2019 December AANnews

VOLUME 33 · ISSUE 12 · December 2019

MEDICARE DELIVERS MAJOR CHANGES FOR NEUROLOGY E/M AND EEG Advocacy Wins Big on E/M On November 1, the Centers for Medicare & Medicaid Services (CMS) issued its final rule updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule (MPFS) in 2020. The final rule illustrates the importance of the AAN’s regulatory advocacy efforts on behalf of neurologists and their patients.

Long-term EEG The AAN, along with the National Association of Epilepsy Centers, American Clinical Neurophysiology Society, and American Epilepsy Society, spent the last several months actively advocating to maintain maximum reimbursement for these critical services. We pursued all means of objecting directly to the Centers for Medicare & Medicaid Services (CMS) and members of Congress, in person and through comment letters, regarding payment reductions to long-term EEG monitoring Continued on page 12

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2020 Presidential and Frontiers Plenary Session Speakers Announced

Attend Free December 12 Webinar on EEG and E/M Coding Updates

An impressive lineup has been confirmed for the 2020 Annual Meeting’s premier lectures during the Presidential Plenary Session on Sunday, April 26, to be moderated by Science Committee Chair Natalia S. Rost, MD, MPH, FAAN, FAHA. Six distinguished experts will also take the stage on Wednesday, April 29, for the Frontiers in Neuroscience Plenary Session where they will share their recent findings, along with clinical implications.

Rost

Continued on page 24

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Power of Advocacy Reflected in Final Medicare Fee Schedule

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Busis

Spanaki-Varelas

Williams

Join us for this free one-hour live webinar on December 12 to learn about how the changes in EEG and E/M coding may affect your practice in 2020.

17 New Conference for Advanced Practice Providers Is a Hit

Continued on page 9

22 Renew Your Membership Before December 31

›

In Multiple

Sclerosis —

GREY MATTERS, TOO

Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2019 Celgene Corporation All rights reserved. 04/19 US-CLG-19-0571

AANnews · December 2019

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

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

Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:

Dementia: Caregiver Education and Support Falls: Querying About Falls for Patients Headache: Medication Prescribed for Acute Migraine Attack

Parkinson's: Psychiatric Symptoms Assessment ALS: End of Life Planning Assistance

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What You Need to Know About Physician Compare and the Axon Registry

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Understanding How You Get Paid: Part 4

Physician Compare, CMS’s public reporting initiative, collects data on selected measures via several means, including registries. Several measures from the Axon Registry ® will be publicly reported soon.

In this final article of the series, we look in detail on how to bill for long-term EEG monitoring services effective January 1.

memberservices@aan.com

Website: AAN.com For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com

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iversity Leadership Program Builds D Confidence in Graduate to Seize New Challenges

“The most important thing that I learned from the Diversity Leadership Program is to affirm my own successes,” says graduate Ima M. Ebong, MD.

AAN Executive Director: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com

AANnews® is published monthly by the American Academy of Neurology for its 36,000 members worldwide.

Access this magazine and other AAN publications online at AAN.com.

The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world.

“American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.

News Briefs

Stroke Reclassified as a Disorder of the Brain in ICD 11 AAN members comprised nearly one-third of the group of 99 specialists who advised and participated in various capacities in reclassifying stroke as a disease of the brain in the new International Statistical Classification of Diseases and Related Health Problems (ICD) 11 from the World Health Organization (WHO) that was announced at the 24th World Congress of Neurology in October. Formerly classified as a cardiovascular disease, stroke’s reclassification as a brain disease will have an effect on health care policy and should make it easier to shift resources and funding to appropriately reflect its status as a neurologic disorder.

Well-being Report Issued The National Academy of Medicine (NAM) has released a new report, “Taking Action Against Burnout: A Systems Approach to Professional Well-being,” that examines scientific evidence regarding the causes of clinician burnout as well as the consequences for clinicians and patients, and interventions to support clinician wellbeing and resilience to help physicians and their organizations address well-being.

Neil A. Busis, MD, FAAN, serves as the AAN’s contributor on the NAM’s Action Collaborative on Clinician Well-being and Resilience. Busis also serves on the AAN’s Joint Coordinating Council on Wellness, chaired by Jennifer Molano, MD, FAAN, and Heidi Schwarz, MD, FAAN. 

President’s Column

Power of Advocacy Reflected in Final Medicare Fee Schedule response to proposed changes. Consequently, in a Last month, the Centers for Medicare & Medicaid significant victory for neurology, CMS will not collapse Services (CMS) published its final Medicare Fee the payment levels for E/M visits and, in 2021, it Schedule for 2020. The results demonstrate the will implement revised office E/M documentation power of the AAN’s comprehensive, award-winning guidelines and increased payments. We foresee that advocacy to increase evaluation and management this could generate an additional $150 million annually (E/M) payment levels for neurologic services. We also in Medicare payments to neurologists for E/M services put extensive effort into mitigating proposed payment Stevens beginning that year. reductions to long-term EEG monitoring codes through numerous meetings and a 41-page response The Academy also was effective in getting CMS to to the overall proposed changes—which Policy & Medicine increase payment for transitional care management and to praised as a “a lengthy tour de force regulatory comment create two new codes for principal care management. And, letter”—and a full-court press on CMS staff and members of as you can read in our complete cover story analysis, the Congress by our members and staff. agency addressed changes to the Quality Payment Program Regarding long-term EEG monitoring services, we took the for 2020 and proposed a new program for 2021 that should initiative early this year to meet with CMS to explain the vital reduce administrative burden and be more meaningful than nature of these services for our patients. The AAN joined the current MIPS system. with the National Association of Epilepsy Centers, American Along with the analysis in the following pages, the AAN is Clinical Neurophysiology Society, and American Epilepsy providing additional resources to help you understand these Society, and advocated for several months to persuade CMS to changes. I hope you will take advantage of the free webinar, maintain maximum reimbursement. After the agency issued “EEG and E/M Coding Updates,” the Academy is offering on its proposed rule last summer, we met with them again. We December 12. Check the cover of this issue for more details lobbied members of Congress to help apply pressure on our about this live event and our expert panel. Please visit AAN. behalf. Despite a tremendous amount of work, we did not com for more information on the effects of the 2020 Medicare negate the proposed reductions as much as we would have Fee Schedule and be sure to read the January AANnews® for a hoped. But we did convince CMS that it undervalued EEG deeper review of changes for the 2020 MIPS reporting year. services in its original proposal and it will increase the rates for E/M was a tremendous win. You can be proud of the amount of several of the professional component codes, helping to offset time and effort volunteer members and staff put into this long the reimbursement cuts. In fact, CMS specifically cited the process, and the respect we have from CMS when we advocate AAN’s comment letter as the reason they changed their mind, on your behalf.  validating our regulatory advocacy efforts.

We were more successful on E/M, completing a long quest begun last year when we successfully dissuaded CMS from collapsing E/M levels and reducing reimbursement (work that was recognized by the American Association of Medical Society Executives with its Profiles of Excellence Award).

As CMS revisited the subject this year, we again met with officials and staff and addressed our concerns in our written

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AANnews • December 2019

James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter

Tools & Resources

Study Examines Quality Measures Impact at an Epilepsy Clinic The paper “Implementation of Quality Measures and Patient Reported Outcomes in Routine Clinical Care: How to Assess and Improve Care at an Epilepsy Clinic” was published in the online Neurology ® journal on October 30 and in the November 26 print issue.

This manuscript was based on a study funded by the AAN that examined the associations between patient-reported epilepsy quality measures and physical and mental health.

The study demonstrates how a reporting system based on the AAN epilepsy quality measurement set can be used to augment the typical verbal encounter between clinician and patient to identify important problems. The key findings include: Patients who report continued seizures, side effects from medications, and poor medication adherence due to cost have reduced scores on physical and mental health The driving rate in patients with recent seizures has decreased over the past two decades but still demonstrates a concern

Neurology.org

Read more about the study at Neurology.org. 

What You Need to Know about Physician Compare and the Axon Registry Physician Compare is an initiative created by the Centers for Medicare & Medicaid Services (CMS) in 2010 as part of the Affordable Care Act and is CMS’s source for publicly reporting performance data on a subset of quality measures from the Quality Payment Program (QPP). CMS began reporting physician performance data in 2012 with a small number of measures from the Physician Quality Reporting System (PQRS). The public reporting initiative has expanded since 2012 to include measures collected via accountable care organizations, electronic health records, registries, and claims. Publicly reported performance information submitted through Qualified Clinical Data Registries (QCDRs) occurred for the first time in 2016. and will be publicly reported on Physician Compare. Data will be available in late 2019. These measures are:

CMS determines which quality measures should be publicly reported on Physician Compare based on an analysis of which measures are comparable across submission mechanisms, have met the threshold for benchmark creation, and have met public reporting standards. Annually, CMS reviews quality measure performance data for the prior year. In the summer each year, CMS notifies the public which measures met the review criteria in order to be added to Physician Compare.

For the Axon Registry ® to be a CMS-approved QCDR, it must identify how it will publicly report performance data submitted for QPP reporting, and Axon Registry has selected Physician Compare for the public reporting. In 2017, CMS selected QPP quality measure “Depression and Anxiety Screening for Patients with Epilepsy” to be reported on Physician Compare. For 2018 QPP quality measures reported, CMS informed the AAN in July 2019 that five measures were selected from Axon Registry

Diabetes/Pre-Diabetes Screening for Patients with DSP DSP Screening for Unhealthy Alcohol Use Depression and Anxiety Screening for Patients with Epilepsy Medication Prescribed for Acute Migraine Attack Exercise and Appropriate Physical Activity Counseling for Patients with MS As the Axon Registry continues to evolve, measure performance data reported in Physician Compare will continue to expand to reflect current measures. To learn more about the Axon Registry and how to enroll, visit the Axon Registry webpage at AAN.com/view/Axon or contact Arnel Rillo at arillo@aan.com. To address any questions you may have, contact registry@aan.com. More information about Physician Compare can be found on the CMS Physician Compare Initiative webpage. 

Dementia: Caregiver Education and Support Falls: Querying About Falls for Patients Headache: Medication Prescribed for Acute Migraine Attack

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Parkinson's: Psychiatric Symptoms Assessment ALS: End of Life Planning Assistance

AANnews • December 2019 5

Tools & Resources

Understanding How You Get Paid: Part 4 The Medicare Physician Fee Schedule Final Rule (published annually in November) sets the final payment rates for the following calendar year, including new codes such as the long-term EEG monitoring codes. Details of the final payment rates are available at AAN.com/view/MedicareNews. All coding changes are effective January 1 and in this final article of the series we will look in detail on how to bill for long-term EEG monitoring services. to site of service; rather, it is differentiated by the timing of physician’s report generation:

Starting January 1, 2020, the following CPT codes for reporting long-term EEG monitoring services will be deleted and should no longer be reported:

95717, 95718, 95719, and 95720 are reported when diagnostic interpretations and professional reports are generated daily (even if the study extends over multiple days) and the physician has access to the data throughout the recording period.

 95951  95953  95956 95950 As a reminder, the new long-term EEG monitoring code set requires the reporting of separate codes for the physician work and the technologist work. Given the number of new codes for 2020, there is not a “1 to 1” crosswalk from the old structure to the new, meaning there will be multiple potential code options to report a service previously billed with a single CPT code. 

95721, 95722, 95723, 95724, 95725, and 95726 are reported when the entire professional interpretation is performed after the entire study is recorded and downloaded at the completion of the recording, and the physician does not have access to the data throughout the recording period.

Professional Services Let’s first look at the professional component codes, or those reported for the physician work. The code set is not specific

Code selection within these categories is dependent on length of recording and whether simultaneous video recording is captured.

2020 Long-term EEG Professional Services (Professional Component Codes) Duration of LTEEG 2 to 12 hours recording Professional Typical 8 hours Service

12 to 26 hours recording Typical 24 hours

36 to 60 hours recording Typical 2 Days

60 to 84 hours recording Typical 3 Days

Greater than 84 hours recording Typical 4 Days

Recording Type

Reports are generated daily—Physician access to data throughout recording

Entire report is retroactively generated—Physician access to data at end of recording

EEG Alone

95717

95719*

95721

95723

95725

EEG With Video

95718

95720*

95722

95724

95726

* 95719 and 95720 are reported for each 24-hour recording period. Additional units are reported for each 24-hour period.

