2022 December AANnews

GOOD NEWS FOR NEUROLOGY IN 2023

Medicare Physician Fee Schedule Final Rule

Each year, the Centers for Medicare & Medicaid Services (CMS) issues regulations that impact the reimbursement of physicians. On November 1, 2022, CMS issued a final rule updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule in 2023. The final rule illustrates the importance of the AAN’s regulatory advocacy efforts on behalf of neurologists and their patients. The AAN previously submitted 50 pages of detailed comments in response to the various proposals made by CMS in July.

Due to budget neutrality requirements, CMS is projecting that the overall impact of changes finalized in this rule will result in a -1 percent change in payments to neurology as a specialty broadly. The expiration of temporary pandemic-related relief measures at year end has forced CMS to finalize a reduction in the fee schedule conversion factor of nearly 4.5 percent. The AAN is committed to payment reform efforts to promote a sustainable payment system and to working with regulators and legislators to ensure that CMS appropriately values the work done by neurologists. Working with Congress to avert the impending cuts before the end of the year will continue to be a top priority for the AAN. The AAN strongly urges you to tell your representatives to take action before the end of the year to prevent impending cuts.

Continued on page 10 ›

Keep Your Benefits! Renew Your Membership by December 31

Be sure you renew your AAN membership by December 31, so you can go into 2023 with uninterrupted access to the highest quality resources—when you need them—from the world’s largest and most trusted community of neurology professionals. Remember: your AAN membership benefits* are valued at up to $4,000 and provide you with exclusive access to:

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350+ online courses, videos, and exams

ƒ Top scientific resources, including 48 issues per year of Neurology ®, the most widely read and highly cited peer-reviewed neurology journal

ƒ Trusted AAN clinical practice guidelines, free member publications, and award-winning patient education resources to help you provide up-to-date care Continued on page 21 ›

Need to Use CME Dollars by Year End? Register Now for 2023 Annual Meeting

Don’t lose your 2022 CME dollars—use them to secure registration for the 2023 AAN Annual Meeting coming April 22–27 both in person in Boston and live online. Visit AAN.com/AM today—when you register now you also save with deep early registration discounts!

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

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December Highlights 12

Lewis’s Term as Continuum Editor-in-Chief to End Continuum® Editor-in-Chief Steven L. Lewis, MD, FAAN, completes his 10-year term this month.

20 Congratulations New Fellows of the American Academy of Neurology!

The AAN congratulates members who were named prestigious Fellows of the American Academy of Neurology (FAAN) between May and September 2022.

21

Transforming Leaders Program Graduate Takes on New Leadership Role

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

Editor-in-Chief: Melissa W. Ko, MD, MBA, CPE, FAAN

Managing Editor: Angela M. Babb, MS, CAE, APR

Editor: Tim Streeter

Writers: Ryan Knoke and Sarah Parsons

Designer: Siu Lee

Email: aannews@ aan.com

AANnews® is published monthly by the American Academy of Neurology for its 38,000 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.

2020 Transforming Leaders Program graduate Roderick Spears, MD, FAHS, FAAN, has taken on a new leadership role as the inaugural endowed chair of migraine and chief of the new Headache Division at Brown Neurology Warren Alpert Medical School of Brown University in Providence, RI.

News Briefs

Free Webinar: 2023 Medicare Physician Fee Schedule Payment and Policy Updates

On December 14, an expert member panel will present a live webinar about the 2023 Medicare Physician Fee Schedule updates and impacts to neurology. Nassim Zecavati, MD, MPH, FAAN; Meghan A. Ward, MD; and Adam Webb, MD, FAAN, will review the public health emergency considerations and its impact on telehealth services, requirements for the Quality Payment Program and MIPS Value Pathways, and education on implementing coding changes for the new year. Learn more and register at AAN.com/practice/medicare-fee-for-service

Annual Meeting Abstracts Campaign Strong Finish

There were 3,269 abstracts submitted (259 more than 2022), which is a strong indicator of eventual Annual Meeting registration. 

The Joy of Giving Through Volunteering

When I joined the Medical Economics Subcommittee in 1998, I didn’t know a sole person there. But its members, who welcomed me from my very first day, included wonderful people like Nelson G. Richards, MD, FAAN, the first practicing neurologist to be elected as AAN president in 1983. Nelson, who has been credited as bringing the community of practicing neurologists into the mainstream of the organization, encouraged me as I started teaching courses at AAN meetings, and later, writing for Neurology Today ®. He sent me occasional emails long after he retired, including one several months prior to his death in December of 2020 when he learned I had been named president elect.

Avitzur

One of the top reasons I’ve looked forward to my AAN work in the decades since has been the opportunity to work with extraordinary people like Nelson and so many who came after him. There is a unique camaraderie from volunteering at the AAN which reaps rewards that far outweigh the sacrifices. Over the years I have met so many remarkable members—as well as dedicated and talented staff—who have enriched my life and made me ever so grateful to be part of this diverse and magnificent organization.

As we reflect on this past year, I want to thank you all for your AAN membership as well as your dedication and support to our profession, and to encourage you to continue to remain part of the AAN community. I asked AAN committee chairs why they enjoy volunteering at the AAN and/or their community, and here is a sampling of their responses.

Happy Holidays, Orly Avitzur, MD, MBA, FAAN President, AAN oavitzur@aan.com @OrlyA on Twitter

For me, one of the greatest joys is volunteering, whether that means staffing a free clinic, helping the AAN complete its mission, or simply assisting where work is needed. It gives me a sense of humility because I know other people and causes are bigger than myself and it allows me to connect with others.

Joseph I. Sirven, MD, FAAN Chair, Education Committee

I truly enjoy volunteering for an organization when I believe in the mission and the core values resonate with me, and I know that collectively my efforts, along with others and an amazing expert staff, will have a definite impact on our profession and the field of neurology. It’s so rewarding to know that together our time and effort will pay off and make a lasting difference for many others. You also make tremendous friends forever and learn so much about strategic planning and organizational structure that you can take back home to help your own practice, department, or community. I always tell people that getting involved with the AAN is the best antidote for burnout and helps you become part of the solution.

Ralph L. Sacco, MD, MS, FAHA, FAAN Chair, Academic Neurology Committee

The AAN is a key hub for the world of neurology, and I regard my participation to be an important part of my identity as a pediatric neurologist. It is an honor to be a member and volunteer in this dynamic organization.

Peter B. Kang, MD, FAAN, FAAP Chair, Grievance Committee

The best antidote for physician burnout is being a volunteer for the AAN. Over the years, I have had the privilege of interacting with wonderful AAN staff and colleagues on many committees and subcommittees. You get to discuss neurology with colleagues you might not otherwise have met, network over delicious crudités, think about complex advocacy topics, and laugh together.

Lynne P. Taylor, MD, FAAN Chair, Fair Hearing Panel Committee

As a volunteer, I have greatly benefited from working with our Academy. What a remarkable way to learn, gain experience, and connect with outstanding people with the same goals of working with an extraordinary organization to advance science and patient care simultaneously.

Ann H. Tilton, MD, FAAN Chair, Meeting Management Committee

The AAN has been a game changer. The staff and volunteers are dedicated, thoughtful, and intelligent. I feel my contribution actually makes a difference and that's not always easy in the massive, ever-changing health care landscape. I've received far more than I have given and achieved more than I could imagine.

James N. Goldenberg, MD, FAAN Chair, Board Planning Committee

Providers continue losing decision making control over patient care. However, volunteering at the AAN helps give back agency, incredible insight into the challenges that impact practice, and better tools to fight for change. The AAN also offers fantastic opportunities to meet others with similar interests and passions, where new ideas are cultivated, and lifelong friendships are made. Not a pitch, just reality.

Several years ago, I was burnt out, and was considering a career change. Volunteering for the AAN I found a new focus, a vibrant and supportive community, and a renewed sense of purpose. Because of my experience, I was able to make decisions with a sense of enthusiasm rather than despondency.

