VOLUME 33 · ISSUE 9 · September 2020
Visit AAN.com/Covid19 for the latest pandemic information and resources to support you and your crucial work.
BRAIN & LIFE COVER CELEBRITIES SHARE INSPIRATIONAL VIDEO MESSAGES Several celebrities profiled in past or future Brain & Life® cover stories now appear in “Messages of Hope,” a series of inspirational videos produced by the AAN. The videos feature actors Emilia Clarke, Dash Mihok, Blair Underwood, and R.J. Mitte; musician Peter Frampton; TV personality Jack Osbourne; and comedian Josh Blue. They share their thoughts on how to cope with the COVID-19 pandemic—especially for viewers who are confronting the daily challenges of living with neurologic diseases—and express their gratitude to neurologists and other health care workers on the front lines.
Peter Frampton @peterframpton
I want the @BrainandLifeMag community to know about the importance of exercise for those who live with inclusion body myositis. Watch my video for more information: https://youtu.be/1SWueryHUWY #NeurologyProud
View a compilation of excerpts from each celebrity video as well as the full-length individual messages at BrainandLife.org/MessagesofHope.
There’s Still Time to Take Part in Virtual Education Series for APPs
Registration Opens this Month for October’s Virtual Fall Conference
The 10-week, self-paced virtual education series for neurology advanced practice providers (APPs) is underway, but there’s still time to benefit from the latest overviews, updates, and resources on a variety of core topics in clinical neurology being presented through the week of October 12.
Be sure to visit AAN.com/20FC when registration goes live mid-September for the Fall Conference, available via a virtual format this October 16–17. As always, the Fall Conference will provide the timeliest clinical updates from noteworthy experts on the hottest topics in neurology, as well as a prime opportunity to fulfill end-of-year CME requirements.
Continued on page 14
“The virtual 2020 Fall Conference will help participants deliver the most up-to-date neurology patient care and provide unique networking opportunities,” Continued on page 13
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23 Proposed Rule: CMS Updates
Physician Payment System and Proposes Regulatory Changes
NEW & APPROVED
ZEPOSIA® (ozanimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.
FOR RELAPSING FORMS OF MS1
DISCOVER THE FIRST AND ONLY S1P WITH NO FIRST-DOSE OBSERVATION REQUIRED1-3a FULL PRESCRIBING INFORMATION FOR ZEPOSIA HAS
NO FDO REQUIRED, NO GENETIC TESTING REQUIRED, AND NO OPHTHALMIC TESTING REQUIRED FOR MOST PATIENTS4b Start at ZEPOSIAhcp.com
Discover More About Once-Daily Oral ZEPOSIA POWERFUL EFFICACY 1c
COMPARABLE1,5,6e
CONSISTENT 7f
Proven superior in reducing relapses vs Avonexd
Safety profile vs Avonex in overall incidence of adverse reactions
Proven superior in reducing GdE and T2 lesions vs Avonex
Consistently low discontinuation rates vs Avonex
ZEPOSIA consistently maintained ALC near the lower limit of normal across 2 large-scale pivotal trials
Comparable rates of serious infections and malignancies vs Avonex 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 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.
Please see Important Safety Information throughout and Brief Summary of Prescribing Information.
ZEPOSIA is commercially available in the US as of June 1, 2020, following FDA approval on March 25, 2020. 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 b 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 a
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.1,5,6 d 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.5,6 e 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% (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 infections include 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.1,5,6 f ALC: ZEPOSIA causes a mean reduction in peripheral blood lymphocyte count to 45% of baseline values because of reversible retention of lymphocytes in lymphoid tissues. ZEPOSIA may therefore increase the susceptibility to infections. Mean ALC was 0.75 × 10 9 cells/L for both SUNBEAM and RADIANCE (at 1 year and 2 years, respectively).1,5,6
c
ALC=absolute lymphocyte count; ARR=annualized relapse rate; CBC=complete blood count; ECG=electrocardiogram; FDO=first-dose observation; GdE=gadolinium enhancing; S1P=sphingosine-1-phosphate; VZV=varicella-zoster virus.
IMPORTANT SAFETY INFORMATION (CONTINUED) Infections (Continued): • 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, noncorticosteroid immunosuppressive, or immune-modulating 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
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
NEW & APPROVED
FOR RELAPSING FORMS OF MS1
Start at ZEPOSIAhcp.com
IMPORTANT SAFETY INFORMATION (CONTINUED) 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 Prescribing Information. References: 1. ZEPOSIA® (ozanimod) [package insert]. Summit, NJ: Bristol Myers Squibb; 2020. 2. Gilenya® (fingolimod) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019. 3. Mayzent® (siponimod) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019. 4. Marrie RA. Comorbidity in multiple sclerosis: implications for patient care. Nat Rev Neurol. 2017;13(6):375-382. 5. Comi G, Kappos L, Selmaj K, et al; for the 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. 6. Cohen JA, Comi G, Selmaj K, et al; for the 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. 7. Data on file, Bristol Myers Squibb. 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. 07/20 US-ZEP-20-0774
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.
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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) Studies 1 and 2 ZEPOSIA IFN beta-1a 0.92 mg 30 mcg (n=882) Intramuscularly % Once Weekly (n=885) %
Adverse Reactions
Upper respiratory infectionb elevationc
26
23
10
5
Orthostatic hypotension
4
3
Urinary tract infection
4
3
Hepatic transaminase
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.
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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 · September 2020
September 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
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New AAN Section Created to Address Needs of Those Underrepresented in Neurology
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2020 MIPS Flexibilities Available Due to COVID-19
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AAN Expands Collaboration with Verana Health to Improve Axon Registry
The new section aims to be a space where Underrepresented in Neurology (UIN) members can come together in fellowship, create programming relevant to the needs of UIN members, and work with the AAN to advance its anti-racism pledge.
Clinicians participating in the Quality Payment Program in 2020 may submit an Extreme and Uncontrollable Circumstances Application through December 31, 2020, to request a reweighting of one or more MIPS components due to COVID-19.
Verana Health will now assume responsibility for integrating electronic health records data into the registry, providing practice support, displaying quality dashboards, and submitting MIPS quality reporting for members contributing to Axon Registry ®.
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: Jim Hopwood 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.
News Briefs Telehealth Advocacy Campaign To ensure the neurology community’s telehealth flexibilities are preserved beyond the public health emergency, the AAN led a virtual advocacy campaign “Speak Up for Telehealth” on July 28–29. The goal was to empower US AAN members and other allied stakeholders to influence policymakers on this critical issue. During the campaign, over 1,200 individuals emailed Congress, their state policymakers, or submitted a story using the AAN Advocacy Action Center, and 72 individuals attended a live webinar with a US Rep. Mikie Sherrill (D-NJ). Nineteen other subspecialties, state neurosocieties, and patient organizations supported the effort, helping produce millions of social media
impressions and making the AAN the top influencer for #telehealth during this campaign.