2020 Long-term EEG Technical Services (Technical Component Codes) 95700 (1) Set Up Code Billed—Set Up Includes Take Down Recording Type

EEG Alone

EEG With Video

6

Unmonitored Or 13+ patients monitored

Intermittent Or 5 to 12 patients monitored

Continuous Or up to 4 patients monitored

2 to 12 hours recording Typical service is 8 hours

95705

95706

95707

2 to 12 hours recording Typical service is 24 hours

95708

95709

95710

2 to 12 hours recording Typical service is 8 hours

95711

95712

95713

12 to 26 hours recording Typical service is 24 hours

95714

95715

95716

Duration of LTEEG

AANnews • December 2019

Technical Services The technical component codes, or those reported for the technologists’ work, also can be reported in any site of services. A single code (95700) includes set up, take down (when performed) and patient/caregiver education by the EEG technologist(s) and should only be reported once per recording period.

Monitoring codes are differentiated by the duration of the recording, whether video is utilized, and the level of technologist monitoring as defined below: Unmonitored—Services that have no real-time monitoring by an EEG technologist during the continuous recording, or the number of patients being intermittently monitored exceeds 12.

CPT® is a registered trademark of the AMA. Visit AAN.com/view/cpt for several additional resources including: A full description of the long-term EEG monitoring code language (also on pages 10–11 in this issue).

Case studies to ensure you are coding correctly.

Read the previous AANnews® articles in this coding series: February 2019: The AAN’s Role in Advancing Coding and Reimbursement for Neurology May 2019: Understanding How You Get Paid: Part 1 July 2019: Understanding How You Get Paid: Part 2 September 2019: Understanding How You Get Paid: Part 3 

Intermittent monitoring (remote or on-site)— Requires an EEG technologist to perform and document real-time review of EEG data at least every two hours during the entire recording period. A single technologist may monitor a maximum of 12 patients concurrently.

Continuous real-time monitoring (may be provided remotely)—Requires an EEG technologist to perform and document real-time concurrent monitoring of the EEG data during the entire recording period. A single technologist may monitor a maximum of four patients concurrently.

Code selection within these categories is dependent on length of recording and whether simultaneous video recording is captured.

Entertainer Fights Chronic Migraine Through Advocacy Kristin Chenoweth, the renowned Broadway singer and actress, had her first migraine attack when she was 25. Since then, she’s been diagnosed with chronic migraine. The December/January Brain & Life® feature story chronicles her journey from silence to advocacy. A sidebar article looks at the newest drugs and how patients and doctors can determine which is the right medication.

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Just se becauan’t you c igraine see mn’t mean does sn’t it doe exist.”

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The magazine covers additional topics such as weight training to improve balance, strength, and walking; which vitamins are best for which neurologic conditions; and how, if, and when to disclose a neurologic condition to employers.

imer’s Alzhe Keep How to Safe PeopleKitchen e in th ure Disclos Work You Tell Should ployer Em ur Yo Your About tion?

Condi ion Nutrit al Deal The Re lements on Supp

— B R AO

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Another article explores the benefits of cooking to combat cognitive decline and profiles cookbook author Paula Wolfert, who, despite a diagnosis of Alzheimer’ disease, collaborated on a hybrid biography/cookbook. This profile of Wolfert includes tips on how to cook safely with someone who has Alzheimer’s as well as three simple recipes to try on BrainandLife.org.

KRIS

HEN TI N C

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Brain & Life magazine is free for AAN members in the United States to distribute to patients, who also can subscribe for free. If you would like to adjust the number of copies you receive for your patients or update your clinic address, email BeGreen@WasteFreeMail.com.

All members have online access to the magazine articles and additional resources at BrainandLife.org. Please share the website with your patients! 

TH

AANnews • December 2019 7

Tools & Resources

Ordering Diagnostic Imaging for Your Patients? Begin Consulting AUC to Avoid Prior Authorization On January 1, 2020, the Centers for Medicare and Medicaid Services (CMS) will begin its “educational and operations testing period” of the legislation requiring clinicians ordering advanced diagnostic imaging to consult appropriate use criteria (AUC) via a qualified clinical decision support mechanism (CDSM).

Background

Priority Clinical Areas

The program, part of 2014’s Protecting Access to Medicare Act, was created to maximize clinical outcomes and reduce costs by decreasing the number of inappropriate imaging studies ordered. The implementation date was pushed back several times, due in part to advocacy efforts of the AAN and other medical societies. Since 2014, the AAN has written several comment letters and met with high-ranking officials at the Department of Health and Human Services to express concerns about the program’s efficacy and increased administrative burden on ordering physicians. In response, CMS has delayed implementation to allow practices and industry members, such as EHR vendors, time to prepare for the launch of this regulation.

What CMS Will Require To reimburse a claim for advanced diagnostic imaging such as MRI, CT, PET, and nuclear medicine, CMS will require furnishing physicians/practices to submit modifier codes indicating which CDSM was consulted, the AUC adherence, and the ordering physician’s NPI. Ordering physicians/practices will need to provide this information to the furnishing physician with the study order. The AAN recommends consulting with your EHR and coding support teams on how this will affect your specific documentation workflows. Because financial reimbursement depends on providing CMS with the necessary

ORDERING PHYSICIAN/PRACTICE

Headache Low back pain Cervical or neck pain

Coronary artery disease Suspected pulmonary embolism Hip pain Shoulder pain Lung cancer

documentation, furnishing physicians may refuse to perform studies requested by clinicians who fail to include information about AUC consultation. As of June 2019, CMS has qualified 15 CDSMs and granted preliminary qualification to an additional seven entities through which physicians can consult AUC. Visit CMS.gov to find the full list of qualified CDSMs. Several of the qualified CDSMs integrate with EHR software or offer free webbased options. The AAN recommends consulting with your EHR vendor for information on qualified CDSMs that integrate best into your practice workflows.

During 2020’s testing period, CMS will continue to reimburse claims regardless of AUC consultation and documentation.

FURNISHING PHYSICIAN

CMS

 Consult AUC via CDSM

 Perform advanced imaging study

 Reimburse furnishing physician

 Document CDSM with appropriate

 Document CDSM consulted,

 Monitor eight priority clinical

G-codes

 Document AUC adherence with

appropriate modifiers

AUC adherence, and ordering physician's NPI

 Submit claim

areas to identify outliers

 2021: Deny claims without

AUC consultation

 2021:

Require identified outlying ordering physciains to request a prior authorization for advanced imaging

8

AANnews • December 2019

What Will Happen in 2021 Beginning in 2021, CMS may deny claims without appropriate CDSM consultation, AUC adherence, and ordering physician NPI documentation. CMS also will review advanced imaging utilization for eight priority clinical areas, including headache (traumatic or nontraumatic), low back pain, and cervical or neck pain. Data gathered from these areas will be used to identify outlying ordering physicians. After the testing period, up to the top 5 percent of outlying ordering clinicians may be required to request prior authorizations when ordering imaging studies on Medicare patients; additional penalties and enforcement dates have not been published.

Exemptions There are some exemptions to this program. Imaging studies obtained during a medical emergency or inpatient services billed to Medicare Part A do not require AUC consultation. Services furnished in federally qualified health centers or critical access hospitals are also exempt.

Some physicians may also qualify for exemptions due to significant hardships, such as limited internet access, EHR or CDSM vendor issues, or extreme and uncontrollable circumstances. CMS has not yet published criteria or details on how to attest to these hardships.

Attend Free December 12 Webinar on EEG and E/M Coding Updates continued from cover

EEG and E/M Coding Updates Faculty: Korwyn Williams, MD, PhD, FAAN; Marianna V. Spanaki-Varelas, MD, PhD; Neil A. Busis, MD, FAAN December 12 at 12:00 p.m. ET. Register by December 11 at AAN.com/view/pmw19.

There will be time for questions and answers from our expert panel members following the presentation. Any additional questions can be answered after the webinar by sending them to practice@aan.com. And, by attending this webinar, AAN members can earn one CME or CMPE credit. 

DECEMBER

12

The AAN will continue to monitor CMS program announcements. To stay up-to-date on regulations that may impact you and the AAN’s response, visit AAN.com/view/MedicareNews and watch for AAN communications in your inbox. 

Neurology® Podcasts: 20 Minutes Pack a Punch!

Download the latest podcast at neurology.org/podcast

AANnews • December 2019 9

Tools & Resources

New 2020 Long-term EEG Monitoring CPT Coding Structure CPT® codes, descriptions, and other data only are copyright 2020 American Medical Association. All Rights Reserved. CPT is a trademark of the American Medical Association (AMA).

2020 Coding Structure: Long-term EEG Monitoring codes 95950, 95951, 95953, and 95956 will be deleted for 2020 and should no longer be reported.

Professional component (physician work) 95717–95726 and technical component (technologist work) 95700, 95705–5716 of the services will now be reported separately.

Technical Services

Long-term EEG Setup 95700 Electroencephalogram (EEG) continuous recording, with video when performed, setup, patient education, and takedown when performed, administered in person by EEG technologist, minimum of 8 channels (95700 should be reported once per recording period) (For EEG using patient-placed electrode sets, use 95999) (For setup performed by non-EEG technologist or remotely supervised by an EEG technologist, use 95999) Monitoring 95705 Electroencephalogram (EEG), without video, review of data, technical description by EEG technologist, 2–12 hours; unmonitored 95706 With intermittent monitoring and maintenance 95707 With continuous, real-time monitoring and maintenance

95708 Electroencephalogram (EEG), without video, review of data, technical description by EEG technologist, each increment of 12–26 hours; unmonitored 95709 With intermittent monitoring and maintenance 95710 With continuous, real-time monitoring and maintenance 95711 Electroencephalogram with video (VEEG), review of data, technical description by EEG technologist, 2–12 hours; unmonitored 95712 With intermittent monitoring and maintenance 95713 With continuous, real-time monitoring and maintenance 95714 Electroencephalogram with video (VEEG), review of data, technical description by EEG technologist, each increment of 12–26 hours; unmonitored 95715 With intermittent monitoring and maintenance 95716 With continuous, real-time monitoring and maintenance

(95705, 95706, 95707, 95711, 95712, 95713 may be reported a maximum of once for an entire longer-term EEG service to capture either the entire time of service or the final 2–12 hour increment of a service extending beyond 26 hours)

Professional Services 95717 Electroencephalogram (EEG), continuous recording, physician or other qualified health care professional review of recorded events, analysis of spike and seizure detection, interpretation and report, 2–12 hours of EEG recording; without video 95718 With video (VEEG) (For recording greater than 12 hours, see 95719, 95720, 95721, 95722, 95723, 95724, 95725, 95726) (95717, 95718 may be reported a maximum of once for an entire long-term EEG service to capture either the entire time of service or the final 2–12 hour increment of a service extending beyond 24 hours)

95719 Electroencephalogram (EEG), continuous recording, physician or other qualified health care professional review of recorded events, analysis of spike and seizure detection, each increment of greater than 12 hours, up to 26 hours of EEG recording, interpretation and report after each 24-hour period; without video 95720 With video (VEEG)

(95719, 95720 may be reported only once for a recording period greater than 12 hours up to 26 hours. For multiple-day studies, 95719, 95720 may be reported after each 24-hour period during the extended recording period. 95719, 95720 describe reporting for a 26-hour recording period, whether done as a single report or as multiple reports during the same time)

(95717, 95718 may be reported in conjunction with 95719, 95720 for studies lasting greater than 26 hours)

(Do not report 95717, 95718, 95719, 95720 for professional interpretation of long-term EEG studies when the recording is greater than 36 hours and the entire professional report is retroactively generated, even if separate daily reports are rendered after the completion of recording)

(When the entire study includes recording greater than 36 hours, and the professional interpretation is performed after the entire recording is completed, see 95721, 95722, 95723, 95724, 95725, 95726)

Free e-Book Examines Child Neurology Cases Child Neurology: A Case-based Approach, a collaboration between the AAN and the Child Neurology Society (CNS), is a collection of reprinted cases from the past 15 years from the Neurology ® Resident & Fellow Section. This invaluable resource for both adult and pediatric neurologists and trainees can be downloaded for free at NPub.org/cnbook.