José G. Merino, MD, MPhil, FAHA, FAAN Chair, Publications Committee Editor-in-Chief, Neurology®

Brad

C. Klein, MD, MBA, FAAN Chair, Medical Economics and Practice

My service to the AAN is a natural extension of the values instilled in me by my family and in keeping with the calling of our profession. My membership and activity in the Academy have allowed me to exercise and develop aspects of my career that would not have been possible in my day job. It is also tremendously energizing to work with the staff and colleagues who share the joy of service!

Charles C. Flippen II, MD, FAAN Chair, Joint Finance Committee

2023 Changes Streamline E/M Guidelines

January 2023 will bring more changes to Current Procedural Terminology (CPT) code set and guidelines leading to consistency across multiple sites of service. History and physical exam will no longer be used to select the level of code for facility-based E/M services, as has been the case for office and other outpatient visits since 2021. Also notable is a single medical decision making (MDM) table which will further streamline the code selection process. While the full revisions include updates to emergency department, nursing facility and home and residence services, key changes relevant to the neurology care team are outlined below.

Meghan Ward, MD, a member of the Coding and Payment Policy Subcommittee and an AAN advisor to the AMA Relative Value Scale Update Committee (RUC), summarized the important takeaways for members: “Hospital inpatient code selection will change in 2023 to mirror the changes recently made to outpatient codes. Code selection will depend solely on time spent on patient care on date of service or medical decision making. When billing based on time, there is no longer a requirement as to how the time is spent.”

Hospital Inpatient and Observation Care Services

Hospital observation care service codes have been deleted. A revised code set combines hospital inpatient care codes for both new and established patients. 99221–99223 are reported for an initial encounter and 99231–99233 are reported for a subsequent encounter. Time measurement has changed from typical time to a threshold of minutes that “must be met or exceeded” if billing based on time.

proposes G2212 or G0316 respectively, when reporting prolonged service time. It is critical to review your payer coverage policies prior to submitting a prolonged service claim to fully understand the payer specific requirements.

Consultations

While consultation codes remain a non-covered service by Medicare, the code set remains for 2023, with the exception of level 1 consultation codes 99241 and 99251 which have been deleted.

MDM Updates

Updates to the MDM table should also help alleviate administrative burden as one will no longer need to refer to both the now-outdated 1997 CMS guidelines and the MDM table, depending on the site of service of the encounter. Notable changes to the MDM table include:

Problems Addressed Column

New entries to low level of the “complexity of problems addressed” category of the table: ƒ 1 stable, acute illness

1 acute, uncomplicated illness or injury requiring hospital inpatient or observation level of care Risk of Complications and/or Morbidity or Mortality Column ƒ

Prolonged Services

The direct patient contact prolonged service codes 99354–99357 have been deleted. Effective as of January 2023, one of two codes will be reported for prolonged services with or without direct patient contact. The code selection will be dependent upon the site of service. 99417 is used for prolonged office or other outpatient E/M services. 99418 is a new code used for prolonged inpatient or observation E/M services.

*Coding tip—The Centers for Medicare & Medicaid Services (CMS) does not recognize 99417 or 99418 as a covered service, as the agency does not agree with the time threshold for reporting a prolonged increment of time. CMS instead

Revision of “Decision regarding hospitalization” to include “Decision regarding hospitalization or escalation of hospital-level care” as an example of high risk ƒ

Addition of “Parenteral controlled substances” as an example of high risk

Visit AAN.com/em to access additional coding resources including the updated MDM table, and to register for a free member webinar “2023 Medicare Physician Fee Schedule Payment and Policy Updates” on December 14. A recording of the webinar will be available in the Online Learning Center at AAN.com/learn 

Ward

Implement These Patient Communication Best Practices to Increase Efficiency

Throughout 2022, the AAN has been by your side, sharing expertise from your colleagues on how to manage staffing challenges and increase efficiencies. In our final installment, the AAN’s Medical Economics and Practice Committee developed best practices on ways to increase efficiency through patient communication. Making these simple changes to your patient interactions can not only optimize your organization but deliver a better patient experience.

Refills

Communicating with patients about refills can help streamline their visits, provide necessary care, and decrease phone calls and portal messages.

ƒ Have patients contact pharmacy for refills. The pharmacy will then send the request electronically. Most EHRs accept the request in a format that is easy to refill with minimal clicks. Patient portal use reduces errors and allows more timely response.

ƒ During the visit, use support staff to prepare potential refills.

Portal Messages

Communicating with patients electronically through the patient portal can be an efficient tool, but it’s important to clearly communicate to establish expectations and proper use.

ƒ Establish expectations for portal message response times.

ƒ Explore charging for portal messages as e-visits, if applicable.

ƒ Consider having portal messages go to clinical support staff for triage before going to the physician (e.g., reschedule requests).

ƒ Communicate that if a patient is having an acute or urgent medical issue they should not send a portal message. Provide appropriate guidance on who the patient should contact.

Scheduling

Developing strong scheduling practices and policies is key to increasing efficiency. Remember to communicate these practices to your patients to establish expectations, streamline visits, and deliver an outstanding patient experience.

ƒ Encourage the patient to schedule follow-up visits with APPs if access is a challenge on physician schedules.

ƒ When patients need to be seen urgently, clearly communicate the wait-time expectations or if they need to see another member of the care team.

ƒ Consider developing language to convert a patient to a telehealth visit.

ƒ Remind care givers that patients need to be present at the visit, including during telehealth encounters.

During Appointment

During the visit, several teams interact with the patient, and each team’s communication can help optimize the clinician’s appointment time with the patient and help minimize post-appointment messages.

ƒ Ask your staff to let the patient know if a clinician is running behind and the expected wait time.

ƒ Involve your patient in the EHR documentation by sharing your screen with them.

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Dictate the summary and plan with the patient in the room. This enables note completion before you leave the room, provides a summary of the visit so that you and the patient are on the same page, and matches the patient summary that is printed out or published to the portal.

ƒ Encourage patients to consult their notes after the visit to decrease follow-up portal messages and phone calls.

Results

The 21st Century Cures Act has led to patients having access to their progress notes and lab/imaging results, frequently before the clinician. Establishing expectations about when and how a patient will receive results is an important way to improve efficiency and meet patient needs. Learn more at AAN.com/SharingNotes

ƒ Prepare patients by discussing potential test results and meanings of those results and set expectations for receipt of results and response.

ƒ Communicate an appropriate time for when labs will be back (e.g., “Most results will show up in the portal in seven to 10 days; others may take longer”).

ƒ Set expectations about when the ordering clinician will reach out (e.g., there won’t be a personal outreach if the result is normal).

The June, August, September, October, and November issues of AANnews at AAN.com/AANnews feature articles with additional information on increasing efficiencies and navigating staffing challenges. Be sure to visit our website for additional information on how to optimize your organization during these challenging times. 

Registry Adds New Organizations, Assists Members Through 2022

The Axon Registry ® is the AAN’s quality improvement registry that provides neurology-specific measures to clinicians. Currently, the Axon Registry works with solo, small group, large health systems, and academic medical centers across the nation. These practices can use the registry for quality improvement, benchmarking, continuing certification credits, and MIPS submission.

In 2022, the Axon Registry started onboarding new organizations, including Innova Health, St. Luke's University, Garnet Health Doctors, and Duly Health and Care. The AAN will continue working with these practices throughout 2023 to provide them with an up-to-date quality dashboard.

Throughout the year, the Axon Registry assisted practices and participants in several ways. During the MIPS submission period, 38 practices submitted their MIPS reporting through the registry. Nineteen practices performed individual MIPS reporting, 23 practices performed group submission, and three practices performed both. The estimated average score for practices that submitted all three categories through the registry for was 71.96.

