) Bradyarrhythmia and Atrioventricular Conduction Delays: Prior to initiation of MAYZENT, an ECG should be obtained to determine if preexisting cardiac conduction abnormalities are present. In all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reduce cardiac effects. MAYZENT was not studied in patients who had:
• In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, or decompensated heart failure requiring hospitalization • New York Heart Association Class II-IV heart failure • Cardiac conduction or rhythm disorders, including complete left bundle branch block, sinus arrest or sino-atrial block, symptomatic bradycardia, sick sinus
Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.
IMPORTANT SAFETY INFORMATION (CONT) Bradyarrhythmia and Atrioventricular Conduction monitored and managed appropriately. Delays (cont): Fetal Risk: Based on animal studies, MAYZENT may cause fetal harm. Women of childbearing syndrome, Mobitz type II second-degree AV-block or higher-grade AV-block (either history or observed potential should use effective contraception to avoid pregnancy during and for 10 days after stopping at screening), unless patient has a functioning MAYZENT therapy. pacemaker Posterior Reversible Encephalopathy Syndrome • Significant QT prolongation (QTc greater than (PRES): Rare cases of PRES have been reported in 500 msec) patients receiving a sphingosine 1-phosphate (S1P) • Arrhythmias requiring treatment with Class Ia or receptor modulator. Such events have not been Class III anti-arrhythmic drugs reported for patients treated with MAYZENT in clinical Reinitiation of treatment (initial dose titration, trials. If patients develop any unexpected neurological monitoring effects on heart rate and AV conduction or psychiatric symptoms, a prompt evaluation should [ie, ECG]) should apply if ≥4 consecutive daily doses be considered. If PRES is suspected, MAYZENT should are missed. be discontinued. Respiratory Effects: MAYZENT may cause a decline Unintended Additive Immunosuppressive Effects in pulmonary function. Spirometric evaluation of From Prior Treatment or After Stopping MAYZENT: respiratory function should be performed during When switching from drugs with prolonged immune therapy if clinically warranted. effects, the half-life and mode of action of these drugs Liver Injury: Elevation of transaminases may occur in must be considered to avoid unintended additive patients taking MAYZENT. Before starting treatment, immunosuppressive effects. obtain liver transaminase and bilirubin levels. Closely Initiating treatment with MAYZENT after treatment with monitor patients with severe hepatic impairment. Patients who develop symptoms suggestive of hepatic alemtuzumab is not recommended. After stopping MAYZENT therapy, siponimod dysfunction should have liver enzymes checked, and remains in the blood for up to 10 days. Starting MAYZENT should be discontinued if significant liver other therapies during this interval will result in injury is confirmed. concomitant exposure to siponimod. Cutaneous Malignancies: Long-term use of S1P Lymphocyte counts returned to the normal range in modulators, including MAYZENT, have been 90% of patients within 10 days of stopping therapy. associated with an increased risk of basal cell However, residual pharmacodynamic effects, such as carcinoma (BCC). Cases of other cutaneous lowering effects on peripheral lymphocyte count, may malignancies, including melanoma and squamous persist for up to 3-4 weeks after the last dose. Use of cell carcinoma, have also been reported in patients immunosuppressants within this period may lead to an treated with MAYZENT and in patients treated with additive effect on the immune system, and therefore, another S1P modulator. caution should be applied 3-4 weeks after the last Periodic skin examination is recommended. Monitor dose of MAYZENT. for suspicious skin lesions and promptly evaluate any Severe Increase in Disability After Stopping that are observed. Exposure to sunlight and ultraviolet MAYZENT: Severe exacerbation of disease, including light should be limited by wearing protective clothing disease rebound, has been rarely reported after and using a sunscreen with high protection factor. discontinuation of an S1P receptor modulator. The Concomitant phototherapy with UV-B radiation or possibility of severe exacerbation of disease should be PUVA-photochemotherapy is not recommended. considered after stopping MAYZENT treatment, thus Increased Blood Pressure: Increase in systolic and patients should be monitored upon discontinuation. diastolic pressure was observed about 1 month after Most Common Adverse Reactions: Most common initiation of treatment and persisted with continued adverse reactions (>10%) are headache, hypertension, treatment. During therapy, blood pressure should be and transaminase increases. Please see additional Important Safety Information on the previous pages and Brief Summary of full Prescribing Information on adjacent pages. References: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; January 2021. 2. Data on file. First and only progressing RMS treatment. Novartis Pharmaceuticals Corp; January 2020. 3. O’Sullivan C, Schubart A, Mir AK, Dev KK. The dual S1PR1/S1PR5 drug BAF312 (siponimod) attenuates demyelination in organotypic slice cultures. J Neuroinflammation. 2016;13:31. 4. Gergely P, Nuesslein-Hildesheim B, Guerini D, et al. The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate. Br J Pharmacol. 2012;167(5):1035-1037. 5. Mannioui A, Vauzanges Q, Fini JB, et al. The Xenopus tadpole: An in vivo model to screen drugs favoring remyelination. Mult Scler. 2018;24(11):1421-1432. 6. Choi JW, Chun J. Lysophospholipids and their receptors in the central nervous system. Biochim Biophys Acta. 2013;1831(1):20-32. 7. Data on file. Long-term Efficacy and Safety of Siponimod in Patients with SPMS: EXPAND Extension Analysis up to 5 Years. Novartis Pharmaceuticals Corp; May 2020. 8. Kappos L, Bar-Or A, Cree BAC, et al; for the EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263-1273. 9. Data on file. A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312. Novartis Pharmaceuticals Corp; July 2020.
MAYZENT and the MAYZENT logo are registered trademarks of Novartis AG.
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080
© 2021 Novartis
2/21
MZT-1400690
MAYZENT® (siponimod) tablets, for oral use Initial U.S. Approval: 2019 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. 4 CONTRAINDICATIONS MAYZENT is contraindicated in patients who have: • A CYP2C9*3/*3 genotype [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.5) in the full prescribing information] • In the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions (5.3)] 5 WARNINGS AND PRECAUTIONS 5.1 Infections Risk of Infections MAYZENT causes a dose-dependent reduction in peripheral lymphocyte count to 20% to 30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues. MAYZENT may therefore increase the risk of infections, some serious in nature [see Clinical Pharmacology (12.2) in the full prescribing information]. Life-threatening and rare fatal infections have occurred in association with MAYZENT. In Study 1 [see Clinical Studies (14) in the full prescribing information], the overall rate of infections was comparable between the MAYZENTtreated patients and those on placebo (49.0% vs. 49.1% respectively). However, herpes zoster, herpes infection, bronchitis, sinusitis, upper respiratory infection, and fungal skin infection were more common in MAYZENT-treated patients. In Study 1, serious infections occurred at a rate of 2.9% in MAYZENT-treated patients compared to 2.5% of patients receiving placebo. Before initiating treatment with MAYZENT, results from a recent CBC (i.e., within 6 months or after discontinuation of prior therapy) should be reviewed. Initiation of treatment with MAYZENT should be delayed in patients with severe active infection until resolution. Because residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3 to 4 weeks after discontinuation of MAYZENT, vigilance for infection should be continued throughout this period [see Warnings and Precautions (5.12)]. Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy. Suspension of treatment with MAYZENT should be considered if a patient develops a serious infection.
