Health Policy Update: January 2023
HEALTH POLICY IN ACTION
MONTHLY HIGHLIGHT
Jack Leslie, former chair of the Duke Global Health Institute’s Board of Advisors, now joins Duke University as a Senior Visiting Fellow at the Duke Global Health Institute and Visiting Fellow at the Duke-Margolis Center for Health Policy. Jack will work with Duke to design plans for building back trust in public health, which became damaged throughout the COVID-19 pandemic. Jack’s experience with humanitarian assistance and global health will help build the foundations for an initiative that strengthens the bonds between public health agencies and communities. We are honored to have Jack on our team and look forward to the work we accomplish together.

Read the press release here.
NATIONAL
Duke-Margolis core faculty member David Ridley and Duke adjunct professor Jeffrey Moe are contributing authors of a new Health Affairs Forefront article on their voucher program proposal that recently became law. On December 29, 2022, President Biden signed a bill to create the Vector Expedited Review Voucher (VERV) program to encourage the creation of new pesticides that fight vector-borne diseases. The voucher program was originally proposed in a 2017 Health Affairs article, written in part by David and Jeffrey, as a more cost-effective method to treat vector-borne diseases at their source. David and Jeffrey were also co-authors of a similar 2006 Health Affairs proposal on Federal Drug Administration (FDA) priority review vouchers, which became law under President Bush in 2007. This latest article discusses next steps for the Environmental Protection Agency (EPA), product developers, and Congress to handle the VERV program to ensure its effective use. Read the full piece here for their insights on the new bill.
The Center for Strategic and International Studies (CSIS) released a report on January 12 that offered recommended actions for the U.S. Center for Disease Control and Prevention (CDC)’s response to future outbreaks. Mark McClellan contributed to the report as part of the advisory board. The report, “Building the CDC the Country Needs,” acknowledges the need to regain the nation’s trust in public health agencies and provides solutions that emphasize greater accountability and equity in the CDC’s operations. Read the report here.
GLOBAL
The COVID Global Accountability Platform (COVID GAP) released two Accountability Reports this month as part of their ongoing series to track and analyze developments in the global COVID-19 pandemic response. COVID GAP, for which Duke-Margolis is a founding member, acts as an independent source for global news on the pandemic, and identifies key issues and recommendations for improving the response on a national and global level.
STATE
The Milbank Memorial Fund recently released their top ten most-read publications of 2022, and a policy brief by Duke-Margolis researchers William Bleser, Katie Huber, Hannah Crook, Rebecca Whitaker, Jasmine Masand, James Zheng, Raman Nohria, Michelle Lyn, and Robert Saunders was fifth on the list. The March 2022 brief, “North Carolina’s COVID-19 Support Services Program: Lessons for Health Policy Programs to Address Social Needs,” outlined health policy recommendations to improve pandemic-related outreach across North Carolina. Read the brief here.
RESEARCH
Duke-Margolis kicked off a three-year project to advance home-based primary care and Age-Friendly Health Systems. While primary care has gradually shifted outside of traditional clinical settings, the COVID-19 pandemic emphasized the need for home-based care to treat more populations effectively. Duke-Margolis is collaborating with the National Home-Based Primary Care Learning Network, the Home Centered Care Institute (HCCI), and the American Academy of Home Care Medicine (AAHCM) to amplify evidence-based policy efforts to scale up home-based primary care. This project is supported by The John A. Hartford Foundation as part of a broader effort, Moving and Scaling Home-Based Primary Care, Phase III: Quality, Training, Advocacy and Policy. Learn more about the project here.
UPCOMING EVENTS
Building Partnerships for Better Health: Launching North Carolina’s State Transformation Collaborative

February 2, 2023
3:00-5:00 PM ET
The State Transformation Collaborative is a public-private partnership that aims to improve population health, enhance patient experience, reduce health care costs, and decrease administrative demands on health care providers, while simultaneously advancing health equity. North Carolina is one of four states—along with California, Colorado, and Arkansas—to be selected to participate in this project. North Carolina Department of Health and Human Services Division of Health Benefits, the Health Care Payment Learning & Action Network (LAN), the U.S. Center for Medicare & Medicaid Services (CMS), and the Duke-Margolis Center will host the official launch of North Carolina’s State Transformation Collaborative on February 2nd through a public event held both in-person at Duke University’s Fuqua School of Business and virtually.

The speakers at this launch event will share the vision and priorities for North Carolina’s State Transformation Collaborative as well as strategies to advance the health of North Carolinians.