New CFO Kevin C. Myren, CPA, started in August as the AAN’s chief financial officer, responsible for Finance, Facilities, and New Business Development. Myren, who previously served as CFO and vice president of administration at CommonBond Communities for 10 years, has over 30 years of experience in the finance field. He replaces Tim Engel, CPA, who retired after serving as the AAN’s CFO for 14 years.
FUNDING LIFELONG RESEARCH CAREERS
The American Brain Foundation’s Next Generation Research Grants program helps fund early-career research projects for investigators seeking to prevent, treat, and cure brain diseases and disorders. With over $30 million awarded and 250 researchers supported, the program helps jump-start researchers’ careers as they work toward life without brain disease.
Researchers like Lenora Higginbotham, MD. As a 2020 Next Generation Research Grant recipient, Dr. Higginbotham seeks to advance the scientific understanding and biomarker discovery of Lewy body dementia. “[This research] has the capacity to change our entire clinical framework and management of this debilitating condition.”
Take the next step in your research career. Apply for a Next Generation Research Grant by October 1, 2020 at AmericanBrainFoundation.org/For-Researchers
President’s Column
Neurology COVID-19 Relief Fund Eases Devasting Effects of Pandemic Last June, I announced the establishment of the Neurology COVID-19 Relief Fund to assist any neurology professional or neurology practice experiencing acute hardship and distress as an immediate result of this health crisis, to enable neurologists and neurology practices to Stevens continue to provide needed health care services in communities that have become distressed as a result of the pandemic. The Academy seeded the fund with $100,000, with an additional $150,000 available through matched donations. We created a work group, comprised of volunteer physician leaders from various practice settings and locations, to review applications and make impartial decisions regarding hardship support grants for individuals and practices impacted by COVID-19. We read many heartbreaking stories about clinics facing staff layoffs, reduced hours, patients postponing appointments, unpaid bills piling up, and lack of personal protective equipment. Even though our hearts ached at not being able to completely satisfy each request, we are pleased that we were able to help many stay afloat through these difficult days so they could continue to be a beacon of care and comfort to their patients and their communities. I am pleased to share these responses from some of the recipients whose dire situations were improved because of a grant from the AAN.
“It is with a heavy sigh of relief and some tears that I gratefully accept the AAN award to my clinic during these dangerous COVID-19 times. This will allow me to keep the clinic open a little longer, and have my staff continue to provide not only for their families, but to continue to provide the most excellent service (as always) in a completely safe environment. We will be able to purchase masks, gowns, sanitizers, glass shields, and everything else to stay in business according to all the safety rules. We are eternally grateful to the AAN and its backers. God bless you!” Steve-Felix Belinga, MD, FAAN Belinga Clinic, Fort Smith, AR
“Many thanks for the much-needed backing from AAN. My small solo practice depends on this help to survive the COVID-19 and continue to provide neurology service to our community. I appreciate President Dr. Stevens’ as well as CEO [Mary] Post’s effort that makes the financial support possible.” Joy Zhao, MD Integrated Neurology Health Services, Burien, WA
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AANnews • September 2020
“This award is a lifesaver when it comes to me and my practice. Being in solo private practice, COVID-19 has hit me hard and patient volumes have dramatically declined while overhead costs have remained in place. This has put a significant strain on the practice and has also led to staff losses, which has diminished the practice's smooth operations. The grant from the AANI will go a long way in improving our staffing levels and maintaining smooth operations in these uncertain times. Thank you so much!” Shervin Eshraghi, MD University Neurological Associates, Charlotte, NC
“We are grateful for your help and the AAN support.” Germano C. Falcao, MD Neurology Children’s Specialty Clinic, Oviedo, FL
“[The] AAN's COVID relief fund has been very beneficial for me as a private practice neurologist working in rural Colorado. This funding will allow us to continue working via telehealth and providing the same services through that technology. We belong to an amazing organization that is focused on solutions rather than problems.” Brooke Allen, MD Roaring Fork Neurology, P.C., Basalt, CO
I would like to recognize and thank our contributing sponsors to the Neurology COVID-19 Relief Fund: Wolters Kluwer, Amlyx Pharmaceuticals, Ovid Therapeutics, and Verana Health. We deeply appreciate their donations, which underscore their commitment to neurology and the neurologists who give so much of themselves. And we, too, at the AAN salute you for all you do, through good days and bad. We’re committed to help you overcome this crisis, and I encourage you to watch your inbox for our COVID-19 Update email with the latest updates and make use of our many resources at AAN.com/COVID19. Stay healthy. Stay strong.
James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter
Registration Opens this Month for October’s Virtual Fall Conference continued from cover
said Jonathan Graff-Radford, MD, chair of the Regional Conference Subcommittee. “The popular neurology update lectures spanning subspecialties will return, and we’ll offer parallel programming with highlights from previous Annual Meetings and practice management lectures—all with faculty Q&A opportunities. We are also using the virtual environment to offer multidisciplinary care lectures featuring neurologists and other specialists coming together to care for complex neurologic patients.” The program* includes: Keynote address on COVID-19 Neurology Update programs covering:
Epilepsy Headache Neuro-ophthalmology Dementia Multiple Sclerosis Movement Disorders Stroke
Practice Management talks
Telemedicine: Taking Virtual Care to the Next Level Recruitment, Hiring, and Retention: Developing Your Talent Management Program
Beyond the Bedside session focusing on the business side of a practice Curbside Consults featuring experts discussing unique cases and providing guidance on diagnosis and treatments in Neuro-oncology and Neuroimaging Tips for the virtual NeuroExam Entertaining educational offerings such as the Neuro Story Slam Continuum® Test Your Knowledge: A Multiple-Choice Question Review I and II with topics on Neuromuscular Disease and Autoimmune Neurology Industry Pipeline talks Special networking opportunities for special interest groups, a NeuroJeopardy social event, and a musical act Virtual Exhibit Hall
Coding Updates: E/M Mastering the Regulatory and Legislative Landscape in 2021 Payer Contract Analysis and Negotiating Strategies Revenue Cycle Optimization Building Service Lines in Your Practice
“How to” lectures on topics such as billing for a teleheath visit or how to combat burnout in the workplace Scientific programs including Controversies in Neurology Plenary Session and Neuroscience in the Clinic Sessions *Program subject to change.
