2019 May AANnews

VOLUME 33 · ISSUE 5 · MAY 2019

APPLICATIONS NOW OPEN FOR FOUR CAREER-CHANGING LEADERSHIP PROGRAMS Applications are now open at AAN.com/view/lead for four one-ofa-kind AAN Leadership Program opportunities. The value of great leadership is more important than ever in today’s challenging health care environment, and these all-expensespaid programs are designed specifically to help participants face those challenges head-on.

Past participants have found them to be incredibly valuable, citing the personalized coaching with industry leading consultants, mentorship by neurology leaders, and expansion of professional network as particularly impactful. Furthermore, the AAN as an organization has also benefited greatly from these graduates, with many continuing on to workgroup, committee, and even board of director positions.

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External Validation of Axon Registry Data Demonstrates Value

Neurology Compensation and Productivity Survey Closes This Month

An external audit of the data collected by the AAN’s Axon Registry ® was completed successfully recently, demonstrating the registry is performing as intended and highlighting ways it can be further refined for optimum use.

The Axon Registry is a clinical quality data registry that uses automated data extraction methods from the EHR and validation of data and processes is critical. Implementation of remediation strategies to improve data accuracy will support the ability of the Axon Registry to perform accurate quality reporting. A prerequisite for the many uses of the Axon Registry is to assure the validity of the data extraction method and to understand the limitations of the data.

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10 Early Registration and Abstract Deadlines Are This Month for Sports Concussion Conference

May 25 is the final day to participate in the AAN’s 2019 Compensation and Productivity survey. This is the largest survey and report dedicated solely to the field of neurology, providing insightful practice data to help you benchmark your performance and make smart business decisions.

For the first time, important members of the care team, nurse practitioners, physician assistants, and other APPs, will be included

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12 How You Get Paid /

How We Fight for You

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28 Second Chairs Summit Strengthens Relationships Between AAN and Academic Neurology

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In Multiple

Sclerosis —

GREY MATTERS, TOO

Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2019 Celgene Corporation All rights reserved. 03/19 US-CLG-19-0257

AANnews · May 2019

CONTENTS Cover Applications Now Open for Four Career-changing Leadership Programs External Validation of Axon Registry Data Demonstrates Value Neurology Compensation and Productivity Survey Closes This Month President’s Column Presidential Reflections on Creating Opportunities out of Every Challenge · · · · · · · · · 4 Conferences & Community Abstracts of Distinction Represent Highest Level of Innovation· · · · · · · · · · · · · · 7 Pipeline Efforts to be Debuted at the 2019 Presidential Plenary Session · 10 Early Registration and Abstract Deadlines Are This Month for Sports Concussion Conference · · · · · · · · · · · · 10 Can’t Make it To All Your Favorite Annual Meeting Sessions? Live Stream Them! 11 Registration Opens Next Month for AAN Fall Conference 11 Tools & Resources How You Get Paid / How We Fight for You Understanding How You Get Paid: Part 1· · · · · · · · · · 12 AAN Meets with CMS to Protect E/M Codes for Neurologists · · · · · · · · · 13

Enhanced Dashboard and Features Improve Registry User Experience· · · · · · · · · The Answer You Need Is an Email Away Using practice@aan.com · · · · · · · Improve Patient Care with New Universal Neurology Quality Measurement Set · · · Learn How to Handle Challenging Conversations with Patients · · · · · · · · · · · AAN Proposes New Timeline for Neurology Fellowship Applications · · · · · · · · · · · Apply for UCNS Accreditation of Fellowship Programs by June 1 · · · · · · · · · · · · · · · Education & Research NeuroPI No Longer Available as of July 1, Complete Your Open Module to Earn CME · · New Neurology Board Prep Course Available · · · · · · · · Second Chairs Summit Strengthens Relationships Between AAN and Academic Neurology · · · · · · · · · · · · Resident Sought to Join Continuum Editorial Board· · ·

For advertising rates, contact:

American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415

Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins

Website: AAN.com

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Tuesday, May 7, will be NIH Day at the Annual Meeting. Starting with an overview of NIH funding with NINDS Director Walter J. Koroshetz, MD, FAAN, and National Institute on Aging Director, Division of Neuroscience Eliezer Masliah, MD, at 8:00 a.m., and continuing with presentations all afternoon, NIH Day will offer many chances to learn about funding opportunities, the grant review process, clinical trials, and more.

New Section

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The AAN has created a new section—the Adults with Intellectual and Developmental Disabilities Section—for those interested in advancing awareness, education, training, curriculum development, and other efforts in this area. Seth M. Keller, MD, is the founding member of the section, which will hold its first meeting at the Annual Meeting on Saturday, May 4, from 12:00 p.m. to 1:00 p.m. in Room 103B of the Philadelphia Convention Center. Join the section and the Synapse® Online Community by getting connected at AAN.com/Synapse.

Dates & Deadlines · · · · · · · · · 35

Contact Information

Email:

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NIH Day at Annual Meeting

Careers

The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction.

(800) 879-1960 (toll free) (612) 928-6000 (international) memberservices@aan.com

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Policy & Guidelines Capitol Hill Report· · · · · · · · 32 Use Newly Improved Advocacy Action Center to Sway Lawmakers · · · · · · · · 33

The Vision of the AAN is to be indispensable to our members.

Phone:

News Briefs

Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com

AAN Chief Executive Officer: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee 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.

President’s Column

Presidential Reflections on Creating Opportunities out of Every Challenge Wow, two years fly by so quickly when you are having fun! I write this last President’s Column for AANnews as I finish my two-year term as president of the AAN. It has been a real honor and privilege to serve as your president and work with so many dedicated members and amazing staff that make up our committees. Working together as a team, they superbly execute the many strategic priorities that we have set as goals for this organization.

When I started, I made it clear that there would be strategic continuity across twoyear presidential terms. We continued the great work of others before me to demonstrate the value of neurology, educate our members to be better neurologists, and inspire others to pursue Sacco careers in neurology. We also continue to be leaders in addressing burnout and improving wellness, providing help for the solo and small neurology clinical practitioner, working on solutions to reduce gender disparities, and implementing the many other activities that we do to advance our mission of promoting the highest quality patient-centered neurologic care and enhancing member career satisfaction. I hope you feel we are close to being indispensable to our members.

Despite the excitement in the field of neurology, we face many challenges.

In the words of Winston Churchill, “A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty.” I feel proud that we have made further progress in addressing many challenges including expanding the neurology workforce to fill the gap in care predicted as our population ages, advocating for increases in research funding and key policies and legislation to improve the lives of our patients and providers, improving the value and quality of care by expanding our quality improvement Axon Registry ®, providing new resources for our academic neurology chairs and their departments, and expanding the scope of neurology practice to include interventional, preventive, and regenerative neurology.

As president of the American Academy of Neurology, I have made expanding the pipeline of neurology care a central focus of my platform. This included programs to inspire more medical students to choose a career in neurology. We have developed some exciting plans to revitalize our SIGN (Student Interest Groups in Neurology) with new media and other enhancements to share the excitement we all feel about the therapeutic possibilities for our patients. We need to more clearly share our personal stories about what sparked our interest in neurology. We published a report on the factors associated with medical students becoming neurologists, created a new Pipeline Subcommittee of the AAN Education Committee, advocated to the Liaison Committee on Medical

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AANnews • May 2019

Education about requiring neurology to be a third-year clerkship, and added more special segments and programming at our Annual Meeting for students. We also have worked hard to engage advanced practice providers, who are among the fastest growing groups in our organization. We need to develop better team-based care models, and engage them as members of our organization and patient care teams to improve access to high-quality neurological care.

Advocacy was a top priority over the last two years on many critical issues to help improve the lives of all our patients and members. We successfully lobbied to expand the NIH research budget by $3B in FY18 and $2B in FY19. We pushed hard against the proposed plan of the Centers for Medicare & Medicaid Services (CMS) to collapse the E/M coding and won a postponement. In fact, we received praise from CMS leaders and Health & Human Services who thanked us for our work and asked for continued input on cognitive reimbursement and reducing regulatory burden. We also took a leadership position to address the rapidly rising annual cost of treating neurologic disorders in the US that has exceeded $500 billion. Our Drug Pricing Task Force made critical recommendations to improve AAN member guidance and patient education, increase public and private payer advocacy, expand regulatory and legislative advocacy, and review industry relations and conflict of interest policies.

These remain key advocacy asks that we constantly emphasized during my term in our 43 comment letters to policy makers, 82 sign-on letters with other collaborative groups, and in the many legislative visits we have made among the hundreds of members who participated in Neurology on the Hill. Our voice is definitely at the table to improve the practice of neurology, and our efforts are greatly enhanced through our BrainPAC. Improving quality by expanding our Axon Registry was also a priority. We now have nearly 5M visits among 1.5M patients from nearly 1,200 providers in our growing registry. We are providing dashboards on neurology-specific quality metrics

and benchmarks to improve care throughout our membership.

Moreover, we are trying to make it easier to meet continuing certification requirements and MIPS incentive targets based on participation in our qualified clinical data registry. The Board, with the wise and cautious input of our legal team, initiated an agreement to license de-identified data to Verana Health, a technology and data company excelling at structuring and curating health data. Our aims are to expand the Axon Registry and utilize the data to improve treatments and discover cures while continuing to provide the registry free to all members.

Funding research to improve the opportunities for our best and brightest to be successful in launching a clinical translational research career and help find cures for our patients was also a high priority. Using money from the AAN Institute, funds raised by the American Brain Foundation, and working with collaborative societies, we have funded $3.6M in 2018 and $4.4M in 2019 for multiple development awards including adding a new, more advanced Career Development Award. There are many worthy applicants for these terrific career-starting awards, and we continue to work to raise more awareness and money for research. I am grateful for all of our members who have supported the American Brain Foundation as our preferred charitable foundation.

All of us get our start as medical students and residents associated with academic departments of neurology. Just as the practice of neurology is under siege, our academic departments are facing many challenges today, including health care reform, research funding cuts, neurology workforce issues, graduate medical education funding cuts, reduced reimbursement for services, and increasing regulatory burden. In order to address these challenges, the AAN has embarked on the academic initiative to provide support across all the constituents of academic neurology departments.

We have held two Neurology Department Chair Summits in March 2018 and 2019 to improve communication with academic department chairs and most recently the academic business administrators. The goals are to evaluate the needs of departments and develop collaborative solutions and resources to support them as they try to meet the increasing clinical, research, and educational demands in an era of shrinking resources. Having the academic business administrators in the same room with chairs was a great opportunity for more engaged discussions, sharing best practices, and working together to develop more innovative solutions for the good of all departments.

Besides chairs and business administrators, the Academy has embarked on a deep dive into developing more comprehensive

resources to support other members of the academic team including neuroscience course directors, neurology clerkship directors, residency program directors, departmental diversity officers, division chiefs, and advanced practice providers. This is in addition to the comprehensive support we provide across the neurology career lifespan for college students, medical students, residents, chief residents, and fellows.

Another critical focus during my term was to truly embrace our AAN core values and work to improve equity, diversity, inclusion, and reduce health disparities. As president, I have commissioned a health care disparities task force, advocated for increased diversity leadership training programs, supported the development of diversity officers in academic departments, expanded educational resources regarding implicit bias, helped to implement the recommendations of the gender disparity task force, and initiated a Joint Coordinating Council on Equity, Diversity, Inclusion, and Disparities to better link this mission across the organization. We have made major changes in our editorial process to enhance cultural sensitivity across our journals and their publications. There is still more work to be done, but the AAN is addressing these issues.

Improving wellness continued to be an important focus on many of our Academy endeavors. We also initiated a Joint Coordinating Council on Wellness to help integrate and align all wellness initiatives across the many committees of the AAN. From our work with advocacy to reduce regulatory burden and improve payment for high-quality care to our voice with multiple organizations, including the National Academy of Medicine work group on burnout in medicine, the AAN continues to be a leader in addressing burnout and improving wellness for neurologists.

It is an exciting time for neurology and neurosciences. Never has there been more hope for our patients with expanded treatments and cures for neurological disorders, opportunities to detect and prevent neurological conditions, and the greater promise of regenerative therapies to restore function and reduce disability. The time is now to expand our scope and practice to truly embrace interventional, preventive, and regenerative neurology. In the words of one of our Transforming Leadership groups, we need to evolve to the “Newrologist,” a more enlightened leader of an innovative health care team, communicating, inspiring, and motivating others to improve the quality of care for our patients.

As John F. Kennedy stated, “There are risks and costs to action. But they are far less than the Continued on page 6

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AANnews • May 2019

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Lastly, I firmly believe leadership as your president has been a position of service. I have humbly executed my duties and worked to distribute the responsibility of leadership across our many talented officers, terrific Board of Directors, dedicated leaders of our committees, and amazing and energetic staff. I am eternally grateful for all of their dedication to uphold our values, accomplish our strategic mission, and elevate the AAN to be an exceptional professional organization With Chief Executive Officer being indispensable Catherine M. Rydell, CAE. „ for our members.

With former AAN presidents at the 2018 Annual Meeting.

long-range risks of comfortable inaction.� All of us need to get involved, stay informed, and be part of the solution to the challenges we face. Working together as united members of the American Academy of Neurology, we can chart a way forward to create a brighter future for our profession and our many patients who are counting on us to succeed.

Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN rsacco@aan.com @DrSaccoNeuro on Twitter

Shine a light on your achievements Apply for a prestigious Fellow of the American Academy of Neurology (FAAN) designation.