Edited by John J. Millichap, MD, and Roy E. Stroud III, MEd, MD, of the Neurology R&F Section and Jonathan W. Mink, MD, PhD, and Phillip L. Pearl, MD, of the Child Neurology Society, each section of the book is dedicated to a specific child neurology discipline, such as epilepsy, stroke, etc. Experts from the AAN and CNS and Neurology Resident & Fellow team members introduce each chapter with adult and pediatric perspectives on presented cases. 

95721 Electroencephalogram (EEG), continuous recording, physician or other qualified health care professional review of recorded events, analysis of spike and seizure detection, interpretation, and summary report, complete study; greater than 36 hours, up to 60 hours of EEG recording, without video 95722 Greater than 36 hours, up to 60 hours of EEG recording, with video (VEEG) 95723 Greater than 60 hours, up to 84 hours of EEG recording, without video 95724 Greater than 60 hours, up to 84 hours of EEG recording, with video (VEEG) 95725 Greater than 84 hours of EEG recording, without video 95726 Greater than 84 hours of EEG recording, with video (VEEG)

(When the entire study includes recording greater than 36 hours, and the professional interpretation is performed after the entire recording is completed, see 95721, 95722, 95723, 95724, 95725, 95726)

(Do not report 95721, 95722, 95723, 95724, 95725, 95726 in conjunction with 95717, 95718, 95719, 95720) 

AANnews • December 2019 11

Policy & Guidelines

Medicare Delivers Major Changes for Neurology E/M and EEG continued from cover services. We met with CMS proactively about these services in early 2019 and then a second time after the proposed rule over the summer of 2019. We met directly with the CMS staffers who write the final rule.

Our advocacy worked: CMS recognized its original proposal devalued the services and have increased the rates for several of the professional component (physician work) codes. While pleased that we were able to slightly offset the cuts, we still are disappointed with the overall decreased reimbursement.

These payment rates will be finalized for 2020.

CMS has also withdrawn its proposed rates for the technical component (technologist work) codes in favor of contractor pricing for 2020, meaning those rates will be set by regional Medicare Administrative Contractors for their geographic jurisdiction and negotiated between private payers and providers. CMS will revisit the possibility of establishing national values for the technical services in future rulemaking.

Contractor Pricing

The long-term EEG monitoring technical component (TC) codes will be contractor-priced codes for 2020 as CMS did not finalize national payment rates for these services. This means Medicare Administrative Contractors (MACs) and private payers establish RVUs and payment amounts for the services. MAC contracted pricing will be set by each regional MAC and is not negotiable. For private payers, it is recommended members review their coverage policies with payers to ensure coverage and discuss rate negotiation with their payer representative.

The AAN recognizes there are different patient populations that require long-term EEG monitoring services, including ambulatory or in-home testing which should also be valued appropriately. As remote services become increasingly more

12

AANnews • December 2019

common, we will continue to monitor their use and advocate for reimbursement accordingly.

In the meantime, the Academy is transitioning from fighting the cuts to ensuring members are educated on the coding changes and understand the financial impact for accurate budgeting.

Major Positive Changes to the Evaluation and Management Codes In a major victory for neurology, CMS will not collapse the payment levels for evaluation and management (E/M) visits and will instead implement revised office E/M documentation guidelines in 2021, as recommended by the AMA CPT Editorial Panel.

Academy members and staff committed extensive resources over the past year to work with CMS and the AMA to build a new E/M structure that will meet the needs of neurologists and their patients.

The AAN estimates that the combined impact of the changes will result in an increase of approximately $150 million annually in Medicare payments to neurologists for E/M services starting in 2021, as compared to what was proposed in the 2019 Physician Fee Schedule.

The revised guidelines maintain the existing five levels of coding for established patients and reduces the number of levels for new patients to four, by eliminating 99201.

The changes also will give clinicians the option of using either medical decision making or time when billing for office E/M visits.

Additionally, in 2021, CMS will implement a new add-on code for prolonged physician service time in 15-minute increments and a separate add-on code to recognize the complexity inherent to E/M services that are part of ongoing care related to a patient’s single, serious, or complex chronic condition.

The Academy lauds CMS for finalizing the revised E/M proposal as it represents a substantial reversal from previous proposals that posed a significant threat to cognitive reimbursement. The AAN appreciates CMS’ attention to the AAN’s advocacy as well as CMS’ understanding that cognitive care must be sufficiently reimbursed to ensure continued patient access to these critical services.

Changes to Care Management Services CMS is making changes to several care management services for 2020, including increased payment for transitional care management (TCM) and eliminating billing restrictions on several codes that cannot currently be billed during the 30-day period.

CMS is creating new codes for principal care management (PCM) services. These new codes account for care management associated with patients with a single high-risk disease or complex chronic condition.

The AAN commends the agency for continuing to recognize the additional care provided to complex patients that occurs outside of a typical face-to-face encounter.

QPP The final rule also contains annual updates to the Quality Payment Program (QPP), which includes the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) tracks.

deemed eligible to participate in 2019 can expect to continue reporting next year. In 2020, clinicians must meet a 45-point threshold to avoid a negative payment adjustment and must achieve 85 points to receive an exceptional bonus payment.

MIPS component weights will remain the same in 2020 as 2019, with Quality remaining as the highest component weight at 45 percent.

The rule finalized a new framework called MIPS Value Pathways (MVPs) to begin in 2021 and are defined as aligned sets of measures and activities based around a clinical specialty or clinical condition. In the final rule, CMS indicates it will work closely with stakeholders, including specialty societies, to ensure MVPs are more meaningful and less burdensome for clinicians to participate in compared to MIPS. The AAN looks forward to working with CMS on MVP development to ensure neurologists can successfully participate in the new framework and appreciates the collaborative opportunity moving forward. 

For the 2020 MIPS performance year, there are no changes to the MIPS low-volume threshold, indicating that most clinicians 19 Online Learning Center Graphic Ad—Half Page Horizontal> AN Placed in AANnews 8.25 x 5.25 +0.125 bleed, 4C

YOUR SOURCE FOR AAN CONTINUING MEDICAL EDUCATION

ONLINE LEARNING CENTER

AAN.com/view/LearningCenter

14

Policy & 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.

Below are some recent highlights.

We Saved E/M! Member Perspective by Brad C. Klein, MD, MBA, FAAN, Chair of AAN’s Medical Economics and Practice Committee As a cognitive specialty, neurologists are at our best when we can spend time with patients, talking with them about their symptoms, taking their history, and performing the exam. For years, that time has been undervalued. With the new documentation guidelines and payment for E/M office visits coming in 2021, the value given to that time is taking a huge leap forward. We’ve worked hard for years to show the Centers for Medicare & Medicaid Services (CMS) that reimbursement for the complex work of E/M needs to increase, and our efforts are paying off. The release of the final rule for the 2020 Medicare Physician Fee Schedule is a clear sign they heard our concerns. CMS responded by adopting the E/M documentation guidelines in 2021 as recommended by the AAN and the AMA CPT Editorial Panel. We’ll spend the next year educating members how to use the new documentation guidelines, the ability to code by time or medical decision making, as well as using the new add-on codes for complex patients and prolonged services. Find more E/M resources at AAN.com/view/EM. Of course, our patients also require tests and other services.

Long-term EEG monitoring is a vital test for diagnosing and treating epilepsy. Like many other procedures across medicine, it came under the radar of CMS and has gone through a code set restructuring and new payment values for 2020. CMS responded to our advocacy efforts, and for several of the professional component (physician work) codes, it has increased the rates from the agency’s original proposal.

Because the entire way of coding is different, it’s not easy to do a one-to-one comparison of old values to new values.

Practices will need to look at how they provide services, how they’ll report under the new codes, and compare the

AANnews • December 2019

amount of the contractor-pricing payment. We know the new payments will create a hardship for practices serving people with seizures and epilepsy and we will ensure that members understand the financial impact for accurate budgeting.

Read the article at AAN.com/view/UnderstandPay to better understand the new long-term EEG code set.

Read the full summary of the physician fee schedule final rule at AAN.com/view/FinalRule. Find more information about new payment rates on the AAN’s Medicare Fee-for-Service page at AAN.com/view/medicare. Sign up for our December 12 free webinar on EEG and E/M Coding Updates in 2020 at AAN.com/view/FreeWebinar.

Complete the AAN Advocacy Annual Priorities Survey Every year, the AAN surveys its members on issues important to them to inform the Advocacy Committee as it sets the organization’s advocacy priorities for the upcoming year.

Please complete the 2020 Advocacy Priorities annual survey at AAN.com/view/AdvocacySurvey. This brief survey is a unique opportunity to influence AAN advocacy efforts in the coming year and provide valuable feedback.

AAN Comments on Prior Authorization On November 5, the AAN submitted comments (available at AAN.com/view/ProgramIntegrity) in response to a request for information from CMS (AAN.com/view/CMSInfo) in relation to the administrative burdens associated with prior authorization.

The AAN’s comments provided the agency with a number of recommendations for how to reduce the burdens associated with prior authorization in future rulemaking. The AAN is committed to reducing the regulatory and administrative burdens faced by neurologists so that patients have timely access to needed care and so that wasteful and unnecessary administrative costs are reduced. 

Conferences & Community

The World’s Best Neurology Meeting Is Coming to One of the World’s Most Diverse Cities Register by March 5 for the best rates

AAN.com/view/AM20

Vote for Section Chair/Vice Chairs This Month Members of the following AAN Sections will have an opportunity to cast their votes for new section chair and vice chair positions when voting opens later this month.

Keep an eye out for email announcements with links to the online voting.

A.B. Baker Section on Neurological Education Adults with Intellectual & Developmental Disabilities Section Clinical Neurophysiology Section Epilepsy Section General Neurology Section Geriatric Neurology Section Global Health Section Government Service Section LGBTQI Section Movement Disorders Section Multiple Sclerosis Section Neural Repair & Rehabilitation Section Neuroendocrinology Section Neuroepidemiology Section Neurohealth & Integrative Neurology Section Neuro-oncology Section Neuro-ophthalmology/Neuro-otology Section Sleep Medicine Section Spine Section Sports Neurology Section Women's Issues in Neurology Section In their new positions, the chair and vice chair will collaborate to use SynapseSM to engage members, share information with other chairs and provide updates and information to section members, attend the Section Leadership Summit at the Annual Meetings, and set and report on section goals and progress to the Section and Subspecialties Subcommittee.

The AAN has 38 sections in a wide range of subspecialties and interest areas, and nearly one-third of AAN members already belong to at least one section. Through sections, members can engage in vibrant conversations and idea exchanges on professional-related topics and issues, share expertise on patient care, and discuss timely news and science affecting the field of neurology.

If you have any questions, please contact sections@aan.com. 

April 25 – May 1 • Toronto, Canada

AANnews • December 2019 15

Conferences & Community

Diversity Leadership Program Builds Confidence in Graduate to Seize New Challenges “As you grow in leadership you will continue to grow in the ability to affirm yourself and not seek external validation.”

These powerful words, as expressed by her AAN Diversity Leadership executive consultant Joanne Smikle, PhD, resonated deeply with Ima M. Ebong, MD, throughout her 10 months in the program—and have served as a source of inspiration, motivation, and guidance ever since.

“The most important thing that I learned from the Diversity Leadership Program is to affirm my own successes,” explained Ebong, a neurologist in clinical neurophysiology at the University of Kentucky in Lexington. “By learning how to affirm my own successes, I have not only empowered myself by being positive about my career and personal life, but I have also empowered those around me to pursue opportunities that they may not have.”

And empowered she is. Since participating in the program, Ebong has enthusiastically seized leadership roles within her own department, as well as in the College of Medicine. “I was named the director of diversity and inclusion of the department of neurology and am also a member of the University of Kentucky Faculty of Color Network Executive Committee,” she said. “And since I returned to the University of Kentucky as faculty, I have become the faculty advisor for the University of Kentucky Medical Education Development program—a program that I started 10 years ago as a first-year medical student—whose purpose is to recruit underrepresented premedical students to the College of Medicine.”

Most recently, Ebong was recognized with the distinguished 2019 Lyman T. Johnson Torch of Excellence Award from the University of Kentucky College of Medicine. “Each college within the University of Kentucky selects one black/African-

16

AANnews • December 2019

American alumnus or alumna whose faith, hard work, and determination has positively affected the lives of people of the University of Kentucky campus, the city of Lexington, the state of Kentucky, or the nation, so this was a huge honor,” said Ebong.