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DELIVERING YOU VALUE
83 Percent* of Member Dues Go Directly to Your Member Benefits
*Based on 2020 budget
Conferences & Community
Married Neurologists Make Professional, Personal Adjustments During Pandemic— Watch the Video The third in a series of Inspirational Member Spotlight videos of AAN members living the values of the AAN in inspiring ways is now available for viewing. It features President James C. Stevens, MD, FAAN, interviewing Linda Wendell, MD, and Brad Thompson, MD, a married pair of neurocritical care specialists at Rhode Island Hospital/Brown University with three children to care for during this unprecedented time.
the pandemic. At the same time, Wendell, as medical student clerkship director, worked hard to make sure that students' education wouldn't be compromised. This and previous spotlight videos that show how members are demonstrating AAN values can be seen on the AAN YouTube channel at YouTube.com/AANchannel
At the start of the pandemic, Wendell and Thompson juggled home life with caring for COVID-19 patients at the hospital, as the neuro critical care unit was turned into a COVID ICU unit. The neuro critical care unit, which moved to a different ICU, continued to run at the same time so the neuro staff still had to care for those patients in addition to their new responsibilities for the COVID-19 patients in their critical care unit. In addition, Thompson worked with leadership to help organize the hospital system's response to
There’s Still Time to Take Part in Virtual Education Series for APPs continued from cover
Content already presented will be available to all registered attendees for the next 12 months, so there is no risk of missing out!
presenters. Registered attendees can earn up to six CME credits. Check out the lineup of programming at AAN.com/APP.
Visit AAN.com/APP to register. Until the week of October 12, look for an email each Tuesday with resources that will preview what is in store for the week. The course video will then go live on Thursday, with some sessions featuring live Q&A with the
Join the conversation at AAN.com/Synapse!
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AANnews • September 2020
2021 Annual Meeting Abstract Submissions Open
Virtual Sports Concussion Conference Draws Attendees, Media
Submit your breakthrough research to the best platform to get your work noticed by your neurology peers from around the world. Abstract submission for the 2021 Annual Meeting opens September 3 at AAN.com/21Abstracts and runs until October 19.
With 440 attendees, the AAN’s seventh annual Sports Concussion Conference was successfully held in a virtual environment at the end of July. Co-directors David W. Dodick, MD, FAAN, and Brian W. Hainline, MD, FAAN, held an online Top Science press conference where they discussed key takeaways from the top three abstracts among 45 submitted. The highlighted abstracts were:
Abstracts will be accepted in all subspecialties and career levels. The submission fee is $100 for AAN members and $200 for nonmembers. Submission is free for residents and medical students. For more information, contact Laura Southwick at science@aan.com.
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Conferences & Community
New AAN Section Created to Address Needs of Those Underrepresented in Neurology As part of the AAN’s ongoing priority to support the professional concerns of neurologists and neuroscience professionals from underrepresented backgrounds—by enhancing career satisfaction, providing an engaging and collaborative community, and working to alleviate the workforce gap—the Academy has created a new section specifically to address these critical needs. While the focus of the Underrepresented in Neurology (UIN) Section is on racial and ethnic groups identified by the Marulanda-Londono National Institutes of Health as underrepresented—Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders—all members of the Academy interested in furthering the mission of the section are welcome to join.
According to founding members Erika Tatiana Marulanda-Londono, MD; Jimmy V. Berthaud, MD; Ima M. Ebong, MD; and Andrew R. Spector, MD, although the section has been in development for over a year, its creation at this moment in time is particularly meaningful and it is more critical than ever that AAN members from racial/ethnic groups that
Berthaud
are underrepresented in neurology have their voices amplified. The new section aims to be a space where UIN members can come together in fellowship, create programming relevant to the needs of UIN members, and work with the AAN to advance
To join the new section—and its corresponding SynapseSM Online Community—visit AAN.com/sections. As the AAN's exclusive online community, Synapse serves as a platform where members from the Academy’s more than 45 sections, consortiums, and Spector open communities come together to engage in conversation; exchange ideas; and share scientific, practice, and professional insights.
Get Ready Now for Neurology Career Week
Help Us Help You Better—Look for 2020 Needs Assessment Survey
Neurology Career Week is coming October 12 to 17, featuring hundreds of open neurology positions searchable online or during the AAN Virtual Career Fair.
Getting input directly from members is the best way for AAN leadership to ensure your Academy is most relevant to you. The AAN is sending its 2020 AAN Needs Assessment Survey via email and mail to select members. If you receive the survey, please complete it so we can continue to improve our understanding of your unique needs. The survey runs through October 13 and should take only about 15 minutes to complete.
Polish your skills for your next job interview—and save $100— with a professional interview coaching session.
Create a new job seeker profile before October 17 on the Neurology Career Center site to receive a free reflex hammer while supplies last. Visit careers.aan.com to learn more and participate.
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Ebong
its anti-racism pledge. It is also the section’s mission to see the field of neurology reflect the racial and ethnic diversity of the patients neurologists treat by supporting UIN students on their journey to neurology.
AANnews • September 2020
Individual responses will be kept confidential and will be reported only in aggregate form. If you have any questions about the survey, contact Chris Keran, Senior Director, Member Insights, at ckeran@aan.com or (612) 928-6116.
Join the New AAN Trainee Trivia Contest! Attention neurology trainees: grab your friends, form a team, and join the AAN’s newest, fun-filled, online case-based neurology trivia contest! The contest will take place on Zoom each month with the next contest scheduled for September 16 from 8:00 p.m. to 9:00 p.m. ET. Look for the Zoom link through the AAN Residents and Fellows Facebook page and other marketing channels. All residents, fellows, and students are encouraged to take part.
media channels for an updated Zoom link ahead of each event. Choose a team with one or more individuals (no limit) and determine a team name (to be entered into Kahoot! once the game begins). A code to access the game on Kahoot! will be provided via Zoom at the beginning of the event.
For each session, hosts Sashank Prasad, MD, of Harvard Medical School, and Raymond Price, MD, FAAN, of University of Pennsylvania, will challenge your clinical acumen using compelling cases presented through brief vignettes that incorporate video and photo media. The winning team earns that session’s title of Top AAN Trainee Trivia Team. The inaugural trivia game was held in July with more than 500 participants. In the end, team ADM won bragging rights for the night.
Each question will be followed by 60 seconds for teams to deliberate and then the team leader will enter the team’s answer in Kahoot! Speed and accuracy earn more points.
Each team designates a team leader who adds the team name to the Kahoot! App (available on Google Play or the App Store) or website (Kahoot.it) and submits responses throughout the game.
