Join Duke-Margolis Center for Health Policy, Duke University leadership, Federal and State policymakers, and our expert collaborators for a series of 5th Anniversary Celebration Events in Washington, DC, on April 12, 2022. We will be gathering at the Ronald Reagan Building and International Trade Center for a series of events featuring dynamic conversations and speakers, including:

HEALTH POLICY IN ACTION

A new COVID GAP report, The Path Forward, calls for an urgent shift in the global pandemic strategy that would rapidly change from an emergency crisis management approach to a sustainable control strategy that also helps to build resilient health systems better prepared to address future COVID-19 outbreaks and other public health threats. Authored by Center Core Faculty members Krishna Udayakumar, Mark McClellan, and Michael Merson, together with Gary Edson of COVID Collaborative, the report includes feedback from and discussions topics covered in the March 29^th public convening co-hosted by COVID GAP and the Pandemic Action Network. Both the report and the convening received support from the Rockefeller Foundation and the Bill and Melinda Gates Foundation. For more information about this work can be found here.

In a first of its kind report, COVID GAP issues strategic steps needed now to ensure that emerging, game-changing COVID oral therapeutics are equitably accessible for affected populations worldwide. While vaccines remain a critical aspect of global pandemic response, Duke-Margolis authors Beth Boyer, Ethan Chupp, Mark McClellan, Michael Merson, Andrea Taylor, and Krishna Udayakumar, together with Gary Edson of COVID Collaborative, contend a vital need for a “vaccination plus” strategy that expands the COVID arsenal to include oral treatments. Read “Pills to People: Accelerating Equitable Global Access to Oral Therapeutics for COVID-19” here. 

Two new Duke-Margolis policy briefs provide federal and state policymakers with further accountings of the structural causes of pandemic-related inequities, and recommendations to sustain emerging health policy efforts to address social needs and inequities beyond the public health emergency.

The first, “Pandemic-Driven Health Policies to Address Social Needs and Health Equity” co-authored by William Bleser, Humphrey Shen, Andrea Thoumi, Rushina Cholera, Rebecca Whitaker, and Robert Saunders and published in Health Affairs, provides guidance for policy makers considering which pandemic-era interventions to continue and, more broadly, address social needs and health equity through health policy. Read the brief here. Coverage of the Duke-Margolis brief includes an article in Governing.

In the second brief, William Bleser, Andrea Thoumi, Rushina Cholera, Robert Saunders, Rebecca Whitaker, and Mark McClellan analyze the Medicare Beneficiary COVID-19 Claims Data and find that, for people of color, disparities in hospitalization ratios were much wider than disparities in COVID case ratios, and that these ratios would be the same if a body’s ability to fight off COVID infection—and the quality of health care—were the same by race and ethnicity. The Duke-Margolis researchers suggest a new conceptual model for policymakers to better understand health inequities as they approach whole-person health policies. Read the brief, “Widened Racial Inequities in Underutilized Medicare Beneficiary COVID-19 Claims Files Illustrate Lifelong Structural Racism Exposure,” here

A new brief about the North Carolina COVID-19 Support Services Program, Duke-Margolis researchers, William Bleser, Katie Huber, Rebecca Whitaker, Robert Saunders, former Margolis Scholar Jasmine Masand and former Margolis Intern James Zheng offer health policymakers and frontline social service implementors key lessons for implementing successful social services interventions. Read the brief here.

Duke-Margolis Center joined The Pew Charitable Trusts, Infectious Diseases Society of America, and more than 35 others organizations in a letter to Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee calling for the PASTEUR Act to be included within the upcoming PDUFA reauthorization. Read the full letter here.

RESEARCH

Duke-Margolis Policy Analysts Katie Huber and John Bollinger with Assistant Research Director Katie Greene co-authored “Priorities and Policy Levers To Support School-Located Vaccination,” an article published by Health Affairs Forefront. The Duke-Margolis authors highlight priorities and strategies for enabling, strengthening, and sustaining school-located vaccination models during the COVID-19 pandemic and beyond, and the policy levers that can help increase equitable access to childhood vaccinations. Read more here.