AAN.com/view/FAAN

Conferences & Community

Abstracts of Distinction Represent Highest Level of Innovation Twenty-five abstracts have been selected for this year’s Abstracts of Distinction. The abstracts were chosen for their high level of innovation and research within the 25 Annual Meeting topic areas. The recipients, research, and type of presentation are:

Aging and a Dementia— Clinical Clinic Trials Plenary Session Amy Amyloid PET Leads to Frequent Changes in Management of Ch C Cognitively Impaired Patients: The Imaging Dementia—Evidence for Im Amyloid Scanning (IDEAS) Study A Gil Dan Rabinovici, MD

Autoimmune Aut Neurology—S21.001 Neuro Cerebr Cerebroventricular Infusion of Patients’ Antibodies Cause Memory Loss and Antib Anxiety Anxi in a Mice Model of Antimetabotropic Glutamate Receptor 5 me (mGluR5) Encephalitis (m Marianna Spatola

General Neurology—S27.009 Association of Phosphorylated Neurofilament Heavy Chain (pNF-H) Levels with Motor Function Achievement in Individuals with Spinal Muscular Atrophy (SMA) Treated with Nusinersen Charlotte Sumner, MD

Global Health—S7.001 Evaluating the Relationship Between Depression and HIVassociated Cognitive Impairment Among Children and Adolescents in Zambia Maria Molinaro

Headache—S17.002 Erenumab (AMG334) An Antagonist to Canonical CGRP-receptor Does Not Impair Vasodilatory or Contractile Responses to Other Agents in Human Isolated Cerebral Arteries Lena Ohlsson

Autonomic i Disorders—S18.003 i S8

History of Neurology—S44.006

Cutaneous Alpha-synuclein Deposition in Multiple System Atrophy Christopher Gibbons, MD, FAAN

Sir Henry Head's Lesser Known Self-experiment in Sensory Physiology Stephen Reich, MD, FAAN

Behavioral and Cognitive Neurology—S13.006 Self- and Informant-reported Subjective Memory Complaints: Association with Depression, Cognitive Impairment, and Decline Leah Zuroff

Cerebrovascular Disease and Interventional Neurology—S35.007 Direct Oral Anticoagulants Versus Vitamin K Antagonists After a Recent Ischemic Stroke or TIA—A Pooled Individual Patient Data Analysis David Seiffge

Child Neurology and Developmental Neurology—S25.001

Infectious Disease— Contemporary Clinical Issues Plenary Session A Pilot Study of Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy with Ex Vivo Generated Polyomavirus-specific T-cells Irene C.M. Cortese, MD

Movement Disorders III—S41.005 Clinical and Imaging Characteristics of Non-manifest LRRK2 and GBA Carriers: The PPMI Cohort Andrew Siderowf, MD

MS and CNS Inflammatory Disease II—S37.003

Nusinersen in Infants Who Initiate Treatment in a Presymptomatic Stage of Spinal Muscular Atrophy (SMA): Interim Efficacy and Safety Results From the Phase 2 NURTURE Study Darryl C. De Vivo, MD, FAAN

Neurofilament-light Chain Levels Are Predictive of On-going Disease Activity in Radiologically Isolated Syndrome Eric Thouvenot, MD, PhD

Epilepsy/Clinical Neurophysiology (EEG)—S48.002

Genetic Risk Loci for Cholesterol Levels are Associated with Risk of Spontaneous Intracerebral Hemorrhage Elayna Kirsch

The Risk Optimizing the Antiseizure Medication Regimen for Pregnancy Planning Paula Voinescu, MD

Neurocritical Care—S2.002

Continued on page 8

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AANnews • May 2019

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Conferences & Community

Neuroepidemiology—S1.003

Neuro Trauma and Sports Neurology—S8.001

The Association Between Elevated Depressive Symptoms and Risk of Incident Ischemic Stroke: The Northern Manhattan Study (NOMAS) Marialaura Simonetto, MD

Resting State Functional Connectivity is Directly Related to Clinical Presentation of Mild Traumatic Brain Injury Teena Shetty, MD

Neuromuscular and Clinical Neurophysiology (EMG)—S58.006

Aberrant Functional Connectivity of the Dorsolateral Prefrontal Cortex and the Insula During Cognitive Control in Chronic Low Back Pain Patients on Opioids Behnaz Jarrahi, PhD

Results of the Dose-escalation Portion of a Phase 2 Study of ACE083, a Local Muscle Therapeutic, in Patients with Charcot-MarieTooth (CMT) Disease Florian Thomas, MD, MA, PhD, FAAN

Neuro-oncology—S14.003 Accelerated Progression of IDH Mutant Glioma After First Recurrence Julie Miller, MD

Neuro-ophthalmology/Neuro-otology— Clinical Trials Plenary Session rAAV2/2-ND4 for the Treatment of LHON: 72-week Data from the REVERSE Phase III Clinical Trial Mark L. Moster, MD, FAAN

Neuro-rehabilitation— Contemporary Clinical Issues Plenary Session Continuous Thera Burst Stimulation Over Right Pars Triangularis Facilitates Naming Abilities in Chronic Post-stroke Aphasia by Enhancing Phonological Access Denise Y. Harvey

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AANnews • May 2019

Pain and Palliative Care—S24.002

Practice, Policy, and Ethics—S50.002 A Novel Practice Model Incorporating Extended Rooming and Scribing Assistance in an Academic Neurology Practice Enrique Alvarez, MD, PhD

Research Methodology and Education—S39.002 Diagnostic Accuracy Among Neurology Residents: Six-year Data from the Close the Loop Resident Clinical Acumen Assessment Project Emily Schorr, MD

Sleep—S46.008A Long-Term Study of the Safety and Maintenance of Efficacy of Solriamfetol (JZP-110) for Treatment of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea Nancy Foldvary-Schaefer, DO, FAAN

Enhance Your Annual Meeting Experience with Annual Meeting On Demand This comprehensive, CME-accredited digital library offers*:

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• Lower Price – By moving Annual Meeting On Demand to the AAN’s Online Learning Center, we’ve been able to lower the purchase price.

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Note, with the move to an online offering, hard drives will not be provided.

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Conferences & Community

Pipeline Efforts to be Debuted at the 2019 Presidential Plenary Session During his speech at the Presidential Plenary Session on May 5 during the Annual Meeting, President Ralph L. Sacco, MD, MS, FAHA, FAAN, will highlight the AAN’s efforts to increase the number of students going into neurology and show results of a recent Academy study, “Characteristics of Graduating US Allopathic Medical Students Pursuing a Career in Neurology,” which was published online in Neurology ® on April 3 and in print on April 23. He also will debut an Academy-produced medical student video titled, “What Is Neurology?” as part of his talk in Philadelphia. An editorial on this topic—"Neurology Workforce Deficits: Is Allopathic Medical Student Recruitment the Answer?”—was published in Neurology on March 29. The AAN’s pipeline efforts, a key platform issue for Sacco, have been supported in part by a grant from the Conrad N. Hilton Foundation. Read the study and editorial at N.Neurology.org.

Early Registration and Abstract Deadlines Are This Month for Sports Concussion Conference Two key deadlines are coming up for the 2019 Sports Concussion Conference. May 16 is the deadline to submit scientific abstracts, and May 23 is the deadline to receive early registration discounts.

The conference, returning to the NCAA’s NCAA hometown of Indianapolis, IN, July 26 through 28, is the t leading voice in shaping the sports-rel sports-related concussion conversation for all clinicians, scientists, clin athletic trainers, and coaches at the high levels. This school, college, and professional p must-attend con conference will offer up the very latest scientific advances and best practices practice via a variety of formats, including hands-on workshops, h curated cura program tracks, and a discussions to help attendees prevent, a diagnose, and manage dia sports-related concussion safely, efficiently, and s with confidence. A special NCAA NCA reception Saturday night will further enhance the w weekend.

A report from the CDC, including an overview of the CDC’s role in sports concussion prevention A keynote address by Paul Pasquina, MD, Colonel, US Army (ret), Department of Defense, on The Science of Concussion: Perspectives from the Department of Defense Two Friday programs: A session specifically for athletic trainers that will focus on sideline evaluation and management of concussion A session focused on neurology and science

Visit AAN.com/view/SCC to learn more and secure your best registration savings before May 23.

Submit Your Concussion-related Abstracts by May 16 Previously presented work is encouraged if it is of interest to the field. Visit AAN.com/view/SCC for more on submission guidelines and to submit.

New This Year: A revamped bootcamp offering more mor hands-on training than ever before More M robust b t science i programming i with an expanded offering of clinical updates

SPORTS CONCUSSION JULY 26–28, 2019 INDIANAPOLIS, IN

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AANnews • May 2019

CONFERENCE

Can’t Make it To All Your Favorite Annual Meeting Sessions? Live Stream Them!

Registered 2019 Annual Meeting attendees now have the option to live stream most courses and sessions from anywhere inside the Pennsylvania Convention Center by using the AAN Conferences Mobile App at AAN.com/view/ MobileApp! Now if a course is full, or you can’t attend in person for any reason, all you need to do is log in to the app using your AAN ID and registration confirmation number to experience it live on your iPhone, iPad, or Android. Access will not be granted without an Annual Meeting registration confirmation number or from outside of the convention center.

Experience what you’ve been missing!

Read free articles. Available for a limited time.

ContinPub.com/Free

The AAN Conferences Mobile App is sponsored by EMD Serono.

Registration Opens Next Month for AAN Fall Conference Registration will open in June for the 2019 AAN Fall Conference, returning to The Cosmopolitan of Las Vegas this October 18 through 20. Attendees can once again expect to get the latest updates in neurology and practice management from expert faculty—plus earn valuable end-of-year CME. The Fall Conference’s all-inclusive registration rate will offer maximum value, flexibility, and customization, allowing attendees to tailor a personal schedule to their specific interests and needs. New this year will be a one-day pre-conference designed specifically for advanced practice providers. Check back at AAN.com/view/19FC for more information and as registration becomes available.

Dementia February 2019, VOL. 25, NO. 1

Subscription now includes Continuum® Audio—AAN members get both products for only $349!

Tools & Resources

How You Get Paid / How We Fight for You Understanding How You Get Paid: Part 1 It might seem as if the Centers for Medicare & Medicaid Services (CMS) arbitrarily makes payment cuts with little explanation or rationale. The AAN believes knowledge is power and recognizes the importance of its members’ understanding how their payment rates are established. In this first in a series of four articles, you will learn how CMS and the American Medical Association (AMA) identify CPT codes to be reviewed and the role the AAN plays in that process.

Services with low work RVUs that are billed in multiple units per patient Services with low work RVUs that have high utilization High Expenditure Procedural Codes: codes under the Medicare Physician Payment Schedule that have not been reviewed in the last five years with the highest payments per specialty

There is not a single mechanism that identifies a given procedure or CPT code for review; rather, several utilization screens that apply to all medical specialties and identify “misvalued codes” are available. In some instances, these screens have ultimately led to major cuts in reimbursement for procedures for many specialties. For example, in 2013, dermatology saw a nearly 30-percent reduction to three of their most highly utilized codes; in 2016, ophthalmology saw significant cuts to reimbursement for glaucoma surgery codes.

Both CMS and the AMA monitor code utilization―the AMA via the Relative Value Scale Update Committee (RUC). The intent is to identify potentially misvalued services using objective mechanisms for reevaluation. The RUC recommends relative values for CPT codes to CMS, and CMS determines the final values.

Once a service has been flagged, the medical specialty society (the AAN in this case) responds with an action plan which includes an explanation of the utilization and a recommendation. The AMA RUC will review the recommendation of the specialty society and either remove the code from the screen, recommend updating the CPT code language to further clarify the service, or recommend the code be reviewed for updated valuation.

The AMA workgroup that monitors utilization trends was formed following comments from the Medicare Payment Advisory Commission (MedPAC) urging CMS to be more diligent in the identification of both potentially over- and undervalued services within the payment schedule. Screens that would flag a code include (but are not limited to) the following:

CMS also monitors code utilization and identifies potentially misvalued services with similar screens. The actions of CMS are driven by law; for example, the Affordable Care Act requires the agency to periodically identify potentially misvalued services and to review and make appropriate adjustments to the relative values for those services.

Bundled CPT services: services often billed together Site-of-Service anomalies: services with site of service shifts (e.g., services that were typically in the inpatient setting and are now typically performed in the outpatient setting or physician office) Shift in specialty: services originally performed by one specialty but are now predominantly performed by a different specialty

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High Volume Growth: services with a utilization increase of 100 percent or more in a three-year period

AANnews • May 2019

Examples of neurology codes that have been identified for review include needle electromyography and nerve conduction studies (2010—Bundled CPT services screen) and long-term EEG monitoring code 95951 (2016— High Volume Growth screen).

Watch for Part 2 in this series of AANnews coding articles, which will focus on what happens after a code has been identified and the role the AAN plays.

Enhanced Dashboard and Features Improve Registry User Experience AAN Meets with CMS to Protect E/M Codes for Neurologists In March, AAN physician representatives and AAN staff met with regulators from the Centers for Medicare & Medicaid Services (CMS) to discuss CMS’ proposal to collapse payment rates for levels 2-4 of the outpatient evaluation and Marc Raphaelson, MD, FAAN (second management codes (E/M) from left) with AAN staff at CMS headquarters. into a single blended rate.

In 2018, the AAN vigorously opposed CMS’s initial proposal to collapse the E/M codes, leading CMS to revise the proposal and delay implementation until 2021. The AAN estimates that our advocacy protected members from $43 million in reductions to Medicare payments for E/M services starting in 2021. The March meeting’s goal was to build upon the AAN’s regulatory advocacy success to ensure that any changes made to the E/M codes fairly compensate neurologists for providing complex care.

AAN Coding Subcommittee member and AAN RVS Update Committee (RUC) Representative Marc Raphaelson, MD, FAAN, led the AAN’s presentation to CMS. In the presentation, the AAN noted that neurologists are disproportionately impacted by changes to the E/M codes, as they constitute more than 60 percent of billed services for two-thirds of neurologists.