Cryptococcal Infections Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with another sphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have also occurred with MAYZENT. Physicians should be vigilant for clinical symptoms or signs of CM. Patients with symptoms or signs consistent with a cryptococcal infection should undergo prompt diagnostic evaluation and treatment. MAYZENT treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. Herpes Viral Infections Cases of herpes viral infection, including one case of reactivation of VZV infection leading to varicella zoster meningitis, have been reported in the development program of MAYZENT. In Study 1, the rate of herpetic infections was 4.6% in MAYZENT-treated patients compared to 3.0% of patients receiving placebo. In Study 1, an increase in the rate of herpes zoster infections was reported in 2.5% of MAYZENT-treated patients compared to 0.7% of patients receiving placebo. Patients without a healthcare professional confirmed history of varicella (chickenpox) or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating MAYZENT (see Vaccinations below). Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Typical symptoms associated with
PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. No cases of PML have been reported in MAYZENT-treated patients in the development program; however, PML has been reported in patients treated with an S1P receptor modulator and other multiple sclerosis (MS) therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or magnetic resonance imaging (MRI) findings that may be suggestive of PML. MRI findings may be apparent before clinical signs or symptoms. If PML is suspected, treatment with MAYZENT should be suspended until PML has been excluded. Prior and Concomitant Treatment with Anti-neoplastic, Immune-Modulating, or Immunosuppressive Therapies Anti-neoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should be coadministered with caution because of the risk of additive immune system effects during such therapy [see Drug Interactions (7.1)]. Vaccinations Patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating MAYZENT treatment. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with MAYZENT, following which initiation of treatment with MAYZENT should be postponed for 4 weeks to allow the full effect of vaccination to occur. The use of live attenuated vaccines should be avoided while patients are taking MAYZENT and for 4 weeks after stopping treatment [see Drug Interactions (7.1)]. Vaccinations may be less effective if administered during MAYZENT treatment. MAYZENT treatment discontinuation 1 week prior to and until 4 weeks after a planned vaccination is recommended. 5.2 Macular Edema Macular edema was reported in 1.8% of MAYZENT-treated patients compared to 0.2% of patients receiving placebo. The majority of cases occurred within the first four months of therapy. An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients before starting treatment and at any time if there is any change in vision while taking MAYZENT. Continuation of MAYZENT therapy in patients with macular edema has not been evaluated. A decision on whether or not MAYZENT should be discontinued needs to take into account the potential benefits and risks for the individual patient.
Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during MAYZENT therapy. The incidence of macular edema is also increased in MS patients with a history of uveitis. In the clinical trial experience in adult patients with all doses of MAYZENT, the rate of macular edema was approximately 10% in MS patients with a history of uveitis or diabetes mellitus versus 2% in those without a history of these diseases. In addition to the examination of the fundus, including the macula, prior to treatment, MS patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations. 5.3 Bradyarrhythmia and Atrioventricular Conduction Delays Since initiation of MAYZENT treatment results in a transient decrease in heart rate and atrioventricular conduction delays, an up-titration scheme should be used to reach the maintenance dosage of MAYZENT [see Dosage and Administration (2.2, 2.3) and Clinical Pharmacology (12.2) in the full prescribing information]. MAYZENT was not studied in patients who had: • In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or decompensated heart failure requiring hospitalization • New York Heart Association Class II-IV heart failure • Cardiac conduction or rhythm disorders, including complete left bundle branch block, sinus arrest or sino-atrial block, symptomatic bradycardia, sick sinus syndrome, Mobitz type II second degree AV-block or higher grade AV-block (either history or observed at screening), unless patient has a functioning pacemaker
• Significant QT prolongation (QTc greater than 500 msec) • Arrhythmias requiring treatment with Class Ia or Class III antiarrhythmic drugs [see Drug Interactions (7.2)] Reduction in Heart Rate After the first titration dose of MAYZENT, the heart rate decrease starts within an hour, and the Day 1 decline is maximal at approximately 3-4 hours. With continued up-titration, further heart rate decreases are seen on subsequent days, with maximal decrease from Day 1-baseline reached on Day 5-6. The highest daily post-dose decrease in absolute hourly mean heart rate is observed on Day 1, with the pulse declining on average 5-6 bpm. Post-dose declines on the following days are less pronounced. With continued dosing, heart rate starts increasing after Day 6 and reaches placebo levels within 10 days after treatment initiation. In Study 1, bradycardia occurred in 4.4% of MAYZENT-treated patients compared to 2.9% of patients receiving placebo. Patients who experienced bradycardia were generally asymptomatic. Few patients experienced symptoms, including dizziness or fatigue, and these symptoms resolved within 24 hours without intervention [see Adverse Reactions (6.1)]. Heart rates below 40 bpm were rarely observed. Atrioventricular Conduction Delays Initiation of MAYZENT treatment has been associated with transient atrioventricular conduction delays that follow a similar temporal pattern as the observed decrease in heart rate during dose titration. The AV conduction delays manifested in most of the cases as first-degree AV block (prolonged PR interval on ECG), which occurred in 5.1% of MAYZENT-treated patients and in 1.9% of patients receiving placebo in Study 1. Second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed at the time of treatment initiation with MAYZENT in less than 1.7% of patients in clinical trials. The conduction abnormalities typically were transient, asymptomatic, resolved within 24 hours, rarely required treatment with atropine, and did not require discontinuation of MAYZENT treatment. If treatment with MAYZENT is considered, advice from a cardiologist should be sought: • In patients with significant QT prolongation (QTc greater than 500 msec) • In patients with arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs [see Drug Interactions (7.2)] • In patients with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension • In patients with a history of second-degree Mobitz type II or higher AV block, sick-sinus syndrome, or sino-atrial heart block [see Contraindications (4)] Treatment-Initiation Recommendations • Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present. • In all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reduce cardiac effects [see Dosage and Administration (2.2, 2.3) in the full prescribing information]. • In patients with sinus bradycardia (HR less than 55 bpm), first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure, if not contraindicated, ECG testing and first-dose monitoring is recommended [see Dosage and Administration (2.1, 2.4) in the full prescribing information and Contraindications (4)]. • Since significant bradycardia may be poorly tolerated in patients with history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, or severe untreated sleep apnea, MAYZENT is not recommended in these patients. If treatment is considered, advice from a cardiologist should be sought prior to initiation of treatment in order to determine the most appropriate monitoring strategy. • Use of MAYZENT in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. If treatment is considered, advice from a cardiologist should be sought prior to initiation of treatment in order to determine the most appropriate monitoring. • Experience with MAYZENT is limited in patients receiving concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, calcium channel blockers - diltiazem and verapamil, and other drugs that may decrease heart rate, such as ivabradine and digoxin). Concomitant use of these drugs during MAYZENT initiation may be associated with severe bradycardia and heart block.