Speakers include:
  • Kody Kinsley, Secretary, NC Department of Health and Human Services
  • Kate Davidson, LCSW, Director, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation
  • Shannon Dowler, MD, Chief Medical Officer, Division of Health Benefits, North Carolina Department of Health & Human Services
  • Stephen Friedhoff, MD, Senior Vice President, Health Care Services, Blue Cross Blue Shield of North Carolina
  • Mark Gwynne, DO, President, UNC Health Alliance
  • Mark McClellan, MD, PhD, Director of the Duke-Margolis Center for Health Policy and co-chair of the Guiding Committee for the Health Care Payment Learning and Action Network (LAN)
  • Purva Rawal, PhD, Chief Strategy Officer, Center for Medicare and Medicaid Innovation
  • Karen Smith, MD, The Family Medicine Practice of Karen L. Smith MD, FAAFP
  • Rebecca Whitaker, PhD, Research Director, Duke-Margolis Center for Health Policy

For more details, or to register for this hybrid event, click here.
Exploring the Utility of Negative Controls for Causal Inference in the Sentinel Initiative

March 8, 2023
10:00 AM – 3:00 PM ET

Duke-Margolis, in cooperation with the Food and Drug Administration (FDA), will host a virtual workshop on March 8 to discuss how negative controls could support new methodological approaches for casual inference in the Sentinel Initiative. The use of real-world evidence (RWE) to address scientific and regulatory questions at the FDA has increased, but evaluation of RWE for regulatory use depends on a robust casual inference framework. The discussion at this workshop will inform the development of methods demonstration projects aimed at the following:

  1. Establishing empirical methods to automate the negative control identification process in Sentinel and integrate it into the Sentinel Initiative tools.
  2. Developing approaches to use a double-negative control adjustment to reduce unmeasured cofounding in studying effectiveness of vaccines.
  3. Developing other methods using negative controls.

This workshop will fulfill a Prescription Drug User Fee Act (PDUFA) VII Commitment. Click here to register for the virtual event.
Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities

March 23, 2023
9:00 AM – 4:30 PM ET

Neonatal research faces unique challenges, and finding relevant, clinically meaningful outcomes from neonatal studies is often difficult. Duke-Margolis’s hybrid event aims to promote discussion of conducting effective clinical trials in neonates, and to foster collaboration among researchers, clinicians, industry, and regulators in neonatal therapeutics. This meeting also is designed to provide a forum for patients and families to share which clinical benefits they find important. The event will take place virtually via Zoom as well as in-person in Washington, D.C., at the National Press Club. Further details on the event, as well as a draft agenda and registration links, are found here.
EDUCATION
Duke-Margolis Postdoc, National Clinician Scholars Awarded Bass Connections Projects
Sandra Yankah, Duke-Margolis postdoc, and three Duke National Clinician Scholars Program (NCSP) FellowsJeylan Close, Gabriela Plasencia, and Carri Polickhave received Bass Connections awards for their research projects.

The Bass Connections projects are:
“Bioethics and the Use of Real-World Mental Health Data” led by Duke-Margolis Research Director Rachele Hendricks-Sturrup, Center postdoc Sandra Yankah, and policy research assistant Maryam Nafie, as well as Core Faculty member Frank Sloan. The researchers will explore questions related to bioethics considerations for the collection and use of real-world data in the mental health field.

“Economic Evaluation of School Mental Health System of Supports” led by NCSP Jeylan Close, Duke Department of Pediatrics and Nicole Lawrence, from the Center for Child and Family Policy at Sanford. Researchers aim to carry out a benefit-cost analysis of Project AWARE, which was created to advance mental health awareness in schools.

“Community-Informed Policy to Improve Latinx Health Outcomes in NC” led by NCSP Gaby Plasencia, Duke Family Medicine and Community Health, and Andrea Thoumi, Duke-Margolis Health Equity Policy Fellowand Faculty Director, Health Equity Education. Researchers have a goal to identify community-informed policy solutions to increase health equity and improve the responsiveness of the local health system for Latinx communities.

