2021 January AANnews

VOLUME 34 · ISSUE 1 · JANUARY 2021

Visit AAN.com/Covid19 for the latest pandemic information and resources to support you and your crucial work.

2021 ANNUAL MEETING GOING FULLY VIRTUAL! Registration Now Open Due to the COVID-19 pandemic and for reasons beyond our control, the 2021 AAN Annual Meeting will be held in a fully virtual format this April 17 through 22. Your Academy has been hard at work taking all the reasonable precautions in our planning to be prepared for this possibility, and the now reimagined virtual 2021 Annual Meeting will bring you an unconventional experience you won’t want to miss. You can expect a new, entirely flexible, virtual experience that promises to bring the world of neurology together even when we’re apart.

Whether you are new to the Annual Meeting or a returning attendee, access to the top neurology meeting in the world has never been easier.

Continued on page 15

April 17– April 22

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New Lyme Disease Guidelines Published New evidence-based clinical practice guidelines for the prevention, diagnosis, and treatment of Lyme disease have been published online in Neurology ® on November 30, 2020. The guidelines were developed by a multidisciplinary panel led by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology. Representatives from an additional 12 medical specialties and patients also served on the panel. ued

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Every year, the Centers for Medicare & Medicaid Services (CMS) proposes regulations that impact the reimbursement of physicians. On December 1, 2020, CMS finalized its rule updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule in 2021. The final rule illustrates the importance of the AAN’s regulatory advocacy efforts on behalf of neurologists and their patients. For next year, CMS expects payments across the specialty of neurology to increase by six percent with variations depending on the individual provider’s practice.

We recom mend that be given to adults prophylactic antib and child iotic thera of removal ren only py of within 72 not for bites an identified highrisk tick bite, hours that are equivocal Commen risk or low but t: risk. a high level If a tick bite cann ot of certa inty as a be classified with wait-andhigh-risk watc bite, bite is cons h approach is recommend a idered to following ed. A tick be high-risk three crite only if it identified ria: Ixodes spp. the tick bite was meets the a highly from a) an vector spec endemic ies, b) area, and for ≥ 36 c) the tick it occurred in hours. was attac hed

Continued on page 16

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AAN Advocacy Succeeds on E/M Improvements, Telehealth Expansion

18 Power Shifts in DC, States, to Impact Health 22 Comment Invited on Prevention

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Care Legislation in 2021 and Beyond

of Stroke Practice Advisory

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Discover an oral therapy for your patients with relapsing forms of multiple sclerosis (MS)1…

ZEPOSIA—FOCUSED ON WHAT COUNTS ZEPOSIA was studied in the largest number of patients with RMS in 2 pivotal head-to-head trials against an active comparator (N=2659)2,3a:

POWERFUL Efficacy1a

Proven superior in reducing relapses vs Avonexc Proven superior in reducing GdE and T2 lesions vs Avonex

COMPARABLE

Safety Profile vs Avonex in Overall Incidence of Adverse Reactions1-3b Consistently low discontinuation rates vs Avonex Comparable rates of serious infections and malignancies vs Avonex

Study designs: SUNBEAM (1 year; N=1346) and RADIANCE (2 years; N=1313) were multicenter, randomized, double-blind, double-dummy, active treatment-controlled studies of daily oral ozanimod 0.46 mg (not approved for maintenance dose) or 0.92 mg vs weekly Avonex (interferon beta-1a), 30-μg intramuscular injection. Primary endpoint: ZEPOSIA reduced ARR vs Avonex by 48% at 1 year (0.18 vs 0.35, respectively) and by 38% at 2 years (0.17 vs 0.28, respectively). Secondary endpoints: ZEPOSIA reduced the number of new or enlarging T2 lesions by 48% at 1 year and by 42% at 2 years and reduced the number of GdE lesions vs Avonex by 63% at 1 year and 53% at 2 years.

9 of 10 patients showed no confirmed 3-month disability progression. There was no significant difference in 3-month confirmed disability between ZEPOSIA and Avonex.1-3 b Adverse reactions: Overall incidence of adverse reactions for ZEPOSIA vs Avonex at 1 year was 59.8% and 75.5%, respectively, and at 2 years was 74.7% and 83.0%, respectively. Across 2 head-to-head trials, the most common adverse reactions with an incidence of at least 2% in patients treated with ZEPOSIA and at least 1% greater than Avonex, respectively, were as follows: upper respiratory infection, 26% (vs 23%); hepatic transaminase elevation, 10% (vs 5%); orthostatic hypotension, 4% (vs 3%); urinary tract infection, 4% (vs 3%); back pain, 4%

a

The FIRST AND ONLY S1P With No First-Dose Observation Required1,4,5d

Full Prescribing Information for ZEPOSIA has NO FIRST-DOSE OBSERVATION required NO genetic testing required NO ophthalmic testing required for most patients6e

(vs 3%); hypertension, 4% (vs 2%); and abdominal pain upper, 2% (vs 1%). Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control. Upper respiratory infection includes nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. Hepatic transaminase elevation includes alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminase increased. Hypertension includes hypertension, essential hypertension, and orthostatic hypertension. Overall discontinuation rates for ZEPOSIA vs Avonex at 1 year were 6% and 8%, respectively, and at 2 years were 10% and 15%, respectively. Discontinuation rates due to adverse reactions for ZEPOSIA vs Avonex at 1 year were 2.9% and 3.6%, respectively, and at 2 years were 3.0% and 4.1%, respectively.

Serious infections: The rate of serious infections at 1 year for ZEPOSIA was 1.1% vs 0.7% for Avonex and the rate at 2 years for ZEPOSIA was 0.9% vs 0.9% for Avonex. Malignancy rates: The rate of malignancies at 1 year for ZEPOSIA was 0.2% vs 0% for Avonex and the rate at 2 years for ZEPOSIA was 0.9% vs 0.5% for Avonex.1-3

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

IMPORTANT SAFETY INFORMATION

Contraindications: • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization,

or Class III/IV heart failure or have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker • Patients with severe untreated sleep apnea • Patients taking a monoamine oxidase (MAO) inhibitor

Please see Important Safety Information throughout and Brief Summary of full Prescribing Information.

A relapse was defined as the occurrence of new or worsening neurological symptoms persisting for more than 24 hours attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days.2,3

c

Start at ZEPOSIAhcp.com

Before initiating treatment with ZEPOSIA, all patients require a recent CBC including lymphocyte count (within 6 months or after discontinuation of prior MS therapy), an ECG to check for preexisting conduction abnormalities, a recent liver function test (within 6 months), and consideration of current and prior medications, including vaccinations.1 Patients without a confirmed history of varicella (chickenpox) or without documented VZV vaccination should be tested for antibodies. If VZV or other live attenuated immunizations are required, administer at least 1 month prior to initiation.1 For patients with a history of uveitis or macular edema, an ophthalmic assessment is required.1 An up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA, as a transient decrease in heart rate and atrioventricular conduction delays may occur.1

d

Diabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation. A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA.1

e

ARR=annualized relapse rate; CBC=complete blood count; ECG=electrocardiogram; GdE=gadolinium enhancing; RMS=relapsing multiple sclerosis; S1P=sphingosine-1-phosphate; VZV=varicella-zoster virus.

IMPORTANT SAFETY INFORMATION (CONTINUED) Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA • Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA • Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator.

If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.

• Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. No cases of PML were identified in active-controlled MS clinical trials with ZEPOSIA. PML has been reported in patients treated with S1P receptor modulators and other MS therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued • In clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immunemodulating therapies used for treatment of MS. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression.

When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA

Discover an oral therapy for your patients with relapsing forms of multiple sclerosis (MS)1…

ZEPOSIA—FOCUSED ON WHAT COUNTS IMPORTANT SAFETY INFORMATION (CONTINUED)

Start at ZEPOSIAhcp.com

Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: • with significant QT prolongation • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension • with a history of Mobitz type II second-degree or higher AV block, sick-sinus syndrome, or sinoatrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated Macular edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation.

Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended Severe Increase in Disability After Stopping ZEPOSIA: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA Most common Adverse Reactions (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.

Please see Important Safety Information throughout and Brief Summary of full Prescribing Information.

References: 1. ZEPOSIA. Prescribing information. Bristol Myers Squibb; 2020. 2. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol.

2019;18(11):1009-1020 and Suppl 1-26. doi:10.1016/S1474-4422(19)30239-X 3. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31. doi:10.1016/S1474-4422(19)30238-8 4. Gilenya. Prescribing information. Novartis Pharmaceuticals Corporation; 2019. 5. Mayzent. Prescribing information.

Novartis Pharmaceuticals Corporation; 2019. 6. Marrie RA. Comorbidity in multiple sclerosis: implications for patient care. Nat Rev Neurol. 2017;13(6):375-382. doi:10.1038/ nrneurol.2017.33

ZEPOSIA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.

All other trademarks are the property of their respective owners. © 2020 Bristol-Myers Squibb Company. All rights reserved. Printed in the USA. 08/20 US-ZEP-19-0074

ZEPOSIA® (ozanimod) capsules, for oral use The following is a Brief Summary; refer to full Prescribing Information for complete product information.

1

• Have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker [see Warnings and Precautions (5.2)]

INDICATIONS AND USAGE

ZEPOSIA 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.