As a result of the Diversity Leadership Program, Ebong says she has become more confident about her own knowledge and expertise in the field of neurology, too, as well as topics pertaining to diversity and inclusion. “I am not afraid to use my voice to convey my thoughts and ideas—whether as an invited speaker or panelist at a world-renowned medical institution, via podcasts, or through my professional social media account on Twitter: @ImaEbongMD.” It’s no surprise that Ebong’s newfound affirmation and confidence has proven infectious. “I have since inspired colleagues—particularly women—to apply for leadership programs within the AAN.” The AAN Diversity Leadership program is a crucial aspect of the AAN’s leadership diversification strategy intended to identify, mentor, and engage AAN members from underrepresented groups. The program provides a meaningful developmental experience that fully engages up to 10 AAN members from underrepresented neurology groups to build self-confidence, relationships, and camaraderie; reduce burnout; hone presentation and management skills; increase AAN engagement; and more through personalized coaching and leadership development training by an executive consultant, individualized mentoring by a neurology leader, and an AAN Board-assigned group project and presentation to the AAN Board of Directors. Learn more at AAN.com/view/DLP. 

New Conference for Advanced Practice Providers Is a Hit, Fall Conference Draws Record Attendance The new conference designed for Advanced Practice Providers (APP) drew strong interest, with more than 170 attendees for the October conference in Las Vegas. Many also attended the Fall Conference, which started the following day and attracted record attendance, with more than 750 attendees.

Annika Ehrlich, NP, enjoyed the APP Pre-conference. “I appreciate and value that the AAN is advancing efforts for its APP population,” said Ehrlich. “It’s a growing segment of the AAN (potentially the largest growing segment) and I really feel like a valued member seeing them invested in our needs. You don’t see that in a lot of associations. Not to mention, the conference and the content are relevant and fun!”

Pamela R. Kinder, MD, and Hema Subbaratnam, MD, attended the Fall Conference. Kinder said, “We really appreciate the fast pace of this conference. It makes it easy to check back and review material if needed, without a big time investment.” 

Specially Priced Memberships for Your Advanced Practice Providers!

The recent Pre-conference for Advanced Practice Providers was just one of many ways the AAN helps your valuable care team increase their knowledge and skills to make your practice more successful. A stronger, more knowledgeable care team helps increase patient volume, improve quality of care, and enhance physician focus. Visit AAN.com/view/CareTeam to give your APPs the edge to grow and thrive throughout their professional lifetimes with $275 APP PLUS membership that includes: Complete online education courses through the AAN at no additional cost Access to the Neurology ® journal, Neurology ® Clinical Practice, and Neurology Today® Opportunities to connect with a network of advanced practice providers, neurologists, and neuroscience professionals worldwide through SynapseSM Online Communities Big savings on AAN conference registration, Continuum®, and other AAN products and services $120 memberships offer many of the same membership benefits, excluding online education courses, Neurology journal (print and online), and Neurology Today (print). 

Pamela R. Kinder, MD, left, and Hema Subbaratnam, MD

AANnews • December 2019 17

FOR THE TREATMENT OF RELAPSING FORMS OF MS

START STRONG. STAY STRONG.

In the 2-year DEFINE and CONFIRM pivotal trials, Tecfidera® (dimethyl fumarate) demonstrated a 53% and 44% relative reduction in annualized relapse rate (ARR) vs placebo, respectively (0.172 vs 0.364; P<0.0001), (0.224 vs 0.401; P<0.0001)1

INDICATION

Tecfidera® (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care.

Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The 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

©2019 Biogen. All rights reserved. 09/19 TEC-US-3189 v5

confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms.

TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months.

In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved.

Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances.

THE #1 PRESCRIBED oral RMS therapy in the US since September 2013 Based on number of prescriptions from IMS NPATM Weekly Data (September 27, 2013 - August 9, 2019).

>415,000

people have been treated with TECFIDERA worldwide2

This includes clinical trial use and patients prescribed TECFIDERA

>780,000

global patient-years of experience2

This includes clinical trial use and patients prescribed TECFIDERA

>11 Years

of combined clinical trial and real-world experience1,2

Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting.

The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.

These abnormalities resolved upon treatment discontinuation.

Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.

TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials.

Please see following pages for Brief Summary of full Prescribing Information.

Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity.

Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization.

Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing.

A transient increase in mean eosinophil counts was seen during the first two months.

TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com.

Study Designs1 DEFINE: A 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with RRMS. Secondary endpoint: ARR. CONFIRM: A 2-year, multicenter, randomized, double-blind, placebo-controlled study in 1417 patients with RRMS. Primary endpoint: ARR. DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS3; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis4; RRMS=relapsing-remitting multiple sclerosis.

References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Data on file, Biogen. 3. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107.

4. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097.

To get started, simply fill out a Start Form at

www.tecfiderahcp.com

Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use Brief Summary of Full Prescribing Information Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use 1 INDICATIONS AND USAGE Brief Summary of Full Prescribing Information TECFIDERA is for treatment relapsing forms ® is indicated indicated forthe the treatmentof of patients with relapsing Tecfidera (dimethyl fumarate) delayed-release capsules, for of oral use 1 INDICATIONS multiple (MS),USAGE to include clinically isolated syndrome, forms of sclerosis multiple AND sclerosis.

Brief Summary of Full Prescribing Information relapsing-remitting disease, and active secondary progressive TECFIDERA is indicated for the treatment of patients with relapsing 2 DOSAGE AND ADMINISTRATION disease, in adults.

1forms INDICATIONS AND USAGE of multiple sclerosis.

2.1 Dosing Information TECFIDERA is indicated for the treatment of patients with relapsing 2 DOSAGE AND ADMINISTRATION The starting dosesclerosis. for TECFIDERA is 120 mg twice a day orally. After 7 forms of multiple 2.1 Dosing Information days, the dose should be increased to the maintenance dose of 240 mg 2twice DOSAGE a dayAND orally.

Temporary doseisreductions to 120 mgorally. twiceAfter a day The starting doseADMINISTRATION for TECFIDERA 120 mg twice a day 7 may be forbe individuals do maintenance not tolerate the maintenance 2.1 Dosing Information days, theconsidered dose should increasedwho to the dose of 240 mg dose.

Within 4 weeks, the recommended dose of 240 mg twice a day twice a day dose orally.forTemporary dose to 120 The starting TECFIDERA is reductions 120 mg twice a day orally. After 7 should be Discontinuation of should be may be forbe individuals domaintenance notTECFIDERA tolerate the maintenance days, theconsidered doseresumed. should increasedwho to the dose of 240 mg considered for patients unable to tolerate return to dose.aWithin 4 weeks, the recommended dosetoof120 240the mgmaintenance twice aa day day twice day orally.

Temporary dose reductions mg twice dose. flushing may reduced by the administration of should be incidence resumed.

Discontinuation TECFIDERA should be may beThe considered forofindividuals who be do of not tolerate maintenance TECFIDERA food.

Alternatively, administration ofmaintenance non-enteric considered patients to tolerate return to the dose.

Within for 4 with weeks, theunable recommended dose of 240 mg twice a day coatedThe aspirin (up to aofdose of 325may mg)be 30ofreduced minutes prior to TECFIDERA dose. flushing by administration of should be incidence resumed.

Discontinuation TECFIDERA should be dosing mayfor reduce the unable incidence or severity of flushing [see Clinical TECFIDERA with food.

Alternatively, administration non-enteric considered patients to tolerate return to theofmaintenance Pharmacology (12.3)]. coated aspirin (up to aofdose of 325 mg)be30reduced minutesby prior to TECFIDERA dose.

The incidence flushing may administration of dosing may reduce the or whole severity of flushing [see Clinical TECFIDERA should beincidence swallowed and intact.

TECFIDERA with food.

Alternatively, administration of TECFIDERA non-enteric Pharmacology (12.3)]. shouldaspirin not be (up crushed or chewed and 30 theminutes capsuleprior contents should not coated to a dose of 325 mg) to TECFIDERA be sprinkled onshould food.the TECFIDERA canseverity be taken or without food. dosing may reduce or of with flushing [see Clinical TECFIDERA beincidence swallowed whole and intact.

TECFIDERA Pharmacology (12.3)]. should not Tests be crushed or Initiation chewed and the capsule contents should not 2.2 Blood Prior to of Therapy be sprinkled on food. TECFIDERA canwhole be taken or without food.

TECFIDERA should be swallowed andwith intact.

TECFIDERA Obtain a complete blood cell count (CBC) including lymphocyte count should not be crushed or and capsule contents(5.3)]. should not 2.2 Blood Tests tochewed Initiation of the Therapy before initiation ofPrior therapy [see Warnings and Precautions be sprinkled on food. TECFIDERA can be taken with or without food.

Obtain complete blood cell count (CBC) lymphocyte Obtain aserum aminotransferase, alkalineincluding phosphatase, and count total 2.2 Blood Testsprior Prior Initiation of Therapy before initiation of therapy [see Warnings and Precautions (5.3)]. and bilirubin levels to to treatment with TECFIDERA [see Warnings Obtain a serum complete blood cell count (CBC) including lymphocyte Precautions (5.4)].

Obtain aminotransferase, alkaline phosphatase, andcount total before initiation of therapy [see Warnings and Precautions (5.3)]. and bilirubin levels prior to treatment with TECFIDERA [see Warnings 3 DOSAGE FORMS AND STRENGTHS Precautions (5.4)].

Obtain serum phosphatase, and total TECFIDERA is aminotransferase, available as hard alkaline gelatin delayed-release capsules bilirubin levels prior treatment with TECFIDERA [see Warnings and 3 DOSAGE FORMS AND STRENGTHS containing 120 mg orto240 mg of dimethyl fumarate. The 120 mg capsules Precautions (5.4)]. have a green cap and whiteas body, withdelayed-release “BG-12 120 mg”capsules in black TECFIDERA is available hardprinted gelatin on the 120 body.

240mg mgofcapsules a green andcapsules a green 3ink DOSAGE FORMS STRENGTHS containing mgThe orAND 240 dimethyl have fumarate.

The cap 120 mg body, “BG-12 240 mg” black with inkdelayed-release on the body. have aprinted greenwith capavailable and white printed “BG-12 120 mg”capsules in black TECFIDERA is asbody, hardin gelatin ink on the120 body.

240mg mgofcapsules have a green cap mg andcapsules a green containing mgThe or 240 dimethyl fumarate.

The 120 4 CONTRAINDICATIONS body,aprinted “BG-12 240 mg” printed in blackwith ink on the body. mg” in black have green with cap and white body, “BG-12 TECFIDERA is contraindicated in patients with known120 hypersensitivity ink on the body.

The 240 have a green cap and a green 4 CONTRAINDICATIONS to dimethyl fumarate or mg to capsules any of the excipients of TECFIDERA. body, printed with “BG-12 240 mg” in black ink on the body.

Reactions have included anaphylaxis and angioedema [see Warnings TECFIDERA is contraindicated in patients with known hypersensitivity and Precautions (5.1)]. or to any of the excipients of TECFIDERA. 4to CONTRAINDICATIONS dimethyl fumarate Reactions have included anaphylaxis and with angioedema [see Warnings TECFIDERA is AND contraindicated in patients known hypersensitivity 5 WARNINGS PRECAUTIONS and Precautions (5.1)].or to any of the excipients of TECFIDERA. to fumarate 5.1dimethyl Anaphylaxis and Angioedema Reactions haveAND included anaphylaxis and angioedema [see Warnings 5 WARNINGS PRECAUTIONS TECFIDERA can(5.1)]. cause anaphylaxis and angioedema after the first dose and Precautions 5.1 Anaphylaxis and Angioedema or at any time during treatment. Signs and symptoms have included 5TECFIDERA WARNINGS AND PRECAUTIONS difficulty breathing, urticaria, and swelling of the throat andfirst tongue. can cause anaphylaxis and angioedema after the dose Patients be instructed to Signs discontinue TECFIDERA seek 5.1 Anaphylaxis and Angioedema or at anyshould time during treatment. and symptoms haveand included immediatebreathing, medical care shouldand theyswelling experience signs and the symptoms of difficulty urticaria, of the throat andfirst tongue.