Furthermore, neurologists are uniquely impacted by CMS’s proposed changes due to the fact that cognitive specialties, such as neurologists, tend to see more complex patients than other specialties. The AAN emphasized the need for multiple levels of complexity to be maintained for E/M services so that providers are fairly reimbursed and able to spend sufficient time with their patients.

The AAN also led a robust discussion of the relative merits of the existing options for reporting E/M services and presented support for using time as the determinant of E/M service level. Representatives of CMS appeared receptive to the AAN’s message and took note of the AAN’s concerns related to potential gaming of E/M code levels to the detriment of providers treating the most complex patients.

Ensuring cognitive care is adequately reimbursed is one of the AAN’s top priorities. The AAN will continue to engage with regulators, legislators, and other stakeholders in advance of the release of the 2020 Physician Fee Schedule proposed rule to ensure that the neurologist perspective is heard. As a follow-up to the March meeting, the AAN plans to meet with CMS leadership in the coming months to bring further attention to the AAN’s concerns and proposed solutions.

The Axon Registry ®, a free product for US-based AAN members, gives participants the ability to take assessing their quality data into their own hands. The platform is easy to use and provides quality measure data to clinicians and practice managers to implement quality improvement and work flow changes. It provides a solution for sending data to the Centers for Medicare & Medicaid Services for the Merit-based Incentive Payment System (MIPS) and participants can receive credit for ABPN’s continuous certification Part IV PIP clinical module activity and waive eight credits of Part II Self-assessment.

After three years of operation, the registry has received a fresh

look for 2019. The dashboard available to providers online 24/7 with up-to-date quality data has a new user-friendly interface.

Newly upgraded capabilities include the ability to customize measure performance ranges and extract the data for quality improvement projects in various ways.

The dashboard enables practices to: Assess quality measures for their practice, providers, and various locations Compare their data to national averages to see how they stack up against their peers Pick out patients that did not meet the quality metrics Assess for ways to improve work flow processes Watch your performance increase over time If a practice wishes to participate in the MIPS program, the Axon Registry dashboard gives them the ability to submit quality data, attest to Promoting Interoperability measures, and attest to Improvement Activities.

Tracking quality throughout the year is important for assessing for high quality care. The Axon Registry enhanced user-friendly dashboard gives providers and practices the necessary resources to harness their data and make improvements.

To learn more about this valuable resource provided by the AAN, visit AAN.com/view/Axon.

AANnews • May 2019

13

IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS (RMS)

START WITH THE POWER AND EXPERIENCE OF TYSABRI

IN THE FIGHT AGAINST RMS In the 2-year AFFIRM pivotal trial: of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with

83% placebo (primary endpoint: percentage with sustained increase in disability was 17% vs 29%; p<0.001)

1,2

INDICATION TYSABRI® (natalizumab) is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. See Important Safety Information regarding the risk of PML with TYSABRI. IMPORTANT SAFETY INFORMATION WARNING: Progressive Multifocal Leukoencephalopathy (PML) TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadoliniumenhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH Prescribing Program. y Infection by the JC Virus (JCV) is required for the development of PML. y There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs. y Postmarketing data suggest that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody index value). y MRI findings may be apparent before clinical signs or symptoms suggestive of PML. Monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present.

Consider monitoring patients at high risk for PML more frequently. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis.

Important Safety Information continues on the following pages. Please see accompanying brief summary of full Prescribing Information, including Boxed Warning.

T R U S T I N T H E E X P E R I E N C E O F T Y S A B R I ® (n at a l iz u m a b) Choose the power of an established therapy

NEARLY

ALWAYS

APPROXIMATELY

200,000

COMMITTED

PATIENTS TREATED

TO SAFETY

1 IN 5

NEW PATIENTS

for relapsing MS with the established therapy of TYSABRI, and counting3,a

The TOUCH® Prescribing Program helps you support patients throughout their treatment on TYSABRI

in the US who start TYSABRI have received no previous DMT4,b

OVER A DECADE OF REAL-WORLD EXPERIENCE VISIT TimeForTYSABRI.com OR TALK TO YOUR BIOGEN REPRESENTATIVE TO LEARN MORE DMT=disease-modifying therapy; a190,800 patients as of August 20183; bAs of July 2017. 4

IMPORTANT SAFETY INFORMATION WARNING: Progressive Multifocal Leukoencephalopathy (PML) (cont’d) y PML has been reported after discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for approximately 6 months after discontinuation of TYSABRI. y Adverse events that may occur during plasma exchange include clearance of other medications and volume shifts, which have the potential to lead to hypotension or pulmonary edema. Although plasma exchange has not been studied in TYSABRI-treated patients with PML, it has been used in such patients in the postmarketing setting to remove TYSABRI more quickly from the circulation. y JCV infection of granule cell neurons in the cerebellum, i.e., JCV granule cell neuronopathy (GCN), with symptoms similar to PML, has been reported in patients treated with TYSABRI. JCV GCN can occur with or without concomitant PML and can cause cerebellar dysfunction. Diagnosis and management of JCV GCN should follow guidance provided for PML. y Immune reconstitution inflammatory syndrome (IRIS) has been reported in the majority of TYSABRI-treated patients who developed PML and subsequently discontinued TYSABRI. In almost all cases, IRIS occurred after plasma exchange was used to eliminate circulating TYSABRI. It presents as a clinical decline in the patient’s condition after TYSABRI removal (and, in some cases, after apparent clinical improvement) that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes in the MRI. TYSABRI has not been associated with IRIS in patients discontinuing treatment with TYSABRI for reasons unrelated to PML. In TYSABRI-treated patients with PML, IRIS has been reported within days to several weeks after plasma exchange.

Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.

Contraindications y TYSABRI is contraindicated in patients who have or have had PML. y TYSABRI is contraindicated in patients who have had a hypersensitivity reaction to TYSABRI. TYSABRI TOUCH Prescribing Program y Because of the risk of PML, TYSABRI is available only through a restricted distribution program under a REMS called the TOUCH® Prescribing Program. y Patients must be enrolled in the TOUCH Prescribing Program, read the Medication Guide, understand the risks associated with TYSABRI, and complete and sign the Patient-Prescriber Enrollment Form.

Herpes Infections – Encephalitis, Meningitis and Acute Retinal Necrosis y TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. y Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI. y The duration of treatment with TYSABRI prior to onset ranged from a few months to several years. y Monitor patients receiving TYSABRI for signs and symptoms of meningitis and encephalitis. If herpes encephalitis or meningitis occurs, TYSABRI should be discontinued, and appropriate treatment for herpes encephalitis/meningitis should be administered.

Important Safety Information continues on the following pages. Please see accompanying brief summary of full Prescribing Information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION (cont’d) Herpes Infections – Encephalitis, Meningitis and Acute Retinal Necrosis (cont’d) y Patients being administered TYSABRI are at a higher risk of acute retinal necrosis (ARN), a fulminant viral infection of the retina caused by the family of herpes viruses. Patients with eye symptoms such as decreased visual acuity, redness or eye pain should be referred for retinal screening as serious cases of ARN can lead to blindness of one or both eyes. y Following clinical diagnosis of ARN, consider discontinuation of TYSABRI. Hepatotoxicity y Clinically significant liver injury, including acute liver failure requiring transplant, has been reported in patients treated with TYSABRI in the postmarketing setting. y Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose; signs of liver injury have also been reported for the first time after multiple doses. y TYSABRI should be discontinued in patients with jaundice or other evidence of significant liver injury (e.g., laboratory evidence).

Hypersensitivity/Antibody Formation y Hypersensitivity reactions have occurred in patients receiving TYSABRI, including serious systemic reactions (e.g., anaphylaxis) which occurred at an incidence of <1%. y Reactions usually occur within 2 hours of the start of the infusion. Symptoms associated with these reactions can include urticaria, dizziness, fever, rash, rigors, pruritus, nausea, flushing, hypotension, dyspnea, and chest pain. y If a hypersensitivity reaction occurs, discontinue administration of TYSABRI and initiate appropriate therapy. Patients who experience a hypersensitivity reaction should not be re-treated with TYSABRI. y Hypersensitivity reactions were more frequent in patients with antibodies to TYSABRI compared with patients who did not develop antibodies to TYSABRI in both MS and CD studies. y Patients who receive TYSABRI for a short exposure (1 to 2 infusions) followed by an extended period without treatment are at higher risk of developing anti-natalizumab antibodies and/or hypersensitivity reactions on re-exposure, compared to patients who received regularly scheduled treatment.

Immunosuppression/Infections y The immune system effects of TYSABRI may increase the risk for infections. y In Study MS1, certain types of infections—including pneumonias and urinary tract infections (including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes infections—occurred more often in TYSABRI-treated patients than in placebotreated patients. One opportunistic infection, a cryptosporidial gastroenteritis with a prolonged course, was observed in a patient who received TYSABRI in Study MS1. y In Studies MS1 and MS2, an increase in infections was seen in patients concurrently receiving short courses of corticosteroids. However, the increase in infections in TYSABRI-treated patients who received steroids was similar to the increase in placebo-treated patients who received steroids. y In a long-term safety study of patients, opportunistic infections (pulmonary mycobacterium avium intracellulare, aspergilloma, cryptococcal fungemia and meningitis, and Candida pneumonia) have been observed in <1% of TYSABRI-treated patients. y Concurrent use of antineoplastic, immunosuppressant, or immunomodulating agents may further increase the risk of infections over the risk observed with use of TYSABRI alone. y In Studies MS1 and MS2, the rate of any type of infection was approximately 1.5 per patient-year in both TYSABRI-treated patients and placebo-treated patients. y In Study MS1, the incidence of serious infections was approximately 3% in TYSABRI-treated patients and in placebo-treated patients.

Most patients did not interrupt treatment with TYSABRI during infections.

Laboratory Test Abnormalities y In clinical trials, TYSABRI was observed to induce increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. Observed changes persisted during TYSABRI exposure, but were reversible, returning to baseline levels usually within 16 weeks after the last dose. Elevations of neutrophils were not observed. TYSABRI induces mild decreases in hemoglobin levels (mean decrease of 0.6 g/dL) that are frequently transient.

Adverse Reactions y The most common adverse reactions reported at an incidence of ≥10% with TYSABRI and ≥2% difference with placebo were headache (38% vs 33%), fatigue (27% vs 21%), infusion reactions (24% vs 18%), urinary tract infections (21% vs 17%), arthralgia (19% vs 14%), depression (19% vs 16%), pain in extremity (16% vs 14%), rash (12% vs 9%), gastroenteritis (11% vs 9%), and vaginitis (10% vs 6%). y The most frequently reported serious adverse reactions in Study MS1 were infections (3.2% vs 2.6% placebo), including urinary tract infection (0.8% vs 0.3%) and pneumonia (0.6% vs 0%), acute hypersensitivity reactions (1.1% vs 0.3%, including anaphylaxis/anaphylactoid reaction [0.8% vs 0%]), depression (1.0% vs 1.0%, including suicidal ideation or attempt [0.6% vs 0.3%]), and cholelithiasis (1.0% vs 0.3%). y Based on animal data, TYSABRI may cause fetal harm. TYSABRI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Please see accompanying brief summary of full Prescribing Information, including Boxed Warning.

STUDY DESCRIPTION: The AFFIRM (NAtalizumab Safety and EFFIcacy in Relapsing-Remitting MS) study was a pivotal 2-year, double-blind, randomized, controlled trial with 942 relapsing MS patients who received either TYSABRI therapy (300 mg by intravenous infusion [n=627]) or placebo (n=315) every 4 weeks for up to 28 months (30 infusions).1,2 References: 1. TYSABRI Prescribing Information, Cambridge, MA: Biogen Inc. 2. Polman CH, O’Connor PW, Havrdova E, et al; for the AFFIRM investigators. A randomized, placebocontrolled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354(9):899-910. 3. Data on file as of August 2018, Biogen Inc. 4. Data on file as of July 2017, Biogen Inc.

© 2019 Biogen. All rights reserved. 02/19 TYS-US-2311

TYSABRI (natalizumab) injection, for intravenous use

Table 1:

Estimated United States Incidence of PML Stratified by Risk Factor

Brief Summary of Full Prescribing Information

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI [see Warnings and Precautions (5.1)].

• Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing shouldbe withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadoliniumenhancedmagnetic enhanced magnetic resonance resonance imaging imaging (MRI) (MRI) scan scan ofof the the brain brain and, and, when when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended [see Contraindications (4), Warnings and Precautions (5.1)].

• Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program [see Warnings and Precautions (5.2)].

1.

INDICATIONS AND USAGE

1.1. Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. See important information regarding the risk of PML with TYSABRI [see Warnings and Precautions (5.1)].

2.

DOSAGE AND ADMINISTRATION

2.1. Multiple Sclerosis (MS) Only prescribers registered in the MS TOUCH® Prescribing Program may prescribe TYSABRI for multiple sclerosis [see Warnings and Precautions (5.2)]. The recommended dose of TYSABRI for multiple sclerosis is 300 mg intravenous infusion over one hour every four weeks.

2.3. Dilution Instructions 1. Use aseptic technique when preparing TYSABRI solution for intravenous infusion. Each vial is intended for single use only. Discard any unused portion.

2. TYSABRI is a colorless, clear to slightly opalescent solution. Inspect the TYSABRI vial for particulate material and discoloration prior to dilution and administration. If visible particulates are observed and/or the liquid in the vial is discolored, the vial must not be used.

3. To prepare the diluted solution, withdraw 15 mL of TYSABRI from the vial using a sterile needle and syringe. Inject TYSABRI into 100 mL of 0.9% Sodium Chloride Injection, USP. No other intravenous diluents may be used to prepare the TYSABRI diluted solution.

4. Gently invert the TYSABRI diluted solution to mix completely. Do not shake. Inspect the solution visually for particulate material prior to administration.