• For patients receiving a stable dose of a beta-blocker, the resting heart rate should be considered before introducing MAYZENT treatment. If the resting heart rate is greater than 50 bpm under chronic beta-blocker treatment, MAYZENT can be introduced. If resting heart rate is less than or equal to 50 bpm, beta-blocker treatment should be interrupted until the baseline heart rate is greater than 50 bpm. Treatment with MAYZENT can then be initiated and treatment with a beta-blocker can be reinitiated after MAYZENT has been up-titrated to the target maintenance dosage [see Drug Interactions (7.3)]. • For patients taking other drugs that decrease heart rate, treatment with MAYZENT should generally not be initiated without consultation from a cardiologist because of the potential additive effect on heart rate [see Dosage and Administration (2.4) in the full prescribing information and Drug Interactions (7.2)]. Missed Dose During Treatment Initiation and Reinitiation of Therapy Following Interruption If a titration dose is missed, or if 4 or more consecutive daily doses are missed during maintenance treatment, reinitiate Day 1 of the dose titration and follow titration monitoring recommendations [see Dosage and Administration (2.2, 2.3) in the full prescribing information]. 5.4 Respiratory Effects Dose-dependent reductions in absolute forced expiratory volume over 1 second (FEV1) were observed in MAYZENT-treated patients as early as 3 months after treatment initiation. In a placebo-controlled trial in adult patients, the decline in absolute FEV1 from baseline compared to placebo was 88 mL [95% confidence interval (CI): 139, 37] at 2 years. The mean difference between MAYZENT-treated patients and patients receiving placebo in percent predicted FEV1 at 2 years was 2.8% (95% CI: -4.5, -1.0). There is insufficient information to determine the reversibility of the decrease in FEV1 after drug discontinuation. In Study 1, five patients discontinued MAYZENT because of decreases in pulmonary function testing. MAYZENT has been tested in MS patients with mild to moderate asthma and chronic obstructive pulmonary disease. The changes in FEV1 were similar in this subgroup compared with the overall population. Spirometric evaluation of respiratory function should be performed during therapy with MAYZENT if clinically indicated. 5.5 Liver Injury Elevations of transaminases may occur in MAYZENT-treated patients. Recent (i.e., within last 6 months) transaminase and bilirubin levels should be reviewed before initiation of MAYZENT therapy. In Study 1, elevations in transaminases and bilirubin were observed in 10.1% of MAYZENT-treated patients compared to 3.7% of patients receiving placebo, mainly because of transaminase [alanine aminotransferase/aspartate aminotransferase/gamma-glutamyltransferase (ALT/AST/GGT)] elevations. In Study 1, ALT or AST increased to three and five times the upper limit of normal (ULN) in 5.6% and 1.4% of MAYZENT-treated patients, respectively, compared to 1.5% and 0.5% of patients receiving placebo, respectively. ALT or AST increased eight and ten times ULN in MAYZENTtreated patients (0.5% and 0.2%, respectively) compared to no patients receiving placebo. The majority of elevations occurred within 6 months of starting treatment. ALT levels returned to normal within approximately 1 month after discontinuation of MAYZENT. In clinical trials, MAYZENT was discontinued if the elevation exceeded a 3-fold increase and the patient showed symptoms related to hepatic dysfunction. Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, rash with eosinophilia, or jaundice and/or dark urine during treatment, should have liver enzymes checked. MAYZENT should be discontinued if significant liver injury is confirmed. Although there are no data to establish that patients with preexisting liver disease are at increased risk to develop elevated liver function test values when taking MAYZENT, caution should be exercised when using MAYZENT in patients with a history of significant liver disease. 5.6 Cutaneous Malignancies Long-term use of S1P modulators, including MAYZENT, have been associated with an increased risk of basal cell carcinoma (BCC). In Study 1, the incidence of BCC was 1.0% in MAYZENT-treated patients. Cases of other cutaneous malignancies, including melanoma and squamous cell carcinoma, have also been reported in patients treated with MAYZENT and in patients treated with another S1P modulator.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Providers and patients are advised to monitor for suspicious skin lesions. If a suspicious skin lesion is observed, it should be promptly evaluated. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy is not recommended in patients taking MAYZENT. 5.7 Increased Blood Pressure In Study 1, MAYZENT-treated patients had an average increase over placebo of approximately 3 mmHg in systolic pressure and 1.2 mmHg in diastolic pressure, which was first detected after approximately 1 month of treatment initiation and persisted with continued treatment. Hypertension was reported as an adverse reaction in 12.5% of MAYZENT-treated patients and in 9.2% of patients receiving placebo. Blood pressure should be monitored during treatment with MAYZENT and managed appropriately. 5.8 Fetal Risk Based on animal studies, MAYZENT may cause fetal harm [see Use in Specific Populations (8.1)]. Because it takes approximately 10 days to eliminate MAYZENT from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping MAYZENT treatment. 5.9 Posterior Reversible Encephalopathy Syndrome Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving an S1P receptor modulator. Such events have not been reported for MAYZENT-treated patients in the development program. However, should a MAYZENT-treated patient develop any unexpected neurological or psychiatric symptoms/signs (e.g., cognitive deficits, behavioral changes, cortical visual disturbances, or any other neurological cortical symptoms/signs), any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, the physician should promptly schedule a complete physical and neurological examination and should consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, MAYZENT should be discontinued. 5.10 Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies When switching from drugs with prolonged immune effects, the halflife and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation, when initiating MAYZENT. Initiating treatment with MAYZENT after treatment with alemtuzumab is not recommended [see Drug Interactions (7.1)]. 5.11 Severe Increase in Disability After Stopping MAYZENT Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of an S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping MAYZENT treatment. Patients should be observed for a severe increase in disability upon MAYZENT discontinuation and appropriate treatment should be instituted, as required. 5.12 Immune System Effects After Stopping MAYZENT After stopping MAYZENT therapy, siponimod remains in the blood for up to 10 days. Starting other therapies during this interval will result in concomitant exposure to siponimod. Lymphocyte counts returned to the normal range in 90% of patients within 10 days of stopping therapy [see Clinical Pharmacology (12.2) in the full prescribing information]. However, residual pharmacodynamics effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3 to 4 weeks after the last dose. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore caution should be applied 3 to 4 weeks after the last dose of MAYZENT [see Drug Interactions (7.1)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Infections [see Warnings and Precautions (5.1)] • Macular Edema [see Warnings and Precautions (5.2)] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.3)]