TECFIDERA can cause anaphylaxis and angioedema after dose anaphylaxis or angioedema.

Patients be instructed discontinue TECFIDERA seek or at any should time during treatment.toSigns and symptoms have and included immediate medical care should they experience signs and and symptoms of difficulty breathing, urticaria, and swelling of the throat tongue.

5.2 Progressive Multifocal Leukoencephalopathy anaphylaxis or angioedema.

Patients should be instructed to discontinue TECFIDERA and seek Progressive multifocal leukoencephalopathy (PML) has occurred in immediate medical care should they experiencePML signsisand of 5.2 Progressive Leukoencephalopathy patients with MSMultifocal treated with TECFIDERA. an symptoms opportunistic anaphylaxis or angioedema. viral infection of the brain caused by the JC virus (JCV) typically Progressive multifocal leukoencephalopathy (PML) has that occurred in onlyProgressive occurs patients whowith are immunocompromised, andopportunistic that usually 5.2 Multifocal Leukoencephalopathy patients within MS treated TECFIDERA. PML is an leadsinfection to death severe disability.

A the fatalJC case of (JCV) PML inina viral oforthe brain caused by virus that typically Progressive multifocal leukoencephalopathy (PML) hasoccurred occurred patient who received TECFIDERA for 4 years enrolled in a only occurs patients who areTECFIDERA. immunocompromised, and that usually patients withinMS treated with PML while is an opportunistic clinical During the clinical trial,byA the patient experienced prolonged leads totrial. death severe disability. fatal of(JCV) PML occurred in a viral infection ofor the brain caused the JCcase virus that typically 9 lymphopenia (lymphocyte counts predominantly <0.5x10 /L usually for in3.5 patient whoin received TECFIDERA for 4 years while a only occurs patients who are immunocompromised, andenrolled that years)towhile taking TECFIDERA [see Warnings and Precautions (5.3)]. clinical trial.

During the clinical trial, patient prolonged leads death or severe disability.

Athe fatal caseexperienced of PML occurred in a 9 The patient had no TECFIDERA othercounts identified medical conditions lymphopenia (lymphocyte predominantly <0.5x10 /L forin3.5 patient who received for systemic 4 years while enrolled a resulting inDuring compromised system function andprolonged had not years) while taking TECFIDERA [see and Precautions (5.3)]. clinical trial. the clinicalimmune trial, theWarnings patient experienced previously been treated with counts natalizumab, which has <0.5x10 a known9association The patient had no other identified systemic medical conditions lymphopenia (lymphocyte predominantly /L for 3.5 with PML. The patient was also not taking any and immunosuppressive or resulting in compromised immune system function and had not years) while taking TECFIDERA [see Warnings Precautions (5.3)]. immunomodulatory concomitantly. previously been treated with natalizumab, which hasmedical a known association The patient had nomedications other identified systemic conditions with The patient was also not taking any immunosuppressive or resulting compromised immune system function and had not PMLPML. has in also occurred in the postmarketing setting in the presence of immunomodulatory medications concomitantly.

9with natalizumab, previously been treated whichthan has a6 known association lymphopenia (<0.8x10 /L) persisting for more months.

While the with The occurred patientinwas also not taking anysetting immunosuppressive or role ofhas lymphopenia these cases is uncertain, theinmajority of cases PMLPML. also in the postmarketing the presence of immunomodulatory medications concomitantly.

9 lymphocyte occurred in patients with counts /L. lymphopenia (<0.8x10 /L) persisting for more<0.5x10 than 6 9months.

While the role of lymphopenia in in these cases is uncertain, theinmajority of cases PML has also occurred thesuggestive postmarketing setting the TECFIDERA presence of At the first sign or symptom of PML, withhold 9 9 occurred in patients with counts <0.5x10 /L. lymphopenia (<0.8x10 /L)lymphocyte persisting for more than 6 months.

While the and perform an appropriate diagnostic evaluation.

Typical symptoms role of lymphopenia in are these cases progress is uncertain, majority of cases associated with or PML diverse, overthe days toTECFIDERA weeks, and At the first sign symptom suggestive of PML, withhold 9 occurred in patients with lymphocyte counts <0.5x10 /L. include progressive weakness on one side of the body or clumsiness of and perform an appropriate diagnostic evaluation.

Typical symptoms limbs, disturbance of are vision, and changes in thinking, associated withorPML diverse, progress over days tomemory, weeks, and At the first sign symptom suggestive of PML, withhold TECFIDERA orientation leading toweakness confusion and personality include progressive on one side of thechanges. body or clumsiness of and perform an appropriate diagnostic evaluation.

Typical symptoms limbs, disturbance vision, and changes in thinking, and associated with PML are diverse, progress days tomemory, weeks,Cases and MRI findings may beofapparent before clinical over signs or symptoms. orientation leading to confusion and personality include weakness onefindings side of the body or clumsiness of of PML,progressive diagnosed based onon MRI andchanges. the detection of JCV limbs, disturbance ofapparent vision,fluid and in thinking, memory, and DNAfindings in the may cerebrospinal inchanges the absence ofsymptoms. clinical signs or MRI be before clinical signs or Cases orientation leading confusion and personality changes. symptoms specifictotobased PML, on have been reported inthe patients treated with of PML, diagnosed MRI findings and detection of JCV DNAfindings in the may cerebrospinal in clinical the absence clinical signs or MRI be apparentfluid before signs orofsymptoms.

Cases symptoms specific to PML,on have been reported patients treated with of PML, diagnosed based MRI findings and inthe detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with

At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. 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. otherfindings MS medications associated PML. Many of these patients MRI may be apparent beforewith clinical signs or symptoms.

Cases subsequently became symptomatic with PML. monitoring of PML, diagnosed based on MRI findings and Therefore, the detection of JCV with MRI for signs that may be consistent with PML be useful, and other medications associated Many of these patients DNA inMSthe cerebrospinal fluid in with the PML. absence ofmay clinical signs or any suspicious findings should towith further investigation to allowwith for subsequently became symptomatic PML. monitoring symptoms specific to PML, havelead been reported inTherefore, patients treated an early diagnosis of PML, if present.

Lower PML-related mortality and with MRI signs that may be consistent with Many PML may be useful, other MS for medications associated with PML. of these patients morbidity havebecame been reported discontinuation of another any suspicious findings shouldfollowing lead to further to allowMS for subsequently symptomatic with PML.investigation Therefore, monitoring medication associated with PML in patients with PML who were initially an early of PML, if present.

Lower and with MRI diagnosis for signs that may be consistent withPML-related PML may bemortality useful, and asymptomatic compared to patients with PML who had characteristic morbidity have findings been reported discontinuation of another any suspicious should following lead to further investigation to allow MS for clinical and symptoms at diagnosis.

It is notPML known whether these medication associated withifPML in patients with who were initially an earlysigns diagnosis of PML, present.

Lower PML-related mortality and differences are due to early detection and discontinuation of MS asymptomatic to patients with PML who hadofcharacteristic morbidity have compared been reported following discontinuation another MS treatment or due differences inindisease patients. clinical signs and to symptoms at diagnosis. isthese notPML known these medication associated with PML patientsItinwith whowhether were initially differences are due to to early detection and who discontinuation of MS asymptomatic compared patients with PML had characteristic 5.3 Lymphopenia treatment or and due symptoms to differencesdiagnosis. in diseaseItinisthese patients. clinical signs not known these TECFIDERA may decreaseatlymphocyte counts.

In thewhether MS placebo differences are due early detection discontinuation of MS 5.3 Lymphopenia controlled trials, meantolymphocyte counts and decreased by approximately treatment or due to differences intreatment disease inwith these patients. and then 30% during the year oflymphocyte TECFIDERA TECFIDERA mayfirst decrease counts.

In the MS placebo remained stable.

Fourlymphocyte weeks after stopping TECFIDERA, mean 5.3 Lymphopenia controlled trials, mean counts decreased by approximately lymphocyte increased but did not return to baseline.

Six percent 30% duringcounts the first year oflymphocyte treatment with TECFIDERA and then TECFIDERA may decrease counts.

In the MS placebo (6%) of TECFIDERA patients and after <1% of placebo TECFIDERA, patients experienced remained stable.

Four weeks stopping mean controlled trials, mean lymphocyte counts decreased by approximately 9 9 counts <0.5x10 (lower limit of normal 0.91x10 /L).

The lymphocyte increased did not return to baseline.

Six percent 30% during counts the first year of/Lbut treatment with TECFIDERA and then incidence of infections (60% vsand 58%) and (2% vs 2%) (6%) of TECFIDERA patients <1% of serious placeboinfections patients experienced remained stable.

Four weeks after stopping TECFIDERA, mean 9 with TECFIDERA or placebo, respectively. was similar counts incounts patients treated lymphocyte <0.5x10 /L of normal 0.91x10 The lymphocyte increased but(lower did notlimit return to baseline.

Six9/L). percent There increased incidence observed in incidence of no infections (60% vs 58%) and seriousinfections infections (2% vs 2%) (6%) of was TECFIDERA patients and <1%of ofserious placebo patients experienced 9 9 9 with<0.8x10 9 patients within lymphocyte counts ≤0.5x10 /L in controlled was similar patients treated TECFIDERA or placebo, respectively. lymphocyte counts <0.5x10 /L (lower limit/Lofornormal 0.91x10 /L). The trials, patient invsan extension study infections developed(2% PML the There although was no one increased of serious observed in incidence of infections (60%incidence 58%) and serious infections vsin2%) 9 9 predominantly setting ofwith prolonged lymphopenia (lymphocyte counts patients lymphocyte counts <0.8x10 /L or or ≤0.5x10 /L respectively. in controlled was similar in patients treated with TECFIDERA placebo, 9 <0.5x10 /L for 3.5 years) [see Warnings and Precautions (5.2)].

In trials, although one patientincidence in an extension studyinfections developedobserved PML in the There was no increased of serious in 9 predominantly controlled and uncontrolled clinical trials,9/L2% of counts patients setting of prolonged lymphopenia (lymphocyte patients with lymphocyte counts <0.8x10 or ≤0.5x10 /L inexperienced controlled 9 9 lymphocyte counts <0.5x10 /Lanforextension at least six months, and inPML this group <0.5x10 /L for 3.5 patient years) in[see Warnings and Precautions (5.2)].

In trials, although one study developed in the 9 the majority of lymphocyte counts /L predominantly with continued controlled and uncontrolled clinicalremained trials, 2%<0.5x10 ofcounts patients experienced setting of prolonged lymphopenia (lymphocyte 9 9 therapy.

TECFIDERA has not inmonths, patients withinpre-existing lymphocyte counts /L been forWarnings at studied least six and this group <0.5x10 /L for 3.5 <0.5x10 years) [see and Precautions (5.2)].

In 9 low counts. the lymphocyte majority of uncontrolled lymphocyte counts /L with continued controlled and clinical remained trials, 2%<0.5x10 of patients experienced 9 therapy. has not been studied inmonths, patients with Obtain a TECFIDERA CBC, including lymphocyte before initiating treatment with lymphocyte counts <0.5x10 /L for at count, least six and inpre-existing this group low lymphocyte counts.

TECFIDERA, months after starting treatment, and 9then every 6 to 12 the majority of 6lymphocyte counts remained <0.5x10 /L with continued monthsaTECFIDERA thereafter, and asnot clinically indicated.

Consider of therapy. has been studied in patients withinterruption pre-existing Obtain CBC, including lymphocyte count, before initiating treatment with 9 TECFIDERA patientsafter withstarting lymphocyte counts 0.5x10 /L low lymphocytein TECFIDERA, 6counts. months treatment, andless thenthan every 6 to 12 persisting for including moreand than months.

Given the potential for delayed months thereafter, assix clinically indicated.

Consider interruption of Obtain a CBC, lymphocyte count, before initiating treatment with 9 recovery of lymphocyte counts, continue to obtain lymphocyte counts TECFIDERA patients withstarting lymphocyte counts less 0.5x10 /L TECFIDERA, 6inmonths after treatment, and thenthan every 6 tountil 12 their recovery if TECFIDERA is discontinued orpotential interrupted due of to persisting for more than months.

Given the for delayed months thereafter, and as six clinically indicated.