5. The final dosage diluted solution has a concentration of 2.6 mg/mL. 6. Following dilution, infuse TYSABRI solution immediately, or refrigerate the diluted solution at 2°C to 8°C, and use within 8 hours. If stored at 2°C to 8°C, allow the diluted solution to warm to room temperature prior to infusion. DO NOT FREEZE. 2.4.

Administration Instructions

• Infuse TYSABRI 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP, over approximately one hour

(infusion rate approximately 5 mg per minute). Do not administer TYSABRI as an intravenous push or bolus injection. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. • Observe patients during the infusion and for one hour after the infusion is complete. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction [see Warnings and Precautions (5.5)].

• Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI. 3.

DOSAGE FORMS AND STRENGTHS Injection: 300 mg/15 mL (20 mg/mL) colorless and clear to slightly opalescent solution in a single-dose vial for dilution prior to infusion.

4.

CONTRAINDICATIONS

• TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see Warnings and Precautions (5.1)].

• TYSABRI is contraindicated in patients who have had a hypersensitivity reaction to TYSABRI. Observed reactions range from urticaria to anaphylaxis [see Warnings and Precautions (5.5)].

5.

WARNINGS AND PRECAUTIONS

5.1. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML), 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, has occurred in patients who have received TYSABRI. Three factors that are known to increase the risk of PML in TYSABRI-treated patients have been identified: • Longer treatment duration, especially beyond 2 years. There is limited experience in patients who have received more than 6 years of TYSABRI treatment.

• Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil).

• The presence of anti-JCV antibodies. Patients who are anti-JCV antibody positive have a higher risk for developing PML. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI.

Anti-JCV Antibody Positive Anti-JCV Antibody Negative

TYSABRI Exposure†

No Prior Immunosuppressant Use

1-24 months

<1/1,000

1/1,000

<1/1,000

25-48 months

3/1,000

12/1,000

49-72 months

6/1,000

13/1,000

Prior Immunosuppressant Use

Notes: The risk estimates are based on postmarketing data in the United States from approximately 69,000 TYSABRI exposed patients. †Data beyond 6 years of treatment are limited.

The anti-JCV antibody status was determined using an anti-JCV antibody test (ELISA)that has been analytically and clinically validated and is configured with detection and inhibition steps to confirm the presence of JCV-specific antibodies with an analytical false negative rate of 3%.

Retrospective analyses of postmarketing data from various sources, including observational studies and spontaneous reports obtained worldwide, suggest that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody index value).

Ordinarily, patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with TYSABRI. Infection by the JC virus is required for the development of PML. Anti-JCV antibody testing should not be used to diagnose PML. Anti-JCV antibody negative status indicates that antibodies to the JC virus have not been detected. Patients who are anti-JCV antibody negative have a lower risk of PML than those who are positive. Patients who are anti-JCV antibody negative are still at risk for the development of PML due to the potential for a new JCV infection or a false negative test result. The reported rate of seroconversion in patients with MS (changing from anti-JCV antibody negative to positive and remaining positive in subsequent testing) is 3 to 8 percent annually. In addition, some patients’ serostatus may change intermittently. Therefore, patients with a negative anti-JCV antibody test result should be retested periodically. For purposes of risk assessment, a patient with a positive anti-JCV antibody test at any time is considered anti-JCV antibody positive regardless of the results of any prior or subsequent anti-JCV antibody testing. When assessed, anti-JCV antibody status should be determined using an analytically and clinically validated immunoassay. After plasma exchange, wait at least two weeks to test for anti-JCV antibodies to avoid false negative test results caused by the removal of serum antibodies. After infusion of intravenous immunoglobulin (IVIg), wait at least 6 months (5 half-lives) for the IVIg to clear in order to avoid false positive anti-JCV antibody test results.

Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom suggestive of PML. 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. The progression of deficits usually leads to death or severe disability over weeks or months. Withhold TYSABRI dosing immediately and perform an appropriate diagnostic evaluation at the first sign or symptom suggestive of PML. MRI findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Consider monitoring patients at high risk for PML more frequently. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of TYSABRI or due to differences in disease in these patients.

There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs. PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least six months following discontinuation of TYSABRI. Because of the risk of PML, TYSABRI is available only under a restricted distribution program, the TOUCH® Prescribing Program.

In multiple sclerosis patients, an MRI scan should be obtained prior to initiating therapy with TYSABRI. This MRI may be helpful in differentiating subsequent multiple sclerosis symptoms from PML. For diagnosis of PML, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. If the initial evaluations for PML are negative but clinical suspicion for PML remains, continue to withhold TYSABRI dosing, and repeat the evaluations.

There are no known interventions that can adequately treat PML if it occurs. Three sessions of plasma exchange over 5 to 8 days were shown to accelerate TYSABRI clearance in a study of 12 patients with MS who did not have PML, although in the majority of patients, alpha-4 integrin receptor binding remained high. Adverse events which may occur during plasma exchange include clearance of other medications and volume shifts, which have the potential to lead to hypotension or pulmonary edema. Although plasma exchange has not been studied in TYSABRI treated patients with PML, it has been used in such patients in the postmarketing setting to remove TYSABRI more quickly from the circulation.

JC virus infection of granule cell neurons in the cerebellum (i.e., JC virus granule cell neuronopathy [JCV GCN]) has been reported in patients treated with TYSABRI. JCV GCN can occur with or without concomitant PML. JCV GCN can cause cerebellar dysfunction (e.g., ataxia, incoordination, apraxia, visual disorders), and neuroimaging can show cerebellar atrophy. For diagnosis of JCV GCN, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA, is recommended. JCV GCN should be managed similarly to PML. Immune reconstitution inflammatory syndrome (IRIS) has been reported in the majority of TYSABRI treated patients who developed PML and subsequently discontinued TYSABRI. In almost all cases, IRIS occurred after plasma exchange was used to eliminate circulating TYSABRI. It presents as a clinical decline in the patient’s condition after TYSABRI removal (and in some cases after apparent clinical improvement) that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes in the MRI. TYSABRI has not been associated with IRIS in patients discontinuing

treatment with TYSABRI for reasons unrelated to PML. In TYSABRI treated patients with PML, IRIS has been reported within days to several weeks after plasma exchange. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken.

5.2. TYSABRI TOUCH® Prescribing Program TYSABRI is available only through a restricted program under a REMS called the TOUCH® Prescribing Program because of the risk of PML [see Warnings and Precautions (5.1)].

For prescribers and patients, the TOUCH® Prescribing Program has two components: MS TOUCH® (for patients with multiple sclerosis) and CD TOUCH® (for patients with Crohn’s disease).

Selected requirements of the TOUCH® Prescribing Program include the following: • Prescribers must be certified and comply with the following: – Review the TOUCH® Prescribing Program prescriber educational materials, including the full prescribing information.

– Educate patients on the benefits and risks of treatment with TYSABRI, ensure that patients receive the Medication Guide, and encourage them to ask questions.

– Review, complete, and sign the Patient-Prescriber Enrollment Form.

– Evaluate patients three months after the first infusion, six months after the first infusion, every six months thereafter, and for at least six months after discontinuing TYSABRI. – Determine every six months whether patients should continue on treatment and, if so, authorize treatment for another six months.

– Submit to Biogen the “TYSABRI Patient Status Report and Reauthorization Questionnaire” six months after initiating treatment and every six months thereafter.

– Complete an “Initial Discontinuation Questionnaire” when TYSABRI is discontinued, and a “6-Month Discontinuation Questionnaire” following discontinuation of TYSABRI. – Report cases of PML, hospitalizations due to opportunistic infections, and deaths to Biogen at 1-800-456-2255 as soon as possible.

• Patients must be enrolled in the TOUCH® Prescribing Program, read the Medication Guide, understand the risks associated with TYSABRI, and complete and sign the Patient-Prescriber Enrollment Form.

• Pharmacies and infusion centers must be specially certified to dispense or infuse TYSABRI. 5.3. Herpes Infections Herpes Encephalitis and Meningitis TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI. Laboratory confirmation in those cases was based on positive PCR for viral DNA in the cerebrospinal fluid. The duration of treatment with TYSABRI prior to onset ranged from a few months to several years. Monitor patients receiving TYSABRI for signs and symptoms of meningitis and encephalitis. If herpes encephalitis or meningitis occurs, TYSABRI should be discontinued, and appropriate treatment for herpes encephalitis/meningitis should be administered.

Acute Retinal Necrosis Acute retinal necrosis (ARN) is a fulminant viral infection of the retina caused by the family of herpes viruses (e.g., varicella zoster, herpes simplex virus). A higher risk of ARN has been observed in patients being administered TYSABRI. Patients presenting with eye symptoms, including decreased visual acuity, redness, or eye pain, should be referred for retinal screening for ARN. Some ARN cases occurred in patients with central nervous system (CNS) herpes infections (e.g., herpes meningitis or encephalitis).

Serious cases of ARN led to blindness of one or both eyes in some patients. Following clinical diagnosis of ARN, consider discontinuation of TYSABRI. The treatment reported in ARN cases included anti-viral therapy and, in some cases, surgery.

5.4. Hepatotoxicity Clinically significant liver injury, including acute liver failure requiring transplant, has been reported in patients treated with TYSABRI in the postmarketing setting. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose; signs of liver injury have also been reported for the first time after multiple doses. In some patients, liver injury recurred upon rechallenge, providing evidence that TYSABRI caused the injury. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients.

TYSABRI should be discontinued in patients with jaundice or other evidence of significant liver injury (e.g., laboratory evidence).

5.5. Hypersensitivity/Antibody Formation Hypersensitivity reactions have occurred in patients receiving TYSABRI, including serious systemic reactions (e.g., anaphylaxis), which occurred at an incidence of <1%. These reactions usually occur within two hours of the start of the infusion. Symptoms associated with these reactions can include urticaria, dizziness, fever, rash, rigors, pruritus, nausea, flushing, hypotension, dyspnea, and chest pain. Generally, these reactions are associated with antibodies to TYSABRI. If a hypersensitivity reaction occurs, discontinue administration of TYSABRI, and initiate appropriate therapy. Patients who experience a hypersensitivity reaction should not be re-treated with TYSABRI. Hypersensitivity reactions were more frequent in patients with antibodies to TYSABRI compared to patients who did not develop antibodies to TYSABRI in both MS and CD studies. Therefore, the possibility of antibodies to TYSABRI should be considered in patients who have hypersensitivity reactions [see Adverse Reactions (6.2)].

Antibody testing: If the presence of persistent antibodies is suspected, antibody testing should be performed. Antibodies may be detected and confirmed with sequential serum antibody tests. Antibodies detected early in the treatment course (e.g., within the first six months) may be transient and may disappear with continued dosing. It is recommended that testing be repeated three months after an initial positive result to confirm that antibodies are persistent. Prescribers should consider the overall benefits and risks of TYSABRI in a patient with persistent antibodies.

Patients who receive TYSABRI for a short exposure (1 to 2 infusions) followed by an extended period without treatment are at higher risk of developing anti-natalizumab antibodies and/or hypersensitivity reactions on re-exposure, compared to patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients [see Adverse Reactions (6.2)].

5.6. Immunosuppression/Infections The immune system effects of TYSABRI may increase the risk for infections. In Study MS1 [see Clinical Studies (14.1)], certain types of infections, including pneumonias and urinary tract infections (including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes infections, occurred more often in TYSABRI-treated patients than in placebo-treated patients [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. One opportunistic infection, a cryptosporidial gastroenteritis with a prolonged course, was observed in a patient who received TYSABRI in Study MS1.

In Studies MS1 and MS2, an increase in infections was seen in patients concurrently receiving short courses of corticosteroids. However, the increase in infections in TYSABRI-treated patients who received steroids was similar to the increase in placebo-treated patients who received steroids.

In a long-term safety study of patients treated with TYSABRI for multiple sclerosis, opportunistic infections (pulmonary mycobacterium avium intracellulare, aspergilloma, cryptococcal fungemia and meningitis, and Candida pneumonia) have been observed in <1% of TYSABRI-treated patients.

In CD clinical studies, opportunistic infections (pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and burkholderia cepacia) have been observed in <1% of TYSABRI-treated patients; some of these patients were receiving concurrent immunosuppressants [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].

In Studies CD1 and CD2, an increase in infections was seen in patients concurrently receiving corticosteroids. However, the increase in infections was similar in placebo-treated and TYSABRI-treated patients who received steroids.

Concurrent use of antineoplastic, immunosuppressant, or immunomodulating agents may further increase the risk of infections, including PML and other opportunistic infections, over the risk observed with use of TYSABRI alone [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. The safety and efficacy of TYSABRI in combination with antineoplastic, immunosuppressant, or immunomodulating agents have not been established. Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not ordinarily be treated with TYSABRI. The risk of PML is also increased in patients who have been treated with an immunosuppressant prior to receiving TYSABRI [see Warnings and Precautions (5.1)].

5.7. Laboratory Test Abnormalities In clinical trials, TYSABRI was observed to induce increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. Observed changes persisted during TYSABRI exposure, but were reversible, returning to baseline levels usually within 16 weeks after the last dose.

Elevations of neutrophils were not observed. TYSABRI induces mild decreases in hemoglobin levels (mean decrease of 0.6 g/dL) that are frequently transient.

5.8. Immunizations No data are available on the effects of vaccination in patients receiving TYSABRI. No data are available on the secondary transmission of infection by live vaccines in patients receiving TYSABRI. 6.

ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Progressive Multifocal Leukoencephalopathy (PML) [see Warnings and Precautions (5.1)] • Herpes Infections [see Warnings and Precautions (5.3)] • Hepatotoxicity [see Warnings and Precautions (5.4)] • Hypersensitivity/Antibody Formation [see Warnings and Precautions (5.5)] • Immunosuppression/Infections [see Warnings and Precautions (5.6)] 6.1. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions (incidence ≥ 10%) were headache and fatigue in both the multiple sclerosis (MS) and Crohn’s disease (CD) studies. Other common adverse reactions (incidence ≥ 10%) in the MS population were arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash. Other common adverse reactions (incidence ≥ 10%) in the CD population were upper respiratory tract infections and nausea.