2

DOSAGE AND ADMINISTRATION

2.1 Assessments Prior to First Dose of ZEPOSIA Before initiation of treatment with ZEPOSIA, assess the following: Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1)].

Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.2)].

Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.3)].

Ophthalmic Assessment In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula [see Warnings and Precautions (5.7)].

Current or Prior Medications • If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

• Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].

Vaccinations Test patients for antibodies to varicella zoster virus (VZV) before initiating ZEPOSIA; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7.3)].

If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. 2.2 Dosing Information Maintenance Dosage After initial titration (see Treatment Initiation), the recommended maintenance dosage of ZEPOSIA is 0.92 mg taken orally once daily starting on Day 8.

ZEPOSIA capsules should be swallowed whole and can be administered with or without food.

Treatment Initiation Initiate ZEPOSIA with a 7-day titration, as shown in Table 1 [see Warnings and Precautions (5.2)].

Table 1: Dose Titration Regimen Days 1-4

0.23 mg once daily

Days 5-7

0.46 mg once daily

Day 8 and thereafter

0.92 mg once daily

2.3 Reinitiation of ZEPOSIA After Treatment Interruption If a dose of ZEPOSIA is missed during the first 2 weeks of treatment, reinitiate treatment using the titration regimen [see Dosage and Administration (2.2)].

If a dose of ZEPOSIA is missed after the first 2 weeks of treatment, continue with the treatment as planned.

4

CONTRAINDICATIONS

ZEPOSIA is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2)]

• Have severe untreated sleep apnea [see Warnings and Precautions (5.2)] • Are taking a monoamine oxidase (MAO) Inhibitor [see Drug Interactions (7.7)] 5

WARNINGS AND PRECAUTIONS

5.1 Infections Risk of Infections ZEPOSIA causes a mean reduction in peripheral blood lymphocyte count to 45% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues [see Clinical Pharmacology (12.2)]. ZEPOSIA may therefore increase the susceptibility to infections, some serious in nature.

Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved.

In Study 1 and Study 2, the overall rate of infections and rate of serious infections in patients treated with ZEPOSIA was similar to that in patients who received interferon (IFN) beta-1a (35% vs 34% and 1% vs 0.8%, respectively). ZEPOSIA increased the risk of viral upper respiratory tract infections, urinary tract infections, and herpes zoster [see Adverse Reactions (6.1)].

The proportion of patients who experienced lymphocyte counts less than 0.2 x 109/L was 3.3%. These values generally returned to greater than 0.2 x 109/L while patients remained on treatment with ZEPOSIA. After discontinuing ZEPOSIA 0.92 mg, the median time for peripheral blood lymphocytes to return to the normal range was 30 days, with approximately 90% of patients in the normal range within 3 months [see Clinical Pharmacology (12.2)].

Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection.

Because the elimination of ZEPOSIA after discontinuation may take up to 3 months, continue monitoring for infections throughout this period.

Herpes Viral Infection In Study 1 and Study 2, herpes zoster was reported as an adverse reaction in 0.6% of patients treated with ZEPOSIA 0.92 mg and in 0.2% of patients who received IFN beta-1a. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA (see Vaccinations below).

Cryptococcal Infection Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with S1P receptor modulators. Physicians should be vigilant for clinical symptoms or signs of CM. Patients with symptoms or signs consistent with a cryptococcal infection should undergo prompt diagnostic evaluation and treatment. ZEPOSIA treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.

Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

PML has been reported in patients treated with S1P receptor modulators and other multiple sclerosis (MS) therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or MRI findings that may be suggestive of PML. MRI findings may be apparent before clinical signs or symptoms. If PML is suspected, treatment with ZEPOSIA should be suspended until PML has been excluded by an appropriate diagnostic evaluation.

If PML is confirmed, treatment with ZEPOSIA should be discontinued.

ZEPOSIA® (ozanimod) capsules, for oral use Prior and Concomitant Treatment with Anti-neoplastic, Immunosuppressive, or Immune-modulating Therapies In clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with anti-neoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for the treatment of MS. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. Antineoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should be co-administered with caution because of the risk of additive immune system effects during such therapy. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects.

Vaccinations Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA, following which initiation of treatment with ZEPOSIA should be postponed for 4 weeks to allow the full effect of vaccination to occur.

No clinical data are available on the efficacy and safety of vaccinations in patients taking ZEPOSIA. Vaccinations may be less effective if administered during ZEPOSIA treatment.

If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA. 5.2 Bradyarrhythmia and Atrioventricular Conduction Delays Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, an up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)].

ZEPOSIA was not studied in patients who had: • A myocardial infarction, unstable angina, stroke, TIA, or decompensated heart failure requiring hospitalization within the last 6 months • New York Heart Association Class III / IV heart failure • Cardiac conduction or rhythm disorders, including sick sinus syndrome, significant QT prolongation (QTcF > 450 msec in males, > 470 msec in females), risk factors for QT prolongation, or other conduction abnormalities or cardiac condition that in the opinion of the treating investigator could jeopardize the patient’s health • Other pre-existing stable cardiac conditions without clearance from a cardiologist • Severe untreated sleep apnea • A resting heart rate less than 55 beats per minute (bpm) at baseline Reduction in Heart Rate Initiation of ZEPOSIA may result in a transient decrease in heart rate. In Study 1 and Study 2, after the initial dose of ZEPOSIA 0.23 mg, the greatest mean decrease from baseline in heart rate of 1.2 bpm occurred at Hour 5 on Day 1, returning to near baseline at Hour 6. With continued up-titration, the maximal heart rate effect of ozanimod occurred on Day 8. The utility of performing first-dose cardiac monitoring when initiating ZEPOSIA in patients with characteristics similar to those studied in the clinical trials of ZEPOSIA is unclear. Heart rates below 40 bpm were not observed. Initiation of ZEPOSIA without titration may result in greater decreases in heart rate [see Dosage and Administration (2.2)].

In Study 1 and Study 2, bradycardia was reported on the day of treatment initiation in 0.6% of patients treated with ZEPOSIA compared to no patients who received IFN beta-1a. After Day 1, the incidence of bradycardia was 0.8% in patients treated with ZEPOSIA compared to 0.7% of patients who received IFN beta-1a.

Atrioventricular Conduction Delays Initiation of ZEPOSIA may result in transient atrioventricular conduction delays. At ZEPOSIA exposures higher than the recommended dosage without dose titration, first- and second-degree type 1 atrioventricular blocks were observed in healthy volunteers; however, in Study 1 and Study 2 with dose titration, second- or third-degree atrioventricular blocks were not reported in patients treated with ZEPOSIA. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: • With significant QT prolongation (QTcF > 450 msec in males, > 470 msec in females) • With arrhythmias requiring treatment with Class 1a or Class III anti-arrhythmic drugs

• With ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension • With a history of with second-degree Mobitz type II or higher AV block, sick-sinus syndrome, or sinoatrial heart block [see Contraindications (4)] 5.3 Liver Injury Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain transaminase and bilirubin levels, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. In Study 1 and Study 2, elevations of ALT to 5-fold the upper limit of normal (ULN) or greater occurred in 1.6% of patients treated with ZEPOSIA 0.92 mg and 1.3% of patients who received IFN beta-1a. Elevations of 3-fold the ULN or greater occurred in 5.5% of patients treated with ZEPOSIA and 3.1% of patients who received IFN beta-1a. The median time to an elevation of 3-fold the ULN was 6 months. The majority (79%) of patients continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2-4 weeks.

In clinical trials, ZEPOSIA was discontinued for a confirmed elevation greater than 5-fold the ULN. Overall, the discontinuation rate because of elevations in hepatic enzymes was 1.1% of patients treated with ZEPOSIA 0.92 mg and 0.8% of patients who received IFN beta-1a.

Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have hepatic enzymes checked, and ZEPOSIA should be discontinued if significant liver injury is confirmed.

Individuals with an AST or ALT greater than 1.5 times ULN were excluded from Study 1 and Study 2. Although there are no data to establish that patients with preexisting liver disease are at increased risk to develop elevated liver function test values when taking ZEPOSIA, caution should be exercised when using ZEPOSIA in patients with a history of significant liver disease.

5.4 Fetal Risk There are no adequate and well-controlled studies in pregnant women.

Based on animal studies, ZEPOSIA may cause fetal harm [see Use in Specific Populations (8.1)]. Because it takes approximately 3 months to eliminate ZEPOSIA from the body, women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA [see Use in Specific Populations (8.1)].

5.5 Increased Blood Pressure In Study 1 and Study 2, patients treated with ZEPOSIA had an average increase of approximately 1 to 2 mm Hg in systolic pressure over patients who received IFN beta-1a, and no effect on diastolic pressure. The increase in systolic pressure was first detected after approximately 3 months of treatment and persisted throughout treatment. Hypertension was reported as an adverse reaction in 3.9% of patients treated with ZEPOSIA 0.92 mg and in 2.1% of patients who received IFN beta-1a. Two patients treated with ZEPOSIA in Study 1 and one patient treated with interferon (IFN) beta-1a in Study 2 experienced a hypertensive crisis that was not clearly influenced by a concomitant medication. Blood pressure should be monitored during treatment with ZEPOSIA and managed appropriately.

Certain foods that may contain very high amounts (i.e., more than 150 mg) of tyramine could cause severe hypertension because of potential tyramine interaction in patients taking ZEPOSIA, even at the recommended doses.