Consider interruption 9 lymphopenia. withholding treatment from patients serious recovery of lymphocyte continue to obtain lymphocyte counts until TECFIDERA inConsider patientscounts, with lymphocyte counts less thanwith 0.5x10 /L infections untilmore about or not restart their recovery ifresolution.

TECFIDERA is discontinued interrupted due to persisting for than sixDecisions months.

Given whether the or potential for todelayed TECFIDERA should be individualized based on clinical circumstances. lymphopenia.

Considercounts, withholding treatment from patients with serious recovery of lymphocyte continue to obtain lymphocyte counts until infections until ifresolution.

Decisions about whether or not todue restart their recovery TECFIDERA is discontinued or interrupted to 5.4 Liver Injury TECFIDERA should be withholding individualized based on clinical circumstances. lymphopenia.

Consider treatment with serious Clinically significant cases of liver injury havefrom beenpatients reported in patients infections until resolution. in Decisions about whether or The not onset to restart 5.4 Liver Injury treated with TECFIDERA the postmarketing setting. has TECFIDERA should individualized months based on clinical circumstances. ranged from a few be days initiation ofintreatment Clinically significant casestoofseveral liver injury haveafter been reported patients withLiver TECFIDERA. Signs and of liver injury, including elevation 5.4 Injury treated with TECFIDERA in symptoms the postmarketing setting.

The onset has of serum aminotransferases to greater thanafter 5-fold the upper limit of ranged from a few cases days toofseveral months initiation ofintreatment Clinically significant liver injury have been reported patients normal and TECFIDERA elevation of and total bilirubin to than 2-fold the upper with TECFIDERA. Signs symptoms of greater liver injury, including elevation treated with in the postmarketing setting.

The onset has limitserum of normal beentoobserved.

These abnormalities upon of aminotransferases to greater than 5-fold the resolved upper limit of ranged from a have few days several months after initiation of treatment treatment Some casesto hospitalization.

None normal anddiscontinuation. elevation total bilirubin greater than 2-fold the upper with TECFIDERA. Signsofand symptoms ofrequired liver injury, including elevation of serum the cases resulted liver failure, liver transplant, orlimit death. limit ofreported normal have been observed.

These abnormalities resolved upon of aminotransferases toingreater than 5-fold the upper of However, combination of bilirubin newcases serum aminotransferase elevations treatment discontinuation.

Some hospitalization.

None normal andthe elevation of total to required greater than 2-fold the upper with increased levels of bilirubin caused by drug-induced hepatocellular of the reported cases resulted in liver failure, liver transplant, or death. limit of normal have been observed. These abnormalities resolved upon injury is an important predictor ofcases serious liver injury that may lead to However, the combination of new serum aminotransferase elevations treatment discontinuation.

Some required hospitalization.

None acute liver failure, liverof transplant, or death sometransplant, patients. with levels bilirubin by in drug-induced hepatocellular of theincreased reported cases resulted incaused liver failure, liver or death. injury is an important of serum serious livernoinjury thatthan may to However, theof combination of new aminotransferase elevations Elevations hepatic predictor transaminases (most greater 3lead times acute liver failure, orobserved death in some patients. with levels of transplant, bilirubin caused by drug-induced hepatocellular the increased upper limit ofliver normal) were during controlled trials injury is an important liverno injury that than may 3 lead to [see Adverse (6.1)].of serious Elevations of Reactions hepaticpredictor transaminases (most greater times acute liver failure, liver transplant, or observed death in some patients. the upper limit of normal) were during controlled Obtain serum aminotransferase, alkaline phosphatase (ALP), andtrials total [see Adverse Reactions (6.1)]. with TECFIDERA Elevations of hepatic transaminases (most no greater thantreatment, 3 times bilirubin levels prior to treatment and during the upper limit of normal) werealkaline observed during controlled as clinically indicated.

Discontinue TECFIDERA if clinically Obtain serum aminotransferase, phosphatase (ALP),significant andtrials total [see Adverse Reactions (6.1)]. withisTECFIDERA liver injury induced TECFIDERA suspected. and during treatment, bilirubin levels prior by to treatment as Discontinue TECFIDERA if clinically Obtain serumindicated. aminotransferase, alkaline phosphatase (ALP),significant and total 5.5 clinically Flushing liver injury induced bytreatment TECFIDERA is suspected. and during treatment, bilirubin levels priorcause to with TECFIDERA TECFIDERA may flushing (e.g., warmth, redness, itching, and/or as clinically indicated.

Discontinue TECFIDERA if clinically significant 5.5 Flushing burning sensation).

In clinical trials, 40% of TECFIDERA treated patients liver injury induced

by TECFIDERA is suspected. experienced flushing.

Flushing generally began soonand/or after TECFIDERA may cause flushingsymptoms (e.g., warmth, redness, itching, initiating TECFIDERA and usually or resolved over time.

In the 5.5 Flushing burning sensation).

In clinical trials,improved 40% of TECFIDERA treated patients majority of patients whoFlushing experienced it redness, was mild or moderate in experienced flushing. generally began soon after TECFIDERA may cause flushingsymptoms (e.g.,flushing, warmth, itching, and/or severity.sensation).

Three percent (3%) of patients for initiating TECFIDERA and usually improved or resolved TECFIDERA over time.

In the burning In clinical trials, 40% ofdiscontinued TECFIDERA treated patients flushing of and <1% had serious symptoms flushing symptoms that were notafter lifemajority patients who experienced flushing, it was mild or moderate in experienced flushing.

Flushing generally began soon threatening but led to hospitalization.

Administration of TECFIDERA severity.

Three percent of patients discontinued TECFIDERA for initiating TECFIDERA and(3%) usually improved or resolved over time. In with the food may reduce incidence flushing.

Alternatively, flushing <1%the had serious of flushing symptoms thatoradministration were not lifemajority ofand patients who experienced flushing, it was mild moderate in of non-enteric aspirin (uppatients to aAdministration dose of 325 mg) 30 minutes prior threatening butcoated led to hospitalization. of TECFIDERA with severity.

Three percent (3%) of discontinued TECFIDERA for to TECFIDERA dosing may reduce the incidence or severity of flushing food may reduce the incidence of flushing.

Alternatively, administration flushing and <1% had serious flushing symptoms that were not life[see Dosingbut and Administration and Clinical (12.3)]. of non-enteric coated aspirin (up(2.1) to aAdministration dose of 325Pharmacology mg) 30 minutes prior threatening led to hospitalization. of TECFIDERA with to TECFIDERA dosing may reduce the incidence or severity of flushing food may reduce the incidence of flushing.

Alternatively, administration 6 ADVERSE REACTIONS [see Dosing and Administration Pharmacology (12.3)]. of non-enteric aspirin (up(2.1) to reactions a and doseClinical of 325 30 minutes prior The followingcoated important adverse are mg) described elsewhere to TECFIDERA dosing may the incidence or severity ofmultifocal flushing 6 ADVERSE REACTIONS in labeling: Anaphylaxis andreduce Angioedema (5.1), Progressive [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)]. leukoencephalopathy Lymphopenia (5.3), Liver Injury (5.4), The following important(5.2), adverse reactions are described elsewhere Flushing (5.5) [see Warnings and Precautions].

6in ADVERSE REACTIONS labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy Lymphopenia (5.3), Liver Injury (5.4), The following important(5.2), adverse reactions are described elsewhere Flushing (5.5) [see Warnings and Precautions]. in labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy (5.2), Lymphopenia (5.3), Liver Injury (5.4), Flushing (5.5) [see Warnings and Precautions].

threatening b food may red of non-enteri to TECFIDER [see Dosing

6 ADVERSE The followin in labeling: A leukoenceph Flushing (5.5

TECFIDERA al symptoms weeks, and umsiness of memory, and

toms. Cases ction of JCV cal signs or treated with

flushing and <1% had serious flushing symptoms that were not lifethreatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)].

6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use of TECFIDERA. 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.

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy (5.2), Lymphopenia (5.3), Liver Injury (5.4), Flushing (5.5) [see Warnings and Precautions].

6.1 Clinical Trials Experience 6.1 Clinical Trialstrials Experience Because clinical are conducted under widely varying conditions, adverse ratesare observed in clinical a drug conditions, cannot be Because reaction clinical trials conducted under trials widelyofvarying directly to rates in the clinical trialstrials of another drugcannot and may adversecompared reaction rates observed in clinical of a drug be not reflect the ratestoobserved in clinical directly compared rates in the clinicalpractice. trials of another drug and may not reflect the rates adverse observedreactions in clinical(incidence practice. ≥10% and ≥2% more The most common than placebo) for TECFIDERA were flushing, abdominal pain,≥2% diarrhea, The most common adverse reactions (incidence ≥10% and more and thannausea. placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea.

Adverse Reactions in Placebo-Controlled Trials Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients TECFIDERA an overall effectiveness, exposure of 1529 2244 In the tworeceived well-controlled studieswith demonstrating person-years [see Clinical Studies (14)]. patients received TECFIDERA with an overall exposure of 2244 person-years [see Clinical Studies (14)].

The adverse reactions presented in the table below are based on safety

Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following TECFIDERA administration in post marketing experience [See Warnings and Precautions (5.4)].

information 769 patients treated 240 mg twice The adversefrom reactions presented in thewith tableTECFIDERA below are based on safety a day and 771 placebo-treated patients.with TECFIDERA 240 mg twice information from 769 patients treated a day and 771 placebo-treated Table 1: Adverse Reactions inpatients.

Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥2% higher incidence thanfor placebo Table 1: Adverse Reactions in Study 1 and 2 reported TECFIDERA 240 mg BID at ≥2% higher incidence than placebo

Flushing Flushing pain Abdominal Abdominal pain Diarrhea Diarrhea Nausea Nausea Vomiting Vomiting Pruritus Pruritus Rash Rash Albumin urine present Albumin urine present Erythema Erythema Dyspepsia Dyspepsiaaminotransferase increased Aspartate Aspartate aminotransferase increased Lymphopenia Lymphopenia

TECFIDERA N=769 TECFIDERA % N=769 % 40 40 18 18 14 14 12 12 9 9 8 8 8 6 6 5 5 5 4 4 2 2

Placebo N=771 Placebo % N=771 % 6 6 10 10 11 11 9 9 5 5 4 4 3 3 4 4 1 1 3 3 2 2 <1 <1

Gastrointestinal Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). incidence of GIvomiting, events was higher TECFIDERA caused GI eventsThe (e.g., nausea, diarrhea, early in thepain, course of treatmentThe (primarily in ofmonth 1) and abdominal and dyspepsia). incidence GI events wasusually higher decreased timeofin treatment patients treated withinTECFIDERA compared early in theover course (primarily month 1) and usually with placebo.

Four percent (4%) of patients with TECFIDERA decreased over time in patients treated withtreated TECFIDERA compared and than 1% of placebo due with to gastrointestinal with less placebo.

Four percent patients (4%) of discontinued patients treated TECFIDERA events. of serious GI discontinued events was 1% treated and lessThe thanincidence 1% of placebo patients dueintopatients gastrointestinal with TECFIDERA. events.

The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA wasof seen primarily during the An increased incidence of elevations hepatic transaminases in first six months treatment, and most with elevations patients treated ofwith TECFIDERA waspatients seen primarily during had the levels times the limit of normal during first six<3months of upper treatment, and most (ULN) patients withcontrolled elevationstrials. had Elevations of alanine aminotransferase and aspartate levels <3 times the upper limit of normal (ULN) duringaminotransferase controlled trials. to ≥3 timesofthe ULNaminotransferase occurred in a small number ofaminotransferase patients treated Elevations alanine and aspartate with and placebo andnumber were balanced to ≥3both timesTECFIDERA the ULN occurred in a small of patientsbetween treated groups.

There were no elevations in transaminases ≥3 times between the ULN with both TECFIDERA and placebo and were balanced with concomitant in total bilirubin >2 ≥3 times groups.

There wereelevations no elevations in transaminases timesthe theULN. ULN Discontinuations to elevated transaminases werethe <1%ULN. and with concomitantdue elevations inhepatic total bilirubin >2 times were similar in patients treated with TECFIDERA or placebo.

Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo.

