An important requirement of the Margolis Scholar education program is to organize a Duke campus event focused on a specific health policy issue. This year’s Scholars event, “Coordinating Health, Not Just Health Care: Engaging North Carolina Communities to Promote Social Drivers of Health,” addressed the growing recognition that policymakers and providers should focus on social factors affecting health, such as housing and food security, and not just health care. More than 70 joined the hybrid event discussion centered around leveraging community partnerships and health system care coordination to better address social factors impact health.

Featured speakers included: Sarah Allin, Duke-Margolis Policy Fellow and Managing Director of North Carolina Integrated Care for Kids (NC InCK), Erik Valera, Chief Operating Officer of El Centro Hispano, and Vaughn Crawford, MSW, Senior Director of Market Success at Unite Us.

Congratulations to the Scholars on a successful event!

Duke-Margolis issued recommendations to the Centers for Medicare & Medicaid Services regarding its initial guidance on the “Medicare Drug Price Negotiation Program” as part of the Inflation Reduction Act (IRA). The Duke-Margolis comments focused on the use of high-quality evidence and the design of drug payments to improve outcomes in conjunction with the IRA’s Negotiation Program as a means to enable CMS to advance its mission of supporting high-value, evidence-based, and affordable use of pharmaceuticals. The Center also emphasized that “a clear and predictable initial process for conducting the negotiations and mechanisms for public input and transparency in refining it over time will be important for a predictable and sustainable Negotiation Program and outcome.” The Center’s recommendations for CMS included implementing a framework to create a clear and predictable process for drug pricing and minimum fair price determinations

Read the full comment letter here.

Duke-Margolis’ work to advance health equity in North Carolina brought together strategic and technical leaders from payer and provider groups in the state. Discussion focused on identifying opportunities to align performance measures to reduce the administrative burden on providers who are documenting the quality of the care they deliver, and heighten the focus on health equity efforts. This workgroup is part of the ongoing North Carolina State Transformation Collaborative, a private-public partnership advancing health care transformation and health in the state.

COVID GAP released two Accountability Reports to discuss the latest in news surrounding the COVID-19 pandemic. Both reports featured the growing number of cases in India, and the global increase of the XBB.1.16 variant.

Duke-Margolis is a founding member of COVID GAP, which identifies key issues and recommendations for improving the pandemic response on a national and global level. Read the reports on their main site here.

FDA’s AgencyIQ highlighted Duke-Margolis’s Drug Supply Chain Resilience and Advanced Manufacturing Consortium, as well as the upcoming Duke-Margolis/Food and Drug Administration’s (FDA) convening on Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches. Both items address the need to improve pharmaceutical manufacturing and supply to minimize the impact of drug shortages.

Contract Pharma also covered the Drug Supply Chain and Advanced Manufacturing Consortium. Read the article here.

The Associated Press article, “Free COVID testing will fade with the US health emergency in May,” featured Research Director Christina Silcox, who commented on the Center’s efforts to raise awareness of the impending changes to accessing over-the-counter COVID-19. The article referenced Duke-Margolis’s recent white paper, “Testing for Respiratory Infection: Beyond the COVID-19 Public Health Emergency.”

A new FDA draft guidance on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-Making” cites the discussion guide from a Duke-Margolis event, Developing Personalized Clinical Outcome Assessments, in 2017. The event discussed the potential of personalized clinical trial endpoints and laid out a few potential methods for implementation—the “most bothersome symptom” approach appears specifically in the FDA’s draft guidance.

The Pharma Intelligence “Pink Sheet” article, “Neonatal Drug Development Could Benefit From Rare Disease Experience,” covered Duke-Margolis/FDA event on Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities. The article likened neonatal research to rare disease research, as the two often overlap and face similar challenges in finding endpoints that are meaningful to both researchers and patients.

Congressional policymakers, federal policymakers, their advisors, and stakeholders interested in addressing drug-resistant infections and antimicrobial resistance (AMR) are invited to learn about the clinical and public health impact of drug-resistant infections and why policymakers are proposing new incentives for novel antimicrobials. Expert speakers will highlight the current and future threat of drug-resistant infections and antimicrobial resistance, market uncertainties that complicate antimicrobial development and commercialization, and existing and proposed incentives for novel antimicrobials, including the PASTEUR Act. Discussion will inform policy approaches that policymakers can leverage to improve the clinical impact, availability, and stewardship of novel antimicrobials.

Learn more and register here.