Respiratory Effects [see Warnings and Precautions (5.4)] Liver Injury [see Warnings and Precautions (5.5)] Cutaneous Malignancies [see Warnings and Precautions (5.6)] Increased Blood Pressure [see Warnings and Precautions (5.7)] Fetal Risk [see Warnings and Precautions (5.8)] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.9)] • Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see Warnings and Precautions (5.10)] • Severe Increase in Disability After Stopping MAYZENT [see Warnings and Precautions (5.11)] • Immune System Effects After Stopping MAYZENT [see Warnings and Precautions (5.12)]
• • • • • •
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions 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 practice. A total of 1737 MS patients have received MAYZENT at doses of at least 2 mg daily. These patients were included in Study 1 [see Clinical Studies (14) in the full prescribing information] and in a Phase 2 placebo-controlled study in patients with MS. In Study 1, 67% of MAYZENT-treated patients completed the double-blind part of the study, compared to 59.0% of patients receiving placebo. Adverse events led to discontinuation of treatment in 8.5% of MAYZENT-treated patients, compared to 5.1% of patients receiving placebo. The most common adverse reactions (incidence at least 10%) in MAYZENT-treated patients in Study 1 were headache, hypertension, and transaminase increases. Table 3 lists adverse reactions that occurred in at least 5% of MAYZENTtreated patients and at a rate at least 1% higher than in patients receiving placebo. Table 3 Adverse Reactions Reported in Study 1 (Occurring in at Least 5% of MAYZENT-Treated Patients and at a Rate at Least 1% Higher Than in Patients Receiving Placebo) MAYZENT 2 mg Placebo Adverse Reaction (N = 1099) (N = 546) % % Headachea Hypertensionb Transaminase increasedc Falls Edema peripherald Nausea Dizziness Diarrhea Bradycardiae Pain in extremityf
15 13 11 11 8 7 7 6 6 6
14 9 3 10 4 4 5 4 3 4
Terms were combined as follows: tension headache, sinus headache, cervicogenic headache, drug withdrawal headache, and procedural headache. bhypertension, blood pressure increased, blood pressure systolic increased, essential hypertension, blood pressure diastolic increased. calanine aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, liver function test increased, hepatic function abnormal, liver function test abnormal, transaminases increased. dedema peripheral, joint swelling, fluid retention, swelling face. ebradycardia, sinus bradycardia, heart rate decreased. fpain in extremity and limb discomfort. aheadache,
The following adverse reactions have occurred in less than 5% of MAYZENT-treated patients but at a rate at least 1% higher than in patients receiving placebo: herpes zoster, lymphopenia, seizure, tremor, macular edema, AV block (1st and 2nd degree), asthenia, and pulmonary function test decreased [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)].
Seizures In Study 1, cases of seizures were reported in 1.7% of MAYZENT-treated patients, compared to 0.4% in patients receiving placebo. It is not known whether these events were related to the effects of MS, to MAYZENT, or to a combination of both.
Respiratory Effects Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) were observed in patients treated with MAYZENT [see Warnings and Precautions (5.4)]. Vascular Events Vascular events, including ischemic strokes, pulmonary embolisms, and myocardial infarctions, were reported in 3.0% of MAYZENT-treated patients compared to 2.6% of patients receiving placebo. Some of these events were fatal. Physicians and patients should remain alert for the development of vascular events throughout treatment, even in the absence of previous vascular symptoms. Patients should be informed about the symptoms of cardiac or cerebral ischemia caused by vascular events and the steps to take if they occur. Malignancies Malignancies such as basal cell carcinoma, squamous cell carcinoma, malignant melanoma, and seminoma were reported in MAYZENT-treated patients in Study 1 (in the core or extension parts). The risk of basal cell carcinoma is increased in MAYZENT-treated patients, and an increased risk of cutaneous malignancies has also been reported in association with another S1P modulator [see Warnings and Precautions (5.6)]. 7 DRUG INTERACTIONS 7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies MAYZENT has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration [see Warnings and Precautions (5.1)]. When switching from drugs with prolonged immune effects, the halflife and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.10)]. Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with MAYZENT after alemtuzumab is not recommended. MAYZENT can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. 7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That May Decrease Heart Rate MAYZENT has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with MAYZENT is considered, advice from a cardiologist should be sought. Because of the potential additive effects on heart rate, treatment with MAYZENT should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties, heart rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., ivabradine, digoxin) [see Warnings and Precautions (5.3) and Drug Interactions (7.3)]. If treatment with MAYZENT is considered, advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering drugs or appropriate monitoring for treatment initiation. 7.3 Beta-Blockers Caution should be applied when MAYZENT is initiated in patients receiving treatment with a beta-blocker because of the additive effects on lowering heart rate; temporary interruption of the beta-blocker treatment may be needed prior to initiation of MAYZENT [see Warnings and Precautions (5.3)]. Beta-blocker treatment can be initiated in patients receiving stable doses of MAYZENT [see Clinical Pharmacology (12.2) in the full prescribing information]. 7.4 Vaccination During and for up to one month after discontinuation of treatment with MAYZENT, vaccinations may be less effective; therefore MAYZENT treatment should be paused 1 week prior and for 4 weeks after vaccination [see Warnings and Precautions (5.1)]. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during MAYZENT treatment and for up to 4 weeks after discontinuation of treatment with MAYZENT [see Warnings and Precautions (5.1)].