Several practices have received a dashboard from the Axon Registry’s new technical vendor Verana Health. These practices reviewed their quality data and are eligible to submit their data for MIPS submission through Verana Health beginning in 2023. The AAN and Verana Health will continue to contact practices with updates regarding their transition of technical vendors.

To focus on quality measure efficiency for 2023, the Axon Registry will remove five quality measures due to low usage by members. These five measures are listed here for reference.

EVENTS

The Axon Registry will also not be adding any new measures for this year. See the complete list of measures in registry at AAN.com/practice/axon-registry-quality-measures

Measures Retired for 2023

Axon 11.1: Diabetes/Pre-Diabetes Screening for Patients with DSP ƒ

Axon 33: Querying for co-morbid conditions of tic disorder (TD) and Tourette syndrome (TS) with follow-up ƒ

Axon 34: Botulinum Toxin Serotype A (BoNT-A) for Spasticity or Dystonia ƒ

Axon 40: Quality of Life Assessment (PROMIS-29) and Follow Up ƒ

Axon 44: BPPV: Dix-Hallpike and Canalith Repositioning Visit AAN.com/axon for information on how to enroll as a new registry participant, full measure specifications, and tips for how to document the measures, including capturing performance with key phrases. If you have any questions, contact the Axon Registry at registry @ aan.com 

Experience the Annual Meeting Your Way

Looking to fuel your energy with face-to-face networking experiences and personal connections at the world’s largest gathering of neurological professionals? Then join us in person in historic Boston! Or, if convenience and cost savings are what you seek, then join us live online. Either way, you can expect a fresh program of top-tier education, the very latest scientific discoveries, and an abundance of opportunities to connect with friends and colleagues from around the globe.

Get the Best Value—Add On Demand

This package includes extended access to most session recordings―and the ability to claim CME―through March 1, 2024. Save 40 percent on the regular price of Annual Meeting On Demand when you bundle with your conference registration.

Capitol Hill Report

Latest Advocacy News

ƒ On October 26, the AAN submitted comments in response to a Request for Information (RFI) released by the Centers for Medicare & Medicaid Services Office of Burden Reduction and Health Informatics seeking public input on access to health care and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency. Read the AAN’s comments at AAN.com/advocacy/comment-letters, which provide recommendations related to provider burnout, telehealth, prior authorization burden, and more.

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The AAN also submitted comments in response to a congressional RFI regarding strategies to stabilize the Medicare payment system. The comments highlighted several areas of MACRA that could be improved, including more timely MIPS data, the creation of more Advanced Alternative Payment Models (Advanced APMs) relevant to neurologists, and more regular review of evaluation and management (E/M) codes. Read the full letter containing our comments and requests at AAN.com/advocacy/comment-letters 

entertaining weekly podcast featuring conversations with neurology experts, celebrity advocates, and people whose lives are affected by brain conditions. Listen wherever you get your podcasts!

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

are some recent highlights.

Good News for Neurology in 2023 continued from cover

Evaluation and Management Visits

CMS is continuing its ongoing review of the evaluation and management (E/M) code descriptors and guidelines, with the next phase of revisions scheduled for implementation on January 1, 2023. Impacted E/M code sets include inpatient/ observation care, consultations, emergency department, nursing facility, home and residence, and prolonged services. As with the first phase of revisions, which included outpatient E/M services, CMS will be aligning its coding and documentation policies with changes laid out by the CPT Editorial Panel for the facility-based services, except when coding for prolonged inpatient services. In the proposed rule, CMS stated its disagreement with the time threshold at which prolonged service code 99418 should be reported. The CPT Editorial Panel finalized 99418 for 2023 to capture prolonged total time on the date of an inpatient EM service. CMS has instead finalized code G0316 and will not cover 99418. While the AAN is highly supportive of the broader updates, the AAN is concerned that the addition of the G-code will lead to confusion among practitioners and prove to be disruptive when medical specialty societies educate members about the correct coding for prolonged services.

In a significant win for AAN advocacy, CMS has finalized a delay of policies impacting split (or shared) E/M visits that were set to go into effect on January 1, 2023, until January 1, 2024, to allow for further dialogue with stakeholders. The AAN has been leading efforts to modify policies finalized in the 2022 Physician Fee Schedule that would detrimentally impact team-based care. The AAN is pleased to see that CMS is delaying implementation of these policies to allow for additional stakeholder feedback. The AAN has previously submitted recommendations to the agency regarding how existing policies could be modified to promote team-based care. The American Medical Association has referred this issue to a work group of members from the CPT Editorial Panel and the Relative Value Scale Update Committee (RUC) which is soliciting feedback from participating societies. The AAN continues to be engaged in this process and will provide comments as solutions are proposed.

Global Surgical Packages

In the proposed rule, the agency solicited comments regarding strategies for improving global surgical package valuations. The

AAN has long held concerns related to inappropriate valuations of these packages and the subsequent fiscal redistributions stemming from budget neutrality requirements. The AAN has particular concerns relating to the number and level of pre-operative and post-operative E/M visits in the packages. In response to the solicitation for comments, the AAN submitted feedback urging the agency to continue its critical work in this area and offered a robust set of recommendations regarding the best path forward. CMS noted in response to commenters that there is no consensus on a strategy for revaluing the global packages and the agency will consider the strategies proposed by commenters as they explore next steps. We remain highly encouraged by CMS seeking comment in preparation for future rulemaking to address potentially inflated values.

Telehealth Regulations

The AAN is pleased that CMS is implementing provisions of the Consolidated Appropriations Act of 2022 that extend certain flexibilities in place during the COVID-19 Public Health Emergency (PHE) for 151 days after the PHE ends, including allowing telehealth services to be furnished in any geographic area and at any originating site, including the beneficiary’s home, and allowing certain services to be furnished via audioonly telecommunications systems.

CMS finalized policy so that the agency will not be adding the Telephone E/M codes to the Medicare Telehealth list. As such, telephone E/M services will remain covered through the expiration of the 151-day period following the end of the PHE, at which point they will revert to bundled status.

Consistent with the AAN’s advocacy, CMS is finalizing a number of policies intended to promote access to telehealth services, including making several services that are temporarily available as telehealth services for the duration of the PHE available through CY 2023 on a Category 3 basis. This will allow more time for collection of data that could support their eventual inclusion as permanent additions to the Medicare telehealth services list.

CMS finalized its proposal to add CPT codes 95970, 95983, and 95984, which describe general brain nerve neurostimulation, to the Medicare Telehealth Services List on a Category 3 basis.

CMS also finalized its proposal to add CPT codes 97151–97158,

0362T, and 0373T on a Category 3 basis, which include emotional/ behavior assessment, psychological, or neuropsychological Testing and Evaluation services.

The agency also finalized a proposal that allows providers to bill for telehealth services with the place of service indicator that would have been used if the service had been furnished in-person. Claims will require the modifier “95” to identify them as services furnished as telehealth services. Claims can continue to be billed with the place of service code that would be used if the telehealth service had been furnished in person through the latter of the end of 2023 or end of the year in which the COVID-19 PHE ends.

EEG National Coverage Determination Changes

The AAN is pleased with the decision by CMS to finalize a proposal to remove the national coverage determination (NCD) for ambulatory EEG monitoring and allow coverage to be determined by local Medicare contractors. Since the implementation of the revised code set in 2020, the NCD no longer reflects the practice of medicine or current standards of care.

Valuation of Specific Codes

As part of the periodic CPT code review process, ultrasound codes 76881, 76882, and new code for neuromuscular ultrasound, 76883, were reviewed by the AMA RUC for 2023. In the proposed rule, CMS did not accept the recommendations of the RUC, and stated their intent to finalize values that would be a decrease to the code set. During the comment period, the AAN stated its disagreement with the agency’s rationale to reduce the values for these services. In a win for the AAN, stakeholder feedback compelled CMS to reverse their proposal and finalize the rates recommended by the RUC, which translates to a work RVU increase for these services.