Duke-Margolis Center authors Nitzan Arad, Brian Canter, Marianne Hamilton Lopez, Aparna Higgins, Trevan Locke, Mark McClellan, Derick Rapista, Barak Richman, and Elizabeth Staton released a series of issue briefs on biosimilars, which address areas where regulatory and payment policy, as well as other interventions, can promote the use of equally effective, lower-cost biosimilars in the U.S. The new series includes a brief that explores how payment reform could create head-to-head price competition between biologics and their biosimilars within Medicare Part B. Read more here. A second brief considers the unique U.S. regulatory construct of interchangeability and overviews the current scientific evidence on switching between biosimilars and reference products, highlighting policy recommendations for the FDA and Congress to consider as they work to advance biosimilar development. More information can be found here. The third and final brief discusses the types of rebate walls and their impact, challenges to overcoming these rebate practices by shifting market shares to the biosimilar, and several solutions including antitrust approaches to increase biosimilar uptake and combat rebate walls in the U.S. Read the full brief here.

As the FDA considers how manufacturers can use real-world data (RWD) to monitor the performance of software tools built with artificial intelligence (AI) in health care settings, a new report from Duke-Margolis authors Thomas Roades and Christina Silcox, “Evaluating AI-Enabled Clinical Decision and Diagnostic Support Tools Using Real-World Data” considers both the potential and the hurdles and if the accuracy of the tools holds up over time. The report, with support from the Gordon and Betty Moore Foundation, provides recommendations for how the evolving regulatory model can facilitate the use of RWD to evaluate software-based medical devices, specifically addressing what type of data would be needed, data access and privacy, and data sharing and security. Read the report here.

In a NEJM Catalyst piece, “How Health Systems Decide to Use Artificial Intelligence for Clinical Decision Support,” co-authors Jonathan Gonzalez-Smith, Humphrey Shen, and Christina Silcox explore how multiple health systems have approached the adoption of AI-enabled Clinical Decision Support, with a focus on how they evaluate the potential investment returns in implementing these tools. This work, with funding from Gordon and Betty Moore Foundation, discusses the challenges health systems face selecting the appropriate AI tool given the recent growth of products on the market. Read the full article here.

Duke-Margolis Research Director Rachele Hendricks-Sturrup co-authored “Selecting Privacy-Enhancing Technologies for Managing Health Data Use,” a paper which provides a scope of the current peer-reviewed evidence regarding the practical use or adoption of various privacy-enhancing technologies (PETs) for managing health data privacy and builds a practical perspective on the steps needed to improve the standardization of the application of PETs for diverse uses of health data. Read the full paper here.

Home-based care is an underutilized resource for providing care to millions of people in the United States who are unable to access or have difficulty obtaining care, such as populations with complex health and social needs. In a new article, published by HealthAffairs, entitled “Policy Opportunities to Expand Home-Based Care For People With Complex Health Needs,” Duke-Margolis co-authors Jonathan Gonzalez-Smith, Montgomery Smith, William Bleser, and Robert Saunders explore the policy window for expanding home-based care, accelerated by the COVID-19 public-health emergency as policy makers, providers, and payers quickly pivoted to support care outside of facility settings, such as telehealth or in-person care delivered at home. Read the full article here.

Duke-Margolis and the U.S. Food and Drug Administration (FDA) are collaborating to host a two-day virtual public workshop focused on identifying gaps in existing opioid prescriber education offerings and core competencies that should be included in educational content for opioid prescribers and other healthcare providers, including prescriber education under a Risk Evaluation and Mitigation Strategy (REMS). Join us on April 4th and 5th for a convening of federal agencies, provider associations, licensing and accrediting organizations, education experts, and other key stakeholders aiming to alleviate the opioid and substance use crisis through improved education for opioid prescribers and other healthcare providers. For more information and to register click here.

Duke-Margolis Digital Health Policy Fellow Christina Silcox will be join an event produced by Duke in DC and Duke Health Government Relations entitled “Vaccines and Countermeasure to Prepare for Future Pandemics,” where Duke experts will discuss the importance of federal investment in research, translation of research to policy, the impacts they already see from their work, and additional recommendations to bolster our nation’s public health and medical preparedness and response systems. To learn more and to register click here.