7.5 CYP2C9 and CYP3A4 Inhibitors Because of a significant increase in exposure to siponimod, concomitant use of MAYZENT and drugs that cause moderate CYP2C9 and moderate or strong CYP3A4 inhibition is not recommended. This concomitant drug regimen can consist of a moderate CYP2C9/CYP3A4 dual inhibitor (e.g., fluconazole) or a moderate CYP2C9 inhibitor in combination with a separate - moderate or strong CYP3A4 inhibitor. Caution should be exercised for concomitant use of MAYZENT with moderate CYP2C9 inhibitors. 7.6 CYP2C9 and CYP3A4 Inducers Because of a significant decrease in siponimod exposure, concomitant use of MAYZENT and drugs that cause moderate CYP2C9 and strong CYP3A4 induction is not recommended for all patients. This concomitant drug regimen can consist of moderate CYP2C9/strong CYP3A4 dual inducer (e.g., rifampin or carbamazepine) or a moderate CYP2C9 inducer in combination with a separate strong CYP3A4 inducer. Caution should be exercised for concomitant use of MAYZENT with moderate CYP2C9 inducers. Concomitant use of MAYZENT and moderate (e.g., modafinil, efavirenz) or strong CYP3A4 inducers is not recommended for patients with CYP2C9*1/*3 and *2/*3 genotype [see Clinical Pharmacology (12.3) in the full prescribing information]. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of MAYZENT in pregnant women. Based on animal data and its mechanism of action, MAYZENT can cause fetal harm when administered to a pregnant woman (see Data). Reproductive and developmental studies in pregnant rats and rabbits have demonstrated MAYZENT-induced embryotoxicity and fetotoxicity in rats and rabbits and teratogenicity in rats. Increased incidences of post-implantation loss and fetal abnormalities (external, urogenital, and skeletal) in rat and of embryo-fetal deaths, abortions and fetal variations (skeletal and visceral) in rabbit were observed following prenatal exposure to siponimod starting at a dose 2 times the exposure in humans at the highest recommended dose of 2 mg/day. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When siponimod (0, 1, 5, or 40 mg/kg) was orally administered to pregnant rats during the period of organogenesis, post-implantation loss and fetal malformations (visceral and skeletal) were increased at the lowest dose tested, the only dose with fetuses available for evaluation. A no-effect dose for adverse effects on embryo-fetal development in rats was not identified. Plasma exposure AUC at the lowest dose tested was approximately 18 times that in humans at the recommended human dose (RHD) of 2 mg/day. When siponimod (0, 0.1, 1, or 5 mg/kg) was orally administered to pregnant rabbits during the period of organogenesis, embryolethality and increased incidences of fetal skeletal variations were observed at all but the lowest dose tested. Plasma exposure (AUC) at the no-effect dose (0.1 mg/kg) for adverse effects on embryo-fetal development in rabbits is less that than in humans at the RHD. When siponimod (0, 0.05, 0.15, or 0.5 mg/kg) was orally administered to female rats throughout pregnancy and lactation, increased mortality, decreased body weight, and delayed sexual maturation were observed in the offspring at all but the lowest dose tested. An increase in malformations was observed at all doses. A no-effect dose for adverse effects on pre- and postnatal development in rats was not identified. The lowest dose tested (0.05 mg/kg) is less than the RHD, on a mg/m2 basis. 8.2 Lactation Risk Summary There are no data on the presence of siponimod in human milk, the effects of MAYZENT on the breastfed infant, or the effects of the drug on milk production. A study in lactating rats has shown excretion of siponimod and/or its metabolites in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MAYZENT and any potential adverse effects on the breastfed infant from MAYZENT or from the underlying maternal condition.
8.3 Females and Males of Reproductive Potential Contraception Females Before initiation of MAYZENT treatment, women of childbearing potential should be counselled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with MAYZENT [see Use in Specific Populations (8.1)]. Since it takes approximately 10 days to eliminate the compound from the body after stopping treatment, the potential risk to the fetus may persist and women should use effective contraception during this period [see Warnings and Precautions (5.8)]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Animal Toxicity Data Oral administration of siponimod (0, 5, 15, or 50 mg/kg/day) to young rats from postnatal day 25 to 70 resulted in mortality, lung histopathology (alveolar/interstitial edema, fibrin, interstitial mixed cell infiltration) and decrease in body weight gain at the mid and high doses. Neurobehavioral impairment (decreased acoustic startle response) was observed at the high dose but was reversible by the end of the recovery period. Decrease in immune function (T-cell dependent antibody response) was observed at all doses and had not fully recovered by 4 weeks after the end of dosing. A no-effect dose for adverse effects in juvenile animals was not identified. 8.5 Geriatric Use Clinical studies of MAYZENT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6 CYP2C9 Genotype Before initiation of treatment with MAYZENT, test patients to determine CYP2C9 genotype. MAYZENT is contraindicated in patients homozygous for CYP2C9*3 (i.e., CYP2C9*3/*3 genotype), which is approximately 0.4% to 0.5% of Caucasians and less in others, because of substantially elevated siponimod plasma levels. MAYZENT dosage adjustment is recommended in patients with CYP2C9*1/*3 or *2/*3 genotype because of an increase in exposure to siponimod [see Dosage and Administration (2.3) and Clinical Pharmacology (12.5) in the full prescribing information]. 10 OVERDOSAGE In patients with overdosage of MAYZENT, it is important to observe for signs and symptoms of bradycardia, which may include overnight monitoring. Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed [see Warnings and Precautions (5.3, 5.7) and Clinical Pharmacology (12.2) in the full prescribing information]. There is no specific antidote to siponimod available. Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body. The decrease in heart rate induced by MAYZENT can be reversed by atropine or isoprenaline. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 MAYZENT is a registered trademark of Novartis AG © Novartis T2021-04
ADVOCACY
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. Latest Advocacy News On July 30, the AAN joined many other physician organizations in a joint statement supporting COVID-19 vaccine mandates for all workers in health and longterm care settings. The AAN joined more than 400 other advocacy groups on a letter to Congress reiterating the need to make permanent telehealth flexibilities following the public health emergency. The AAN joined a letter led by the Epilepsy Foundation urging Congress to include provisions to improve medication access in emergencies in their upcoming pandemic preparedness legislation. The AAN is committed to intentional action to be a fully inclusive, deliberately diverse, and anti-racist organization. To that end, the AAN endorsed the Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act (H.R. 3085), which takes steps to foster inclusion of diversity in Alzheimer’s disease clinical trials. Issue in Focus On July 29, the House Energy & Commerce Health Subcommittee held a hearing entitled, “The Path Forward: Advancing Treatments and Cures for Neurodegenerative Diseases.” The hearing consisted of two panels that included NIH officials, researchers, caregivers, patients, and drug manufacturers. Among the panelists was AAN member Walter J. Koroshetz, MD, FAAN, director of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. Ahead of the hearing, the
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During opening remarks from Energy & Commerce wis somuemthoinr g e’ve found always Committee Chairman Frank Pallone, Jr. (D-NJ), mentioned for copuseful ing the importance of the BRAIN Initiative, saying, “In 2016, we .” passed the 21st Century Cures Act, which authorized over $1.5 billion to support the National Institutes of Health’s (NIH) Brain Research through Advancing Innovative Neurotechnologies Initiative or the BRAIN Initiative. This initiative’s mission is to revolutionize our understanding of the human brain and discover new ways to treat, cure, and prevent brain disorders, including neurodegenerative diseases. By accelerating the development of novel Ih my stoope of technologies to map a new picture and understanding helps rery the st duce the brain, the BRAIN Initiative is providing a revolutionary aroundigma To urette’s foundation for future research and clinical development. .” This work will be augmented by the Advanced Research Projects Agency for Health, or ARPA-H, proposed by President Biden.” — COM
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EDUCATION Search Announced for New Continuum Editor-in-Chief
The opening is a result of current Editor-in-Chief Steven L. Lewis, MD, FAAN, reaching the 10-year limit in this position.