Quality Payment Program

As in previous years, the rule includes proposed policy updates impacting the Quality Payment Program (QPP), which includes the Merit-based Incentive Payment System (MIPS), Advanced Alternative Payment Model (APM), and MIPS Value Pathways (MVPs).

As required by statute for the 2023 performance year, the weights for MIPS performance categories are: 30 percent for Quality, 30 percent for Cost, 15 percent for Improvement Activities, and 25 percent for Promoting Interoperability. The category weights have not changed in comparison to last year. CMS will maintain the 75-point performance threshold for performance year 2023. CMS notes that performance year 2022 was the final year for MIPS adjustments for exceptional performance.

To better account for improvements made within the Cost category, CMS has established a maximum cost improvement score of one percentage point out of 100 percentage points

available for the Cost performance category starting with the 2022 performance period. Within the Improvement Activities component, CMS is has added four activities: two in the Achieving Health Equity category (IA_AHE_10 and IA_AHE_11), one geared towards Expanding Practice Access (IA_EPA_6), and the last for Emergency Response Preparedness relating to the COVID-19 pandemic (IA_ERP_6). Within the Promoting Interoperability category, query of prescription drug monitoring program (PDMP) will now be a required measure worth 10 points. In the Quality performance category, CMS is amending benchmarking policy and clarifying policy relating to topped out measures.

The rule makes permanent the eight-percent minimum Generally Applicable Nominal Risk Standard for Advanced APMs that was set to expire in 2024.

MIPS Value Pathway

The rule finalizes five new MIPS Value Pathways (MVPs), two of which focus on neurologic conditions to be made available beginning with the 2023 performance year. By adding these five MVPs to the seven finalized last year, providers will have access to 12 MVPs starting in 2023, three of which are available to neurologists:

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“Optimal Care for Patients with Episodic Neurological Conditions MVP” focuses on the clinical theme of promoting quality care for patients suffering from episodic neurologic conditions.

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“Supportive Care for Neurodegenerative Conditions MVP” focuses on the clinical theme of promoting quality care for patients with cognitive-based neurologic disorders such as dementia, Parkinson’s disease, and amyotrophic lateral sclerosis.

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“Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP,” which was finalized last year, focuses on the clinical theme of providing fundamental prevention and treatment of those patients at risk for, or that have had, a stroke. This rule makes a minor change to what was previously finalized, with the addition of an ONC Direct Review attestation requirement for this MVP.

The AAN actively engaged with CMS during the development process for these MVPs and provided the agency with feedback throughout. The AAN will continue to provide feedback to the agency in refining these models in our comments.

CMS has committed that, for future MVP development and adjustments, it will post a draft version of each candidate MVP on the Quality Payment Program website (qpp.cms.gov ) and will communicate the opportunity to provide public feedback on the candidate MVP through QPP standard channels, including QPP listserv messaging. This is consistent with the AAN’s request for a more transparent and stakeholder-focused MVP development process.

Access AAN resources at AAN.com/practice/quality-paymentprogram to help you understand MVPs and explore the new Stroke MVP, and the new Episodic and Neurodegenerative MVPs. 

Lewis’s Term as Continuum Editor-in-Chief to End

Continuum® Editor-in-Chief Steven L. Lewis, MD, FAAN, completes his 10-year term this month.

“It has been a highlight of my career to have had the privilege and responsibility of serving as editor-in-chief of Continuum, the official CME journal of the AAN,” said Lewis. “I am so thankful to our incredible editorial team, editorial board, the AAN, and to our many thousands of devoted readers worldwide, who trust Continuum as their main source of clinically relevant information to inform their diagnosis and management of the wide variety of common and uncommon neurologic disorders that each of us encounter in our busy clinical practices.”

Lewis’ numerous accomplishments include:

ƒ Updating the Continuum curriculum of major topics in neurology that are covered in each three-year cycle

ƒ Appointing associate editors with specific expertise in neuroimaging, child neurology, medicolegal issues, practice, and CME/self-assessment, a pharmacotherapeutics reviewer, and editorial board members reflecting the diversity of neurologic clinical practice and subspecialty and general neurology expertise

ƒ Ensuring that authors of Continuum address health disparities in every issue

AAN President Orly Avitzur, MD, MBA, FAAN, saluted Lewis for his valued leadership. “The AAN is very grateful to Dr. Lewis

Pub: 22Continuum_Editor-in-Chief-ThankYou Ad—Half Page Horizontal> AN Placed in AANnews 8.25 x 5.25 +0.125 bleed, 4C

for his contributions as editor-in-chief to Continuum: Lifelong Learning in Neurology ® over the past decade. During his tenure, he increased worldwide subscriptions, broadened the AAN’s collaborative program with the World Federation of Neurology that provides access of Continuum to neurologists and trainees in lower-income countries, and enhanced Continuum's commitment to health equity. Always a pleasure to work with, he will be greatly missed, and we wish him much success in his future endeavors.”

Lyell K. Jones, Jr., MD, FAAN, will succeed Lewis as Continuum’s next editor-in-chief in January. 

The American Academy of Neurology

Steven L. Lewis, MD, FAAN Editor-in-Chief

With appreciation and gratitude for your decade of devoted Continuum: Lifelong Learning in Neurology® and Audio. Your dedication to the mission and vision of the Academy’s premier education publication has enhanced its quality and regard with the neurology community and helped improve the care of countless patients with neurologic diseases.

Lewis

Check out These Online Learning Opportunities

Whether you’re looking to meet end-of-year CME requirements or planning your 2023 education goals, the AAN has convenient online learning programs to get you up-to-date on all the latest advancements and fulfill your educational requirements, including these new options:

NeuroReady: Continuing Certification

READY

Continuing Certification Edition

Preparing for the American Board of Psychiatry and Neurology (ABPN) Continuing Certification (CC) exam—also known as the Maintenance of Certification (MOC) exam?

Or just looking to assess your strengths and areas of weakness? Either way, NeuroReady® is the AAN’s comprehensive online review and update program. See how your results compare to your peers and earn up to 15 self-assessment CME credits. Registration includes 12 months of access, score results, and examination feedback. The convenient online format allows you to take it at your own pace. Highlights include:

ƒ Syllabi on the 14 most heavily weighted categories from the ABPN content, which cover new and updated science and therapies

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Audio interviews from syllabi authors

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Over 130 multiple-choice question self-assessment exam with feedback, suggestions for further reading, and comparative peer performance results

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New NeuroSAE Editions and Format

Starting in January, the AAN’s popular NeuroSAE® examinations will be released in monthly, more digestible formats to provide increased convenience and accumulated access to 300 new questions per year. Written by neurologists for neurologists, each new case-based NeuroSAE examination offers convenient learning opportunities and clinical questions to help you test your knowledge and stay current. Upon completion of all editions, participants can earn up to 2 self-assessment CME per edition. New editions include:

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NeuroSAE: September 2022

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NeuroSAE: General Neurology

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NeuroSAE: Clinical Outpatient Neurology 

Touch lives with the work you do

Muscle and Neuromuscular Junction Disorders Explored in Continuum

The latest information on muscle and neuromuscular junction disorders is presented in the December issue of Continuum: Lifelong Learning in Neurology®

Guest Editor Michael Hehir II, MD, said, “This is an exciting time to care for patients with neuromuscular conditions due to the rapidly expanding number of available disease-modifying therapies. This issue focuses on new genetic therapies for patients with muscular dystrophies and new targeted immune treatments for patients with autoimmune neuromuscular disorders. Unique articles on genetic treatment strategies and experimental therapeutics will provide readers with a basic understanding of targeted genetic therapies and how to incorporate research into clinical practice.”