How to participate: No registration is required to play; simply join via Zoom. To participate, watch your email and AAN social
Each team decides how they will confer during the game—conference call, video conference, chat app, or whatever works best for the group. For more information, contact Lucy Persaud at LPersaud@aan.com.
CESC: 19 Clinical Research Scholarship (CRTS) Program Ad—Half Page Horizontal> AN Placed in AANnews 8.25 x 5.25 +0.125 bleed, 4C
Research Funding Available
What will the 2021 Research Program do for you? I am grateful to use this award to support my postdoctoral fellowship training and to complete important research aimed at reducing dysphagiaassociated mortalities and improving swallowing-related health and quality of life in Parkinson’s disease. James Curtis, MS, CCC-SLP, BCS-S 2020 Clinical Research Training Scholarship in Parkinson’s Disease Recipient
Apply for grants today: AAN.com/2021Research
AANnews • September 2020 17
Conferences & Community
Diversity Leadership Program Graduate Focuses on Elevating Others “My participation in the AAN’s Diversity Leadership Program helped refine my focus, allowing my energy to be used toward goals that were most meaningful for me,” began 2018 program graduate Alyx B. Porter, MD, FAAN. “Through the program I was able to identify the shape Porter I wanted this next phase of my career to take and put specific efforts in place to ensure my success.” And focused and successful she is. Deeply concerned with the country’s health care disparity crisis, establishing focus was easy for Porter who subsequently was able to apply the skills she gained from her time in the program directly to her goal of elevating budding young—but underrepresented— talent in her community, to great effect. In November 2018, Porter, along with her husband Gregory L. Porter, MD, a physical medicine and rehabilitation physician at Barrow Neurological Institute, founded ElevateMeD, a nonprofit organization working toward achieving a physician workforce that is racially and ethnically representative of the communities it serves. “The cost of medical education in the United States has become prohibitive, distracting bright students from seeking a career in medicine,” explained Porter. “Medical students from racial and ethnic backgrounds traditionally underrepresented in medicine are facing unprecedented levels of indebtedness, stifling their future career choices.” Improving physician workforce diversity is a critical component in ElevateMeD’s mission to fight against health care disparities. “The limited representation of Black, Latinx, and Native American physicians is the result of historical exclusion, limited preparedness, and financial inequity,” said Porter. In response, the ElevateMeD Scholars program provides significant financial assistance to medical students while providing them access to mentorship, leadership training, and financial management education. “ElevateMeD is poised to make significant strides in mitigating challenges impacting medical students from historically underrepresented backgrounds and our hope is that ElevateMeD Scholars will become the next generation of physician leaders, well
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AANnews • September 2020
poised to continue the cycle of philanthropy and dedication to community,” added Porter. Porter’s successful elevating efforts don’t end there. Since graduating from the Diversity Leadership Program, she has been promoted to associate professor of neurology at her institution—the Mayo Clinic in Phoenix, AZ—"an achievement held by few black women neurologists,” she explained, and has become the co-chair for the Central Nervous System Disease Group for the Mayo Clinic Cancer Center. She also received the Mayo Clinic Alix School of Medicine Dean’s Recognition Award for Diversity and Inclusion for her outstanding contributions to furthering the school’s vision for recruitment and retention of diverse students while creating a learning environment that embraces diversity and inclusion. More recently, Porter was honored with the 2020 Anne B. Young MGH Diversity Scholar Award for her contribution to the understanding or enhancement of community health equity, diversity, and inclusion as it pertains to neurology. Through all of her success, Porter is quick to credit the influence of the skills she
learned in the Diversity Leadership Program. “Understanding the components of transformational leadership has been essential to the success that has followed my participation in the program.” The Diversity Leadership Program is a crucial aspect of the AAN’s leadership diversification strategy intended to identify, mentor, and engage AAN members from underrepresented groups. Learn more at AAN.com/view/DLP.
Education & Research
Apply by October 1 for 2021 AAN Research Program Grants The American Academy of Neurology is committed to supporting researchers— particularly during what has been a difficult year due to COVID-19 pandemic. We know that making a profound difference in the lives of researchers ultimately makes a profound difference in the lives of patients with brain disease. The 2021 AAN Research Program grants exemplify our commitment to promoting neurology and neuroscience research training across career levels and discovery stages, and we encourage you to visit AAN.com/ResearchProgram to learn more about the following opportunities and apply by October 1, 2020. 2021 Clinical Research Training Scholarship Funded by the American Academy of Neurology 2021 Clinical Research Training Scholarship in ALS Funded by The ALS Association and American Brain Foundation In collaboration with the American Academy of Neurology
2021 Richard Olney Clinician Scientist Development Award in ALS Funded by The ALS Association and American Brain Foundation In collaboration with the American Academy of Neurology
2021 Clinical Research Training Scholarship in Neuromuscular Disease Funded by the Muscle Study Group and American Brain Foundation In collaboration with the American Academy of Neurology
2021 Clinical Research Training Scholarship in Parkinson's Disease Funded by the Parkinson's Foundation and American Brain Foundation In collaboration with the American Academy of Neurology
New Neurologic Research Community Now on Synapse
2021 McKnight Clinical Translational Research Scholarship in Cognitive Aging and Age-Related Memory Loss Funded by the McKnight Brain Research Foundation through the American Brain Foundation, and the American Academy of Neurology
The AAN has launched a new Neurologic Research Community on Synapse designed to provide a space for researchers to share new opportunities, programs, and resources; discuss the challenges of returning to the lab post-COVID-19; and more. Join the discussion at AAN.com/Sections.
2021 Susan S. Spencer, MD, Clinical Research Training Scholarship in Epilepsy Funded by the American Epilepsy Society, Epilepsy Foundation, and American Brain Foundation In collaboration with the American Academy of Neurology
2021 AAN Award Applications Now Open Applications are now open for AAN awards that recognize outstanding achievements across career levels. The AAN values your unique contributions to the field of neurology and AAN awards offer opportunities to be honored during conferences, receive travel stipends, or to present your work to your colleagues. Apply—or nominate a colleague—for a variety of prestigious AAN awards to be presented during the 2021 AAN Annual Meeting. The application deadline is October 21. Visit AAN.com/21Awards to learn more and apply or nominate.
April 17– 23 • San Francisco
AANnews • September 2020 19
OUR UNDERSTANDING OF ALZHEIMER’S DISEASE IS EVOLVING. SO SHOULD THE WAY WE MANAGE IT.