Interested AAN members should submit a current curriculum vitae with a letter outlining scientific editing experience, a vision for Continuum’s role within
The editor-in-chief is responsible for publishing six issues of Continuum® F E B R UA
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the AAN, and an editorial vision for Continuum by December 15, 2021. For more information or to submit Lewis nominations, contact Andrea Weiss, Executive Editor, Education and News Publications, at aweiss@aan.com or (612) 928-6134.
a year. The appointment is five years beginning January 1, 2023, with a sixmonth transition with the current editor beginning July 2022, and the opportunity to extend an additional five years. The Editor-in-Chief Search Committee members are James C. Stevens, MD, FAAN, chair; Neil A. Busis, MD, FAAN; Charlene Gamaldo, MD, FAAN; Shannon M. Kilgore, MD, FAAN; Karlo J. Lizarraga, MD, MS; and Aaron E. Miller, MD, FAAN.
The Editor-in-Chief Search Committee for Continuum: Lifelong Learning in Neurology ® is requesting applications for editor-in-chief of the Academy’s official continuing medical education journal. Candidates must be active or fellow AAN members in good standing. A position description, including requirements, is available at continpub.com/EICSearch.
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AANnews • September 2021 25
EDUCATION UCNS Certification Approved by Quest Analytics BetterDoctor Physician Platform United Council for Neurologic Subspecialties (UCNS) certification has been approved by Quest Analytics for inclusion in the list of certifications in the BetterDoctor physician profile system. UCNS diplomates can now add this information to their BetterDoctor profiles. BetterDoctor is a part of the Quest Analytics’ mission to provide health
plans with insights about their networks so that they can make better decisions about how they provide access to care to individuals across the nation. They deliver the only software that enables health plans to measure, manage, and monitor both network adequacy and provider directory accuracy within a single platform to more than 425 health plans, including all eight of the nation’s
largest health plans, the Centers for Medicare & Medicaid Services, multiple state regulatory agencies, and many of the nation’s leading health systems. Visit UCNS.org/News for more information.
2021 C-cert Activities Approved for ABPN Self-Assessment Credits The American Board of Psychiatry and Neurology (ABPN) has approved the United Council for Neurologic Subspecialties’ application for ABPN Self-assessment credits to be granted to UCNS diplomates for completion of the 2021 UCNS Continuous Certification (C-cert) activities. ABPN approved the 2021 C-cert program as a part of a comprehensive self-assessment (SA) program, which is mandated by the American Board of Medical Specialties as a necessary component of maintenance of certification. Diplomates will now have the opportunity to earn up to 11 ABPN SA credits in addition to up to 11 AMA PRA Category 1TM credits for meeting the 2021 UCNS C-cert requirements. The total credits earned are based on the actual time spent completing the 2021 C-cert activities, up to a maximum of 11 credit hours
contingent on passing the C-cert quiz. Confirmation of the credits earned is emailed to diplomates within 10 business days of passing the 2021 C-cert subspecialty quiz(zes). Diplomates eligible for ABPN SA credits should attest to the credits in their ABPN Physician Folios account at ABPN.com/folios. For questions regarding ABPN certification requirements or ABPN Physician Folios accounts, contact questions@abpn.com. Visit UCNS.org/News for more information.
Leadership Program Graduate Honored with National MS Society’s Woman of Spirit Award MS specialist, AAN member, and AAN Women Leading in Neurology (WLN) Program graduate Dina Jacobs, MD, is being honored this month with the Delaware Valley Chapter of the National MS Society’s Woman of Spirit award for the significant mark she’s made treating patients with MS. The 2019–2020 WLN graduate is quick to credit her experience in the program with helping her explore and better understand the work that is most meaningful to her, discover her core values and greatest strengths, and hone the skills necessary to inspire and guide her along her successful journey culminating in this well-deserved recognition. “I learned a tremendous amount from the WLN program. It taught me a great deal about how to evolve into leadership and, although it was a challenging Jacobs program that required a great deal of commitment, that work paid off with great dividends,” said Jacobs, who points out that the most important thing she learned from the program was how to lead from her core values. “Our coach, Joanne Smikle, PhD, created an exercise in which we narrowed down our three most critical core values. I didn’t know it at the time, but those core values would be my guiding principles that would light my path when I needed to make critical leadership decisions. In the past, I might struggle for a while with such decisions, but this exercise and the subsequent work created a ‘muscle memory’ for me that has made such decisions much clearer.” Tapping into that ‘muscle memory’ proved particularly critical during the COVID-19 pandemic when Jacobs assumed the role of Clinical Lead for the COVID Clinical Resurgence Committee within her department at Penn Medicine. “There were many difficult decisions to be made during the pandemic, and I know with absolute certainty that having the AAN WLN Leadership Program enabled me to do this,” she said, adding that “I cannot imagine having made it through these hurdles during the pandemic without the WLN Program.” As a result of her excellent leadership during this particularly trying time, Jacobs was subsequently appointed Clinical Director and Director of Community Outreach of the Multiple Sclerosis and Related Disorders Program at Penn Medicine. “The AAN WLN Leadership Program gave me the tools and skill set I needed to succeed in this role. I am so incredibly fortunate to have had this opportunity and know that it clearly shaped the leader I have become. I am incredibly grateful to my mentor, Dr. Carlayne Jackson, who wisely shepherded me through my period of growth and development.” The National MS Society selected Jacobs for the Woman of Spirit Award to recognize these and other contributions she has made to provide valuable support and services to women with MS in her Philadelphia community. “It is an incredible honor to be recognized with this award,” said Jacobs. “Caring for women living with MS throughout their life spans and addressing important medical issues such has family planning, hormonal impact on MS disease state and symptoms, and comprehensive care for women living with MS has been my passion through the course of my career. This recognition is much appreciated, but I know that so much more work needs to be done to improve the lives of women and men living with MS; this recognition makes me want to work even harder towards that goal.” Jabobs will be honored on September 17 during the empowering Women Against MS event hosted by Penn Medicine. Since its inception in 2002, the Women Against MS Luncheon has raised more than $2.7 million to help fund cutting-edge research, facilitate education, and provide programs and services that empower people with MS and their families to move their lives forward.