Topics in this Continuum issue include: ƒ

Approach to the Patient with Neuromuscular Weakness

Nicholas J. Silvestri, MD, FAAN ƒ Lambert-Eaton Myasthenic Syndrome and Botulism

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Muscle Channelopathies

Jaya R. Trivedi, MD, FAAN ƒ

Genetic-Based Treatment Strategies for Muscular Dystrophy and Congenital Myopathies

Myasthenia Gravis

Shruti M. Raja, MD ƒ

Michael Hehir II, MD; Yuebing Li, MD, PhD, FAAN ƒ

Inflammatory Myopathies

Georgios Manousakis, MD, FAAN ƒ

Inclusion Body Myositis

Namita A. Goyal, MD, FAAN ƒ

The Dystrophinopathies

Bo Hoon Lee, MD ƒ

The Limb-Girdle Muscular Dystrophies

Nicholas E. Johnson, MD, FAAN; Jeffrey M. Statland, MD ƒ Myotonic Dystrophy

Johanna Hamel, MD ƒ

Facioscapulohumeral Muscular Dystrophy

Andrew R. Findlay, MD; Conrad C. Weihl, MD, PhD ƒ Experimental Neurotherapeutics in Neuromuscular Disease

Lauren B. Reoma, MD, FAAN; Avindra Nath, MD, MBBS, FAAN; Robert C. Griggs, MD, FAAN

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

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Metabolic Myopathies

Karlien Mul, MD, PhD ƒ

Mark A. Tarnopolsky, MD, PhD, FRCP

UCNS Announces New Interventional Neurology Diplomates

The United Council for Neurologic Subspecialties has certified 28 new diplomates in the neurologic subspecialty of Interventional Neurology. Demonstrating their expert knowledge in their subspecialty, these physicians now hold the distinction of being UCNS Diplomates after passing the 2022 UCNS Interventional Neurology certification examination. The next UCNS Interventional Neurology certification examination will take place in 2024. To see the list of new diplomates, visit “News” at UCNS.org 

Hehir

Muscle and Neuromuscular Junction Disorders EDITOR-IN-CHIEF:

FOR PATIENTS WITH CERTAIN VHL-ASSOCIATED TUMORS

DISCOVER WELIREG TM THE FIRST AND ONLY SYSTEMIC TREATMENT 1,2 APPROVED

WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Simple, once-daily, oral dosing

• The recommended dosage is 120 mg once daily until progression of disease or unacceptable toxicity. WELIREG may be taken with or without food.

1x daily

SELECTED SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY

• Exposure to WELIREG during pregnancy can cause embryo-fetal harm.

• Verify pregnancy status prior to the initiation of WELIREG.

• Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Before prescribing WELIREG, please read the additional Selected Safety Information on the following pages and the adjacent Brief Summary of the Prescribing Information, including the Boxed Warning about embryo-fetal toxicity.

WELIREG DEMONSTRATED TUMOR SHRINKAGE ACROSS CERTAIN TUMORS IN PATIENTS WITH VHL DISEASE

WELIREG ACHIEVED AN OBJECTIVE RESPONSE ACROSS 3 TUMOR TYPES PER RECIST v1.1

In RCC (N=61)

49%

ORRa

(95% CI, 36–62) (n=30/61)b

All responses were partial responses (complete response, 0%)b

Median DOR was not reached (range of ongoing responses: 2.8+ to 22+ months)

56% of patients who responded (n=17/30) maintained a response that lasted ≥12 months

Patient Subgroups

With CNS hemangioblastomas (n=24)

63%

ORRa

(95% CI, 41–81) (n=15/24)c

Complete response, 4%; partial response, 58%

Median DOR was not reached (range of ongoing responses: 3.7+ to 22+ months)

73% of patients who responded (n=11/15) maintained a response that lasted ≥12 months

With pNET (n=12)

83%

ORRa

(95% CI, 52–98) (n=10/12)c

Complete response, 17%; partial response, 67%

Median DOR was not reached (range of ongoing responses: 11+ to 19+ months)

50% of patients who responded (n=5/10) maintained a response that lasted ≥12 months

Complete response defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response defined as ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline.3

Median DOR could not be estimatedd since the majority of patients who responded to treatment maintained their response (did not experience disease progression per RECIST v1.1) at the time of data cutoff.4

aMeasured by radiology assessment using RECIST v1.1 as assessed by IRC.

bAll patients with a response were followed for a minimum of 18 months from the start of treatment.

cNumber of patients with measurable solid lesions, based on IRC assessment. dBy Kaplan-Meier method.

+ Denotes ongoing response.

DOR = duration of response; RECIST v1.1 = Response Evaluation Criteria

In Solid Tumors v1.1; ORR = objective response rate; CI = confidence interval.

STUDY DESIGN: Patients (N=61) had VHL-associated RCC diagnosed based on a VHL germline alteration and with at least 1 measurable solid tumor (as defined by RECIST v1.1) localized to the kidney. Patients had other VHL-associated tumors, including CNS hemangioblastomas and pNET. CNS hemangioblastomas and pNET in these patients were diagnosed based on the presence of at least 1 measurable solid tumor in brain/spine or pancreas, respectively, as defined by RECIST v1.1 and identified by central independent review committee (IRC). The study excluded patients with metastatic disease. Patients received WELIREG 120 mg once daily until progression of disease or unacceptable toxicity. Median age of patients was 41 years (range 19 to 66 years). Of the 61 patients included in the study, 3.3% were age 65 years or older, and 53% were male. Ninety percent were White, 3.3% were Black or African-American, 1.6% were Asian, and 1.6% were Native Hawaiian or other Pacific Islander. Eighty-two percent had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 16% had an ECOG PS of 1, and 1.6% had an ECOG PS of 2; and 84% had VHL Type I Disease. The median diameter of RCC target lesions per IRC was 2.2 cm. Median time from initial radiographic diagnosis of VHL-associated RCC tumors that led to enrollment to the time of treatment with WELIREG was 17.9 months (range: 2.8 to 96.7 months). Seventy-seven percent of patients had prior surgical procedures for RCC. The major efficacy end point for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 as assessed by IRC. Additional efficacy end points included DOR and time to response (TTR).

References: 1. Shuch B. HIF2 inhibition for von-Hippel Lindau associated kidney cancer: will urology lead or follow? Urol Oncol. 2021;39(5):277–280. 2. Chittiboina P, Lonser RR. Von Hippel–Lindau disease. Handb Clin Neurol. 2015;132:139–156. 3. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247. 4. Delgado A, Guddati AK. Clinical endpoints in oncology - a primer. Am J Cancer Res. 2021:11(4):1121–1131.

In Study 004, an open-label clinical trial for patients with VHL-associated RCC (N=61)

SELECTED SAFETY INFORMATION (continued )

Anemia

• WELIREG can cause severe anemia that can require blood transfusion. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, anemia occurred in 76% of patients and 28% had Grade 3 anemia.

• Monitor for anemia before initiation of and periodically throughout treatment. Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolizers due to potential increases in exposure that may increase the incidence or severity of anemia.

• Transfuse patients as clinically indicated. For patients with hemoglobin (Hb) <9 g/dL, withhold WELIREG until Hb ≥9 g/dL, then resume at reduced dose or permanently discontinue depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until Hb ≥9 g/dL, then resume at a reduced dose or permanently discontinue.

• The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG.

Hypoxia

• WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

In Study 004, hypoxia occurred in 1.6% of patients.

In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, hypoxia occurred in 29% of patients; 16% were Grade 3 hypoxia.

• Monitor oxygen saturation before initiation of and periodically throughout treatment. For decreased oxygen saturation with exercise (eg, pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (eg, pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a health care provider.

Embryo-Fetal Toxicity

• Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

• Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

• In Study 004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

• WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

• Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

• Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

• The most common adverse reactions (≥25%) were decreased hemoglobin (93%), anemia (90%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

• In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, the following additional adverse reactions have been reported: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration.

Drug Interactions

• Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

• Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

• Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

• WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

• Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

• Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

• Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

Before prescribing WELIREG, please see the adjacent Brief Summary of the Prescribing Information, including the Boxed Warning about embryo-fetal toxicity.