IF ACCUMULATING AMYLOID BETA IS PART OF HIS PAST, DETECTING MILD COGNITIVE IMPAIRMENT MAY BE YOUR BEST CHANCE TO CHANGE HIS FUTURE.1
A
lzheimer’s disease (AD) is a slow, progressive disease. Amyloid beta can accumulate for decades before there are any symptoms. But after symptoms appear, a patient has, on average, 2 to 6 years before dementia sets in.2-4
This symptomatic predementia is called mild cognitive impairment (MCI) due to AD, and it is the earliest opportunity to begin managing the disease. It is possible to mistake MCI due to AD for normal aging or other forms of MCI with different causes. But advancements in biomarker testing mean it is now possible to confirm whether AD pathology is the underlying driver.1,4-7
Some may believe the lack of treatments indicated for the MCI due to AD stage means there is no benefit to early detection. But progress surrounding our understanding of the disease is a cause for optimism. New studies show that diagnosis with biomarker confirmation may lead to more optimal management, including nonpharmaceutical interventions.1,8,9 As our understanding of AD continues to evolve, it’s important that our approach to managing it does as well. And that change can begin by taking steps to detect it earlier.
MCI due to AD is the first symptomatic stage of Alzheimer’s disease.4 Preclinical AD
MCI DUE TO AD
Mild AD Dementia
Moderate AD Dementia
Severe AD Dementia
Mild cognitive symptoms appear, but they do not yet interfere with daily activities.
There is more to know about MCI due to AD. See what early detection can mean for your patients at identifyalz.com. References: 1. Anderson ND. State of the science on mild cognitive impairment (MCI). CNS Spectr. 2019;24(1):78-87. 2. Masters CL, Bateman R, Blennow K, Rowe CC, Sperling RA, Cummings JL. Alzheimer’s disease. Nat Rev Dis Primers. 2015;1:15056. doi:10.1038/nrdp.2015.56. 3. Wilson RS, Leurgans SE, Boyle PA, Bennett DA. Cognitive decline in prodromal Alzheimer disease and mild cognitive impairment. Arch Neurol. 2011;68(3):351-356. 4. Alzheimer’s Association. Alzheimer’s Association Report: 2020 Alzheimer’s disease facts and figures. Alzheimers Dement. 2020;16(3):391-460. 5. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer’s disease: recommendations from the National Institute on Aging–Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):270-279. 6. Jack CR Jr, Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging–Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):257-262. 7. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA research framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562. 8. Rabinovici GD, Gatsonis C, Apgar C, et al. Association of amyloid positron emission tomography with subsequent change in clinical management among Medicare beneficiaries with mild cognitive impairment or dementia. JAMA. 2019;321(13):1286-1294. 9. Ngandu T, Lehtisalo J, Solomon A, et al. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015;385(9984):2255-2263.
©2020 Biogen. All rights reserved. 07/20 ALZ-US-0367
Education & Research
Even More Science Added to 2020 Science Highlights The AAN’s free, popular online platform for showcasing science has added some exciting new opportunities for getting the latest and greatest scientific updates in neurology. Now, in addition to being able to view more than 1,600 presentations, you can hear from and engage with abstract presenters about their work, and more. Visit AAN.com/2020science to experience the following lineup of programming; note that some content will not be available until late September. Presidential Plenary Talks: Physician Leadership and the Future of Health Care: A Conversation with John H. Noseworthy, MD, FAAN George C. Cotzias Lecture: Endogenous Retroviral Elements in Neurodegenerative Diseases with Avindra Nath, MD, MBBS, FAAN Sidney Carter Award in Child Neurology: Precision Medicine in the Epilepsies—Reality or Fantasy? with Ingrid E. Scheffer, AO, MBBS, PhD, FRACP Robert Wartenberg Lecture: The Threatened Brain: Preventing Stroke and Dementia Together with Vladimir Hachinski, MD, DSc, FAAN
1,600+
POSTER PRESENTATIONS UPLOADED
135,000+ POSTER VIEWS
OVER
146,000
Emerging Science: Hear authors present their findings followed by a moderated Q&A session.
VISITS
Mock Study: Observe the typical process and mechanism of a K23 grant review at a study section, including review of initial submission and revised submission. Awards: Learn directly from recipients about their work and what this honor means to them, and watch a special video celebrating all 2020 recipients. Virtual Posters: Medical students and neurology residents will get valuable information about educational and training opportunities from neurology programs across the country.
Assess Your Knowledge with New NeuroSAE 13th Edition A new edition of the AAN’s popular online self-assessment program is now available. Featuring a lineup of new questions—all based on the ABPN content outline for cognitive expertise component (Part III) of Continuing Certification (CC)— NeuroSAE 13th Edition is an excellent, convenient, and free* way for AAN members to assess their strengths and weaknesses, compare their performance to other neurologists, and earn up to eight Self-Assessment CME credits per exam. Additional features include: 125 multiple-choice questions in 20 subject areas Up to 20 percent of questions with images Feedback provided by subspecialty area along with suggestions for further reading
Mobile-friendly: take the exam on your own schedule, as a timed test, or at your own pace Neurologist-written content specifically for neurologists Ability to retake the test until you receive a passing score Visit AAN.com/NeuroSAE to get started. *Free access is limited to one exam at a time, with the exception of NeuroSAE Medical Student and Annual Meeting editions. Additional exams can be purchased at the member rate of $99. Medical Students, Business Administrators at the lower dues rate, and Advanced Practice Provider members at the lower dues rate are not eligible for free access.
Policy & Guidelines
Proposed Rule: CMS Updates Physician Payment System and Proposes Regulatory Changes Every year, the Centers for Medicare & Medicaid Services (CMS) proposes regulations that impact the reimbursement of physicians. On August 3, CMS issued a proposed rule updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule in 2021. The proposed 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. Evaluation and Management (E/M) Codes CMS intends to move forward with its planned implementation of a new coding and payment structure for office Evaluation and Management (E/M) services. Finalized in the 2020 Medicare Physician Fee Schedule, CMS will be 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 without delay or significant modification. In addition to moving forward with the new structure, CMS is proposing modifications to the times associated with prolonged E/M services, revaluing certain services that are analogous to E/M services including transitional care management, and is requesting additional stakeholder feedback on the GPC1X complexity add-on code. Although E/M services will receive a significant increase starting in 2021, the AAN notes that due to budget neutrality, the increase in payment for E/M services results in an across-the-boardcut 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. Telehealth Regulations Noting the significant expansion of telehealth due to the COVID-19 Public Health Emergency (PHE), CMS is proposing substantial modifications 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 proposing to add a number of new services to the Medicare telehealth list permanently and is proposing to add additional services to the telehealth list temporarily through the end of the calendar year during which the PHE ends. CMS is not proposing to make permanent separate payment for audio-only telephone E/M services. CMS is instead seeking comment on whether the agency should develop coding and payment for a service similar to the audio-only virtual check-in but for a longer unit of time and with greater reimbursement.