Applications Now Open for 2022 Women Leading in Neurology Program Visit AAN.com/WLN to learn more and apply for this empowering and inspirational leadership program designed to help mid-career participants tackle gender disparities head-on, create a peer network with other female AAN members, and advance to the top levels of leadership in their fields and within the Academy.
Thank you to the organizations supporting this program in part:
Adamas Pharmaceuticals, Inc. Amgen Eisai, Inc. Lundbeck, LLC
AANnews • September 2021 27
RESEARCH Applications Now Open for 2022 AAN Awards Applications are now being accepted for the 2022 AAN awards, which recognize outstanding achievements across career levels. The AAN values your unique contributions to the field of neurology and AAN awards offer opportunities to be honored during conferences, receive travel stipends, or present your work to your colleagues. Apply—or nominate a colleague—for a variety of prestigious AAN awards to be celebrated in person during the 2022 AAN Annual Meeting in Seattle.
I am delighted to see the ever-expanding portfolio of the AAN scientific awards being offered this year. This is a unique opportunity to jumpstart a career in neurological research for so many talented young investigators! Whatever your subspecialty area is, or whether you are interested in clinical, basic, or practice research—there is an award for you to consider. The
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AAN is firmly committed to supporting careers in neuroscience and neurological research—and I personally would like to encourage everyone to apply. —Natalia S. Rost, MD, MPH, FAHA, FAAN Chair, AAN Science Committee
The application deadline is October 28. Visit AAN.com/Awards to learn more and apply or nominate.
Take Advantage of NINDS Education Debt Relief The National Institute of Neurological Disorders and Stroke has a loan repayment program that helps support education costs for virtually all clinician-scientists. The NIH Loan Repayment Program (LRP) is a congressionally mandated program that was designed to address the problem of large educational debt for those working in the research community. The program will pay off up to $50,000 per year of educational debt for health professionals who are dedicated to pursuing research as a significant component of their
professional activities. This support can help AAN members doing research, encourage neurologists to stay in research, and bolster the neurology research community. The timeline for application is September 1 to November 18, 2021, for extramural researchers outside of the NIH system. NINDS prioritizes applicants who show a
clear and ongoing dedication to research and the ability or potential to develop a successful career as an independent investigator. The LRP will support clinician-scientists engaged in research funded by NIH as well as by private sources. Eligible clinician-scientists with K award funding are very highly likely to receive support. For more information, visit lrp.nih.gov.
October 1 Application Deadline Nears: 2022 AAN Research Program continued from cover The program exemplifies the AAN’s commitment to promoting neurology neuroscience research training across a wide range of career levels and discovery stages—with 88 percent of recipients going on to receive further longer-term research funding. Visit AAN.com/ResearchProgram to learn more about the various funding opportunities and application requirements, and take advantage of the new, more streamlined application process before the October 1, 2021, deadline—or pass along this opportunity to anyone who you think might be interested. The 2022 AAN Research Program grants are made possible in collaboration with the American Academy of Neurology, American Brain Foundation, and other associations through partnerships.
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MEMBERSHIP
AAN Joins Collaboration to Launch ‘ACGME Equity Matters’ Learning Communities Inclusion is the reason the AAN was founded. To be an organization that is the home for all neurologists. It is what makes us stronger. In 2020, the AAN Board of Directors adopted a new goal to be a fully inclusive, deliberately diverse, and anti-racist organization. We also expanded our core values of Diversity and Equity to now include Inclusion, Diversity, Equity, Anti-racism, and Social Justice, otherwise known as IDEAS. We are working hard to achieve this new goal and demonstrate these expanded values through an actionable roadmap approved by the Board. Members should look for these monthly updates in AANnews to follow our progress. The Council of Medical Specialty Societies (CMSS), which includes the AAN as a member, is partnering with the Accreditation Council for Graduate Medical Education (ACGME) to launch ACGME Equity Matters™. This is a new initiative that introduces a framework for continuous learning and process improvement in the areas of diversity, equity, inclusion (DEI) and anti-racism practices. The initiative aims to drive change within graduate medical education by increasing physician workforce diversity and building safe and inclusive learning environments, while promoting health equity by addressing racial disparities in health care and overall population health. The AAN’s President Orly Avitzur, MD, MBA, FAAN, will represent the AAN, with CEO Mary E. Post, MBA, CAE, and Chief Human Resources and Diversity Officer Deanna Ekholm, SPHR, also participating. “We are proud to be joining CMSS and ACGME as part of the first cohort of Learning Communities,” said Avitzur. “We look forward to begin the process of learning and supporting efforts that work to create safe, inclusive, and accessible environments in the teaching and practice of medicine.”
To make significant progress, those charged with physician training and ongoing education for physicians must commit to advance advancing equity and counter racism across the full continuum. In this collaborative effort, the ACGME and CMSS will drive measurable improvements in equity by working to increase physician workforce diversity and create clinical and learning environments that are safe, inclusive, and equitable. CMSS and the Organization of Program Director Associations (OPDA), a convened group of CMSS, launched their participation in the program in July with the convening of two Learning Communities (specialty societies and program director associations from the same specialty) that will embark on an 18-month engagement cycle. Core teams from CMSS and OPDA members will include an elected leader to champion the initiative and senior executive leaders who will be accountable for implementing the policy and practice changes. The program will offer a phased curriculum, tools, and skills training which will provide lessons to help drive implementation of innovative interventions, practices, policies, and data strategies that support DEI and anti-racism.
AANe-news. Because Your Time Is Valuable. Sent to your email address the second and fourth Wednesday of each month, AANe-news™ delivers the latest top headlines and resources from the Academy so you can quickly scan and connect directly with the information you need to know. Another members-only solution from your AAN.