The most frequently reported adverse reactions resulting in clinical intervention (i.e., discontinuation of TYSABRI) in the MS studies were urticaria (1%) and other hypersensitivity reactions (1%), and in the CD studies (Studies CD1 and CD2) were the exacerbation of Crohn’s disease (4.2%) and acute hypersensitivity reactions (1.5%) [see Warnings and Precautions (5.5)].

A total of 1617 multiple sclerosis patients in controlled studies received TYSABRI, with a median duration of exposure of 28 months. A total of 1563 patients received TYSABRI in all CD studies for a median exposure of 5 months; of these patients, 33% (n=518) received at least one year of treatment and 19% (n=297) received at least two years of treatment.

Multiple Sclerosis Clinical Studies The most common serious adverse reactions in Study MS1 [see Clinical Studies (14.1)] with TYSABRI were infections (3.2% versus 2.6% in placebo, including urinary tract infection [0.8% versus 0.3%] and pneumonia [0.6% versus 0%]), acute hypersensitivity reactions (1.1% versus 0.3%, including anaphylaxis/anaphylactoid reaction [0.8% versus 0%]), depression (1.0% versus 1.0%, including suicidal ideation or attempt [0.6% versus 0.3%]), and cholelithiasis (1.0% versus 0.3%). In Study MS2, serious adverse reactions of appendicitis were also more common in patients who received TYSABRI (0.8% versus 0.2% in placebo).

Table 2 enumerates adverse reactions and selected laboratory abnormalities that occurred in Study MS1 at an incidence of at least 1 percentage point higher in TYSABRI-treated patients than was observed in placebo-treated patients.

Table 2:

Table 3:

Adverse Reactions in Study MS1 (Monotherapy Study) Adverse Reactions (Preferred Term)

TYSABRI n=627 %

Placebo n=312 %

General Headache Fatigue Arthralgia Chest discomfort Other hypersensitivity reactions** Acute hypersensitivity reactions** Seasonal allergy Rigors Weight increased Weight decreased

38 27 19 5 5 4 3 3 2 2

33 21 14 3 2 <1 2 <1 <1 <1

Infection Urinary tract infection Lower respiratory tract infection Gastroenteritis Vaginitis* Tooth infections Herpes Tonsillitis

21 17 11 10 9 8 7

17 16 9 6 7 7 5

Psychiatric Depression

19

16

Musculoskeletal/Connective Tissue Disorders Pain in extremity Muscle cramp Joint swelling

16 5 2

14 3 1

Gastrointestinal Abdominal discomfort Diarrhea NOS Abnormal liver function test

11 10 5

10 9 4

Skin Rash Dermatitis Pruritus Night sweats

12 7 4 1

9 4 2 0

Menstrual Disorders* Irregular menstruation Dysmenorrhea Amenorrhea Ovarian cyst

5 3 2 2

4 <1 1 <1

Neurologic Disorders Vertigo Somnolence

6 2

5 <1

Renal and Urinary Disorders Urinary urgency/frequency Urinary incontinence

9 4

7 3

Injury Limb injury NOS Skin laceration Thermal burn

3 2 1

2 <1 <1

* Percentage based on female patients only. ** Acute versus other hypersensitivity reactions are defined as occurring within 2 hours post-infusion versus more than 2 hours.

In Study MS2, peripheral edema was more common in patients who received TYSABRI (5% versus 1% in placebo).

Infections Progressive Multifocal Leukoencephalopathy (PML) occurred in three patients who received TYSABRI in clinical trials [see Warnings and Precautions (5.1)]. Two cases of PML were observed in the 1869 patients with multiple sclerosis who were treated for a median of 120 weeks. These two patients had received TYSABRI in addition to interferon beta-1a [see Warnings and Precautions (5.1)]. The third case occurred after eight doses in one of the 1043 patients with Crohnâ&#x20AC;&#x2122;s disease who were evaluated for PML. In the postmarketing setting, additional cases of PML have been reported in TYSABRI-treated multiple sclerosis and Crohnâ&#x20AC;&#x2122;s disease patients who were not receiving concomitant immunomodulatory therapy.

In Studies MS1 and MS2 [see Clinical Studies (14.1)], the rate of any type of infection was approximately 1.5 per patient-year in both TYSABRI-treated patients and placebo-treated patients. The infections were predominately upper respiratory tract infections, influenza, and urinary tract infections. In Study MS1, the incidence of serious infection was approximately 3% in TYSABRI-treated patients and placebo-treated patients. Most patients did not interrupt treatment with TYSABRI during infections. The only opportunistic infection in the multiple sclerosis clinical trials was a case of cryptosporidial gastroenteritis with a prolonged course.

In Studies CD1 and CD2 [see Clinical Studies (14.2)], the rate of any type of infection was 1.7 per patient-year in TYSABRI-treated patients and 1.4 per patient-year in placebo-treated patients. In Study CD3, the incidence of any type of infection was 1.7 per patient-year in TYSABRI-treated patients and was similar in placebo-treated patients. The most common infections were nasopharyngitis, upper respiratory tract infection, and influenza. The majority of patients did not interrupt TYSABRI therapy during infections, and recovery occurred with appropriate treatment. Concurrent use of TYSABRI in CD clinical trials with chronic steroids and/or methotrexate, 6-MP, and azathioprine did not result in an increase in overall

Adverse Reactions in Studies CD1 and CD2 (Induction Studies)

Adverse Reactions*

TYSABRI n=983 %

Placebo n=431 %

General Headache Fatigue Arthralgia Influenza-like illness Acute hypersensitivity reactions Tremor

32 10 8 5 2 1

23 8 6 4 <1 <1

Infection Upper respiratory tract infection Vaginal infections** Viral infection Urinary tract infection

22 4 3 3

16 2 2 1

6 3

4 <1

17 5 4 3 2

15 3 2 2 <1

Skin Rash Dry skin

6 1

4 0

Menstrual Disorder Dysmenorrhea**

2

<1

Respiratory Pharyngolaryngeal pain Cough Gastrointestinal Nausea Dyspepsia Constipation Flatulence Aphthous stomatitis

* Occurred at an incidence of at least 1% higher in TYSABRI-treated patients than placebo-treated patients. ** Percentage based on female patients only.

Table 4:

Adverse Reactions in Study CD3 (Maintenance Study)

Adverse Reactions*

TYSABRI n=214 %

Placebo n=214 %

General Headache Influenza-like illness Peripheral edema Toothache

37 11 6 4

31 6 3 <1

Infection Influenza Sinusitis Vaginal infections** Viral infection

12 8 8 7

5 4 <1 3

Respiratory Cough

7

5

Gastrointestinal Lower abdominal pain

4

2

12

8

6

3

Musculoskeletal and Connective Tissue Back pain Menstrual Disorder Dysmenorrhea**

* Occurred at an incidence of at least 2% higher in TYSABRI-treated patients than placebo-treated patients. ** Percentage based on female patients only. infections compared to TYSABRI alone; however, the concomitant use of such agents could lead to an increased risk of serious infections.

In Studies CD1 and CD2, the incidence of serious infection was approximately 2.1% in both TYSABRItreated patients and placebo-treated patients. In Study CD3, the incidence of serious infection was approximately 3.3% in TYSABRI-treated patients and approximately 2.8% in placebo-treated patients.

In clinical studies for CD, opportunistic infections (pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and burkholderia cepacia) have been observed in <1% of TYSABRI-treated patients; some of these patients were receiving concurrent immunosuppressants [see Warnings and Precautions (5.6)]. Two serious non-bacterial meningitides occurred in TYSABRI-treated patients compared to none in placebo-treated patients.

Infusion-related Reactions An infusion-related reaction was defined in clinical trials as any adverse event occurring within two hours of the start of an infusion. In MS clinical trials, approximately 24% of TYSABRI-treated multiple sclerosis patients experienced an infusion-related reaction, compared to 18% of placebo-treated patients. In the controlled CD clinical trials, infusion-related reactions occurred in approximately 11% of patients treated with TYSABRI compared to 7% of placebo-treated patients. Reactions more common in the TYSABRI-treated MS patients compared to the placebo-treated MS patients included headache, dizziness, fatigue, urticaria, pruritus, and rigors. Acute urticaria was observed in approximately 2% of patients. Other hypersensitivity reactions were observed in 1% of patients receiving TYSABRI. Serious systemic hypersensitivity infusion reactions occurred in <1% of patients [see Warnings and Precautions (5.5)]. All patients recovered with treatment and/or discontinuation of the infusion.

Infusion-related reactions that were more common in CD patients receiving TYSABRI than those receiving placebo included headache, nausea, urticaria, pruritus, and flushing. Serious infusion reactions occurred in Studies CD1, CD2, and CD3 at an incidence of <1% in TYSABRI-treated patients.

MS and CD patients who became persistently positive for antibodies to TYSABRI were more likely to have an infusion-related reaction than those who were antibody-negative.

6.2. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to natalizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Patients in Study MS1 [see Clinical Studies (14.1)] were tested for antibodies to natalizumab every 12 weeks. The assays used were unable to detect low to moderate levels of antibodies to natalizumab.

Approximately 9% of patients receiving TYSABRI developed detectable antibodies at least once during treatment. Approximately 6% of patients had positive antibodies on more than one occasion. Approximately 82% of patients who became persistently antibody-positive developed detectable antibodies by 12 weeks.

Anti-natalizumab antibodies were neutralizing in vitro.

The presence of anti-natalizumab antibodies was correlated with a reduction in serum natalizumab levels.

In Study MS1, the Week 12 pre-infusion mean natalizumab serum concentration in antibody-negative patients was 15 mcg/mL compared to 1.3 mcg/mL in antibody-positive patients. Persistent antibodypositivity resulted in a substantial decrease in the effectiveness of TYSABRI. The risk of increased disability and the annualized relapse rate were similar in persistently antibody-positive TYSABRI-treated patients and patients who received placebo. A similar phenomenon was also observed in Study MS2.

Infusion-related reactions that were most often associated with persistent antibody-positivity included urticaria, rigors, nausea, vomiting, headache, flushing, dizziness, pruritus, tremor, feeling cold, and pyrexia.

Additional adverse reactions more common in persistently antibody-positive patients included myalgia, hypertension, dyspnea, anxiety, and tachycardia.

Patients in CD studies [see Clinical Studies (14.2)] were first tested for antibodies at Week 12, and in a substantial proportion of patients, this was the only test performed given the 12-week duration of placebocontrolled studies. Approximately 10% of patients were found to have anti-natalizumab antibodies on at least one occasion. Five percent (5%) of patients had positive antibodies on more than one occasion.

Persistent antibodies resulted in reduced efficacy and an increase in infusion-related reactions with symptoms that include urticaria, pruritus, nausea, flushing, and dyspnea.

The long-term immunogenicity of TYSABRI and the effects of low to moderate levels of antibody to natalizumab are unknown [see Warnings and Precautions (5.5), Adverse Reactions (6.1)].

6.3. Postmarketing Experience The following adverse reactions have been identified during post approval use of TYSABRI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood disorders: hemolytic anemia 8.

USE IN SPECIFIC POPULATIONS

8.1.

Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of TYSABRI in pregnant women. In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose. These doses were not maternally toxic but produced the expected pharmacological effects in maternal animals [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal Data In developmental toxicity studies conducted in guinea pigs and monkeys, at natalizumab doses up to 30 mg/kg (7 times the recommended human dose based on body weight [mg/kg]), transplacental transfer and in utero exposure of the embryo/fetus was demonstrated in both species.

In a study in which pregnant guinea pigs were administered natalizumab (0, 3, 10, or 30 mg/kg) by intravenous (IV) infusion on alternate days throughout organogenesis (gestation days [GD] 4-30), no effects on embryofetal development were observed.

When pregnant monkeys were administered natalizumab (0, 3, 10, or 30 mg/kg) by IV infusion on alternative days throughout organogenesis (GDs 20-70), serum levels in fetuses at delivery were approximately 35% of maternal serum natalizumab levels. There were no effects on embryofetal development; however, natalizumabrelated immunological and hematologic changes were observed in the fetuses at the two highest doses. These changes included decreases in lymphocytes (CD3+ and CD20+), changes in lymphocyte subpopulation percentages, mild anemia, reduced platelet count, increased spleen weights, and reduced liver and thymus weights associated with increased splenic extramedullary hematopoiesis, thymic atrophy, and decreased hepatic hematopoiesis.

In a study in which monkeys were exposed to natalizumab during pregnancy (IV infusion of 30 mg/kg) on alternate days from GD20 to GD70 or GD20 to term, abortions were increased approximately 2-fold compared to controls. In offspring born to mothers administered natalizumab on alternate days from GD20 until delivery, hematologic effects (decreased lymphocyte and platelet counts) were also observed.

These effects were reversed upon clearance of natalizumab. There was no evidence of anemia in these offspring. Offspring exposed in utero and during lactation had a normal immune response to challenge with a T-cell dependent antigen.

In a study in which pregnant guinea pigs were exposed to natalizumab (30 mg/kg IV) on alternate dates during GDs 30-64, a reduction in pup survival was observed.

8.2.

Lactation

Risk Summary Natalizumab has been detected in human milk. There are no data on the effects of this exposure on the breastfed infant or the effects of the drug on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TYSABRI and any potential adverse effects on the breastfed infant from TYSABRI or from the underlying maternal condition.

8.4. Pediatric Use Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn’s disease below the age of 18 years have not been established. TYSABRI is not indicated for use in pediatric patients.

8.5. Geriatric Use Clinical studies of TYSABRI did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide).

General Counseling Information Counsel patients to understand the risks and benefits of TYSABRI before an initial prescription is written.