CMS is proposing to 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 proposing several modifications related to coverage of remote physiologic monitoring. In addition to the proposed modifications to telehealth policy, CMS is seeking feedback from the public in relation to how telehealth services have been in use in various communities during the response to COVID-19. Specifically, the agency seeks to understand how the use of telehealth services may have contributed to the quality of care provided to beneficiaries during the PHE so that CMS can understand which services should be retained on the Medicare telehealth services list after the PHE has ended. Quality Payment Program The rule includes proposed updates to the Quality Payment Program (QPP), which includes the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Model (APM) tracks. For the MIPS track, CMS is proposing to increase the 2021 performance threshold to 50 points and maintain the 85-point threshold for an exceptional performance bonus. CMS proposes decreasing the weight of the MIPS Quality component to 40 percent from 45 percent and increasing the weight of the MIPS Cost component to 20 percent from 15 percent. In the rule, CMS also proposes to include telehealth services in measures in the Quality and Cost components. There are minimal changes proposed for the Improvement Activities and Promoting Interoperability components. The rule also includes flexibilities for the current 2020 performance period related to COVID-19. In addition to CMS considering Extreme and Uncontrollable Circumstances exception applications for MIPS participants, the rule proposes a maximum 10-point bonus for complex patients in the Quality component. The rule proposes to delay implementation of the MIPS Value Pathways (MVP) track until at least 2022 due to the COVID-19 public health emergency. CMS also proposes an additional performance track called APM Performance Pathway (APP), similar to MVPs, that would allow MIPS-APM participants to report a fixed set of measures for each performance category in MIPS as an individual or group. For the APM track, CMS is proposing to eliminate the APM scoring standard and sunset the CMS Web Interface as a reporting option. Instead of the CMS Web Interface, Accountable Care Organizations (ACOs) participating in the Shared Savings Program will be required to report quality measure data via the newly proposed APP track.
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Policy & Guidelines
Join AAN Advocacy for Telemedicine Coverage with Private Payers Since the onset of the COVID-19 public health emergency, the AAN, including members of the Coding and Payment Policy (COPAY) Subcommittee, has advocated to both Medicare and private payers for expanded coverage for telehealth services. COPAY members have met with several private payers and provided recommendations in response to payers’ requests regarding telehealth coverage. Our interactions continue to be positive, with several major payers indicating they are extending their coverage of telehealth services until the end of 2020. To help identify areas where the Academy should focus its efforts with payers, member feedback was requested about claims denials or limited coverage for telemedicine services. Specifically, we wanted to hear from our members to identify denial trends (i.e., wrong modifier, wrong place of service, or non-covered services).
Survey results have shown that among those claims that were denied, the majority were due to an incorrect modifier or place of service. This is positive news as this is a submission error that can be corrected vs. a denial based on non-covered services. When asked about Medicare claims for telemedicine services, many survey respondents were uncertain if they had in fact been paid the in-person rate. Payment parity remains a top priority for the AAN when advocating for telemedicine coverage. Lastly, the most common challenge reported by members in implementing telemedicine is getting their patients to accept and successfully navigate the technology of a telemedicine visit. If you receive a denied claim, make sure you understand the denial reason on the explanation of benefit (EOB) statement as there may be an easy fix! A denial reason of “incorrect place of service” or
“incorrect modifier” could be remedied with the submission of a corrected claim. A denial due to “non-covered service” will require further investigation and potential outreach to the payer. Regular review of your payers’ coverage policies is critical during this time to ensure you are following their guidelines for correct billing. The AAN has produced several resources for members who want to participate in advocating for telehealth coverage. Members can check Top 5: Ways to Advocate for Telemedicine Coverage with Private Payers at AAN.com/PayerAdvocacy to find helpful tips for working with private payers and the AAN’s requests to private payers for coverage following the public health emergency. There is also a template letter for members to contact private payers in their area on the telemedicine page at AAN.com/telehealth.
Capitol Hill Report Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport. Below are some recent highlights.
Register for Virtual Rally for Medical Research on September 16–17 The Rally for Medical Research is held every September and includes more than 300 national organizations coming together to meet with congressional offices to advocate for increased NIH funding and raise awareness about the importance of
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AANnews • September 2020
continued investment in medical research. This year’s event will be held virtually on September 16–17. For more information and to register, please visit rallyformedicalresearch.org.
Tools & Resources
2020 MIPS Flexibilities Available Due to COVID-19 Clinicians participating in the Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS) in 2020 may submit an Extreme and Uncontrollable Circumstances Application through December 31, 2020, to request a reweighting of one or more MIPS components due to COVID-19. Practices should consider their unique circumstances and experience with COVID-19 and MIPS reporting in the past when deciding whether they should consider submitting an Extreme and Uncontrollable Circumstances Application. There are no automatic MIPS exceptions at this time. MIPS clinicians must submit an exception and reweighting application to be considered.
If an application requests to reweight two MIPS components to zero percent, the clinician or group still must submit for the two other MIPS components. For example, if a group applies to have the Quality and Cost components reweighted to zero percent, the group must still submit data for the Improvement Activities and Promoting Interoperability components. Members participating in MIPS should check the QPP COVID-19 Response page at QPP.cms.gov/about/covid19 and the AAN’s QPP Resources at AAN.com/view/QPP regularly for the most updated information.
CMS will review applications on a case-by-case basis. Applicants can choose the MIPS components they wish to have reweighted to zero percent in their application (Quality, Cost, Improvement Activities, Promoting Interoperability) if they are unable to collect data on any/all components due to COVID-19.
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Tools & Resources
AAN Expands Collaboration with Verana Health to Improve Axon Registry Data Quality, Physician Experience The AAN has announced the selection of Verana Health as its new data and technology partner to improve Axon Registry ® data quality and member experience. Verana Health will now assume responsibility for integrating electronic health records data into the registry, providing practice support, displaying quality dashboards, and submitting MIPS (Merit-based Incentive Payment System) quality reporting for members contributing to Axon Registry.
“We’re excited about this new opportunity to further support the AAN on the next generation of the Axon Registry,” said Miki Kapoor, CEO of Verana Health. “Verana Health is committed to providing an excellent practice experience, critical practice level insights, and innovative, user-friendly technology applications. Our goal is to advance the long-term vision of the Axon Registry by creating a secure and accurate data source to improve the quality of patient care.”