Because of an increased sensitivity to tyramine, patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. 5.6 Respiratory Effects Dose-dependent reductions in absolute forced expiratory volume over 1 second (FEV1) were observed in patients treated with ZEPOSIA as early as 3 months after treatment initiation. In pooled analyses of Study 1 and Study 2, the decline in absolute FEV1 from baseline in patients treated with ZEPOSIA compared to patients who received IFN beta-1a was 60 mL (95% CI: -100, -20) at 12 months. The mean difference in percent predicted FEV1 at 12 months between patients treated with ZEPOSIA and patients who received IFN beta-1a was 1.9% (95% CI: -2.9, -0.8). Dose-dependent reductions in forced vital capacity (FVC) (absolute value and %-predicted) were also seen at Month 3 in pooled analyses comparing patients treated with ZEPOSIA to patients who received IFN beta-1a (60 mL, 95% CI (-110, -10); 1.4%, 95% CI: (-2.6, -0.2)), though significant reductions were not seen at other timepoints. There is insufficient information to determine the reversibility of the decrease in FEV1 or FVC after drug discontinuation. One patient discontinued ZEPOSIA because of dyspnea. Spirometric evaluation of respiratory function should be performed during therapy with ZEPOSIA, if clinically indicated.

ZEPOSIA® (ozanimod) capsules, for oral use 5.7 Macular Edema S1P modulators, including ZEPOSIA, have been associated with an increased risk of macular edema.

In Study 1 and Study 2, macular edema was observed in 0.3% of patients treated with ZEPOSIA and in 0.3% of patients who received IFN beta-1a.

An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients at any time if there is any change in vision while taking ZEPOSIA. Continuation of ZEPOSIA therapy in patients with macular edema has not been evaluated. A decision on whether or not ZEPOSIA should be discontinued needs to take into account the potential benefits and risks for the individual patient.

B:11.125" T:10.875" S:9.875"

Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus Patients with a history of uveitis and patients with a history of diabetes mellitus are at increased risk of macular edema during ZEPOSIA therapy.

The incidence of macular edema is also increased in MS patients with a history of uveitis. In addition to the examination of the fundus, including the macula, prior to treatment, MS patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations.

5.8 Posterior Reversible Encephalopathy Syndrome Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving a S1P receptor modulator. In controlled clinical trials with ZEPOSIA, one case of PRES was reported. Should a ZEPOSIA-treated patient develop any unexpected neurological or psychiatric symptoms/signs (e.g., cognitive deficits, behavioral changes, cortical visual disturbances, or any other neurological cortical symptoms/signs), any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, the physician should promptly schedule a complete physical and neurological examination and should consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued.

5.9 Unintended Additive Immunosuppressive Effects From Prior Treatment with Immunosuppressive or Immune-Modulating Drugs When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation, when initiating ZEPOSIA. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended [see Drug Interactions (7.1)].

5.10 Severe Increase in Disability After Stopping ZEPOSIA Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment. Patients should be observed for a severe increase in disability upon ZEPOSIA discontinuation and appropriate treatment should be instituted, as required.

5.11 Immune System Effects After Stopping ZEPOSIA After discontinuing ZEPOSIA, the median time for peripheral blood lymphocytes to return to the normal range was 30 days, with approximately 90% of patients in the normal range within 3 months [see Clinical Pharmacology (12.2)].

Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA [see Drug Interactions (7.1)].

6

ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1)] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2)] • Liver Injury [see Warnings and Precautions (5.3)] • Fetal Risk [see Warnings and Precautions (5.4)] • Increased Blood Pressure [see Warnings and Precautions (5.5)] • Respiratory Effects [see Warnings and Precautions (5.6)] • Macular Edema [see Warnings and Precautions (5.7)] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8)] • Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.9)] • Severe Increase in Disability After Stopping ZEPOSIA [see Warnings and Precautions (5.10)] • Immune System Effects After Stopping ZEPOSIA [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of ZEPOSIA was evaluated in two randomized, double-blind, active comparator-controlled clinical studies in which 882 patients received ZEPOSIA 0.92 mg [see Clinical Studies (14)].

Table 2 lists adverse reactions that occurred in at least 2% of ZEPOSIA-treated patients and greater than comparator. The most common adverse reactions that occurred in at least 4% of ZEPOSIA-treated patients and greater than in patients who received IFN beta-1a were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.

Table 2: Adverse Reactions with an Incidence of at Least 2% in ZEPOSIA-Treated Patients and at Least 1% Greater than IFN beta-1aa (Pooled Study 1 and Study 2)

Adverse Reactions

Studies 1 and 2 ZEPOSIA IFN beta-1a 0.92 mg 30 mcg (n=882) Intramuscularly % Once Weekly (n=885) %

Upper respiratory infectionb

26

23

Hepatic transaminase elevationc

10

5

Orthostatic hypotension

4

3

Urinary tract infection

4

3

Back pain

4

3

Hypertensiond

4

2

Abdominal pain upper

2

1

a

Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control. b Includes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. c Includes the following terms: alanine aminotransferase increased, gammaglutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased. d Includes hypertension, essential hypertension, and orthostatic hypertension.

Reduction in Heart Rate Initiation of ZEPOSIA may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].

Respiratory Effects Dose-dependent reductions in absolute FEV1 and FVC were observed in patients treated with ZEPOSIA [see Warnings and Precautions (5.6)].

Malignancies Malignancies, such as melanoma, basal cell carcinoma, breast cancer, and seminoma, were reported with ZEPOSIA in the active-controlled trials for ZEPOSIA. An increased risk of cutaneous malignancies has been reported with another S1P receptor modulator.

Hypersensitivity Hypersensitivity, including rash and urticaria, has been reported with ZEPOSIA in active-controlled MS clinical trials.

7

DRUG INTERACTIONS

7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies ZEPOSIA has not been studied in combination with anti-neoplastic, immunemodulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration [see Warnings and Precautions (5.1)].

When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.9)].

ZEPOSIAÂŽ (ozanimod) capsules, for oral use Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with ZEPOSIA after alemtuzumab is not recommended.

ZEPOSIA can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.

7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That may Decrease Heart Rate ZEPOSIA has not been studied in patients taking QT prolonging drugs.

Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought.

Because of the potential additive effects on heart rate, treatment with ZEPOSIA should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties [see Warnings and Precautions (5.2)]. If treatment initiation with ZEPOSIA is considered in patients on QT prolonging drugs, advice from a cardiologist should be sought.

7.3 Vaccination During, and for up to three months after, discontinuation of treatment with ZEPOSIA, vaccinations may be less effective. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ZEPOSIA treatment and for up to 3 months after discontinuation of treatment with ZEPOSIA [see Warnings and Precautions (5.1)].

7.4 Strong CYP2C8 Inhibitors Co-administration of ZEPOSIA with strong CYP2C8 inhibitors increases the exposure of the active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may increase the risk of ZEPOSIA adverse reactions. Therefore, co-administration of ZEPOSIA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended.

7.5 Breast Cancer Resistance Protein (BCRP) Inhibitors Co-administration of ZEPOSIA with BCRP inhibitors increases the exposure of the active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may increase the risk of ZEPOSIA adverse reactions. Therefore, co-administration of ZEPOSIA with inhibitors of BCRP (e.g., cyclosporine, eltrombopag) is not recommended.

7.6 Strong CYP2C8 Inducers Co-administration of ZEPOSIA with strong CYP2C8 inducers (e.g., rifampin) reduces the exposure of the major active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may decrease the efficacy of ZEPOSIA. Therefore, co-administration of ZEPOSIA with strong CYP2C8 inducers should be avoided.

7.7 Monoamine Oxidase (MAO) Inhibitors Co-administration of ZEPOSIA with MAO-B inhibitors may decrease exposure of the active metabolites of ozanimod. In addition, metabolites of ozanimod may inhibit MAO [see Clinical Pharmacology (12.3)]. The potential for a clinical interaction with MAO inhibitors has not been studied; however, the increased risk of nonselective MAO inhibition may lead to a hypertensive crisis. Therefore, co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors.

7.8 Adrenergic and Serotonergic Drugs Because an active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis.

Therefore, co-administration of ZEPOSIA with drugs or over-the-counter medications that can increase norepinephrine or serotonin [e.g., opioid drugs, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), tricyclics, tyramine] is not recommended.

Monitor patients for hypertension with concomitant use.

Opioid Drugs Serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, or tramadol) and MAOIs, including selective MAO-B inhibitors. Although a small number of patients treated with ZEPOSIA were concomitantly exposed to opioids, this exposure was not adequate to rule out the possibility of an adverse reaction from co-administration.

Serotonergic Drugs Although a small number of patients treated with ZEPOSIA were concomitantly exposed to serotonergic medications, this exposure was not adequate to rule out the possibility of an adverse reaction from co-administration.

Sympathomimetic Medications Concomitant use of ZEPOSIA with pseudoephedrine did not potentiate the effects on blood pressure [see Clinical Pharmacology (12.3)]. However, hypertensive crisis has occurred with administration of ZEPOSIA alone [see Warnings and Precautions (5.5)] and hypertensive crisis has been reported with co-administration of other selective and nonselective MAO inhibitors (e.g., rasagiline) with sympathomimetic medications.