Eosinophilia Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 therapy.in mean eosinophil counts was seen during the first A months transientofincrease 2 monthsReactions of therapy.in Placebo-Controlled and Uncontrolled Studies Adverse Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have receivedand TECFIDERA andclinical been followed up to In placebo-controlled uncontrolled studies,for a periods total of 2513 4 years with overallTECFIDERA exposure of and 4603been person-years. patients havean received followed forApproximately periods up to 1162 patients received more thanperson-years.

2 years of treatment with 4 years with anhave overall exposure of 4603 Approximately TECFIDERA. profile of TECFIDERA the 1162 patients The haveadverse receivedreaction more than 2 years of treatmentin with uncontrolled studies was consistent experience inin the TECFIDERA.clinical The adverse reaction profilewith of the TECFIDERA placebo-controlled trials. uncontrolled clinicalclinical studies was consistent with the experience in the placebo-controlled trials.

6.2 Post Marketingclinical Experience 6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use TECFIDERA. these reactions areduring reported The of following adverseBecause reaction has been identified postvoluntarily approval from population of uncertain is not always possible voluntarily to reliably use ofa TECFIDERA. Because size, theseitreactions are reported estimate their frequency or establish causal relationship drug from a population of uncertain size, it is anot always possible to to reliably exposure. estimate their frequency or establish a causal relationship to drug exposure.

Liver function abnormalities (elevations in transaminases ≥3 times ULN concomitant elevations in total bilirubin >2 times ULN) have Liver with function abnormalities (elevations in transaminases ≥3 times been reported followingelevations TECFIDERA administration postULN) marketing ULN with concomitant in total bilirubin >2 in times have experience [See Warnings and Precautions (5.4)]. in post marketing been reported following TECFIDERA administration experience [See Warnings and Precautions (5.4)].

8 USE IN SPECIFIC POPULATIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.1 Pregnancy Pregnancy Exposure Registry There is a Exposure pregnancy exposure registry that monitors pregnancy Pregnancy Registry outcomes women exposed TECFIDERA during pregnancy.

There is ainpregnancy exposuretoregistry that monitors pregnancy Encourage enroll bytocalling 1-866-810-1462 or visiting outcomes inpatients womentoexposed TECFIDERA during pregnancy. www.tecfiderapregnancyregistry.com.

Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com.

Risk Summary Risk Summary There are no adequate data on the developmental risk associated with the useare of TECFIDERA pregnant In animals, adverse effects There no adequate in data on the women. developmental risk associated with on survival, growth, sexual maturation, and neurobehavioral the offspring use of TECFIDERA in pregnant women.

In animals, adverse effects function were observed fumarate (DMF) was on offspring survival, growth,when sexualdimethyl maturation, and neurobehavioral administered during pregnancy and lactation function were observed when dimethylat clinically fumaraterelevant (DMF)doses. was [see data]. during pregnancy and lactation at clinically relevant doses. administered [see In thedata].

U.S. general population, the estimated background risk of major birth and miscarriage recognized pregnancies is In thedefects U.S. general population, in theclinically estimated background risk of major 2-4% and 15-20%, respectively. background risk pregnancies of major birth birth defects and miscarriage in The clinically recognized is defects and15-20%, miscarriage for the indicated population risk is unknown.

2-4% and respectively.

The background of major birth defects and miscarriage for the indicated population is unknown.

Data Data Data Animal In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout Animal Data organogenesis, embryofetal toxicity fetal body weight and In rats administered DMF orally (25, (reduced 100, 250 mg/kg/day) throughout delayed ossification) were observed at the highest organogenesis, embryofetal toxicity (reduced fetal dose body tested. weight This and dose also produced were evidence of maternal toxicitydose (reduced delayed ossification) observed at the highest tested. body This weight).

Plasma exposure (AUC) of for maternal monomethyl fumarate (MMF), the dose also produced evidence toxicity (reduced body major circulating metabolite, at the no-effect dose is approximately weight).

Plasma exposure (AUC) for monomethyl fumarate (MMF), the three that inmetabolite, humans at at thethe recommended human dose (RHD) major times circulating no-effect dose is approximately of 480times mg/day.

DMF orally (25, 75, and 150 three that In in rabbits humansadministered at the recommended human dose (RHD) mg/kg/day) organogenesis, embryolethality of 480 mg/day.throughout In rabbits administered DMF orally (25, 75, and and 150 decreased body weight were observed at the highest dose mg/kg/day)maternal throughout organogenesis, embryolethality and tested.

The plasmabody AUC for were MMFobserved at the at no-effect dose is decreased maternal weight the highest dose approximately 5 times that RHD.no-effect dose is tested. The plasma AUCin humans for MMFat the at the approximately 5 times in (25, humans the 250 RHD.mg/kg/day) to rats Oral administration of that DMF 100,atand throughout organogenesis lactation resulted in increased Oral administration of DMF and (25, 100, and 250 mg/kg/day) to rats lethality, reductions body weight, sexual throughoutpersistent organogenesis and inlactation resulteddelayed in increased maturation (male andreductions female pups), at lethality, persistent in and bodyreduced weight,testicular delayedweight sexual the highest (male dose tested.

Neurobehavioral impairment was observed maturation and female pups), and reduced testicular weight at at doses.

A no-effect dose for developmental toxicity was not theall highest dose tested. Neurobehavioral impairment was observed identified.

TheAlowest dosedose tested associated with plasma at all doses. no-effect forwas developmental toxicity wasAUC not for MMF lower than that in humans at the RHD. identified.

The lowest dose tested was associated with plasma AUC for lower than that in humans at the RHD. 8.2 MMF Lactation 8.2 Lactation Risk Summary Risk ThereSummary are no data on the presence of DMF or MMF in human milk.

The theonbreastfed infant milk production are Thereeffects are noon data the presence of and DMFon or MMF in human milk. unknown.

The effects on the breastfed infant and on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with thehealth mother’s clinical for TECFIDERA The developmental and benefits ofneed breastfeeding shouldand be any potential adverse on theclinical breastfed infant from the drug or considered along with effects the mother’s need for TECFIDERA and from the underlying maternal condition. any potential adverse effects on the breastfed infant from the drug or from the underlying 8.4 Pediatric Use maternal condition.

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use 8.5 Geriatric Use Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over todid determine whether they respond Clinical studies of TECFIDERA not include sufficient numbers of differently from younger patients aged 65 and patients. over to determine whether they respond differently from younger patients.

10 OVERDOSE 10 OVERDOSE Cases of overdose with TECFIDERA have been reported. The symptoms these cases werehave consistent the known Cases of described overdose in with TECFIDERA been with reported.

The adverse event profile in of these TECFIDERA. symptoms described cases were consistent with the known adverse profiletherapeutic of TECFIDERA. There areevent no known interventions to enhance elimination of TECFIDERA northerapeutic is there ainterventions known antidote.

In theelimination event of There are no known to enhance overdose, initiatenor symptomatic treatment as event clinically of TECFIDERA is there a supportive known antidote.

In the of indicated. overdose, initiate symptomatic supportive treatment as clinically indicated.

17 PATIENT COUNSELING INFORMATION 17 PATIENT COUNSELING Advise the patient to read theINFORMATION FDA-approved patient labeling (Patient Information) Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Dosagepatients that they will be provided two strengths of TECFIDERA Inform when 120 capsules the 7 day starter dose Informstarting patientstreatment: that they will bemg provided twofor strengths of TECFIDERA and mg capsules for120 themg maintenance to be taken when240 starting treatment: capsules fordose, the 7both day starter dose twice daily. patients to swallow TECFIDERA capsules and 240 mgInform capsules for the maintenance dose, both to be whole taken and not crush, chew, or sprinkle twiceintact. daily. Inform patients to swallow TECFIDERA capsulescapsule whole contents on Inform food. Inform patients TECFIDERA be taken with and intact. patients to notthat crush, chew, or can sprinkle capsule or withouton food [see Dosage and Administration (2.1)]. contents food.

Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].

Advise the pat Information) Dosage Inform patient when starting and 240 mg c twice daily. In and intact. In contents on fo or without foo

voluntarily to reliably p to drug

≥3 times ULN) have marketing

Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].

Anaphylaxis and Angioedema Advise patients to discontinue TECFIDERA and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)].

Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received TECFIDERA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months.

Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform 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 [see Warnings and Precautions (5.2)].

Lymphocyte Counts Inform patients that TECFIDERA may decrease lymphocyte counts.

A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.3), Adverse Reactions (6.1)].

Liver Injury Inform patients that TECFIDERA may cause liver injury. Instruct patients treated with TECFIDERA to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.4)].

Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking TECFIDERA with food or taking a non-enteric coated aspirin prior to taking TECFIDERA may help [see Adverse Reactions (6.1)].

Pregnancy and Pregnancy Registry Instruct patients that if they are pregnant or plan to become pregnant while taking TECFIDERA they should inform their physician.

Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA. [see Use in Specific Populations (8.1)].

10 41347-09

Manufactured by: Biogen Cambridge, MA 02142 TECFIDERA is a trademark of Biogen.

9 Biogen © 2013-2017 7/19 2/18

Conferences & Community

Renew Your Membership Before December 31 Don’t risk losing ready access to your community of neurology professionals with the resources and education needed to help you grow and thrive throughout your professional career! Visit AAN.com/dues today, so you can be assured your AAN will be there for you come January 1 with the essential education, science, and support, you’ve come to depend on, including: Deep discounts to the upcoming 2020 Annual Meeting in vibrant, multicultural Toronto Unique education opportunities to meet continuing education requirements Up-to-date information on breakthrough scientific research Valuable clinical practice guidelines The latest news relevant to the profession Representation of your interests in the US and globally Special pricing on AAN products, services, or meetings Exclusive access to AAN.com member-only resources Find the full list of exclusive member benefits at AAN.com/view/benefits. For more information, contact AAN Member Services at memberservices@aan.com, (800) 879-1960, or (612) 928-6000 (international), or use the chat feature on AAN.com. 

Stevens, Board Members Attend World Congress of Neurology in Dubai The World Congress of Neurology was held recently in Dubai, and AAN President James C. Stevens, MD, FAAN; Board Members Brad C. Klein, MD, FAAN, and Janis M. Miyasaki, MD, MEd, FRCPC, FAAN; and other Academy leaders and staff were in attendance to strengthen the AAN’s global relationships and recruit new members.

“It was a wonderful opportunity to represent the AAN at the World Congress of Neurology.” Stevens said, “With neurologists from over 120 countries in attendance, I was humbled by the high regard our organization is held. Many expressed gratitude over the educational content we make available to our international colleagues, and the impact our products have had on their careers.”

renewals. These members work in Bangladesh, Brazil, India, Iran, Israel, Nepal, New Zealand, Nigeria, Pakistan, Peru, Russian Federation, Singapore, Somalia, South Korea, Sudan, and the United Kingdom. Madhu Soni, MD, FAAN, chair of the AAN Undergraduate Education Subcommittee, spent time in the booth discussing information on starting SIGN chapters internationally. 

Staff enrolled 53 attendees (medical students, trainees, and neurologists) as new members of the AAN and received 15 Madhu Soni, MD, FAAN (right) spoke with attendees.

(From left) AAN membership staff Christi Kokaisel and Katie Boyle with President James C. Stevens, MD, FAAN, and Board Member Brad C. Klein, MD, FAAN.

(From left) Ronald C. Petersen, PhD, MD, FAAN; Diane Petersen; John C. Morris, MD, FAAN; and Stevens.

AANnews • December 2019 23

Conferences & Community

2020 Presidential and Frontiers Plenary Session Speakers Announced continued from cover Both sessions are open to all meeting attendees.

Presidential Plenary Session Sunday, April 26, 2020 9:15 a.m.–12:00 p.m.

Presidential Lecture In non-AAN election years, this premier lecture is awarded to a neurologist chosen by the AAN president. In election years, the lecture is presented by the outgoing president.

TBD

George C. Cotzias Lecture Endowed by ROCHE Pharmaceuticals, this lecture is awarded to a neurologist for excellence in neuroscience and is presented every other year during the Presidential Plenary Session.

Avindra Nath, MD, MBBS, FAAN National Institutes of Health, Bethesda, MD "Endogenous Retroviral Elements in Neurodegenerative Diseases"

Sidney Carter Award in Child Neurology Endowed by Isabelle Rapin, MD, FAAN, and presented every year during the Presidential Plenary Session, this lecture recognizes outstanding work by an individual in the field of child neurology/ developmental neurobiology.