“We are excited to bring our members a best-in-class registry to improve the quality of the care they give their patients,” said AAN President James. C. Stevens, MD, FAAN. “We’re confident Verana Health’s ability to easily integrate EHR systems, offer highly reliable data, responsive practice support, and performance and benchmarking dashboards will help improve care and drive more members to use the Axon Registry. The more members we have participating, the more we can improve neurologic care across the nation.”
The roll-out of the expanded relationship with Verana Health will begin in July 2020 and continue over the next 18 to 24 months as Verana Health increases the number of electronic health record systems used by Axon Registry participants into its operations. Current participants will continue to participate with the existing vendor until their EHR system is integrated with Verana Health. The AAN will contact practices as they become eligible for EHR integration and quality reporting through Verana Health. Current services will not be disrupted, and there will be no impact to 2020 reporting. Practices will continue to be supported by the current registry services provider until the transition is complete.
Since 2018, the AAN has collaborated with Verana Health to curate de-identified health care data for research projects aimed at improving treatments and potentially discovering cures for the one in six people affected by neurologic disease. This announcement means Verana Health will be the AAN’s end-to-end data and technology partner for the Axon Registry. “Safeguarding privacy remains paramount,” said Mary E. Post, MBA, CAE, CEO of the AAN. “Members can trust the patientidentifiable health data provided to Verana Health for registry data integration has the same level of security and protection that has always been provided with the Axon Registry.” The Axon Registry is a quality improvement registry developed to help AAN members improve patient care and simplify federal government reporting. It is a data warehouse that collects relevant patient data from electronic health records provided by participating AAN members.
AAN members may access a list of frequently asked questions at AAN.com/Axon or contact registry@aan.com. The AAN continues to own and control the Axon Registry. AAN member neurologists’ relationships to the AAN and the Axon Registry will remain unchanged: Participation in the Axon Registry remains free to all US AAN members in good standing Member physicians will continue to benefit from federal government quality reporting capabilities and performance benchmarking Compliant, secure, and responsible data governance continues
Practice Support Network Grows to Answer Your Practice Questions The AAN’s Practice Support Network has grown to 29 members strong with the addition of the 2020 Practice Leadership Program graduating class. Originally created by graduates of the 2018 Practice Leadership Program out of a desire to give back to the AAN and share their practice knowledge to support their colleagues, the members of the network provide timely answers to practice questions emailed to the practice@aan.com inbox. In the first half of 2020, more than 100 inquiries were answered by network members or staff.
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If you have questions about issues including MIPS/MACRA, practice management, and coding, email practice@aan.com. AAN staff monitor this inbox and respond within one business day. If the question is outside their area of expertise, they will reach out to the Practice Support Network. Questions submitted to the network are de-identified to protect anonymity. The network’s insights are gathered and returned to the questioner. In this way, members are free to ask about sensitive topics they would prefer not to bring out in the AAN’s public forums, such as the SynapseSM online community.
AAN.com/careers
Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added.
Academic Neurologist (Specializing in Movement Disorders) —Cooper University Health Care Cooper University Health Care and Cooper Medical School of Rowan University are seeking a full-time academic neurologist who specializes in movement disorders to join the Department of Neurology. Cooper provides the most advanced movement disorder care in the region, serving a large, diverse population with needs that range from common neurological conditions to the most complex. Our team is committed to delivering high-quality patient care, community outreach, student and resident education, and clinical research. Our specialists work closely with our colleagues in neurosurgery, physical medicine and rehabilitation, psychiatry, and neuropsychology. Applicants should be board-certified in neurology and have completed a movement disorders fellowship. Preference will be given to those demonstrating excellence in patient care, enthusiasm for medical student and resident education, and interest in clinical or translational research. This outpatient position does not involve hospital coverage or call, and DBS programming and botox injection capability are strongly preferred. Candidates are eligible for a faculty appointment at a level commensurate with their experience and accomplishments at Cooper Medical School at Rowan University. Cooper University Health Care is the leading academic tertiary health care system and only state-designated Level 1 Trauma Center in South Jersey, with clinical experts in more than 75 specialties. Cooper University Hospital is a 635-bed facility with over 7,500 employees, a network of more than 100 medical offices, and three urgent care centers throughout the region. The Department of Neurology has 24 providers and continues to expand. Cooper was the first Joint Commission Certified Comprehensive Stroke Center in South Jersey. Email thomas-tammara@CooperHealth.edu Faculty Opportunity in Pediatric Child Neurology and Neurodevelopmental Disabilities - Symphony Talent Faculty Opportunity in Pediatric Child Neurology and Neurodevelopmental Disabilities Instructor, Assistant Professor, Associate Professor, Professor Division of Child Neurology and Neurodevelopmental Disabilities Department of Pediatrics Rutgers Robert Wood Johnson Medical School New Brunswick, NJ The Department of Pediatrics at Rutgers Robert Wood Johnson Medical School is seeking a dynamic physician with a proven commitment and passion for academic medicine to join the Division of Child Neurology and Neurodevelopmental Disabilities. This is an exciting opportunity for a physician dedicated to a career in academic medicine, with the potential for either clinical or lab bench research. Leadership opportunities in headache medicine and in research are open. The position is offered at open academic rank, commensurate with prior experience and achievement. The successful candidate will join 4 faculty members and will provide both inpatient and outpatient care. S/he is responsible for fulfilling the Division’s mission by caring for both inpatient and outpatient children with neurological diseases, including those with complex medical issues. The Division currently supports an active Level 4 epilepsy program, concussion program and a pediatric multiple sclerosis program. Numerous opportunities are available for engagement in bench and clinical research in the division or in collaboration with faculty in other Divisions and Departments. Faculty members also participate in a rich gamut of teaching for medical students, pediatric residents, neurology residents, child psychiatry fellows, and developmental fellows, employing both clinical and didactic teaching methods. Our educational mission is focused on the development of the next generation of multi-talented physicians who will become leaders in patient care, education and research. RWJMS enrolls 175 medical students each year, and oversees outstanding ACGME-accredited training programs, including a pediatric residency with 33 residents and subspecialty fellowship training programs. The inpatient clinical services are provided at the Bristol-Myers Squibb Children’s Hospital of the Robert Wood Johnson University Hospital in New Brunswick, NJ, a five-time Magnet recipient that is recognized as “One of America’s Best Children’s Hospitals” by U.S. News and World Report. BMSCH is a 105-bed acute care hospital located on the only pediatric academic health campus in New Jersey. The outpatient services are located in the Rutgers Child Health Institute of NJ, a state of the art facility that includes a Pediatric CRC,