7.9 Tyramine MAO in the gastrointestinal tract and liver (primarily type A) provides protection from exogenous amines (e.g., tyramine). If tyramine were absorbed intact, it could lead to severe hypertension, including hypertensive crisis. Aged, fermented, cured, smoked, and pickled foods containing large amounts of exogenous amines (e.g., aged cheese, pickled herring) may cause release of norepinephrine resulting in a rise in blood pressure (tyramine reaction).

Patients should be advised to avoid foods containing a large amount of tyramine while taking recommended doses of ZEPOSIA [see Warnings and Precautions (5.5)].

8

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women. In animal studies, administration of ozanimod during pregnancy produced adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity. In rabbits, fetal blood vessel malformations occurred at clinically relevant maternal ozanimod and metabolite exposures (see Data). The receptor affected by ozanimod (sphingosine-1-phosphate) has been demonstrated to have an important role in embryogenesis, including vascular and neural development.

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

Data Animal Data Oral administration of ozanimod (0, 0.2, 1, or 5 mg/kg/day) to female rats during organogenesis resulted in a marked increase in embryofetal mortality, increased fetal malformations and skeletal variations (abnormal/delayed ossification), and reduced fetal body weight at the highest dose tested. No maternal toxicity was observed. At the no-effect dose (1 mg/kg/day) for adverse effects on embryofetal development, plasma ozanimod exposure (AUC) for ozanimod was approximately 60 times that in humans at the maximum recommended human dose (MRHD) of 0.92 mg/day. Plasma AUCs for major human metabolites, CC112273 and CC1084037, were similar to and less than, respectively, those in humans at the MRHD. Oral administration of ozanimod (0, 0.2, 0.6, or 2.0 mg/kg/day) to female rabbits during organogenesis resulted in a marked increase in embryofetal mortality at the highest dose tested and increased fetal malformations (malformed blood vessels) and skeletal variations at the mid and high doses.

Maternal toxicity was not observed. At the no-effect dose (0.2 mg/kg/day) for adverse effects on embryofetal development in rabbit, plasma ozanimod exposure (AUC) was approximately 2 times that in humans at the MRHD; plasma AUCs for major human metabolites, CC112273 and CC1084037, were less than those in humans at the MRHD. Oral administration of ozanimod (0, 0.2, 0.7, or 2 mg/kg/day) to female rats throughout gestation and lactation resulted in persistent body weight reductions and long-term effects on reproductive (prolonged estrus cycle) and neurobehavioral (increased motor activity) function in offspring at the highest dose tested, which was not associated with maternal toxicity. At the no-effect dose (0.7 mg/kg/day) for adverse effects on pre- and postnatal development, plasma ozanimod exposure (AUC) was 30 times that in humans at the MRHD; plasma AUCs for major human metabolites, CC112273 and CC1084037, were less than those in humans at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.

Following oral administration of ozanimod, ozanimod and/or metabolites were detected in the milk of lactating rat at levels higher than those in maternal plasma.

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

ZEPOSIA® (ozanimod) capsules, for oral use 8.3 Females and Males of Reproductive Potential Contraception Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment with ZEPOSIA [see Use in Specific Populations (8.1)]. Because of the time it takes to eliminate the drug from the body after stopping treatment, the potential risk to the fetus may persist and women of childbearing age should also use effective contraception for 3 months after stopping ZEPOSIA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use Clinical studies of ZEPOSIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of the ozanimod major active metabolites is unknown [see Clinical Pharmacology (12.3)].

Use of ZEPOSIA in patients with hepatic impairment is not recommended.

13

NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of ozanimod (0, 8, 25, or 80 mg/kg/day) to Tg.rasH2 mice for 26-weeks resulted in an increase in hemangioma and hemangiosarcoma (combined) in males and females at the mid and high doses tested.

Oral administration of ozanimod (0, 0.2, 0.7, or 2 mg/kg/day) to rats for 2 years resulted in no increase in tumors. At the highest dose tested (2 mg/kg/day), plasma exposure (AUC) for ozanimod was approximately 100 times that in humans at the maximum recommended human dose (MRHD) of 0.92 mg/day. Plasma AUCs for major human metabolites, CC112273 and CC1084037, were similar to and less than, respectively, those in humans at the MRHD. Mutagenesis Ozanimod was negative in a battery of in vitro (Ames, mouse lymphoma tk) and in vivo (rat micronucleus) assays. Metabolite CC1122273 was negative in in vitro (Ames, chromosomal aberration in mammalian cell) assays.

Metabolite CC1084037 was negative in an Ames assay, and positive in an in vitro chromosomal aberration assay in human (TK6) cells but negative in an in vivo rat micronucleus/comet assay.

Impairment of Fertility Oral administration of ozanimod (0, 0.2, 2, or 30 mg/kg/day) to male and female rats prior to and during mating and continuing through gestation day 7 resulted in no adverse effects on fertility. At the highest dose tested (30 mg/kg/day), plasma ozanimod exposure (AUC) was approximately 1600 times that in humans at the maximum recommended human dose (MRHD) (0.92 mg/day); plasma AUCs for metabolites, CC112273 and CC1084037, at 30 mg/kg/day were 13 and 3 times, respectively, those in humans at the MRHD. 17

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Infections Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking ZEPOSIA and for 3 months after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection [see Warnings and Precautions (5.1)].

Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection. Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with ZEPOSIA. If immunizations are planned, administer at least 1 month prior to initiation of ZEPOSIA. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA. Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating ZEPOSIA. Cardiac Effects Advise patients that initiation of ZEPOSIA treatment may result in a transient decrease in heart rate. Inform patients that to reduce this effect, dose titration is required. Advise patients that the dose titration is also required if a dose is missed for 1 day or more during the first 14 days of treatment [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.2)].

Liver Injury Inform patients that ZEPOSIA may increase liver enzymes. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.3)].

Pregnancy and Fetal Risk Inform patients that, based on animal studies, ZEPOSIA may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant. Advise women of childbearing potential of the need for effective contraception during treatment with ZEPOSIA and for 3 months after stopping ZEPOSIA. Advise a female patient to immediately inform her healthcare provider if she is pregnant or planning to become pregnant [see Warnings and Precautions (5.4)].

Respiratory Effects Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.6)].

Macular Edema Advise patients that ZEPOSIA may cause macular edema, and that they should contact their healthcare provider if they experience any changes in their vision. Inform patient with diabetes mellitus or a history of uveitis that their risk of macular edema maybe increased [see Warnings and Precautions (5.7)].

Posterior Reversible Encephalopathy Syndrome Advise patients to immediately report to their healthcare provide any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological consequences [see Warnings and Precautions (5.8)].

Severe Increase in Disability After Stopping ZEPOSIA Inform patients that severe increase in disability has been reported after discontinuation of a S1P receptor modulator like ZEPOSIA. Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of ZEPOSIA [see Warnings and Precautions (5.10)].

Immune System Effects After Stopping ZEPOSIA Advise patients that ZEPOSIA continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 3 months after the last dose [see Warnings and Precautions (5.11)].

Manufactured for: Celgene Corporation Summit, NJ 07901 Patent: www.celgene.com/therapies ZEPOSIA® is a trademark of Celgene, a Bristol-Myers Squibb Company. © 2020 Bristol-Myers Squibb Company. All rights reserved.

ZEP_HCP_BSv.001.05 03/2020

AANnews · January 2021

January 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:

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

AAN Chief Executive Officer: Mary E. Post, MBA, CAE

Editor-in-Chief: Melissa W. Ko, MD, FAAN, CPE Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com AANnews® is published monthly by the American Academy of Neurology for its 36,000 members worldwide.

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

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

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

The inclusion of advertisements and/or promotions of Sponsors and other Internet sites or resources that offer content, goods, or services on the Website does not imply endorsement of the advertised/promoted products or services by AAN.

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Emerging Leaders Graduates Make Recommendations for Leading with Inclusion

Participant Christine Kim, MD, said, “Looking back, it is difficult to think of a year in which clinical leadership worldwide could have been put to a tougher test or one in which the value of the Emerging Leaders Program could have been more apparent.”

14

Neurology Article Examines Vital Role of Immigrant Neurologists in the US

15

AMA Honors Past CEO Rydell with Lifetime Achievement Award

The article provides a review of the unique challenges facing international medical graduates who are trained in the US.

Former AAN CEO Catherine M. Rydell, CAE, received the Medical Executive Lifetime Achievement Award from the American Medical Association for her more than 25 years of leadership in organized medicine.

News Briefs Free Education Resource Don’t forget to take advantage of your free access to 2019 Annual Meeting programming with Annual Meeting On Demand, as well as extended availability of up to 242.75 CME until March 31, 2021.

To access, visit the Online Learning Center at learning.AAN.com and login with your AAN ID or associated email address. This access was made possible through a generous grant from the American Board of Psychiatry and Neurology.

Coding Resources The AAN has developed several resources to help members prepare for changes to the outpatient E/M code set and documentation guidelines, scheduled for January 1, 2021.

Resources include: a checklist to

prepare, case studies to understand the revised Medical Decision Making (MDM) table, and a three-part recorded webinar series (five minutes each).

Visit AAN.com/tools-and-resources/ practicing-neurologists-administrators.

Medical Student Resources The Medical Student Symposium presents a twice-monthly case studies and subspecialty discussion for medical students where they are able to hear from AAN physician members as they present on case studies related to their subspecialty and provide an informational overview of their field.

View our educational resources for medical students at AAN.com/toolsand-resources/medical-students. 