Ingrid E. Scheffer, AO, MBBS, PhD, FRACP Melbourne Brain Centre, Heidelberg, Victoria, Australia TBD

24

AANnews • December 2019

Robert Wartenberg Lecture

Andy Shih, PhD

This annual lecture is awarded to a neurologist for excellence in clinically relevant research.

Seattle Children’s Research Institute, Seattle, WA

Vladimir Hachinski, MD, DSc, FAAN London Health Sciences Centre, London, ON, Canada “The Threatened Brain: Preventing Stroke and Dementia Together”

Frontiers in Neuroscience Plenary Session Wednesday, April 29, 2020 9:15 a.m.–11:30 a.m.

Edward F. Chang, MD University of California San Francisco, San Francisco, CA “Decoding Speech Cortex”

“Dissecting the Control of Blood Flow Through Brain Capillaries” Ivan Soltesz, PhD Stanford University School of Medicine, Stanford, CA “Organization and Control of Hippocampal Circuits” Mark H. Tuszynski, MD, PhD, FAAN University of California San Diego, La Jolla, CA “Spinal Cord Recovery” 

Antonina RollMecak, PhD Porter Neuroscience Research Center, National Institute of Neurological Disorders and Stroke, Bethesda, MD “Tubulin Neurobiology” Nenad Sestan, MD, PhD Yale University, New Haven, CT “Restoration of Brain Circulation and Cellular Functions Hours Post-mortem”

April 25 – May 1 • Toronto, Canada

Education & Research

Get Up-to-date on Muscle and Neuromuscular Junction Disorders with Continuum The range of muscle and neuromuscular junction disorders are covered in the new Continuum: Lifelong Learning in Neurology ®.

“Neurologists will be interested in the evolving therapeutic landscape in these disorders,” said Guest Editor Nicholas E. Johnson, MD, MSc, FAAN. “Additionally, there continue to be new developments in the diagnosis and classification of these muscle disorders.”

Myasthenia Gravis and Congenital Myasthenic Syndromes / Emma Ciafaloni, MD

Topics include: Approach to Muscle and Neuromuscular Junction Disorders / Mamatha Pasnoor, MD, FAAN; Mazen M. Dimachkie, MD, FAAN, FANA

Lambert-Eaton Myasthenic Syndrome, Botulism, and Immune Checkpoint Inhibitor–related Myasthenia Gravis / Amanda C. Guidon, MD

Immune-Mediated Myopathies / Namita A. Goyal, MD, FAAN

The issue also includes a postreading self-assessment and test with the opportunity to earn up to 20 AMA PRA Category 1™ toward SA-CME.

Sporadic Inclusion Body Myositis and Other Rimmed Vacuolar Myopathies / Conrad C. Weihl, MD, PhD The Limb-Girdle Muscular Dystrophies / Matthew P. Wicklund, MD, FAAN The Dystrophinopathies / Mathula Thangarajh, MD, PhD Congenital Muscular Dystrophy and Congenital Myopathy / Russell J. Butterfield, MD, PhD, FAAN Facioscapulohumeral Muscular Dystrophies / Kathryn R. Wagner, MD, PhD

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Johnson

CON TINU

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VOL. 25

NO. 6

AAN members pay only $349* per year for a subscription to Continuum® and Continuum® Audio. Hurry and subscribe

by December 30, 2019, by contacting Wolters Kluwer at (800) 361-0633 or (301) 223-2300 (international) or visit Shop.LWW. com/continuum. AAN Junior members who are transitioning to neurologist memberships can receive a 50-percent discount on the already low member rate for the Continuum and Continuum Audio subscription. *As of December 31, 2019, the 2020 AAN member subscription rate will be $399 per year. 

Continuum, Brain & Life Honored by Publishing Awards Continuum®: Lifelong Learning in Neurology was the recipient of three FOLIO Ozzie Awards in the association/nonprofit categories of cover design and overall design excellence for medical journals as well as redesign.

The AAN’s patient education magazine Brain & Life® won an editorial award for “The Long Reach of Grief,” in the category Single Article: Professional/ Membership Association. The FOLIO Ozzie Awards “recognize excellence in gorgeous design across all sectors of the publishing industry.” 

AAN staff Andrea Weiss and Amanda Doering accepted the AAN's awards.

AANnews • December 2019 25

AAN.com/careers

Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added.

Pediatric Neurology—Join one of the best health care providers and teaching hospital in West Virginia Employed Position. Competitive salary with full benefit package. $50K sign-on bonus. More than 30 specialties are represented. Procedures performed: Advanced MS infusion therapies, Electromyography (EMG), Electroencephalogram (EEG), Evoked potentials studies, Lumbar puncture, Nerve conduction studies, Therapeutic injections for migraine and Epilepsy Monitoring Unit for long-term monitoring. Neurology department specializes in the following conditions Autism, Cerebral palsy, Dementia, Epilepsy, Multiple sclerosis (MS), Neuropathy, Stroke, Seizures, Migraine, Nerve and muscle disorders and Tremors. Wild and wonderful . . . almost heaven. The cultural, recreational, and business capital of the Appalachian Mountains.

Excellent Public and Private Schools. NCAA Division I Intercollegiate Sports Teams. Driving distance for skiing, water sports, hiking, etc. Bike friendly community with a network of trails. Art walks, downtown street festivals and brown bag concert series. Come play—multiple family friendly venues and activities. Timothy Stanley, Direct: (404) 591-4224; (800) 492-7771. Email: tstanleyweb@phg.com; Fax: (404) 5914237. Cell/Text: (770) 265-2001; Mention Code 180802—CHN. Inpatient Neurologist Inova Neuroscience and Spine Institute is part of the Inova Health System and a regional leader in the diagnosis, treatment and research of complex neurological conditions involving the brain, spine and nervous system.

From its hub at Inova Fairfax Hospital, the Institute also encompasses specialized programs at Inova Alexandria Hospital, Inova Fair Oaks Hospital, Inova Loudoun Hospital and Inova Mount Vernon Hospital. With a network of five hospitals and more than 14,000 neuroscience patients treated annually, Inova Neuroscience and Spine Institute is the largest program of its kind in Northern Virginia and one of the most comprehensive within the mid-Atlantic region.

Led by highly trained, nationally recognized physicians, the Institute diagnoses and treats adult and pediatric patients with neurotrauma, concussions, stroke and cerebrovascular disease, memory disorders, spine conditions, brain and spinal tumors. Its comprehensive sub-specialty offerings, multidisciplinary approach and seamless interactions within the health system ensure that every patient receives the appropriate level of leading-edge care in the most convenient and appropriate setting.

Inova Neuroscience and Spine Institute includes experts from multiple disciplines including emergency medicine, radiology, neurology, pharmacy, critical care, nursing and rehabilitation working closely together to give each patient the best chance at recovery. We offer sophisticated, minimally invasive technology and advanced imaging by interventional neuroradiologists, and cerebrovascular and endovascular surgeons. We are seeking a full-time neurologist to work a 7-day/12-hour shift schedule every other week at Inova Alexandria Hospital. The successful candidate will join a team of experienced and supportive clinicians. This is a full-time position with a compensation package that includes medical, dental, vision and life insurance, CME

reimbursement, as well as defined contribution retirement plans. Inova is a not-for-profit healthcare system based in Northern Virginia that serves more than 2 million people each year from throughout the Washington, DC, metro area and beyond. Inova is a comprehensive network of hospitals, outpatient services and facilities, primary and specialty care practices, and health and wellness initiatives. Email Allison.spindle@inova.org Cognitive/Behavioral Neurologist Inova Neuroscience and Spine Institute is part of the Inova Health System and a regional leader in the diagnosis, treatment and research of complex neurological conditions involving the brain, spine and nervous system. From its hub at Inova Fairfax Hospital, the Institute also encompasses specialized programs at Inova Alexandria Hospital, Inova Fair Oaks Hospital, Inova Loudoun Hospital and Inova Mount Vernon Hospital. With a network of five hospitals and more than 14,000 neuroscience patients treated annually, Inova Neuroscience and Spine Institute is the largest program of its kind in Northern Virginia and one of the most comprehensive within the mid-Atlantic region.

Led by highly trained, nationally recognized physicians, the Institute diagnoses and treats adult and pediatric patients with neurotrauma, concussions, stroke and cerebrovascular disease, memory disorders, spine conditions, brain and spinal tumors.

Its comprehensive sub-specialty offerings, multidisciplinary approach and seamless interactions within the health system ensure that every patient receives the appropriate level of leading-edge care in the most convenient and appropriate setting. Inova Neuroscience and Spine Institute includes experts from multiple disciplines including emergency medicine, radiology, neurology, pharmacy, critical care, nursing and rehabilitation working closely together to give each patient the best chance at recovery. We offer sophisticated, minimally invasive technology and advanced imaging by interventional neuroradiologists, and cerebrovascular and endovascular surgeons. Our comprehensive research program is committed to the advancement of treatment protocols. We are seeking an experienced Cognitive/Behavioral Neurologist to serve as Medical Director of the new Inova Brain Health and Performance Enhancement Center in Northern Virginia. Partnering with the established Center for Brain Health at the University of Texas at Dallas, the Inova Brain Health and Performance Enhancement Center will offer a variety of specialized services for individuals with disease and recovering from surgery, as well as healthy adults and adolescents wanting to improve their overall brain performance. In addition to administrative responsibilities, the successful candidate will provide outpatient services as a member of Inova Medical Group - Neurology. IMG provides patients with the highest level of care relating to diagnostic, treatment and research services for neurological and related disorders. Our physicians are board certified in neurology, clinical neurophysiology, sleep medicine, internal medicine, electroencephalography, vascular neurology and electrodiagnostic medicine. Our practice also offers in-office testing for a wide range of neurological and sleep disorders. Inova is a not-for-profit healthcare system

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AANnews • December 2019

based in Northern Virginia that serves more than 2 million people each year from throughout the Washington, DC, metro area and beyond. Inova is a comprehensive network of hospitals, outpatient services and facilities, primary and specialty care practices, and health and wellness initiatives.

Full time position with compensation package that includes medical, dental, vision and life insurance, paid time off, CME reimbursement, as well as defined contribution retirement plans. Email allison.spindle@inova.org General and Subspecialty Primarily Outpatient Neurologists—Northwestern Virginia Premier neurology practice in Winchester, VA seeks outstanding general and subspecialty neurologists. Opportunity to join 4 established neurologists with subspecialty training including neuroimaging, behavioral neurology, neurophysiology, and epilepsy. Generalists and all subspecialists welcome. MS and Neuromuscular specialists would be especially wellreceived. Long standing practice with high patient volume and significant growth potential. Call 1:5, consultative. Call to decrease as practice is recruiting neurohospitalists. Night call is Teleneurology only. NPs/PAs in hospital to assist with hospital care. Neuroimaging training for formal interpretation of neurorelated CT studies & ultrasound. Excellent reimbursement with current neurologists earning >90th percentile MGMA average. First year package $350-400K. Attractive 2-year partnership track with income guarantee. Winchester Medical Center is a 495- bed regional referral, level II trauma center with a thriving service area. The hospital partners with the practice and supports recruitment. Winchester, Virginia is a model community in the Shenandoah Valley with specially endowed public schools, outstanding private school systems, local music conservatory, outdoor recreation, rich history and affordable housing. While the local community offers many advantages of tranquility and beauty, we are only 60 miles from the cultural activities in Washington, DC. Please contact: Nancy Hiett, Manager, Physician Recruitment, Valley Health; (540) 536-8025. Email: nhiett@valleyhealthlink.com AANnews® Classified Advertising

he AAN offers a complete package of print, online, T and in-person recruitment advertising opportunities.

Visit careers.AAN.com for all AAN options, rates, and deadlines. d copy for the February 2020 print edition of A AANnews must be submitted by January 1, 2020. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.

Dates & Deadlines

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FEBRUARY 11–16 RITE® Exam AAN.com/view/RITE

FEBRUARY 24–25 Neurology on the Hill Washington, DC AAN.com/view/NOH

DECEMBER 6

Registration Deadline: RITE® Exam AAN.com/view/RITE

DECEMBER 12

Webinar: EEG and E/M Coding Updates Register by December 11 AAN.com/view/pmw19

DECEMBER 31

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