Pediatric subspecialty offices, and a modern research for Neurological Subspecialties; Eligibility for Ohio medical facility. Our New Brunswick–based clinical programs have licensure; ABPN certification in Neurology; Experience achieved Accredited Status for Ambulatory Health Care by the and interest in directing a clinical brain tumor program and Joint Commission, one of only a small number of academic neuro- oncology fellowship training program are preferred; ambulatory practices with this status. Adjacent to the RWJ An active, investigator initiated research program supported Barnabas Bristol-Myers Squibb Children’s hospital is the by extramural grants. The OSUCCC-James is the only cancer PSE&G Children’s Specialized Hospital, which is one of the program in the United States that features a National Cancer country’s largest inpatient acute rehabilitation facilities for Institute (NCI) – designated comprehensive cancer center children. Across the street is the Rutgers Cancer Institute of aligned with a nationally ranked academic medical center and NJ – the only NCI designated center in the state of New Jersey. a freestanding cancer hospital on the campus of one of the The Department of Pediatrics is composed of 123 full-time nation’s largest public universities. The OSUCCC-James is and more than 200 volunteer faculty members, organized the third largest cancer hospital in the nation with a 356-bed into 18 divisions including all of the pediatric subspecialties adult patient-care component and a 36 bed BMT unit. The and four key surgical services. Our centers of excellence OSUCCC-James is one of the top cancer hospitals in the nation include The Boggs Center on Developmental Disabilities, as ranked by U.S. News & World Report and has achieved Child Health Sciences, and the Institute for the Study of Child Magnet® designation for quality patient care and professional Development. The Department is undergoing a renaissance nursing practice. At 21 floors with more than 1.1 million following the recent integration of the medical school with square feet, The OSUCCC-James is a new, transformational Rutgers, The State University of New Jersey, and the merger facility that fosters collaboration and integration of cancer of two major health systems to form RWJ Barnabas. The research and clinical cancer care. This position comes with Department has recently expanded by more than 40 new a highly competitive compensation and benefits package. To faculty members and plans to recruit additional faculty, to learn more about this position or apply, please send inquiries expand our research, education, and clinical programs and with cover letter and curriculum vitae to: David E. Cohn, MD, provide improved care to our patients. As the State’s premier MBA Chief Medical Officer, James Cancer Hospital & Solove academic institution, there are many opportunities to collaborate Research Inst, David.Cohn@osumc.edu Raphael E. Pollock, across campuses with all the health professional schools MD, PhD, FACS Director, OSU Comprehensive Cancer Center and biomedical science school at the Rutgers Biomedical and James Cancer Hospital & Solove Research Inst, Professor, Health Sciences. Rutgers Biomedical and Health Sciences Department of Surgery Raphael.Pollock@osumc.edu The strategic plan includes neuroscience as a signature program Ohio State University is an equal opportunity employer. All with the establishment of the Brain Health Institute. Rutgers, qualified applicants will receive consideration for employment The State University of New Jersey, does not discriminate without regard to race, color, religion, sex, sexual orientation, on the basis of race, color, national origin, sex, sexual gender identity, national origin, disability status or protected orientation, gender identity or expression, disability, age, or veteran status. katlyn.spano@osumc.edu any other category covered by law in its admission, programs, activities, or employment matters. Qualified candidates AANnews® Classified Advertising must be board certified/board eligible in Neurology with special qualifications in Child Neurology. RWJMS provides a The AAN offers a complete package of print, online, competitive salary and comprehensive benefits package. This and in-person recruitment advertising opportunities. is an excellent opportunity for a dynamic academic career Visit careers.AAN.com for all AAN options, rates, oriented physician. Interested candidates should email a cover and deadlines. letter and CV to: Vikram Bhise, MD Associate Professor and Ad copy for the November 2020 print edition of Division Chief, Department of Pediatrics Child Neurology NCC: 20 Career Center Ad—Full Page> AANnews, NJ, NCP Placed in AANnews, Neurology Journal, or Neurologymust Clinical Practice AANnews be submitted by October 1, 2020. The and Neurodevelopmental Disabilities Rutgers Robert 8.25 Wood x 10.875 +0.125 bleed, 4C same deadline applies to changes/cancellations. Johnson Medical School 89 French Street, CHI-2216 New Brunswick, NJ 08901 bhisevi@rwjms.rutgers.edu The American Academy of Neurology reserves the right to decline, withdraw, or edit advertisements at Division Director, Neuro-Oncology - The Ohio State Wexner its discretion. Every care is taken to avoid mistakes, Medical Center The Ohio State University Wexner Medical but the responsibility for clerical or printer errors Center Department of Neurology, in conjunction with The Arthur does not exceed the cost of the ad. G. James Cancer Hospital and Richard J. Solove Research Institute, and the Ohio State University Comprehensive Cancer Center (OSUCCC-James), seeks a talented physician scientist to lead the Division of Neuro-Oncology. This leadership position will be under the direction of Dr. Benjamin Segal, MD, Professor and Chair of the Department of Neurology, and Director of the Neuroscience Research Institute. The Division of Neuro-Oncology offers a broad array of clinical, A JOB TOP TALENT research and educational opportunities. It is composed of a high interactive team of physicians and scientists, nurse practitioners, nurses and clinical trial coordinators, and Learn more! Careers.AAN.com supports a thriving clinical fellowship program. The Division of Neuro-oncology has strong collaborative relationships with colleagues in Radiation Oncology, Neuroradiology and Neurosurgery. The division director position comes with a robust portfolio of discretionary funds, and a generous startup package that will help support the candidate’s personal research program and allow the recruitment of additional bench scientists, physician scientists, and/ or clinical trialists in Neuro-oncology. The position is located on the OSUWMC main campus. The ideal Division Director candidate will be a national leader in the field of neuro-oncology. Ideally the successful candidate will have: Strong faculty academic experience, with a track record of extramural funding and mentorship; Strong track record of clinical operations leadership; Demonstrated leadership skills in building innovative programs as well as recruiting and retaining faculty; Prior demonstrated commitment to recruitment, development, and retention of women, underserved minorities, and disability status; Subspecialty fellowship training in Neuro-Oncology and Diplomate in Neuro-oncology from the United Council
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Dates & Deadlines
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Advanced Practice Provider Neurology Education Series AAN.com/APP
AAN Trainee Trivia
SEPTEMBER 17
Registration Opens: Fall Conference AAN.com/20FC
Deadline: AAN Research Program Application AAN.com/ResearchProgram Neurology Career Week Careers.AAN.com
OCTOBER 13
Early Registration Deadline: AAN Fall Conference AAN.com/20FC
OCTOBER 16–17 AAN Fall Conference AAN.com/20FC
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Deadline: AAN Awards AAN.com/21Awards
OCTOBER 21
Deadline: Annual Meeting Abstract Submission AAN.com/21Abstracts
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