President’s Column

Board Accepts Report of the AAN’s Special Commission on Racism, Inequity, and Social Justice Dear Members, Inclusion is the reason the AAN was founded. In 1948, the AAN was created because there was a need for an inclusive organization that would be the home for all neurologists.

Inclusion would make our specialty much stronger, and through it our patients would receive much better care.

More than 70 years later, we are proud to share with you how our commitment to inclusion continues with your AAN Board of Directors unanimously accepting the report of the AAN’s Special Commission on Racism, Inequity, and Social Justice, providing an actionable roadmap to be an anti-racist organization as outlined in the AAN’s position statement on racism and inequities in society issued on June 4, 2020.

We firmly believe the recommendations made by the Special Commission will further the intentions of our founders to be a home where everyone feels included and belongs, while still maintaining our core activities—unparalleled education, science, advocacy, and networking that you depend on from the world’s largest association of neurologists.

Specifically, the Board of Directors has agreed to a new organizational goal to demonstrate and communicate our commitment to be a fully inclusive, diverse, and anti-racist organization that promotes neurologic health equity and actively works to recruit and support a diverse membership.

Our core values of Community, Leadership, Integrity, Professionalism, and Respect remain, and we are expanding our Diversity & Equity core value to now include Inclusion, Diversity, Equity, Anti-racism, and Social Justice (IDEAS), in which we commit to intentional action to become a fully inclusive, deliberately diverse, and anti-racist organization that respects and values our membership, our staff, and the communities we serve. We will actively promote equity and social justice in neurology and the neurosciences.

In addition, the Board accepted the following recommendations of the Special Commission: Ensure that the CEO and Board of Directors are committed to and accountable for creating an anti-racist, inclusive organization

Ensure all programming is created and implemented in an anti-racist and inclusive manner Educate and train leaders, members, and staff about the nature of anti-Black and other forms of racism Stevens Recognize the substantial contributions to the AAN and neurology by members who are Black or other underrepresented in neurology (UIN) racial and ethnic groups

Engage proactively and intentionally in two-way communication with Black and other UIN members as well as nonmembers from communities of color Recruit, retain, and promote a racially diverse staff We would like to thank the members of the Special Commission and the AAN’s Equity, Diversity, and Inclusion Joint Coordinating Council for their outstanding work.

To be a fully inclusive, diverse, and anti-racist organization strengthens the AAN, makes our specialty stronger, and most importantly, improves our ability to continue our mission of delivering the highest quality patient-centered neurologic care.

Please look for more progress updates from us in the months ahead.

Thank you for the opportunity to lead our incredible organization— where truly everyone feels included and belongs.  Sincerely,

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

Conferences & Community

Emerging Leaders Participants Make Recommendations for Leading with Inclusion “We never could have anticipated the trajectory of the upcoming year upon embarking on the Emerging Leaders Program in October 2019,” explained program graduate Christine Kim, MD. “Looking back, it is difficult to think of a year in which clinical leadership worldwide could have been put to a tougher test or one in which the value of the Emerging Leaders Program could have been more apparent.”

“We kicked off the program with excitement in Las Vegas, meeting each other and our mentors over personality color wheels, intensive workshops, and good food. We returned home and throughout the fall immersed ourselves in our group project: to identify bold actions that would allow the AAN to become a fully inclusive society. We researched, defined, redefined (and redefined again) ‘inclusion’ and increasingly understood its context and importance. We worked to translate abstract concepts and personal experiences into an actionable plan for the AAN.”

of the country—quickly cemented a unique bond over shared experiences and observations, particularly the increasingly apparent importance of inclusion. “We witnessed early reports of anti-Asian racism and saw long-standing racial disparities in health care heightened as Black and Latinx patients were disproportionally affected,” explained Kim. “Unrest from a

But as the COVD-19 pandemic developed in real time and became inextricably integrated into the program’s experience, the group—which included members from some of the earliest-hit areas

L to R: Luca Bartolini, MD; Daniel Burdick, MD; Gillian Gordon-Perue, MD; Kendra Cagniart, MD; Lakshmi Warrior, MD; Christine Kim, MD; Karen Orjuela, MD; Neha Dangayach, MD; Elliot Dawson, MD; and Daniel Ackerman, MD

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AANnews • January 2021

long history of racial injustice grew around us and resonated worldwide. These events galvanized our efforts in building inclusion within the Academy.”

The immediacy of the moment pushed the graduates to consolidate their ideas into an editorial regarding the critical need for inclusion during the pandemic. Participants worked with project advisors Jeremy Cutsforth-Gregory, MD, and Mona Bahouth, MD, along with physician liaison Gabriele De Luca, MD, DPhil, FRCPath, FAAN, and Career Leadership Subcommittee Chair Jeffrey McClean II, MD, FAAN, to successfully research, write, and eventually publish “Leading with Inclusion During the COVID-19 Pandemic” in the August 14, 2020, issue of the Neurology® journal. The article explores how COVID-19 impacts social and health care disparities in marginalized communities and discusses strategies that the AAN and other organizations can implement to be more inclusive of all individuals whether in the workplace or patient setting.

“Inclusion is the deliberate practice of ensuring that each individual is heard, all personal traits are respected, and all can make meaningful contributions to achieve their full potential,” begins the piece. “As COVID-19 spreads globally and across the United States, we have viewed this pandemic through the lens of equity and inclusion. Here, we discuss how this pandemic has magnified preexisting health and social disparities and will summarize why inclusion is an essential tool to traverse this uncertain terrain and discuss strategies that can be implemented at organizational and individual levels to improve inclusion and address inequities moving forward.”

The paper examines the disproportionate effects of COVID-19 on vulnerable populations and patients with neurologic disease; how chronic diseases are associated with higher mortality; how racial and ethnic disparities in chronic disease may contribute to disparities in mortality and severity; and how the pandemic has impacted many preexisting social disparities, leaving marginalized populations—including individuals with disabilities, people experiencing homelessness, immigrants, and people who self-identify as Lesbian, Gay, Bisexual, Transgender, and Queer or Questioning (LGBTQ)—at particular risk for poor access to care.

The 2019-2020 Emerging Leaders participants took it upon themselves to propose bold solutions and actions, not only for the AAN, but for neurologists and health care systems in general. Specifically, the cohort proposes that the AAN: establish and promote a culture of inclusion; measure inclusion specifically; build accountability for leadership; build inclusion into its pathways to leadership and support advancement of inclusion at individual institutions and practices; continue to raise the standard of excellence and inclusion in all publications and scientific programs within the AAN; and employ advocacy groups to influence political structures and policymakers to

promote inclusion in private organizations and public society.

Recommendations for neurologists and health care systems stress the need to stand together to fight fear and intolerance as a professional global community and the importance of working together to recognize and dispel misconceptions while standing united to support our colleagues and patients.

Specific actions include developing and implementing outreach programs to identify vulnerable patients and work to meet their needs, as well as looking inward and reaching out to employees who are made more vulnerable by the COVID-19 crisis and developing an inclusive approach to improving these vulnerabilities.

“As physicians, we are in a new world,” reads the summary.

“For some of us, this means converting our face-to-face visits to telephone or virtual visits. For others, it means fighting on the front lines against this invisible enemy in the intensive care unit or on the hospital floors. Whether facing the fear of working without essential personal protective equipment or the discomfort of caring for a broader patient population beyond our usual focus, we are in uncharted territory. More than ever before, we need each other. Regardless of our individual experiences, adapting to the new normal and fighting for a healthier, more inclusive and equitable future is something we do together. In this time of uncertainty, there is one clear truth: our world is changed forever. But with change comes opportunity. Let us work together to build a stronger, more inclusive future.”

Added Kim, “Being a part of the ELP this year was truly a privilege. In a year filled with uncertainty, being a part of a diverse group of neurologists and of a project meant to endure and grow beyond the COVID-19 pandemic was grounding and energizing. Our mentors went above and beyond to address the unique challenges. The experience was invaluable in itself, but also one that will be a starting point for each of us in our careers. And, we must be addicted to Zoom now—we are already planning our next call together.”

To read the full article, visit N.Neurology.org/content/95/12/537.

The Emerging Leaders Program is a multi-month leadership development program designed to identify, engage, and mentor talented early-career members who have the disposition to lead and are interested in future roles within the AAN and the field of neurology. Learn more at AAN.com/ELP. The AAN thanks the organizations that supported this program in part: ACADIA Pharmaceuticals, Inc., Acorda Therapeutics, Inc., Alexion Pharmaceuticals, Inc. Allergan, Inc., Sanofi Genzyme, Supernus Pharmaceuticals, Inc., and UCB, Inc. 

AANnews • January 2021 13

Conferences & Community

Neurology Article Examines Vital Role of Immigrant Neurologists in the United States The AAN has published an article on immigrant neurologists in the US in the “Contemporary Issues” section of Neurology ®. The article provides a review of the unique challenges facing international medical graduates (IMGs) who are trained in the US. The paper also calls for advocacy and legislation to reduce barriers facing IMGs and continue to address the neurology physician workforce gap.