AANnews • September 2021 29
Careers.AAN.com 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. Neurologist Outpatient Opportunity, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma INTEGRIS Health—Oklahoma City, Oklahoma INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma is looking for a BC/BE Neurologist to join an established group of experienced Neurologists. This position will join five other Neurologists and one APRN in the outpatient neurology clinic on the campus of INTEGRIS Baptist Medical Center. INTEGRIS Baptist Medical Center is a Certified Comprehensive Stroke Center offering comprehensive Neurological services including specialized services for Neuromuscular Diseases, Cognitive disorders, Multiple Sclerosis and Stroke. The James R. Daniel Cerebrovascular and Stroke Center is located on our campus providing highly specialized stroke services and endovascular therapy to our inpatients. Outpatient services are provided at our INTEGRIS Neurology clinic within a building adjoining the hospital. INTEGRIS Baptist Medical Center is a 774 licensed bed, tertiary care and level 2 trauma center that serves as the hub and flagship hospital of INTEGRIS Health. The hospital is at the center of leading-edge medicine across two campuses, housing nine Centers of Excellence, including a full-service heart hospital, a comprehensive transplant institute and one of the nation’s foremost burn centers. INTEGRIS Health is a not-for-profit, Oklahoma-owned health care system and one of the state’s largest employers with more than 10,000 employees. INTEGRIS Health offers an extensive referral network through INTEGRIS Health Partners, the first and largest clinically integrated network in Oklahoma. INTEGRIS Health Partners has over 450 employed INTEGRIS physicians and 600 private practice physicians providing a tremendous referral network for our Neurologists. Employed position, Initial salary guarantee, Sign-on bonus, CME allowance, Comprehensive benefits package, Malpractice coverage with tail, 401(k) / 403(b) retirement with yearly employer contribution + additional option of 457(b) retirement, System wide EPIC EMR, Education Stipend Available, Relocation Allowance, Paid state license, DEA and OBNDD license renewal – Contact Deidre Wyly-Oldham at deidre.wyly@integrisok.com with interest or for further information. Suburban Pittsburgh Adult Neurology Center Seeking Candidates The Adult Neurology Center—Pittsburgh, Pennsylvania The Adult Neurology Center, located in the suburbs of Pittsburgh, Pennsylvania, is seeking additional neurologists to join their practice in beautiful Washington, PA. The new neurologists will be joining their team and working alongside with the physicians at Washington Health System and the Washington Physicians Group at Washington Hospital and at their nearby clinic. The team at the private practice is excited to welcome a new neurologist to join their friendly group in the community. The overall need at the Adult Neurology Center and Washington Health System is for a Neurologist to see general volume, however neurologists with subspecialty interests in Neuromuscular medicine could see a majority of
EMG/Neuromuscular. Interests in EEG/Epilepsy, Multiple Sclerosis, and Movement Disorders would also be well-supported and encouraged to build subspecialty clinics. Washington Hospital Highlights: 30-minutes from Pittsburgh, 300-bed hospital, Referring hospital for University of Pittsburgh Medical Center and Allegheny Health, Primary Stroke Center. Position Highlights: 1:3 call schedule, moving to 1:4, Call is consultative and is taken from home, No Stroke call - tele-stroke provided by UPMC, Neuromuscular interests would be very well supported, Neurologists with backgrounds in Epilepsy, Multiple Sclerosis, and Movement Disorders would also be great fits, Clinic located less than 5 minutes from the hospital, APP support, Teaching available and encouraged with their large family medicine residency, Above MGMA Median compensation, Base + productivity compensation model. About Washington, PA: Located just 30 minutes Southwest of Pittsburgh, Washington, PA is a charming and affluent suburb rife with history and ways to stay busy. The area is proud to offer the top school districts in the region and is home to nearly a dozen different museums of local and regional history. Washington also allows for easy access to modern commercial districts, major metropolitan living in Pittsburgh, and beautiful outdoor trails and farms. The area boasts among the lowest cost of living in the region and offers several suburbs and neighborhoods that are popular among physicians at the practice. Enjoy a reverse commute from the city to have the best of both city living and a suburban workplace. For questions and to apply, please contact us at jhermanutz@ rosmansearch.com, (216) 905-5666.
Desirable Orange County, California Location with Partner Buy-In Option Fullerton Neurology and Headache Center—Orange County, California The Best Opportunity You Will See in Your Career –Desirable Orange County, California Location with Partner Buy-In Option – Join the most respected neurology practice in Orange County, established over 40 years. High earning potential. A perfect fit for a productive mid-career neurologist or a new trainee. NMSS-designated Comprehensive Multiple Sclerosis Center. Children’s Headache Foundation Certified Center. Active clinical trials program. Infusion suite. Opportunity to teach. Prefer expertise/interest in MS, headache, movement disorders, memory disorders. Contact jflorin@fullertoneuro.net. Visit fullertonneurocenter. com and jackflorin.com. AANnews® Classified Advertising The AAN offers a complete package of print, online, and in-person recruitment advertising opportunities. Visit careers.AAN.com for all AAN options, rates, and deadlines. Ad copy for the November 2021 print edition of AANnews must be submitted by October 1, 2021. The same deadline applies to changes/cancellations. The American Academy of Neurology reserves the 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.
FOUNDATION Goadsby Headache Research Fund Established in Honor of Prominent Migraine Researcher of biologics and drugs for preventive and acute treatment of migraine. He was most recently honored with the Foundation’s 2021 Scientific Breakthrough Award in recognition of the role his work has had on changing the lives of the countless people living with migraine across the world.
The American Brain Foundation has established a new research fund in honor of Peter Goadsby, MD, PhD. The Goadsby Headache Research Fund is designed to support innovative research projects in the field of migraine. In addition, projects will address health disparities in evaluation of health services, access to care and treatments, quality of care, implementation of therapies, physician performance, or patient adherence.
Goadsby
Visit AmericanBrainFoundation.org/Goadsby to learn more about the fund and how you can help support this initiative.
Over the past three decades, Goadsby has led seminal migraine research into the discovery of the role of calcitonin gene-related peptide (CGRP) and identification of it as a target for drug development clinical trials, which have led to the development
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Deadline: UCNS 2021 Continuous Certification UCNS.org/C-cert
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Neurology Career Week Careers.AAN.com
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Deadline: 2022 AAN Awards AAN.com/Awards
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Apply Now to Launch Your Research Career
Next Generation Research Grants Our Next Generation Research Grants fund a broad range of innovative research projects by early-career investigators, encouraging passion for research and laying the groundwork for long-term research careers.
Impact by the Numbers
Applications are open now until October 1! View our upcoming opportunities at AmericanBrainFoundation.org/For-Researchers