Brief Summary of the Prescribing Information for WELIREG™ (belzutifan) 40 mg tablets, for oral use

WARNING: EMBRYO-FETAL TOXICITY

• Exposure to WELIREG during pregnancy can cause embryo-fetal harm.

• Verify pregnancy status prior to the initiation of WELIREG.

• Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective.

INDICATIONS AND USAGE

WELIREG is indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of WELIREG is 120 mg administered orally once daily until disease progression or unacceptable toxicity. WELIREG should be taken at the same time each day and may be taken with or without food.

Advise patients to swallow tablets whole. Do not chew, crush, or split WELIREG prior to swallowing.

If a dose of WELIREG is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for WELIREG the next day. Do not take extra tablets to make up for the missed dose.

If vomiting occurs any time after taking WELIREG, do not retake the dose. Take the next dose on the next day.

Dosage Modifications for Adverse Reactions

Dosage modifications for WELIREG for adverse reactions are summarized in Table 1.

The recommended dose reductions are:

• First dose reduction: WELIREG 80 mg orally once daily

• Second dose reduction: WELIREG 40 mg orally once daily

• Third dose reduction: Permanently discontinue

Table 1: Recommended Dosage Modifications for Adverse Reactions

Adverse ReactionSeverity Dosage Modification

Hemoglobin <9 g/dL or transfusion indicated

Anemia

Life-threatening or urgent intervention indicated

Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%)

• Withhold until hemoglobin ≥9g/dL.

• Resume at reduced dose or discontinue depending on the severity of anemia.

• Withhold until hemoglobin ≥9g/dL.

• Resume at a reduced dose or permanently discontinue.

• Consider withholding until resolved.

• Resume at the same dose or at a reduced dose depending on the severity of hypoxia.

The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG. For patients treated with WELIREG who develop anemia, the safety and effectiveness for use of ESAs have not been established. Randomized controlled trials in patients with cancer receiving myelosuppressive chemotherapy with ESAs have shown that ESAs increased the risks of death and serious cardiovascular reactions, and decreased progressionfree survival and/or overall survival. See the prescribing information for ESAs for more information.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

In Study 004, hypoxia occurred in 1.6% of patients. In another clinical trial [Study 001 (n=58)] in patients with advanced solid tumors who received the same dosage of WELIREG, hypoxia occurred in 29% of patients, including Grade 3 hypoxia in 16%.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same dose or at a reduced dose.

For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening hypoxia or for recurrent symptomatic hypoxia, permanently discontinue WELIREG.

Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposures (AUC) at the recommended dose of 120 mg daily.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with WELIREG and for 1 week after the last dose, since WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

• Anemia

• Hypoxia

Clinical

Trials Experience

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

The safety of WELIREG was evaluated in an open-label clinical trial (Study-004) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney. Patients received WELIREG 120 mg orally once daily. The median duration of exposure to WELIREG was 68 weeks (range: 8.4 to 104.7 weeks).

Hypoxia

Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated

Life-threatening or recurrent symptomatic hypoxia

Other Adverse Reactions

Grade 3

Grade 4

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Anemia

• Withhold until resolved.

• Resume at reduced dose or discontinue depending on the severity of hypoxia.

• Permanently discontinue.

• Withhold dosing until resolved to

≤ Grade 2.

• Consider resuming at a reduced dose (reduce by 40 mg).

• Permanently discontinue upon recurrence of Grade 3.

• Permanently discontinue.

WELIREG can cause severe anemia that can require blood transfusion.

In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). In another clinical trial [Study 001 (n=58)] in patients with advanced solid tumors who received the same dosage of WELIREG, anemia occurred in 76% of patients and 28% had Grade 3 anemia. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolizers due to potential increases in exposure that may increase the incidence or severity of anemia.

Transfuse patients as clinically indicated. For patients with hemoglobin <9g/dL, withhold WELIREG until ≥9g/dL, then resume at reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥9g/dL, then resume at a reduced dose or permanently discontinue WELIREG.

Serious adverse reactions occurred in 15% of patients who received WELIREG, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

Permanent discontinuation of WELIREG due to adverse reactions occurred in 3.3% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG were dizziness and opioid overdose (1.6% each).

Dosage interruptions of WELIREG due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea. Continued on next page.

Brief Summary of the Prescribing Information for WELIREG™ (belzutifan) 40 mg tablets, for oral use (continued )

Table 2 summarizes the adverse reactions reported in patients treated with WELIREG in Study 004.

Table 2: Adverse Reactions Occurring in ≥10% of Patients Who Received WELIREG in Study 004

Adverse Reaction WELIREG N=61

All Grades* (%) Grade 3-4 (%)

Blood and Lymphatic Anemia 90 7

General

Fatigue† 64 5 Nervous System

Headache‡ 39 0 Dizziness§ 38 0

Gastrointestinal Nausea 31 0

Constipation 13 0 Abdominal pain¶ 13 0

Eye Disorders

Visual impairment# 21 3.3 Infections

Upper respiratory tract infectionÞ 21 0 Respiratory, Thoracic and Mediastinal Dyspnea 20 1.6

Musculoskeletal and Connective Tissue

Arthralgia 18 0 Myalgia 16 0 Vascular

Hypertension 13 3.3 Metabolism and Nutrition

Weight increased 12 1.6

*Graded per NCI CTCAE v4.0

† Includes fatigue and asthenia

‡ Includes headache and migraine

§Incudes dizziness and vertigo

¶Includes abdominal discomfort, abdominal pain, abdominal pain upper and abdominal pain lower

#Includes visual impairment, vision blurred, central retinal vein occlusion and retinal detachment

ÞIncludes bronchitis, sinusitis, upper respiratory tract infection, and viral upper respiratory infection

Table 3 summarizes the laboratory abnormalities in Study 004.

Table 3: Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received WELIREG in Study 004

Laboratory Abnormality*

Chemistry

WELIREG (n=61)

Grades 1-4 % Grades 3-4 %

Increased creatinine 64 0

Increased glucose 34 4.9

Increased ALT 20 0

Increased AST 16 0

Decreased calcium (corrected) 10 0

Decreased phosphate 10 1.6

Hematology

Decreased hemoglobin 93 7 Decreased leukocytes 11 0

*The denominator used to calculate the rate is based on all patients in the safety analysis population.

Other Clinical Trials Experience

In Study 001 (NCT02974738), a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose in which the median age of enrollment was 62.5 years (range 39-75) and the median number of prior therapies for cancer was 3 (range 1-9), the following additional adverse reactions have been reported following administration of WELIREG at the recommended dosage: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration.

DRUG INTERACTIONS

Effects of Other Drugs on WELIREG

UGT2B17

or CYP2C19 Inhibitors

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions of WELIREG. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Effect of WELIREG on Other Drugs

Sensitive CYP3A4 Substrates

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A substrates, which may reduce the efficacy of these substrates. The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolizers. Avoid coadministration of WELIREG with sensitive CYP3A4 substrates, for which minimal decrease in concentration may lead to therapeutic failures of the substrate. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information.

Hormonal Contraceptives

Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary

Based on findings in animal studies, WELIREG can cause fetal harm when administered to a pregnant woman. There are no available data on the use of WELIREG in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposure (AUC) at the recommended dose of 120 mg daily (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

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

Data

Animal Data

In a pilot embryo-fetal development study, pregnant rats received oral doses of 6, 60, or 200 mg/kg/day of belzutifan during the period of organogenesis. Belzutifan caused embryo-fetal lethality at doses ≥60 mg/kg/day (approximately 1 time the human exposure at the recommended dose based on AUC). Reduced fetal body weights, fetal rib malformations, and reduced skeletal ossification occurred at doses of 6 and 60 mg/kg/day (approximately ≥0.2 times the human exposure at the recommended dose based on AUC).