Key findings and conclusions in the paper, developed by a work group of the Graduate Education Subcommittee, include: IMGs provide essential health care delivery in the US, particularly in underserved areas Immigrant neurologists who do residency training in the US improve patients’ lives, create and implement policy, lead practices and academic departments, and make new discoveries to help treat neurologic disease Current immigration complexities must be revised to support IMG neurologists in the US “The goal of this paper was to demonstrate the impact that IMGs have on the practice of neurology and the care of patients living with neurologic disease in the United States, as well as to describe potential limitations and barriers for IMGs to practice neurology here,” said Jaffar Khan, MD, FAAN. “As members of the Graduate Education Subcommittee deeply involved in the

training of future neurologists, we were aware of the positive impact IMGs had on the neurology training and practice in the Khan US. Additionally, we were very aware of existing barriers IMGs faced when seeking neurology training in this country. As we discussed this topic, we witnessed actual and proposed changes to federal policies that further restricted entry of IMGs into the US. As a result, we desired to characterize the impact of IMGs on the practice of neurology and care of patients with neurologic disease in the United States.”

By addressing the role and challenges faced by IMGs, the Work Group hopes that AAN members, inclusive of clinicians, scientists, and trainees, will be better prepared to advocate against changes in policy that restrict IMGs who wish to pursue training and careers in neurology in the United States.

To read the complete paper, visit bit.ly/32SEm88. 

AAN Urges You to Take Care of Yourself in Stressful Times As the new year begins, the AAN calls on members to be mindful of their physical and emotional needs as they strive to deliver excellent care during the COVID-19 pandemic.

FEEL YOUR

BEST! 14

AANnews • January 2021

“Is your default switch set to always do more than you think you possibly can?” asks Jenifer R. Molano, MD, FAAN, co-chair of the Joint Coordinating Council on Wellness and chair of the Live Well, Molano Lead Well Work Group. “Many of us relish opportunities to stretch beyond our limits to grow professionally or give back to our patients and communities. But there are times—particularly in stressful environments as we’re living through right now—when it is important to take a breath and examine where you’re at and how well you’re juggling all the balls. If you’re feeling exhausted, irritable, numb, or burned out, your body and mind are signaling it’s time to recalibrate.”

The AAN has an abundance of resources online to help you understand how stress diminishes one’s abilities and enjoyments and encourage you to take care of yourselves and each other. Through time-proven self-care routines, you can prevent burnout, regain your energy, and restore your resiliency and well-being. Visit AAN.com/LiveWell to learn more. 

AMA Honors Past CEO Rydell with Lifetime Achievement Award Former AAN CEO Catherine M. Rydell, CAE, is the recipient of the Medical Executive Lifetime Achievement Award from the American Medical Association (AMA) for her more than 25 years of leadership in organized medicine. The award honors a medical association executive who has contributed substantially to the goals and ideals of the medical profession. The AMA presented the award to Rydell during the November 2020 Special Meeting of the AMA House of Delegates.

AMA Board Chair Russ Kridel, MD, said “Through her hard work and leadership over the last 20 years, Catherine Rydell has been instrumental in expanding the reach of the American Academy of Neurology—forging numerous international ties with neurology advocates across the globe and more than doubling the Academy’s neurologist members. Catherine is being recognized for her tireless advocacy on behalf of the entire neurology community and I am pleased to present her with this award for a lifetime of service.”

Accepting the award virtually, Rydell said, “In my 21 years at the American Academy of Neurology, I've watched thousands of volunteers unselfishly give of their time and talent for the good of the whole. I've seen leaders and volunteers passionately advocate for their profession and their patients. I will

2021 Annual Meeting Going Fully Virtual!

No matter where you are in the world, with just a click of a button the 2021 Annual Meeting will open the doors to: 60+ new, top-tier education programs in nearly every topic and subspecialty imaginable 2,000+ scientific abstract presentations on breakthrough findings Experiential Learning Area talks All the CME you’ll need for the year

forever be grateful to the Academy for the opportunity to work with and learn from extraordinary physician leaders.

The added bonus: many have become my lifelong friends.” 

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own convenience after the meeting, and the upgraded Gold Registration option will give you longer access and more than 30 additional educational courses with 2021 Annual Meeting On Demand.

We look forward to bringing the AAN Annual Meeting to you, wherever you are. Visit AAN.com/21AM today to explore the preliminary program and register by March 25 for the best rates. 

Highly popular plenary sessions featuring premier lectures Access to a variety of industry representatives bringing leading-edge solutions to the field of neurology Networking and community building that has made the AAN Annual Meeting the most preeminent global neurology meeting What’s more, the virtual format will allow you to view session recordings and access program materials at your

April 17– April 22

Tools & Resources

AAN Advocacy Succeeds on E/M Improvements, Telehealth Expansion continued from cover in the 2020 Medicare Physician Fee Schedule, CMS is aligning the agency’s E/M visit coding and documentation policies with changes laid out by the CPT Editorial Panel. The AAN is highly supportive of the new coding and payment structure and lauds the agency for moving forward with implementation.

In addition to moving forward with the new structure, CMS finalized modifications to the times associated with prolonged E/M services and increased the valuations for certain services that are valued in accordance with E/M services including transitional care management and cognitive impairment assessment and care planning.

E/M services will receive a significant increase starting in 2021, but the AAN notes that due to budget neutrality, the increase in payment for E/M services results in an across-the-board cut to all other services. Although neurology as a specialty is expected to experience a significant increase in reimbursement due to the E/M changes, some neurologists may experience payment reductions if they provide few E/M services. These finalized policies could be modified by Congress and the AAN continues to actively engage with representatives on this issue. We are supportive of efforts to waive budget neutrality to offset cuts to reimbursement for non-E/M services provided that it would not result in a delay or in any way undermine CMS’s decision to fully implement the new E/M payment structure on January 1, 2021.

Telehealth Regulations Noting the significant expansion of telehealth due to the COVID-19 Public Health Emergency (PHE), CMS is implementing a number of substantial changes to its existing telehealth reimbursement and regulatory policies. It is important to note that these changes do not supersede the regulatory flexibilities that are in place for the duration of the PHE. Key updates include: CMS is adding a broad array of new services to the Medicare telehealth list permanently and will add additional services to the telehealth list temporarily through the end of the calendar year during which the PHE ends.

CMS is discontinuing payment for audio-only E/M visits upon the termination of the PHE and is implementing, on an interim basis for CY 2021, separate coding and payment for an extended audio-only virtual check-in assessment service.

CMS will allow direct supervision to be provided to members of the care team using real-time, interactive audio and video technology through the latter of the end of the PHE or December 31, 2021.

CMS is also modifying requirements related to the coverage of remote physiologic monitoring.

Earlier this year, CMS sought feedback from the public in relation to how telehealth services have been in use in various communities during the response to COVID-19. In response, the AAN provided the agency with experiential feedback from AAN members and an overview of the literature as it pertains to telehealth in neurology to guide future policymaking.

Given feedback from stakeholders, CMS announced that it has commissioned a study of the telehealth flexibilities provided during the COVID-19 PHE. The study will explore new opportunities for services where telehealth, virtual care supervision, and remote monitoring can be used to more efficiently bring care to patients.

Quality Payment Program The final rule includes changes for the 2021 Quality Payment Program (QPP) performance year, which includes the Meritbased Incentive Payment System (MIPS) and Advanced Alternative Payment Model (APM) tracks.

For 2021 MIPS reporting, CMS finalized increasing the performance threshold to 60 points, requiring participants to score at least 60 points to avoid a negative payment adjustment, and maintained the 85-point threshold for an exceptional performance bonus. The MIPS Quality component will decrease to 40 percent from 45 percent and the MIPS

Cost component will increase to 20 percent from 15 percent.

There are minimal changes to the Improvement Activities and Promoting Interoperability components. Payment adjustments for the 2021 reporting year will continue to range between +/-9%. For the APM track, CMS finalized eliminating the APM scoring standard in 2021 and sunsetting the CMS Web Interface as a reporting option in 2022.

CMS also finalized a maximum 10-point bonus for complex patients in response to the COVID-19 pandemic and extended its Extreme and Uncontrollable Circumstances Policy to all QPP participants—individuals, groups and APM entities—with the option to request waiving any or all components due to COVID-19. The deadline to apply for the 2020 reporting year is February 1, 2021.

CMS finalized a new performance track to begin in 2021 called the APM Performance Pathway (APP) that will require Medicare Shared Savings Program (MSSP) participants, and be optional for other MIPS-APM participants, to report a fixed set of measures for each performance category in MIPS as an individual, group, or APM entity. The rule also finalized delaying implementation of MIPS Value Pathways (MVPs) until at least 2022 and released guiding principles, development criteria, and a standardized template for MVP proposals. 

Introducing the Axon Registry Ambassador Program to Support Members To support and promote the value of the Axon Registry ®, the AAN has recently introduced the Axon Registry ambassador program. This new initiative will boost the registry’s recruitment efforts as physician ambassadors advocate for the Axon Registry, a quality improvement registry that, among many benefits to members, has been designated by CMS to support MIPS reporting.

A quality improvement registry like the Axon Registry can help monitor patient safety, promote high-quality care, and assess quality and outcomes of neurologic care. The Axon Registry helps improve the quality of care patients receive by collecting data from clinicians and reporting this data to CMS. It can also be used for benchmarking at large health systems and academic medical centers.

The Axon Registry ambassadors are AAN member volunteers serving on the Quality Committee and its subcommittees, including the Registry Subcommittee and the Quality Measures Subcommittee, as well as other influential members of the AAN. The ambassadors have in-depth knowledge of the Axon Registry and also work on advocating for quality improvement. Each ambassador provides unique experiences

with engaging different stakeholders across the health care field. An ambassador can provide the necessary support for clinicians seeking to implement the Axon Registry in their own organization.