The patient may be educated by either the enrolled prescriber or a healthcare provider under that prescriber’s direction. INSTRUCT PATIENTS USING TYSABRI TO: • Read the Medication Guide before starting TYSABRI and before each TYSABRI infusion.

• Promptly report any new or continuously worsening symptoms that persist over several days to their prescriber [see Warnings and Precautions (5.1)].

• Inform all of their physicians that they are receiving TYSABRI. • Plan to see their prescriber three months after the first infusion, six months after the first infusion, every six months thereafter, and for at least six months after discontinuing TYSABRI. Progressive Multifocal Leukoencephalopathy Inform patients that Progressive Multifocal Leukoencephalopathy (PML) has occurred in patients who received TYSABRI. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Instruct the patient that 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. Instruct the patient that the progression of deficits usually leads to death or severe disability over weeks or months.

Instruct patients to continue to look for new signs and symptoms suggestive of PML for approximately 6 months following discontinuation of TYSABRI [see Warnings and Precautions (5.1)].

TYSABRI TOUCH® Prescribing Program Advise the patient that TYSABRI is only available through a restricted program called the TOUCH® Prescribing Program. Inform the patient of the following requirements: Patients must read the Medication Guide and sign the Patient Prescriber Enrollment Form. Advise patients that TYSABRI is available only from certified pharmacies and infusion centers participating in the program [see Warnings and Precautions (5.2)].

Herpes Infections Inform patients that TYSABRI increases the risk of developing encephalitis, and meningitis, which could be fatal, and acute retinal necrosis, which could lead to blindness, caused by the family of herpes viruses (e.g., herpes simplex and varicella zoster viruses). Instruct patients to immediately report any possible symptoms of encephalitis and meningitis (such as fever, headache, and confusion) or acute retinal necrosis (such as decreased visual acuity, eye redness, or eye pain) [see Warnings and Precautions (5.3)].

Hepatotoxicity Inform patients that TYSABRI may cause liver injury. Instruct patients treated with TYSABRI to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.4)].

Hypersensitivity Reactions Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction (e.g., urticaria with or without associated symptoms) during or following an infusion of TYSABRI [see Warnings and Precautions (5.5)].

Immunosuppression/Infections Inform patients that TYSABRI may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.6)].

Full Prescribing Information is available at TYSABRIhcp.com.

TYSABRI (natalizumab) Manufactured by: Biogen Inc. Cambridge, MA 02142 USA US License No. 1697 1-800-456-2255 © 2015-2018 Biogen Inc. All rights reserved.

09/2018 U.S. Patent Numbers: 5,840,299; 6,602,503

Tools & Resources

The Answer You Need Is an Email Away Using practice @aan.com Got a practice-related question that stumps you?

Payer Relations

Using the practice@aan.com email inbox is an efficient way to reach AAN staff and member expertise on practice related topics such as payers, MIPS/MACRA, coding, and practice management. Staff experts respond within one business day and can seek the assistance of the Practice Support Network (PSN), a group of 10 practicing neurologists and graduates of AAN’s Practice Leadership Program, for real-world expertise.

Below are some common questions that have been received recently.

Q: A local payer has recently stopped covering a procedure I use frequently. Is there a consolidated response from the AAN?

Practice Management Q: Our office wait time is four to six months for new patients.

Do you have any advice or resources on how to improve patient access?

A: From the PSN: Have you explored the possibility of adding an advanced practice provider (APP)? When our wait times exceed two to three months, we have been hiring additional providers.

We are in the process of hiring a second nurse practitioner currently, which we use for follow-up visits only. We have found APPs very helpful in decompressing our follow-up schedule, so we have more new patient availability for the neurologists. The APPs do require up-front time to train and teach, however we have found this time investment worthwhile to date.

A: From the AAN: While it depends on the procedure, the AAN has many resources that our members have used successfully to advocate with payers in the past. For example, our clinical practice guidelines are AAN documents that include clinical practice recommendations and can be used to support medical necessity. We also have payment policy perspectives and model coverage policies that offer the AAN position on select coding and reimbursement issues.

If you find yourself needing quick answer to questions, email practice@aan.com and staff can help you determine if the AAN has a resource that fits your needs. We then suggest you contact your local carrier directly, including a letter and all supporting materials. We will also let you know if this is an issue we are seeing across other regions and carriers. Each year, the AAN launches advocacy campaigns that address select coverage issues impacting large numbers of our members, and if your concern falls in this category, we can provide letters and more personalized support.

From the AAN: The 2019 Annual Meeting in Philadelphia features several courses on integrating APPs into practice.

Additionally, the 2018 practice management webinar series featured two courses regarding integrating APPs into practice and improving patient access. View them and learn more at AAN.com/education-and-research/online-learning-programs/ webinars/.

Coding Q. How do I know if a given service will be covered if provided via telehealth?

A. From the AAN: This is a great question we receive often!

There are a number of things to take into consideration when submitting a claim for a service provided through telehealth.

Our response is based on coverage by the Centers for Medicare & Medicaid Services (CMS) which many private carriers model their coverage after. First, the patient must be located in a health professional shortage area and the service must be provided in a CMS-approved originating site (location of the patient). If your patient meets these criteria, it is next important to review the list of telehealth eligible procedures. The Medicare Learning Network has a great online resource that includes all of this information in one place at AAN.com/view/ telehealthservices.

NOTE: It is always important to keep in mind that the ultimate coverage decision lies with the carrier, so always review your coverage policies before submitting a claim for a new service.

AANnews AAN • M May 2019

21 2

Tools & Resources

External Validation of Axon Registry Data Demonstrates Value continued from cover To perform the audit of the Axon Registry data, the AAN in 2017 contracted with IQVIA, a highly respected company in the health care industry that has started several registries, serves as a clinical research organization, and performs data analytics.

The data validation project was composed of two major phases, where phase one included virtual chart audits of 720 patient charts across nine Axon Registry participating practices. Phase two included measure calculation analysis.

Registry’s calculations and IQVIA’s calculations using the original measure specifications. Considerable variation was found in the degree of agreement across sites, measures, and EHRs. Based on the study, many improvements to registry quality measure processes have been implemented. The validation study was a very useful project and will have lasting and far-reaching impact on quality measure development, practice onboarding, and provider education.

The external validation study revealed that Axon Registry’s data elements match the EHR data elements. For future uses of the registry data, including data analytics and research reports, the Axon Registry data can be trusted to be a surrogate of the source EHR data. The Academy is working with external data analytics centers in preparation for future clinical and health services research study opportunities. Using de-identified data collected via the Axon Registry database, these studies may include assessments of medication effectiveness in post-market surveillance or identification of gaps in care for certain neurologic disease states and evaluation of potential health inequities.

To learn more about the Axon Registry data validation study and results, read the article published in the April 5, 2019, online issue of Neurology ® at NPub.org/AxonData.

The quality measure calculations performed in phase two of the validation study revealed findings of a moderate degree of agreement in measure performance results between Axon

Demographic data matched more than

New Web Resource for Academic Institutions The Axon Registry website now has a new section for academic and large institutions that are interested in learning more about the registry. Get answers to your questions and tips on how to promote the Axon Registry to your key decision makers at AAN.com/view/registry.

9

Practices

90%

720 Patient Charts

EHR source data See article in Neurology® “Axon Registry Data Validation” published online April 5, 2019

22

AANnews • May 2019

1

Independent Validation

Improve Patient Care with New Universal Neurology Quality Measurement Set The AAN published a new Universal Neurology quality measurement set online in the journal Neurology ® on February 1, 2019. The set includes 12 new measures on cross-cutting topics like patient falls and back pain.

The measures are intended to apply to a broad range of neurology practitioners including general neurologists and subspecialists.

View the full measure set and tools at AAN.com/view/ othermeasures. For more information, contact Erin Lee at elee@aan.com.

Neurology Compensation and Productivity Survey Closes This Month continued from cover in the survey collection so you can benchmark your compensation and productivity.

Neurologists: compare your compensation to peers in your same subspecialty.

Administrators: discover powerful practice benchmarks to help you make data informed decisions.

All collected data is confidentially secured, de-identified, and used to report only aggregate data.

Your participation is vital to ensuring a representative sample size and maintaining the survey’s reputation as the largest neurology-specific survey.

Participants will receive free access to the 2017 benchmarking report and the new 2019 interactive, customizable dashboard, available about six weeks after the survey closes—a $600 AAN member benefit.

For more information visit aan.com/view/benchmark report.

Email your questions to benchmark@aan.com.

Top 5 Reasons You Should Benchmark Your Productivity and Compensation Assess compensation plans Align compensation with performance Increase practice volume and revenue Boost practice efficiency

Neurology Disputes & Debates:

Improve patient access

Join the Discussion!

Comment on Neurology® journal articles and read what others are saying at Neurology.org/N

AANnews • May 2019

23

Tools & Resources

Learn How to Handle Challenging Conversations with Patients

Daly

Doughty

There are some things that are difficult to talk about with your patients. At times, it gets so difficult and confusing that we hold back on engaging with them on these topics. This webinar will help you remember why these conversations are important.

Learn how to screen these questions in a way that makes your patient feel heard and respected, and makes you feel like an efficient and confident neurologist.

Everything You Wanted to Know About Your Patients but Were Afraid to Ask: Having Difficult Conversations with Neurology Patients from Vulnerable Populations Farrah N. Daly, MD, MBA; Christopher T. Doughty, MD; Justin P. Martello, MD; Allan Ding Wu, MD May 21 at 12:00 p.m. ET

Martello

Wu

A live, 30-minute session with all course faculty will introduce the topic and enable registrants to ask questions. Several shorter recorded lectures will be posted on learning.AAN.com the week following the overview that explore the topic in greater depth, and participants can access these at their convenience. Finally, each topic will conclude with a 30-minute live webchat, so participants can ask further questions.

Both live components take place at 12:00 p.m. ET and can be accessed at learning.AAN.com .

Schedule May 21 at 12:00 p.m. ET: Live Course Overview Week of May 27: Lectures Posted Lecture I: How Do These Conversations Improve Patient Care?

Lecture II: Difficult Questions: Safety Screenings Lecture III: Difficult Questions: End-of-Life Care and Advanced Planning Lecture IV: Keeping Your Patients Engaged Through these Conversations

June 11 at 12:00 p.m. ET: Live Q&A Learning Objectives 1. Know how to identify vulnerable patients and screen for domestic violence, suicide, and other safety issues 2. Improve your value as a neurologist by incorporating quality measures to ask about advanced care planning for end-oflife and/or memory patients 3. Incorporate proven patient engagement techniques, like shared decision making and improved patient portal usage, into your practice 4. Identify how your own implicit biases may be producing worse health outcomes for your patients, particularly during pain screenings, mental health screenings, and identifying difficult pathologies 5. Develop a strategy for you and your practice to continually improve these patient relationships You can purchase a single webinar series for $99 or purchase a 2019 Practice Management Webinar subscription for only $189—that’s less than $32 per webinar! Webinars are accessible through the AAN Online Learning Center at learning.AAN.com and feature: Convenient live sessions starting at 12:00 p.m. ET On-demand access to recording and presentation slides if you miss the live event On-demand access to shorter, in-depth chapters for you to access at your convenience 2 AMA PRA Category 1 Credits™ per webinar for physicians, or certificate of completion for non-physicians Visit AAN.com/view/pmw19 to learn more and register or contact Jessica Nickrand at jnickrand@aan.com.

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IT’S TIME TO RETHINK SEIZURE RESCUE In addition to daily antiepileptic medication, patients at risk for increased seizure activity should be prepared with a seizure response plan that includes an on-hand rescue treatment to stop seizures.

We’re changing the conversation.

Visit LetsTalkSeizures.com

© Neurelis, Inc. 2019. All rights reserved. US-PRC-19-00001

Education & Research

AAN Proposes New Timeline for Neurology Fellowship Applications The timeline for neurology fellowship application has long been a point of discussion within the field, with many stakeholders and organizations holding the opinion that the current, highly competitive process does not give residents enough time to make informed career decisions about their subspecialty training. Furthermore, recent AAN member survey results emphasize residents’ and program directors’ dissatisfaction with the current, varied, application timelines, with nearly half of residents stating that they did not have enough outpatient exposure before selecting their fellowship and 74 percent of program directors concerned that the process begins too early.

In response, the AAN has authored a position statement recommending that all adult neurology fellowship programs participate in a unified interview process with a common final offer date early in the final year of neurology residency (the post graduate year 4). Currently, some fellowship subspecialties participate in a formal match, while others do not. The fellowship application cycle varies significantly among subspecialties, with some beginning their application cycle as early as October of PGY-3. Often, residents are offered a fellowship position over a year before they complete their residency training, well before they have the opportunity to explore the full spectrum of neurological subspecialties.

“The current neurology fellowship application timeline, which has moved progressively earlier over the past years, requires residents to select a fellowship before they are exposed to many neurological subspecialties, and does not give them adequate time to make an informed career decision,” said AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN. “Dissatisfaction of the

current fellowship application timeline is prevalent among both neurology program directors and residents. Data from the 2017 AAN Adult Neurology Program Director Survey demonstrate that 78 percent of the 106 participating directors believe the fellowship application process starts too early. This is further supported by the results of the 2017 Graduating Neurology Residents survey, 88 percent of the participants felt that the fellowship application cycle should start no sooner than the second half of PGY-3 year.”

The AAN is proposing a modified timeline with the application process beginning March 1 of PGY-3 Adult/PGY-4 Child/ Neurodevelopmental Disabilities, and a determination no sooner than August 1 of PGY-4 Adult/ PGY-5 Child/NDD. In an effort to strengthen its position, the Academy is currently seeking review, feedback, and endorsement of the official statement from neurology subspecialty organizations, the American Neurological Association, and the Association of University Professors of Neurology.