“Noninvasive Neuromodulation for Addiction: Treatment Development” led by NCSP Carri Polick, VA Postdoctoral Fellow from the Duke School of Nursing, and Jonathan R. Young and Jean C. Beckham, both from the Department of Psychiatry and Behavioral Sciences. This project aims to evaluate a multimodal smoking cessation treatment that includes neuronavigated rTMS, cognitive behavioral therapy and nicotine replacement therapy.
Student Collaborative on Health Policy (SCOHP) Health Policy Week 2023
SCOHP’s annual Health Policy Week will take place February 6-10, 2023. Health Policy Week is a series of activities and events designed to engage Duke students in various health care policy-related opportunities. SCOHP and Duke-Margolis’s Education team will host a number of events throughout the week:
  • Career Panel: Students can learn more about the various career trajectories for health policy and the steps they can take to achieve their professional goals. The panel is geared toward current, incoming, or prospective Duke students and will take place on Monday, February 6th, from 12:00-1:00 PM ET. This virtual event is free to attend. Please register here.
  • Community Engagement Fair: Students who want to become involved in community health care initiatives can visit this fair on Wednesday, February 8th at the Broadhead Center, Room 068. The fair will be open from 11:00 AM - 1:00 PM ET.
  • Fireside Chat: On February 10th, Center Director Mark McClellan and Core Faculty member and Faculty Director of the Summer Experience Dev Sangvai, will discuss the future of health care and health policy, as well as potential career opportunities for future health policy students. Join them at Rubenstein Hall, Room 153 from 1:00-2:00 PM ET.
PEOPLE
Duke-Margolis authors Brian Canter, Trevan Locke, and Mark McClellan’s issue brief on interchangeable biosimilar products was recently cited by the FDA in their Biosimilar User Fee Act (BsUFA) Research Roadmap. The original issue brief highlights policy recommendations for the FDA and Congress to consider as they work to advance biosimilar development and promote the use of equally effective, lower-cost biosimilars in the United States. Read the full brief here.
Mark McClellan and Rebecca Whitaker spoke at the Virtual Value-Based Payment Summit, produced by Global Health Care, LLC, as part of their Heritage Value-Based Care series. Mark was a panelist on the first day of the event for the Value-Based Care State of the Union panel, and Rebecca participated in the Medicaid Update roundtable later in the week. The virtual event was livestreamed and is now available as a recording that can be accessed for the next six months. Register to access the recordings here.
Mark McClellan, Core Faculty member Krishna Ukayakumar, and Visiting Fellow Jack Leslie participated in “Building Trust in Public Health: A Post-COVID Roadmap,” a hybrid event hosted by the Duke Global Health Institute (DGHI). Mark and Krishna, along with the other speakers at this event, addressed the issue of declining trust in public health agencies in the wake of the COVID-19 pandemic and discussed actions needed to restore that trust. A recording of the event is available to watch on DGHI’s YouTube channel here.
Krisha Ukayakumar is quoted in the Voa News article, “The Inside Story—Farewell 2022,” where he commented on the continued inequities in global COVID-19 vaccination. Read the full interview transcript here.

Krishna was also quoted in the Devex article, “Exclusive: A Covid-19 initiative for vaccine delivery is winding down.” The article addresses the future of global vaccination and strategies for the long-term COVID-19 response. Read more here.

Mark McClellan was quoted in DOTmed’s article, “What should alternative payment models look like in radiology?” The article covers the panel Mark participated in during the Radiological Society of North America (RSNA)’s 2022 event and discusses potential changes in payment models for imaging services. Read the article here.


Core Faculty member Kate Bundorf contributed insights to the Health Affairs podcast, “A Health Podyssey,” that addresses changes in employment and health insurance coverage through the COVID-19 pandemic. Listen to the podcast or read the full interview transcript here.


Core Faculty member Ziad Gellad was quoted in Medscape’s article, “Is it time for a more personalized approach to CRC screening?” on routine colorectal cancer tests. The article focuses on the release of a new study which indicates that an extended screening interval could be safe for adults with lower risk. Read the full article here.

Core Faculty member Gavin Yamey was quoted in a recent Technology Networks article, “The Future of Science: Humanity Takes a Front Seat,” which considers the future of science and what trends might be seen next. Read the article here.
Team Welcomes
Hannah Vitello, MA, is the Center’s new Communications Specialist. Hannah holds a BA in English from Webster University and received her Master’s in Science Writing from Johns Hopkins University. She has worked with a range of industries, including in the health care sector for Mercy, where her writing connected potential patients to the latest treatments and technologies, and kept the company website fresh during the COVID-19 pandemic. Internationally, with the ITER Organization in France, Hannah wrote engaging and informative stories on fusion energy. She brings her talents to Duke-Margolis where she will contribute further engaging and informative content about your important work across all of the Center’s internal and external communications. Welcome Hannah!