By helping large health care organizations understand registry data collection and how it works with privacy laws such as HIPAA and PHI as well as how the registry interacts with EHR systems, the program should be able to achieve its goal to enroll additional organizations to further improve quality of care for patients. The ambassadors also are willing to help providers from smaller health systems if needed.

If you are interested in joining the Axon Registry and would like an ambassador to lead you through the process, please email registry@aan.com. 

AANnews • January 2021 17

Policy & Guidelines

Power Shifts in DC, States, to Impact Health Care Legislation in 2021 and Beyond On the heels of a highly contentious election season—which really doesn’t end until January in Georgia—the 117th Congress comes to order with a host of implications. The fact that there are slim majorities in each chamber leaves little room for big, bold legislation. Despite Democrat Joseph R. Biden winning the presidency, neither party has a clear mandate. This could result in more gridlock as parties propose “messaging bills” to strengthen their positions with constituents.

From the Biden administration, we could possibly expect policies to address Medicare negotiation of drug prices, support for the Affordable Care Act that draws in a public option, lower eligibility age for Medicare, and a roll back of Trump administration regulations and executive orders. Biden will likely instigate a more robust federal approach to address the pandemic and push for COVID-19 relief/stimulus legislation.

Indeed, COVID relief will be a major focus of his first 100 days, along with appointments to Cabinet positions, the federal budget, and executive orders.

In Congress, Democrats retain a reduced majority in the House, and control of the Senate will be decided by two runoff elections in Georgia. Conventional wisdom suggests it will be challenging for the Democrats to win one, let alone both Georgia Senate seats, but we find ourselves in unconventional times.

Nonetheless, the AAN employs a simple and effective advocacy model that has been the basis for many past successes: Anticipate changes in health care delivery systems; influence the process, decisions, and structures; and engage our members and patient groups to become partners in the process.

AAN Priorities for the 117th Congress and Biden Administration With a divided government and slim majorities in each house of Congress, we expect to see much of its activities focus on “must-pass” legislation. This includes funding bills and bills reauthorizing federal health programs. However, the AAN can still make progress on our key priorities that have bipartisan support like research funding, reducing regulatory burdens, and telehealth: Demonstrate value of neurology E/M reimbursement Regulatory reform Access to neurologists COVID-19 relief Telehealth Drug pricing Affordable Care Act Workforce including visas and GME Increase research funding NIH, BRAIN Initiative, National Neurologic Conditions Surveillance System

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AANnews • January 2021

The Academy’s previous advocacy actions have laid the groundwork for many of the major issues that are expected to come before Congress in this session. Here’s a look at what we are anticipating at this point.

Drug Pricing In the 116th Congress, both the Senate Finance Committee and House Democrats released broad drug pricing bills.

AAN staff worked closely with legislators and staff to ensure key priorities were included, like allowing Medicare to negotiate drug prices, creating an out-of-pocket cap for prescription drugs in Medicare, drug importation, and increased research funding.

Both bills had support from their respective parties, but once the pandemic hit, all momentum halted.

With slim majorities in both chambers there is a chance that a drug pricing compromise bill could be passed giving each side a “win” going into 2022.

Regulatory Reform The AAN will continue to work with stakeholders and coalitions like the Regulatory Relief Coalition and the Safe Step Working Group to advance our policy goals.

The Academy has worked with these coalitions to develop legislative language to reform prior authorization and step therapy protocols. We identified key bill sponsors and have helped to garner hundreds of bipartisan cosponsors.

These bills will be reintroduced in the 117th Congress and may have a greater chance of passing when Congress will likely be avoiding controversial bills.

Affordable Care Act The Biden administration campaigned on expanding the ACA with a goal of getting to universal coverage. However, the makeup of the new Congress will make it difficult to do this legislatively. Many believe the Biden administration will take advantage of executive orders and allow the Centers for Medicare and Medicaid Services and other agencies to undo what the Trump administration did to the ACA. In the summer of 2021, the Supreme Court will rule on the constitutionality of the ACA’s “individual mandate.”

This prompts the question, will justices strike down the whole law or just the individual mandate? We expect both Democrats and Republicans to be ready to offer alternatives to the ACA if it is struck down.

Telehealth Telehealth has broad bipartisan support in both chambers, and the AAN has worked closely with multiple legislators and endorses multiple bills to support the expansion of telehealth under the public health emergency. Congress and the administration will need to consider how big they want to go, or if they want to rein in telehealth after the public health emergency.

Research Funding The AAN works closely with legislative champions each year to ensure our priorities are fully funded.

These champions send “Dear Colleague” letters to the Appropriations Committee requesting funding levels for certain programs and agencies. Academy staff support them by meeting with legislators and staff and explaining how these programs and agencies impact neurology and encourage the members to sign on to the Dear Colleague.

AAN staff will be working with them again in the 117th Congress to support the BRAIN Initiative, the National Institutes of Health, the National Neurologic Conditions Surveillance System, and other federal research efforts critical to neurology.

Other issue we’re tracking include medicinal cannabis, medical liability reforms, prescription payment reform, the opioid crisis, and health care disparities.

State Races Will Influence 2021 Redistricting One far-reaching outcome of the 2020 state elections is that state legislators will use the 2020 Census results to draw congressional boundaries for the House of Representatives.

Some states use nonpartisan commissions to draw boundaries, but in other states it is the party that controls the legislature that determines how congressional boundaries for the House are drawn for the next decade.

In this instance, Republicans overperformed at the state level, which means Republican-controlled legislatures will be responsible for redrawing boundaries for at least 181 congressional districts. Legislatures controlled by Democrats will draw maps for at least 76 congressional seats.

State legislatures that split control between Republicans and Democrats will draw 47 seats, and nonpartisan commissions will draw boundaries for 124 seats. 

Stand up for Neurology in 2021!

There is much to accomplish this year, and we can’t do it alone. We need your passion for neurology to ignite your participation in AAN advocacy initiatives and drive our success. Here’s how you can get involved.

Respond to AAN Action Alerts​: When we send Action Alert emails, please take a couple of minutes to read and respond to your lawmakers in Congress so they can hear directly from you.

Read Capitol Hill Report: Twice monthly we send you emails linking to these timely reports posted on AAN.com.

Learn the latest from our advocacy staff about activities that are affecting your profession and patients.

Palatucci Advocacy Leadership Forum: Apply for this intensive four-day workshop that will equip you with the skills you need to become a successful advocate in your institution or community.

Neurology on the Hill: Apply to join us to engage with Washington, DC, where we educate you on major issues and bring you to virtual Capitol Hill meetings with your lawmakers to make the case for neurology.

BrainPAC: This is the ONLY federal political action committee in Washington, DC, that specifically represents the profession of neurology by making contributions only to candidates for the US House and Senate. This tool is used by the AAN to build relationships with current and potential legislators to impact health care policy in support of the AAN’s legislative goals. Learn more at BrainPAC.com.

Follow us on social media at #AANadvocacy: Get the scoop on our latest initiatives and victories! 

AANnews • January 2021 19

Global Community

Online Learning

Virtual Conferences

Networking

Scientific Research

Count on the AAN to provide top-quality education, events, networking, and other programs and opportunities—in new virtual formats that offer greater flexibility and easy access to your worldwide neurology community. Join or renew today!

AAN.COM/MEMBERSHIP

Policy & Guidelines

New Lyme Disease Guidelines Published

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The guidelines provide practical recommendations for clinicians treating patients with Lyme disease, including, but not limited to, primary care physicians, infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists, and dermatologists.

These recommendations aim to serve as a meaningful resource for the safe, effective, evidence-based care of people with Lyme disease. They address clinical questions related to the prevention, diagnosis, and treatment of Lyme disease; complications from neurologic, cardiac, and rheumatic symptoms; disease expression commonly seen in Eurasia; and complications from coinfection with other tick-borne pathogens.

The guidelines include 43 recommendations related to diagnostic testing, including testing scenarios (such as for certain neurologic, psychologic, behavioral, cardiac, and rheumatologic syndromes); detailed recommendations about Lyme carditis; and a discussion of “chronic Lyme disease.”

Among the diagnostic testing recommendations, the guidelines recommend clinical diagnosis without laboratory testing for people with a skin rash characteristic of early Lyme disease. For people with other signs of Lyme disease, such as swollen joints or meningitis, the guidelines recommend antibody testing.

Among the treatment recommendations, the guidelines recommend oral antibiotic therapy for most patients with Lyme disease. The recommended duration of therapy is 10 to 14 days for early Lyme disease, 14 days for Lyme carditis, 14 to 21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis. Retreatment may be indicated for individuals with arthritis who have failed a first course of treatment.

The recommendations are grounded in a rigorous, systematic review of available evidence surrounding prevention, diagnosis,

PODCAST

and treatment of the disease. The panel adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and strength of recommendations. The guidelines are voluntary, and it is up to clinicians to determine which treatments are best for individual patient scenarios.

Each of the three sponsoring organizations elected a co-chair to lead the guideline panel. A fourth co-chair was selected for expertise in guideline methodology. A total of 36 people comprised the full panel, and the panel also included three patient representatives and one health care consumer representative.

About 30,000 cases of Lyme disease are reported annually, but the Centers for Disease Control and Prevention estimates there are more than 300,000 cases in the United States each year.