Duke-Margolis partnered with the Stanford Byers Center for Biodesign for a virtual event focused on “The Need for Transitional Coverage for Emerging Technologies (TCET).” Recent policy and legislative proposals have highlighted a need for a Medicare coverage pathway centered around early and sustained multi-stakeholder collaboration to ensure appropriate use for breakthrough devices. The Centers for Medicare & Medicaid Services (CMS) is currently exploring options for a coverage pathway for breakthrough devices that strikes a balance between supporting innovation, access and Medicare beneficiary protections. The webinar explored research findings, stakeholder perspectives, and potential policy solutions to inform CMS in their efforts for coverage reform. For more information, click here.

Duke-Margolis Center held a public webinar to spotlight updates and progress made since the release of FDA’s Artificial Intelligence/Machine Learning Action Plan in early 2021. The event featured a fireside chat between Jeff Shuren, FDA’s director of the Center for Devices and Radiological Health (CRDH), and Center Director Mark McClellan as well as panel discussions on regulating and evaluating AI, good machine learning practices, and post-market evaluation of AI/ML SaMD. The event was covered in articles from BioWorld and Regulatory Affairs Professionals Society (RAPS). For more information and to watch a recording of the event click here.

Former Margolis Scholar Madhu Vulimiri gave the keynote speech at the Morehead-Cain Scholarship dinner and was introduced by North Carolina Governor Roy Cooper. Click here to watch her remarks.

Margolis Summer Interns Angela Huang and Ronit Sethi, presented their research posters at the virtual 2022 Consortium of Universities for Global Health. They conducted their research projects with the Huang Fellows and the Margolis Summer Internship programs. Click for more information on Angela and Ronit’s presentations.

Congratulations to our Postdoctoral Research Associate Michelle Franklin on receiving the Postdoctoral Professional Development Award from the Office of Postdoctoral Services, with support from the Vice Provost for Research and the Vice Dean for Basic Sciences. The award is designed to support postdocs’ professional development needs by providing reimbursement for activities that directly enhance the individual’s professional growth. Michelle will use her award to virtually attend the 2022 ResearchTalk course “Implementation Research: Using Qualitative Research Methods to Improve Policy and Practice.”

Margolis Scholar Ethan Borre, now Dr. Ethan Borre, successfully defended his PhD dissertation, “Economic Evaluation and Research Prioritization of Adult Hearing Screening in the US.” This month Dr. Borre also was selected as a recipient of the Society of General Internal Medicine’s 2022 National Young Scholars in GIM Scholarship. Way to go, Ethan! Duke-Margolis is very proud of you.

The Academy of Managed Care Pharmacy (AMCP) Foundation presented Center Director Mark McClellan with the 2022 Steven G. Avey Award. The award recognizes a managed care leader for sustained, exemplary, and distinguished service to the practice of pharmacy. “It is my pleasure to bestow managed care pharmacy’s highest honor to Dr. McClellan,” said Executive Director of AMCP Foundation, Paula J. Eichenbrenner. “He has consistently demonstrated excellence and dedication to the practice, and we are honored to recognize his contributions.” Read more here.

Core Faculty Member Charlene Wong has been selected by the National Academy for State Health Policy to join the its Academy Members. For more information on this NASHP program click here.

Digital Health Policy Fellow Christina Silcox spoke at a NEJM Catalyst event entitled “AI and Machine Learning for Health Care Delivery.” The program was part of a companion event for NEJM’s AI Issue. Click here for more information.

Robert Saunders, Research Director, Payment and Delivery Reform, was quoted in a Modern Healthcare article on community health center involvement in value-based payment reforms. Click here to read the full piece.

Core Faculty Member Lesley Curtis was awarded the Duke School of Medicine’s 2022 Excellence in Professionalism Award. Read More.

Deepshikha Charan Ashana, MD, MBA, MS is an Assistant Professor of Medicine in the Division of Pulmonary and Critical Care. In her research, she uses mixed methods to identify and mitigate clinician- and health system-level contributors to disparities in serious illness care.

John Purakal, MD, is an Assistant Professor of Emergency Medicine at Duke University School of Medicine and a faculty affiliate at the Samuel Dubois Cook Center on Social Equity. His research interests include health equity, racial and ethnic disparities of emergency care, access to care, and screening for unmet social needs.

Do you want to be part of health policy in action? Do you want to work on the leading health policy issues confronting cities, states, the nation, and the globe? The Duke-Margolis team is a dynamic, high impact national leader in leveraging policy to ensure high quality, affordable care for all. Multiple positions are currently available and new positions have been posted this week! Click here to view all of our career opportunities.