Lactation Risk Summary

There are no data on the presence of belzutifan or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential WELIREG can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Contraception

Females

Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective.

Males

Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Infertility

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential. The reversibility of the effect on fertility is unknown.

Pediatric Use

Safety and effectiveness of WELIREG have not been established in pediatric patients.

Geriatric Use

Of the patients who received WELIREG in Study 004, 3.3% were ≥65 years old. Clinical trials of WELIREG did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

Renal Impairment

No dosage modification of WELIREG is recommended in patients with mild (eGFR 60-89 mL/min/1.73 m2 estimated by MDRD) and moderate (eGFR 30-59 mL/min/1.73 m2) renal impairment. WELIREG has not been studied in patients with severe (eGFR 15-29 mL/min/1.73 m2) renal impairment.

Hepatic Impairment

No dosage modification of WELIREG is recommended in patients with mild [total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin >1 to 1.5 x ULN and any AST] hepatic impairment. WELIREG has not been studied in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x ULN and any AST).

Dual UGT2B17 and CYP2C19 Poor Metabolizers

Patients who are dual UGT2B17 and CYP2C19 poor metabolizers have higher belzutifan exposures, which may increase the incidence and severity of adverse reactions of WELIREG. Closely monitor for adverse reactions in patients who are dual UGT2B17 and CYP2C19 poor metabolizers.

OVERDOSAGE

There is no specific treatment for WELIREG overdose. In cases of suspected overdose, withhold WELIREG and institute supportive care. Grade 3 hypoxia occurred at dosages of 120 mg twice a day and Grade 4 thrombocytopenia occurred at dosages of 240 mg once daily (approximately 2 times the recommended dosage).

For more detailed information, please read the Prescribing Information.

uspi-mk6482-t-2108r000

Revised: 08/2021

Copyright © 2022 Merck & Co., Inc., Kenilworth, NJ, USA and its affiliates All rights reserved. US-BEL-00158 02/22

Congratulations New Fellows of the American Academy of Neurology!

The AAN congratulates the following members who were named prestigious Fellows of the American Academy of Neurology (FAAN) between May and September 2022.

Sasha Alick-Lindstrom, MD, FAAN

Tyler Jared Allison, MD, FAAN

Rolando Ania, MD, FAAN

Amir Manzoor Arain, MD, FAAN

Robert F. Armstrong, MD, FAAN

Miya Asato, MD, FAAN

Jonathan Mark Beary, DO, FAAN

Luis E. Bello-Espinosa, MD, FAAN

Richard T. Benson, MD, PhD, FAAN

Shamik Bhattacharyya, MD, FAAN

Rohini Bhole, MD, MS, FAAN

Bruce Campbell, MD, FAAN

Anna Marisa Cervantes-Arslanian, MD, FAAN

Madeline A. Chadehumbe, MD, FAAN

Jocelyn Y. Cheng, MD, FAAN

Katherine Coerver, MD, PhD, FAAN

Glen A. Cook, Jr., MD, FAAN

Elizabeth A. Coon, MD, FAAN

Barry M. Czeisler, MD, MS, FAAN

Kate Daniello, MD, FAAN

Anindita Deb, MD, FAAN

Sylvia R. Delgado, MD, FAAN

Alfonso Fasano, MD, PhD, FAAN

Wayne W. Feng, MD, FAAN

Joanna S. Fong, MD, FAAN

Paulo Pacheco Fontoura, MD, PhD, FAAN

Kristin Gabriel, DO, MPH, FAAN

James S. Gaffney, MD, FAAN

Carrie Katherine Grouse, MD, FAAN

Charles Guardia, MD, FAAN

Steven K. Hata, MD, FAAN

Nabeel Herial, MD, MPH, FAAN

Matthew T. Hoerth, MD, FAAN

Samantha K. Holden, MD, MS, FAAN

AAN in the News

Etedal Ahmed Ibrahim, MD, MBBS, FAAN

Md. Nazrul Islam, MD, MBBS, MCPS, FAAN

Saiju Jacob, MD, FAAN

Amanda L. Jagolino-Cole, MD, FAAN

Yasir Nihad Jassam, MD, MRCP, FAAN

Sudhir Kumar Jha, MD, FAAN

Michael Anthony Leander Johnson, MD, FAAN

Kimberly S. Jones, MD, FAAN

Marielle Kabbouche, MD, FAAN

Anil K. Kapoor, MD, MBBS, FAAN

Paramjit Kaur, MD, FAAN

Seth M. Keller, MD, FAAN

Ariane Lewis, MD, FAAN

Michael J. Lyerly, MD, FAAN

Carolina B. Maciel, MD, MSCR, FAAN

Elisabeth B. Marsh, MD, FAAN

Haider Ali Mohammed, MD, FAAN

Kavita Nair, PhD, FAAN

Sandra Narayanan, MD, FAAN

Antonio M.P. Omuro, MD, FAAN

Ezequiel A. Piccione, MD, FAAN

Kathleen Poston, MD, FAAN

Geetanjali Singh Rathore, MD, FAAN

Melissa Lynn Rayhill, MD, FAAN

Robert Reddig, MD, FAAN

Gregory A. Rippon, MD, FAAN

Priyanka Sabharwal, MD, MBBS, FAAN

Veronica E. Santini, MD, MA, FAAN

Pournamy Sarathchandran, MD, PhD, MBBS, FAAN

Korak Sarkar, MD, FAAN

Konrad Schlick, MD, FAAN

Sai L. Shankar, PhD, FAAN

Abul K. Shoab, MD, FAAN

Christen L. Shoesmith, MD, BSc, FAAN

Christos Sidiropoulos, MD, FAAN

Shobhit Sinha, MD, FAAN

William Sommers, DO, FAAN

Jun Sone, MD, PhD, FAAN

Achal K. Srivastava, MD, FAAN

N.V. Sundarachary, MD, FAAN

Kiran Thakur, MD, FAAN

Ashraf V. Valappil, MD, FAAN

Binod Wagle, MD, FAAN

Rebecca E. Wells, MD, FAAN

Victoria S. Wong, MD, FAAN

Glynnis Zieman, MD, FAAN

Paulo L. Zortea, MD, FAAN

Deepti Zutshi, MD, FAAN 

Interested in Elevating Your Membership Status to FAAN?

Visit AAN.com/FAAN to see if you’re eligible to apply for the FAAN designation—or encourage a qualifying colleague to apply. Applying for FAAN status is free; acknowledges exemplary work and achievements in the neurosciences, the clinical practice of neurology, or academic/administrative neurology; helps set you apart both within the Academy and throughout your professional career; and offers eligibility to serve on the AAN Board of Directors. 

A Neurology ® study that links ultra-processed foods like chips and cookies to a higher risk of developing dementia was covered by CNN and CBS Boston, and broadcast more than 70 times on CBS, NBC, and ABC affiliates around the country. A study that shows physical and mental activities such as household chores, exercise, and visiting with family may help lower the risk of dementia was picked up by Good Morning America and HuffPost. Another study that suggests physical and mental activity may help preserve thinking skills and delay dementia was also mentioned by CNN, Daily Mail, and US News & World Report 

Transforming Leaders Program Graduate Takes on New Leadership Role

2020 Transforming Leaders Program graduate Roderick Spears, MD, FAHS, FAAN, has taken on a new leadership role as the inaugural endowed chair of migraine and chief of the new Headache Division at Brown Neurology Warren Alpert Medical School of Brown University in Providence, RI. Spears will help start and develop an academic headache program and division that will include comprehensive clinical care for patients, and education for medical students, residents, and fellows. He will also develop curriculum for neurologists and other health care specialists on headache care, as well as participate in research involving migraine and other headache

disorders. “Rhode Island has never had a comprehensive migraine headache center to service the population here,” he said, “and I am excited about the opportunity to develop such a center and program.”