There is a precedent for standardizing a later application cycle in other medical specialties. In 2011, Internal Medicine fellowships began using a standardized timeline, with applications opening in July of the final year of training, and a match occurring in December of the same year. Internal medicine program directors reported that this timeline benefits fellowship applicants, fellowship programs, and residency programs, with fellowship applicants benefiting the most.

Apply for UCNS Accreditation of Fellowship Programs by June 1 The United Council for Neurologic Subspecialties (UCNS) is accepting accreditation applications for fellowship training programs through June 1, 2019. Applications received by the deadline will be reviewed at the UCNS Accreditation Council meeting in the fall of 2019. Approved programs will be accredited effective December 1, 2019.

Programs that attain accreditation status offer the core content established by the subspecialty and meet the required quality standards established by UCNS. Residents seeking fellowships in UCNS subspecialty areas know that the UCNS training programs offer the training defined by experts in that subspecialty and the programs have the oversight of the UCNS Accreditation Council. Fellows graduating from UCNS-accredited training programs meet the training eligibility requirements for

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certification in their respective UCNS-recognized subspecialty, creating a strong career path for fellow graduates.

UCNS accredits programs in nine neurologic subspecialty areas including Autonomic Disorders, Headache Medicine, Neurocritical Care, Neuroimaging, Neuro-oncology, Clinical Neuromuscular Pathology, Geriatric Neurology, Behavioral Neurology & Neuropsychiatry, and Neural Repair and Rehabilitation. The next application period deadline will be December 1, 2019.

For more information, visit UCNS.org or contact Amanda Carpenter, UCNS Senior Manager Accreditation, at acarpenter@ucns.org or (612) 987-6065.

Education & Research

NeuroPI No Longer Available as of July 1, Complete Your Open Module to Earn CME The NeuroPI online program, designed to help neurologists meet the American Board of Psychiatry and Neurology (ABPN) Maintenance of Certification (MOC) Improvement in Medical Practice (PIP) Clinical Module activity requirement, will cease effective July 1, 2019. Users with open modules are encouraged to complete their module activities on or before July 1 in order to earn their associated CME and fulfill the PIP requirement. After July 1, 2019, NeuroPI will no longer be available.

Since NeuroPI’s launch in 2011, the ABPN has made several changes designed to provide diplomates with greater flexibility and options for meeting their PIP requirements.

To learn more the ABPN’s PIP requirements for MOC, visit AAN.com/view/ABPN.

Applications Now Open for Four Career-changing Leadership Programs continued from cover The application deadline is June 17 and the available programs are: Emerging Leaders Designed to identify, engage, and mentor talent among early-career members interested in future leadership roles within the AAN and the field of neurology.

Transforming Leaders Designed to help innovative leaders with aspirations to transform their communities, institutions, or the field of neurology realize their goals through executive-level coaching and a fully customized intensive leadership development training program.

Women Leading in Neurology An empowering and inspirational leadership development opportunity designed to tackle gender disparities head-on and help women leaders advance to the top levels of leadership in their fields and within the AAN. Practice Leadership Designed to identify and engage solo and small practitioners interested in helping to shape the future of neurology within the AAN and/or their communities. The program’s flexible schedule easily accommodates the restricted schedules of busy practitioners.

Meet PIP Requirements with the Axon Registry As an exclusive benefit of membership, AAN US members receive free access to the Axon Registry ® to assist them in meeting the ABPN’s PIP requirement. The registry is a qualified clinical data registry (QCDR) focused on quality improvement, enabling neurology practices to identify and improve gaps in the quality of neurological care, demonstrate their value to payers, and compare their performance to neurologists nationwide. Learn more and enroll at AAN.com/view/Axon.

New Neurology Board Prep Course Available A new online Neurology Board Prep Course is now available to help make preparing for the American Board of Psychiatry and Neurology (ABPN) initial certification exam easy and convenient. Available at AAN.com/view/BoardPrep, the course: Features syllabi on the 21 most heavily weighted categories from the ABPN content outline for the initial certification exam in neurology Allows convenient learning on the go with audio interviews from syllabi authors—listen during your commute or at the gym Includes a practice exam made up of 250 multiplechoice questions with feedback by subspecialty area and suggestions for further reading Offers 12 months of access, providing ample time to prepare As a result of the course, participants can expect to identify areas of neurology that require more focused study and review in preparation for the ABPN initial certification examination, self-assess knowledge after completion of the educational program to further focus study and review, and demonstrate improved competency and performance in basic science, clinical neurology, and psychiatry.

The course is available to AAN members at a discounted price.

Junior members pay just $299 and Neurologist members pay only $449, compared to the $649 nonmember pricing.

AANnews • May 2019

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Education & Research

Second Chairs Summit Strengthens Relationships Between AAN and Academic Neurology The AAN seeks new ways to maximize the effectiveness of its ongoing support for academic neurology. Paramount to this initiative is strengthening the AAN’s relationship with chairs, understanding the needs of academic neurology departments, and efficiently identifying unmet needs of chairs and their departments and improving collaborations and communication to develop resources and solutions to effectively addressing them.

In late March, the AAN hosted a daylong Neurology Department Chair and Academic Business Administrator Summit in Chicago. This was the Academy’s second such summit, following the initial meeting with department chairs in March 2018, and the first time that departmental business administrators were invited.

Gender Identity). The speakers shared recommendations for supporting equity, diversity, inclusion, and disparities efforts in neurology departments.

Keeping the neurology academic community up to speed on the AAN’s efforts and the myriad resources available to them has been a key component of both summits. Sacco reviewed the Academy’s accomplishments since last year, touching on the Annual Meeting, the student pipeline, and research support, among other things.

He urged attendees to complete the Neurology Productivity and Compensation Survey

by May 25 so academic neurology would have strong representation in the results. The president also shared how the AAN’s 2019 goals support the academic mission by demonstrating the value of neurology, expanding the workforce, ensuring the health of the organization, member satisfaction and well-being, providing resources to support the financial health of the practice of neurology, expanding neuroscience training and research, educating on high-value clinical care, and strengthening advocacy.

Based on the outcome of the last summit, this year’s focus was on financial pressures and resource allocation related to achieving the clinical, research, and educational missions of running a department, including critical discussions and strategies related to these areas. Having the departmental administrators plan and participate at the recent summit was a bold new idea, since they serve a vital role in departmental success. More than 240 attendees were hosted by the Academy, including 112 chairs, vice chairs, or other designees; 106 business administrators; and 12 faculty and guests.

Board member Brett Kissela, MD, FAAN, chair of neurology at the University of Cincinnati, and AAN Chief Executive Officer Catherine M. Rydell, CAE, presented an overview of the Axon Registry ® and how neurology departments can harness its power to benchmark improvements in care delivery.

After welcoming remarks from AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN, the meeting launched into a presentation on diversity and gender disparity, led by Roy Hamilton, MD, MS, FAAN, (Race and Ethnicity); Cynthia Comella, MD, FAAN, (Gender Disparities), and Nicole Rosendale, MD (Sexual Orientation/

The AAN’s work to protect neurology from unfair regulatory decisions was highlighted by Orly Avitzur, MD, MBA, FAAN, chair of the Medical Economics and Management Committee and nominee for president elect on the 2019–2012 Board of Directors. She provided an update on key reimbursement

issues impacting neurology, including the AAN’s successful effort to delay a proposed change in E/M coding. Avitzur outlined the Academy’s strong plan to oppose any future cuts to E/M including participation in cognitive care coalitions, data analysis, and meetings with CMS leadership. The AAN is also pushing back against significant revisions to the long-term EEG monitoring code set, scheduled for implementation in 2020.

The theme for the second half of the morning was Funds Flow: Models, Challenges, and Opportunities, a key concern for neurology departments that was led by S. Andrew Josephson, MD, FAAN, chair of neurology at UCSF. Following a presentation, topics for breakout sessions addressed benchmarking options, growth, demonstrating value to inform funds flow, and financing the education mission.

The chairs and business administrators broke off for separate networking lunches. The afternoon presentations and discussions centered on additional issues faced by academic departments and health systems that was led by S. Thomas Carmichael, MD, PhD, chair of neurology at UCLA. Several speakers shared recent initiatives in their departments, such as establishing a stroke service line, promotion of the value of specialty translational research, and relationship building.

The challenges of developing precise metrics and capitalizing on a best-case scenario of overlapping missions of neurology department and health system interaction were also discussed.

As he concluded the event, Sacco assured attendees that the AAN’s academic initiative will be continued by President Elect James C. Stevens, MD, FAAN, who embarks on his term after the Annual Meeting. In the coming weeks, work groups will meet by phone to translate outcomes of the summit (especially breakout sessions) into white papers, resources, or program aids.

What They Said About the Summit “Thanks for hosting. I’m taking away so much valuable information and it was a great opportunity to get to know and network with other BAs across the country. I have a new network of colleagues.” ―Business Administrator “Great summit. I’ve been a chair for several years but still the information shared at this summit was extremely helpful―and the networking opportunities gave me an opportunity to learn from other institutions.” ―Department Chair “This is my first time attending this event, and I am pretty impressed with what I’ve learned so far. It’s refreshing to hear my colleagues around the country are sharing the same experiences. I am going to be an active participant moving forward. Thanks for including business administrators.” ―Business Administrator “Appreciated the opportunity to bring my business administrator. Enables us to work better as a team to support and grow our department.” ― Department Chair “Very good meeting. I definitely want to be able to get access to data. I see the value of becoming a member and being more involved in the AAN. Well worth the time/travel!” ―Business Administrator

“Our second chairs summit was an amazing success,” said Sacco, “thanks to the dedicated planning of our Chairs and Academic Business Administrators Work Groups, engaged participation of everyone who attended, and enthusiastic collaborative spirit to share best practices and raise the tide for all academic departments of neurology. We have much more work to do and the AAN is fulfilling its vision to be indispensable to all members.”

Sacco was joined by faculty and members of the two groups that planned and presented the Summit, the Neurology Department Chair Work Group and the Neurology Business Administrator Work Group.

AANnews • May 2019

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Education & Research

Resident Sought to Join Continuum Editorial Board AAN member residents are encouraged to apply to serve on the Continuum® Editorial Board. The Editorial Board provides oversight of Continuum: Lifelong Learning in Neurology ®, the official CME journal of the AAN, and Continuum® Audio. It is responsible for providing input on the direction of Continuum, for topic and guest editor suggestions, and review and evaluation of issues in accordance with the ACCME. One or two residents will be selected to serve a one-year term on the Editorial Board during the 2020 calendar year representing the perspective of Junior Lewis members of the Academy for Continuum, which is provided complimentary to all Junior members. The resident member is expected to attend the spring and fall meetings in 2020. Eligible applicants should be, or have been, in their PGY3, PGY4 (or PGY5 if in child neurology) year of training during the academic year ending June 30, 2019.

resident to learn the ‘ins and outs’ of production of a major clinical journal,” said Continuum Editor-in-Chief Steven L. Lewis, MD, FAAN. Michael Bradshaw, MD, who served as a resident member in 2018, said, “Working as a resident/fellow member of the Continuum Editorial Board was an incredible opportunity. The insights I gained have helped me to grow as an editor, peer reviewer, and scientific writer. In addition, by representing the interests of residents and fellows, I was able to help the board develop areas of particular interest for trainees and felt that I was an appreciated member of the team. It was a once-in-a lifetime experience, and I’m grateful to have had the opportunity!”

To apply, candidates should submit a one-page letter of interest, CV, and a letter of recommendation from their program director or department chair. For more information or to apply, contact Amanda Doering, Continuum Managing Editor, at adoering@ aan.com by July 31, 2019. Applicants will be notified of selection

by November 1, 2019.

“Having a neurology resident on our Editorial Board provides an important voice to our trainees in the direction of Continuum, while at the same time providing a unique opportunity for a

DELIVERING YOU VALUE

84 Percent* of Member Dues Go Directly to Your Member Benefits

*2019 projection

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AANnews • May 2019

ONE IN SIX PEOPLE ARE AFFECTED

BY BRAIN DISEASE WEâ&#x20AC;&#x2122;RE TRYING TO GET TO

Z E R O. The American Brain Foundation brings researchers and donors together to cure brain diseases and disorders.

Learn more at AmericanBrainFoundation.org.

Policy & Guidelines Guidelines

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. t Below are some recent highlights..

AAN Gets Signatures on Influential ‘Dear Colleague’ Letters Over the years, AAN advocates have asked their members of Congress to sign onto “Dear Colleague” letters in support of legislation important to neurology. These letters are an important tool that Congress uses to communicate between members and gather support for different legislative priorities. Earlier this year, in the House, Reps. Blumenauer (D-OR), Pascrell (D-NJ) and McMorris Rodgers (R-WA) led a Dear Colleague letter for the BRAIN Initiative that resulted in 71 signatures. Thanks to the hard work of AAN advocates, the Senate version of the letter led by Sens. Blumenthal (D-CT), Rounds (R-SD), and Markey (D-MA) had a record number of 16 signatures, a 50-percent increase from last year’s letter.

AAN, American Brain Coalition Bring Research Funding Message to House Members The American Brain Coalition (ABC), of which the AAN is a founding board member, met with six House offices including leadership of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies in late March. The AAN, along with the Cure Alzheimer’s Fund, the Tourette Association of America, and an d Br Brid idge ge the Gap ap–S SYN YNGA GAP P Ed Educ ucat atio ion n an and d Re Rese sear arch ch Foundation, talked to congressional offices about the importance of providing robust funding for the NIH, the BRAIN Initiative, and the National Science Foundation (NSF) in FY 2020. The meetings focused on introducing these issues to new members of the appropriations subcommittee and reinforcing the need and continued strong support from past champions.