Read the guidelines and access a clinician summary at AAN.com. For more information, email guidelines@aan.com. 

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AANnews • January 2021 21

Policy & Guidelines

Apply by February 26 for 2021 Neurology on the Hill Would you like to share the challenges neurology is facing with your congressional representatives―without having to travel to Washington, DC? This year you can, as Neurology on the Hill will take place virtually on May 19, 2021, due to the ongoing pandemic.

This is your chance to tell Congress your personal story. You don't need a public policy background, just a passion for neurology and the desire for positive change.

The application period for Neurology on the Hill 2021 will be open from January 11 to February 26, 2021. Learn more and apply at AAN.com/NOH. Contact noh@aan.com with any questions. 

Comment Invited on Prevention of Stroke Practice Advisory The AAN invites public comment on a draft of “Practice Advisory: Prevention of Stroke in Patients with Symptomatic Large Vessel Intracranial Atherosclerotic Disease.” The public comment period for this practice advisory is open online at AAN.com/view/ PublicComment through 11:59 p.m. ET on February 8.

This practice advisory includes conclusions and recommendations that address: The use of antithrombotic medications for preventing the combined endpoint of stroke, intracerebral hemorrhage, and vascular death in patients with symptomatic intracranial atherosclerotic arterial stenosis (s-ICAS).

The management of vascular risk factors in patients with s-ICAS. The safety risks and lack of evidence regarding the use of percutaneous angioplasty and stenting (PTAS) for stroke prevention in patients with s-ICAS. Current data support the use of medical management, including antiplatelet agents, high-intensity statins, blood pressure control, and lifestyle modification, to reduce the risk of stroke in patients with s-ICAS. Due to safety concerns and

a lack of supporting evidence for efficacy, the authors do not recommend PTAS as the initial treatment for stroke prevention in patients with severe s-ICAS. Additional trials are needed to develop safe and durable treatments for high-risk patients with s-ICAS. New endovascular and surgical treatments must be compared with optimal medical management.

This draft manuscript is made available at this time only for the purpose of obtaining comments from professionals and public stakeholders. Because this document is not in its final, publishable form, we ask that you do not publish, post, disseminate, or otherwise release the contents of this document.

Submit your comments on the website through 11:59 p.m.

ET on February 8. For questions or more information, email guidelines@aan.com. 

Education & Research

Medical Students Speak out for Neuroscience Is… Rewarding Day On November 30—the birthday of German neurologist Wilhelm Heinrich Erb, MD, who is credited with popularizing the reflex hammer—the AAN reached out to college and medical students to encourage their interest in neuroscience with Neuroscience Is…™ Rewarding Day. Students were asked to post a picture on social media along with the hashtags #NeuroscienceIs and #FutureNeurologist, about why they find neuroscience rewarding. 

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AAN ONLINE LEARNING Browse a variety of online CME, self-assessment, and other learning activities to suit your wide-ranging interests and learning styles.

AAN.com/learn

Education & Research

UCNS Seeks Journal Articles, Practice Guidelines for Continuous Certification Reading List The United Council for Neurologic Subspecialities (UCNS) is engaging each of its neurologic subspecialties in the process of identifying the most important developments in their subspecialty field for the 2022 continuous certification cycle. All certified diplomates and subspecialty sponsoring organizations are encouraged to submit journal articles or practice guidelines that meet the submission criteria for continuous certification, including: Reflects recent advances within the past four years or current clinical knowledge in the subspecialty field Clinically relevant articles Drawn from peer-reviewed journals relevant to the subspecialty and/or the related primary specialty field New or updated practice guidelines published in print or electronic form Available to and easily accessible by UCNS diplomates

The deadline to submit is August 31, 2021. For more information on submission criteria and to submit, visit ucns.org/ArticleSubmission. For questions, contact Todd Bulson, Senior Manager Certification, at tbulson@ucns.org or (612) 928-6067. 

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American Brain Foundation

‘Cure One, Cure Many’ Philosophy Drives American Brain Foundation’s Efforts The American Brain Foundation’s mission is to bring researchers and donors together in the relentless pursuit of discovery research in the hope that it will lead to improved diagnoses, treatments, and ultimately cures for brain diseases. While the brain is a complex organ with distinct parts and unique functions, different brain diseases often interconnect with one another. As such, research into one area can inform investigative work on another, and because a cure for one disease could lead to cures for many diseases, the Foundation’s philosophy of “cure one, cure many” drives its commitment to invest in research across the whole spectrum of brain diseases and disorders.

“When researchers make breakthroughs for one brain disease, what we learn will apply in understanding, preventing, or treating others,” said former Foundation Board Member Ralph Józefowicz, MD, FAAN. “For example, while Parkinson’s disease, Lewy body dementia, and ALS are different diseases with their own symptoms and progressions, they are all degenerative diseases and what’s causing one disease is very similar to what’s causing the other disease. Funding research not for a specific disease, but a category of diseases, will allow us to more quickly develop treatments for these disorders.”

In support of its “cure one, cure many” philosophy, the Foundation has developed partnerships with organizations across a wide spectrum of brain diseases, bringing together the best researchers from respected organizations fighting diseases of the brain and nervous system. Specifically, the Foundation’s partnership with the American Academy of Neurology offers unique access to a massive network of

“The Foundation’s practice of studying the whole brain and funding research across the full spectrum of brain disease gives us the best hope for better prevention, treatment, and cures,” explained Józefowicz. “For instance, the American Brain Foundation’s 2019 Scientific Breakthrough Awardee Dr. Jerry Mendell’s groundbreaking gene therapy treatment for spinal muscular atrophy is not only improving motor milestones by treating the disease in children younger than two years old, but it is also being used effectively to treat Duchenne muscular dystrophy.”

Visit AmericanBrainFoundation.org to learn more about how the American Brain Foundation’s philosophy fuels its partnerships, its commitment to funding research, and its passionate pursuit of a life without brain disease. 

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26

AANnews • January 2021

Jozefowicz

neurologists and brain disease researchers engaged in cutting-edge research that could cure diseases and change lives.

DRIVEN TO FIND A CURE

Since 1992, the American Brain Foundation has funded over 260 researchers in pursuit of treatments and cures across the whole spectrum of brain disease.

Learn more at AmericanBrainFoundation.org.

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JANUARY 1

FEBRUARY 1

Applications Open: UCNS Clinical Neuromuscular Pathology Certification UCNS.org/CNMPcertification

Applications Open: UCNS Neurocritical Care Certification UCNS.org/NCCcertification

JANUARY 11

Submission Deadline: Emerging Science Abstracts AAN.com/EmergingScience

Applications Open: Neurology on the Hill AAN.com/NOH

FEBRUARY 8

MARCH 1

Applications Open: UCNS Autonomic Disorders Certification UCNS.org/ADcertification

MARCH 25

Early Registration Deadline 2021 AAN Annual Meeting AAN.com/21AM

FEBRUARY 9–17

RITE® Administration Dates AAN.com/RITE2021

FEBRUARY 26

Application Deadline: Neurology on the Hill NCC: 20 Career Center Ad—Full Page> AANnews, NJ, NCP in AANnews, Neurology Journal, or Neurology Clinical Practice AAN.com/NOH Placed 8.25 x 10.875 +0.125 bleed, 4C

The American Academy of Neurology is proud to offer

THE #1 CAREER AAN.com/careers CENTER

FOR NEUROLOGISTS

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.

Neurology positions available—variety of subspecialty and General Neurology opportunities—Ochsner Health System— New Orleans, Louisiana The Ochsner Neuroscience Institute is actively recruiting BC/BE Neurologists to join our expanding practices. Opportunities exist at our Main, Baptist, and West Bank campuses in New Orleans as well as our facilities located on the North Shore, Kenner, and Baton Rouge for BC/BE General Neurologists and those with subspecialty training in the following areas: Cognitive Disorders, Movement Disorders, Headache, Neuromuscular, Pediatric Epilepsy, Stroke/Vascular. Both newly trained and experienced physicians are encouraged to apply. We offer a highly competitive salary with comprehensive benefits. The opportunities at our community hospitals in Covington and Baton Rouge are for general neurology with up to 20% sub specialization to start. Physicians will join a practice with a mix of inpatient and outpatient responsibilities in Baton Rouge and 100% outpatient in Covington. With the New Orleans opportunities there is availability to practice neurology in a collegial and patient-focused environment. Academic appointments are available at our affiliated institutions, including Tulane, LSU, and the University of Queensland.

The Department of Neurology has a complement of over 40 Neurologists system-wide with subspecialty representation in Stroke, Neurocritical Care, Interventional Neurology, Neuromuscular Disease, Movement Disorders, Epilepsy, MS, Headache, Cognitive Disorders, Sleep, Traumatic Brain Injury and Sports Medicine. We are a top 50 Neuroscience Center

in the latest US News and World report rankings. For more information, please visit our website! https://www.Ochsner.Org/ neurorecruitment. Sorry, no J1 visa opportunities. Ochsner is an equal opportunity employerA andJOB all qualified applicants TOP will TALENT receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, disability status, protected veteran status, or any other characteristic protected by law. 

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Visit AAN.com/careers for all AAN options, rates, and deadlines.

Ad copy for the March 2021 print edition of AANnews must be submitted by February 1, 2021. The same deadline applies to changes/cancellations.

The American Academy of Neurology reserves the right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad. 