We asked Spears how the skills he learned through the Transforming Leaders Program helped him achieve

LEADERSHIP DEVELOPMENT AAN

this new career success. He spoke specifically about the skills around leading self, leading others, and working with a team—all of which are a fundamental part of the program.

“I learned the importance of time management—of carving out reflective time each week to assess positives and negatives from the previous week and areas of needed change. This also allowed time for vision development based on core values,” he explained. “And the importance of listening; of providing and receiving constructive feedback. And advocacy for those I am leading—and directing and/or leading where I am called to do so." Finally, he said, “I learned the importance of working with a team to identify roles on the team based on strengths and weaknesses and seeking a balance in team structure to move the team forward.” 

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Savings of 30 percent or more on industry-leading in-person and virtual conferences

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The opportunity to exchange diverse insights and ideas among 38,000 colleagues from 138 countries representing all facets and subspecialties through more than 60 SynapseSM Member Communities

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The chance to add your voice to impactful legislation and regulatory advocacy at the US federal and state level to transform the field of neurology and ensure access to care for patients

Visit AAN.com/membership to see all the ways your membership provides the resources you need to succeed! For more information, contact AAN Member Services at memberservices @ aan.com, (800) 879-1960, or (612) 928-6000 (international).

*AAN member benefits vary by member type. For a full list of benefits, visit AAN.com/membership/member-benefits 

Don’t Forget About Care Team Memberships!

Membership also expires on December 31 for valuable care team members like advanced practice providers (APPs) and business administrators (BAs). APPs and BAs receive valuable benefits to help them excel in their careers—and help improve your practice and patient care. Additionally, APPs can choose between two membership options:

Advanced Practice Provider PLUS (best value!)

All member benefits, including Neurology ® journal, Neurology ® Clinical Practice, Neurology Today ®, and free access to online learning programs (NeuroSAE® and NeuroLearnSM).

Advanced Practice Provider

All member benefits, excluding Neurology journal, Neurology Today in print, and free access to online learning programs (NeuroSAE and NeuroLearn). 

Spears

2022 Was a Busy Year for IDEAS Initiatives

Inclusion is the reason the AAN was founded. To be an organization that is the home for all neurologists. It is what makes us stronger. To support our goal of being a fully inclusive, deliberately diverse, and anti-racist organization and our core values of Inclusion, Diversity, Equity, Anti-racism, and Social Justice (IDEAS), we are excited to share progress and updates with you.

The AAN and its Board of Directors remain committed to the IDEAS work at the AAN. Some of the notable accomplishments of 2022 include:

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Implemented awards and grants offered in the IDEAS space, including a Clinical Research and Training Scholarship in Neurodisparities, IDEAS Changemaker Award, AAN IDEAS Innovator Grants, AAN IDEAS Project Grants, and the Health Care Equity Research Award

ƒ In December, completed involvement in the ACGME Equity Matters Program, presenting to other medical associations through a cohort program project of expanding the AAN member demographic profile categories to be more inclusive and representative of membership

ƒ 475 users enrolled in the AAN’s Anti-racism Education Program

ƒ Created a Residency Pilot Program, offering guidance and training for pilot leaders on facilitating the AAN’s Anti-racism Education Program with a cohort

ƒ Launched a microlearning series focused on building IDEAS principles in neurology practices

ƒ Many AAN publications have incorporated IDEAS review of all manuscripts and abstracts:

Ž Continuum® authors are directed to add sections on health disparities in their articles, as applicable. Staff

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and editors carefully review all content for inclusive and unbiased language

Neurology Today ® and Brain & Life® have EDI associate editors who review and advise on inclusive language in stories

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Neurology ® journals achieved gender equity on all five journal editorial boards

ƒ Efforts to improve collection of race and ethnicity data in neurologic practice using informatics solutions

ƒ Increased IDEAS-related programming at the 2022 Annual Meeting in Seattle

ƒ Increased transparency into the Board and Committee selection processes. The current 2022 AAN Board of Directors membership reflects a 22-percent increase in racial diversity compared to the 2017 board of directors, while gender and practice setting representation have remained similar

“On behalf of the AAN Board of Directors, I am proud of all the work our committees, physician volunteers, and staff have done to ensure IDEAS is incorporated into the wide range of products, programs, and services the AAN offers,” said AAN President Orly Avitzur, MD, MBA, FAAN. “We remain committed to this important work that ensures the AAN is home to everyone in neurology.” 

Shift Planned for AAN Section Election Schedule

The AAN is shifting AAN Section elections so all are held on the same schedule, to better align with AAN presidential and committee term cycles. Moving all sections to a biennial election cycle will simplify planning for member volunteers involved in multiple sections when working to identify upcoming leaders and encouraging them to consider applying for a section leadership role.

With the launch of 2023 elections just around the corner—and 2023 being a transition year—those sections that are up for election will still host their elections as planned. Beginning in 2025, all sections will hold elections. Watch for “Call for Nominations” emails and announcements on Synapse beginning this month. Voting will occur in February and new 2023–2025 leaders will be announced by mid-March. 

Not a Section Member? Join Us!

If you don’t already belong to one or more AAN Sections, your neurology community wants to hear from you! Consider joining to lend your voice to rich and timely discussions in neurology and share ideas and concerns with others from around the globe within your subspecialty or area of interest. Section membership also includes access to our associated Synapse Member Communities and Synapse mobile app where a growing number of participants are discussing the latest health care topics. Visit AAN.com/Sections to learn more and to join. 

DECEMBER

December 9

Registration Deadline: RITE® (Residency In-service Training Exam) AAN.com/RITE

December 14

Free Webinar: 2023 Medicare Physician Fee Schedule Payment and Policy Updates

AAN.com/practice/medicare-fee-for-service

JANUARY

January 1

Applications Open: UCNS Neuro-oncology Certification

UCNS.org/NOcertification

January 31

Application Deadline: UCNS Accreditation UCNS.org/Accreditation

FEBRUARY

February 1

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

February 2

Early Registration Deadline: 2023 Annual Meeting AAN.com/AM

February 14–20

RITE® (Residency In-service Training Exam) AAN.com/RITE

AMERICAN BRAIN FOUNDATION

American Brain Foundation Wraps up Year of Successes

The American Brain Foundation funds vital research across all brain diseases in pursuit of improved treatments, prevention, and cures. The Foundation has provided more than $34 million to aid nearly 300 researchers investigating a broad spectrum of brain and nervous system disorders. Our belief is that by curing one disease, we will cure many. Throughout 2022, we took our commitment to raising awareness of brain disease and the need for research to new heights, closing out the year with the following key successes:

ƒ Granted $3 million to identify a biomarker for early diagnosis of Lewy body dementia

ABF established the Cure One, Cure Many Award and convened partners, including the Alzheimer’s Association, the Michael J. Fox Foundation for Parkinson’s Research, and the American Academy of Neurology. We granted $3 million to a team of researchers from Mayo Clinic to accelerate progress in the early diagnosis of Lewy body dementia.

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Funded 29 Next Generation Research Grants

We funded 29 grants across multiple brain diseases, 18 of which were new research grants.

ƒ Supported Research Across Broad Spectrum of Brain Diseases

Our 2022 funded researchers investigated potential causes, diagnosis, and treatment for brain diseases such as ALS, epilepsy, stroke, multiple sclerosis, Parkinson’s, Alzheimer’s, Lewy body dementia, and others.

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Raised Nearly $875,000 at Commitment to Cures Gala Nearly $875,000 was raised at our annual Commitment to Cures fundraiser which took place during the AAN Annual Meeting in Seattle. The gala featured special guests, including actor and comedian Seth Rogen and his wife, Lauren Miller Rogen.

In 2023, we will continue funding groundbreaking research, raising awareness, and sharing resources about brain diseases through our webinars, blogs, and in-person events. Join us in the new year by visiting AmericanBrainFoundation.org to learn how, together, we can make life without brain disease a reality. 