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AANnews • May 2019

Specifically, the ABC and the AAN are asking Congress for a $2.5 billion increase in NIH funding, including $500 million total funding for the BRAIN Initiative. The AAN submitted these requests as testimony for the record to the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

Mark Rasenick, PhD, a member of ABC’s Board of Directors, also attended the meetings and spoke specifically about the impact off fundi ding on his neurosciience research. h In the Senate, the AAN has met with eight offices, reiterating the same message of the importance of neurology related research. As the appropriators in Congress continue to consider many competing funding priorities, the AAN continues to be a leading voice on the importance of funding research on the brain and nervous system which could lead to life-saving treatments and cures.

‘Yes’ to Lower Drug Costs, ‘No’ to Step Therapy: AAN Comments on Rebate Rule The AAN submitted regulatory comments in response to a proposed rule that would significantly reform the existing prescription drug rebate system. In the AAN’s comments, the AAN supported the administration’s proposal aimed att loweriing outt-of-pock f kett costs t for neurologi l ic and d oth ther high-cost patients. The AAN also opposed linking lowered spending on prescription drugs to utilization management tools like step therapy and prior authorization.

Policy & Guidelines

Use Newly Improved Advocacy Action Center to Sway Lawmakers The AAN’s online Advocacy Action Center, accessible at AAN.com/view/ActNow, always has been an important tool for members to use to reach their state and federal legislators on

Updated Action Center Features No need to remember a password; enter your home address and you’ll immediately be able to contact the federal and state legislators who represent you New features beyond writing an email and posting on social media

Share your story Comment on federal regulations Sign a petition Automatic phone calls

Learn about your legislators and their latest legislative activity

How to Use the Advocacy Action Center 1. Go to AAN.com/view/ActNow and watch for action alert emails from the AAN 2. You either will be automatically logged in or need to enter your name and address 3. Choose the issues you want to act on and personalize your message to your legislators issues important to neurology. For example, more than 700 members contacted their members of Congress to oppose the proposed E/M cuts last year, showing the power of making your voice heard.

Use the new and improved Action Center to communicate with your legislators on issues like step therapy legislation and research funding. You also can use the Action Center to tell the AAN about how important issues like drug pricing have personally affected you and your patients. These personal stories are powerful when the AAN is talking to members of Congress and their staff about potential solutions to make neurologic drugs more accessible.

4. Click “Send!”

Sharing your thoughts and concerns—your voice—is vital to the success of the AAN’s advocacy efforts. Stay engaged by reading AANnews and Capitol Hill Report and participate in this easy grassroots lobbying when you receive an action alert email from the AAN.

What Is an Action Alert Email?

The AAN is actively fighting for you every day in Washington, DC. When legislation is active or an important issue comes up Congress, it’s important for constituents like you to speak up in a timely manner.

The AAN periodically sends action alert emails to members when these windows of opportunity arise. It only takes two clicks to respond and send a message to your legislator!

AAN.com/view/ActNow

AANnews • May 2019

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Careers

f AAN.com/careers

f 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.

Director of Neurology opportunity at Kendall Regional Medical Center located in sunny Miami, FL This position will lead our newly established inpatient neurology program and is fulltime with a Monday-Friday, 8am-5pm schedule with an excellent compensation package. Physicians with previous leadership experience or physicians looking to advance their career into a leadership position are encouraged to apply.

Candidates must be a vascular trained neurologist. Kendall Regional Medical Center is an award-winning hospital recognized with many prestigious awards and accolades. To learn more about this exciting opportunity, contact Kimberly Parker at 214.712.2480 or kimberly.parker@evhc.net .

Neurologist Opportunities Central, South-Central and Northeastern PA. At Geisinger, we’ve been focused on advancing the future of health for more than a century. Today we continue with MyCode Community Health Initiative, our groundbreaking genomics program, to diagnose medical conditions earlier, including patients predisposed to neurological disorders. What you do at Geisinger shapes the future of health and improves lives – for our patients, communities, and you. Join our neurology team with the opportunity to practice general neurology or in several specialties, including Neuro-Oncology, Neuromuscular, Movement Disorder and many more. Interested candidates, please reach out to Lori Surak at ljsurak@geisinger.edu .

West Virginia Vascular Neurology Job 180419. Join medical school Department of Neurology including general neurology & neurophysiology, faculty members including general, pediatric, neuromuscular, movement and rpilepsy specialists, established, accredited long-term epilepsy monitoring unit, opportunity to focus on any and all subspecialties, new intensive care units, new neurology residency program, flexible call schedule, excellent starting salary, full benefits and sign-on bonus, educational stipend available. An outdoor enthusiast´s haven: enjoy the scenic shores of a historic River, take in the four-season views while mountain hiking, enjoy a sunset cruise under the stars, the region´s best skiing at your doorstep, year-round family fun, a down-to-earth place to live combined with amazing cultural sensations, NCAA Division One intercollegiate sports teams, excellent public and private schools, short distance to 4 major metro areas, grand prize winner America´s Best Communities Competition. Mention code 180419 VN. Minimum Requirements: MD or DO Medical Degree, eligible to be state licensed in the United States. United States Residency and/or Fellowship training. To apply for this job contact, Rob Rector Direct: 404-591-4218, 800-492-7771, rrectorweb@phg.com , Fax: 404-591-4269, Cell / Text: 678-234-6192.

General Neurologist for Busy Practice in Florida. Excellent opportunity for a new or experienced neurologist seeking a busy, collegial physician owned group! Our neuroscience program is dedicated to the comprehensive diagnosis and treatment of patients with a wide variety of neurological disorders so fellowship training in headache, behavioral neurology, sleep medicine, neuromuscular, stroke, or movement disorders is helpful. Our expanding in-house neuroscience program boasts an accredited Sleep Disorders Center, EEG, EMG, evoked potential capabilities and neuroimaging capabilities (MRI, CT, PET, SPEC). Convenient access to one 800-bed hospital located 2 blocks from the Clinic. Watson Clinic is a physician owned group practice with over 220 physicians and maintains a strong referral base with over 50 primary care specialists in outpatient and inpatient practices. Our convenient location between Tampa & Orlando provides easy access to 2 international airports just 45 minutes away! Watson Clinic fosters an atmosphere of clinical excellence in an area offering high quality of life, complete with affordable housing, safe neighborhoods, and a wealth of recreational activities year-round including golf, football, hockey, baseball, basketball as well as local attractions. And no state income tax. In addition to a salary guarantee, we offer a signing bonus, paid relocation assistance, retirement program, malpractice insurance along with many other benefits. Partnership is offered after 2 years. Job requirements: board certification or eligibility by the American Board of Psychiatry and Neurology. To apply for this job, contact Kacee Fagan, WCPhysicians@watsonclinic.com , Phone: 8636807380.

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AANnews • May 2019

West Virginia Neurohospitalist Job 180418. Opportunity to join growing neurology department of 8 neurologists. Faculty members including general, pediatric, neuromuscular, movement, epilepsy and vascular. 7 days on 7 days off schedule with opportunity for outpatient clinic. Accredited Neurophysiology Center on site. Multidisciplinary team includes radiologists, pharmacists, nursing, dietitians, physical, occupational and speech therapists. New neurology residency program, comprehensive benefits package including malpractice, excellent starting salary and sign-on bonus, academic appointment, educational stipend available. An outdoor enthusiast´s haven: enjoy the scenic shores of a historic River, take in the four-season views while mountain hiking, enjoy a sunset cruise under the stars, the region´s best skiing at your doorstep, year-round family fun, a down-to-earth place to live combined with amazing cultural sensations, NCAA Division One intercollegiate sports teams, excellent public and private schools, short distance to 4 major metro areas, grand prize winner America´s Best Communities Competition. Mention code 180418 NHO. Minimum Requirements: MD or DO Medical Degree, eligible to be state licensed in the United States. United States Residency and/or Fellowship training. To apply for this job contact, Rob Rector Direct: 404-591-4218, 800-492-7771, rrectorweb@phg.com , Fax: 404-591-4269, Cell / Text: 678-234-6192.

Movement Disorders Neurologist. Norton Neurology Services, a part of Norton Neuroscience Institute, is seeking a fellowshiptrained physician to provide movement disorder services.

Norton Neuroscience Institute is composed of 65 neuroscience providers, including 19 neurologists, 14 neurosurgeons, two neuropsychologists and more than 30 advanced practice providers. The ideal candidate will join two fellowship-trained movement disorder neurologists. The practice enjoys referral patterns from other neurologists in the practice as well as other physicians and providers within Norton Medical Group.

Ability to practice majority movement disorder neurology, no mandatory system stroke call, monthly multidisciplinary deep brain stimulation (DBS) conference to discuss surgical candidates, opportunity to work with fellowship-trained functional neurosurgeons experienced in awake and asleep DBS surgery, opportunity to participate in the annual Norton Neuroscience Institute Symposium, as well as other continuing medical education events, weekly neuroscience clinical conference with neurosurgery and neurology providers, research opportunities and support available through the Norton Healthcare Research Office, and neurological rehabilitation services. Because of an increasing elderly population in Greater Louisville, Parkinson’s disease is a significant health concern. As the region’s leader in providing care for neurological conditions, Norton Neuroscience Institute is dedicated to offering the most advanced treatments for people with Parkinson’s disease. Cressman Neurological Rehabilitation, a service of Norton Neuroscience Institute, provides rehabilitation for patients managing neurological conditions. Patients have access to some of the most advanced technology and specialized services in one location to help with gait, balance, strength, flexibility, speech, fine motor skills, swallowing, driving, cognition, vision and more.

Specialized features include the ZeroG Gait and Balance System, the Biodex Gait Training System, deep brain stimulation, Parkinson Wellness Recovery-certified therapists, videostroboscopy, and one-on one personalized training and follow-up programs. About Norton Neuroscience Institute.

Established in early 2009, Norton Neuroscience Institute is the region’s leading provider of neurological care. The comprehensive program is led by more than 34 subspecialty, fellowship-trained neurosurgeons, neurologists and neuropsychologists, as well as 31 advanced practice providers who are trained to provide patients and their families with advanced treatment for complex neurological disorders, including ALS; aneurysms; brain tumors; epilepsy; headache and concussion; movement disorders, including Parkinson’s disease; multiple sclerosis; pediatric neurosurgery; spinal injuries and disorders; stroke; and more. Norton Brownsboro Hospital, designated as a Comprehensive Stroke Center by The Joint Commission and the American Heart Association/ American Stroke Association, offers treatment for the most complex stroke cases. In 2016, Norton Neuroscience Institute was the first in the region to use ROSA, a robotic surgical

assistant, to provide advanced treatment for patients with epilepsy and brain tumors. ROSA allows neurosurgeons to use a minimally invasive approach for brain surgery procedures such as stereoelectroencephalography that once were possible only through open cranial surgery. Norton Neuroscience Institute also is one of the first in the region to use systems such as NeuroPace and NeuroBlate for performing minimally invasive surgical procedures. Job Requirements: medical degree/diploma, residency/fellowship certification, Kentucky medical license or license eligible. To apply for this job, contact Amanda Bailey, amanda.bailey@nortonhealthcare. org Phone: (502) 439-5144, Apply URL: https://nortonhealthcare. com .

West Virginia Neurology Opening 171116. Primarily Outpatient Neurology opportunity in new medical building, opportunity to join growing neurology department of 8 neurologists, faculty members including general, pediatric, neuromuscular, movement, epilepsy and vascular, accredited Neurophysiology Center on site, multidisciplinary team includes radiologists, pharmacists, nursing, dietitians, physical, occupational and speech therapists, new neurology residency program, excellent starting salary, full benefits and sign-on bonus, H1b candidates accepted, and an educational stipend available.

An outdoor enthusiast´s haven: enjoy the scenic shores of a historic River, take in the four-season views while mountain hiking, enjoy a sunset cruise under the stars, the region´s best skiing at your doorstep, year-round family fun, a downto-earth place to live combined with amazing cultural sensations, NCAA Division One intercollegiate sports teams, excellent public and private schools, short distance to 4 major metro areas, grand prize winner America´s Best Communities Competition. Mention code 171116 - N. Minimum Requirements: MD or DO Medical Degree, eligible to be state licensed in the United States. United States Residency and/or Fellowship training. To apply for this job contact, Rob Rector Direct: 404-591-4218, 800-492-7771, rrectorweb@phg.com , Fax: 404-591-4269, Cell / Text: 678-234-6192.

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 July 2019 print edition of AANnews must be submitted by June 1, 2019. 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.

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THU

FRI

SAT

MAY 4–10

JUNE 1

JULY 1

AAN Annual Meeting Philadelphia, PA AAN.com/view/AM19

Deadline: UCNS Subspecialty Fellowship Training Program Accreditation Applications UCNS.org

Deadline: Early Deadline to Apply for UCNS Neurocritical Care Certification Examination Apply by July 1 and save $500 UCNS.org/go/subspecialty/neurocritical/ certification

MAY 4 AAN Business Meeting Philadelphia, PA AAN.com/view/AM19

MAY 9 AAN Brain Health Fair Philadelphia, PA BrainHealthFair.com

May 16 Deadline: Sports Concussion Conference Abstracts Submission AAN.com/view/SCC

JUNE 17 Deadline: Leadership Program Applications (Transforming Leaders, Emerging Leaders, Practice Leadership, and Women Leading in Neurology) AAN.com/view/lead

JUlY 26–28 Sports Concussion Conference Indianapolis, IN AAN.com/view/SCC

JUNE 20 Deadline: Sports Concussion Conference Advance Registration AAN.com/view/SCC

MAY 21 Webinar: Everything You Wanted to Know About Your Patients but Were Afraid to Ask Register by May 20 AAN.com/view/pmw19

May 23 Deadline: Sports Concussion Conference Early Registration AAN.com/view/SCC

MAY 25 Deadline: Neurology Compensation and Productivity Survey AAN.com/view/BenchmarkReport

We are returning to the home of the NCAA to offer the most cutting-edge concussion management and evolving science available.

Register at

AAN.com/view/SCC Programming conjunction with Programmingin in conjunction with

AANnews • May 2019

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