Join us for our 2023 Health Policy Conference, offered in-person at the Renaissance Hotel, Washington, DC, and virtually. National health policy experts, public officials and policymakers, as well as private sector leaders, will engage participants in strategic discussions around solving the nation’s most pressing health policy challenge: Reversing the Slide in America's Health. Featured speakers include:

Ashish Jha, COVID-19 Response Coordinator at The White House

The Honorable Richard Burr, former US Senator (R-NC) and Principal Policy Advisor and Chair, Health Policy Strategic Consulting, DLA Piper

Learn more, view the agenda, and register here. 

This two-day event will illustrate challenges and opportunities in rare disease endpoint development, introduce stakeholders to the Rare Disease Endpoint Advancement (RDEA) Pilot Program, and highlight how the RDEA is structured to support sponsors who may encounter challenges with endpoint development. Workshop discussion will highlight challenges and opportunities of endpoint development, key features of the RDEA Pilot Program, and relevant learnings from other FDA pilot programs. This event is intended to serve as a resource for sponsors and other relevant stakeholders interested in learning how to engage with the FDA through this new venue. 

Learn more and register here.

Innovative manufacturing technologies have the potential to improve the manufacture of pharmaceuticals and bring benefits to patients. Our hybrid workshop will discuss regulatory strategies to support the utilization of innovative manufacturing technologies for drugs and biological products. Attend in person at the National Press Club in Washington, DC, or virtually via Zoom.

Learn more and register here.

In response to recent changes by the CMS to its risk adjustment methodology, this webinar discussed the implications of the changes and opportunities to improve the risk adjustment system. The webinar featured two panels, one focused on reactions to the finalized CY 2024 Medicare Advantage Rate Notice and short-term steps to continue to reform the Hierarchical Condition Category (HCC) risk adjustment system, and a second panel focused on longer-term solutions, including social risk adjustment and how advanced analytics and data methodologies like machine learning and artificial intelligence may improve HCC.

Learn more about the event here, and read the Center’s comment letter on CMS’s risk adjustment policy reforms here.

We are excited to announce our next summer cohort for the Duke Margolis Summer Experience Program. This summer, we welcome 20 undergraduate and graduate interns coming from a multitude of universities. Students will work closely with their faculty and senior research staff mentors on a range of research projects across the Center’s portfolio.

The 2023 program will operate out of both Durham and DC offices, beginning on May 22 and closing on July 28.

We celebrated the end of the academic year with a luncheon and program to congratulate students for their hard work. Mark McClellan, Gillian Sanders Schmidler, and Kate Bundorf presented at the event to appreciate the students’ progress over the last year, and to offer encouragement for the future. The Margolis Scholars in attendance took a photo to commemorate the occasion (pictured).

Root Causes is a Duke-based organization that serves the local Durham community through a number of food justice efforts, including their Fresh Produce Program that delivers fresh produce to those in need. To help with this effort, the Margolis Scholars spent a morning packing boxes with this produce that would later be delivered across Durham. To learn more about Root Causes or to volunteer, visit their site here.

Congratulations to our 2022-23 Bass teams for their presentations at the 2023 Fortin Foundation Bass

Connections Showcase! This year’s showcase featured presentations from more than 50 project teams. During the showcase, Devan Desai (2023) and Anna Tharakan (2025) presented for the Closing the Gap on Health Disparity and Outcomes in Hypertension team in a Showcase Lightning Talk.

Congratulations to Olivia Ferris (J.D. Student) for being a finalist in the Mentorship Award as a member of the Improving Access to Behavioral and Mental Health Services for Latinx Children in NC team.

Mark McClellan was a speaker at the Virtual Fourth National Medicare Advantage Summit on April 28. His presentation addressed The Future of Medicare Advantage during the closing plenary session on Politics, Policy, and the Future. Learn more here.

Mark will also be the keynote speaker for an in-person conference, “A Prescription for the Future of Drug Pricing,” hosted by the University of Pennsylvania’s Leonard Davis Institute of Health Economics (Penn LDI) on Friday, May 5^th from 9:00 AM - 2:30 PM ET. The conference will address new and pending policy changes surrounding drug pricing, and discuss public and private sector innovations. Learn more and register here.

USA Today interviewed Mark for the launch of the new book, “Lessons from the COVID War,” and discussed how the COVID-19 pandemic response can teach health leaders to more effectively address public health emergencies in the future. A co-author with the COVID Crisis Group, the book takes a “good, honest look with an eye toward the future,” Mark notes. “Not so much about complaining, but about what could have gone better and making sure it doesn't happen again.” Read the full interview here.

In the Vanity Fair article, “’They’re Winning’: How the Mifepristone Case Could Sabotage the FDA,” Mark McClellan emphasizes the merits of the FDA. Read it here.

Health Equity Policy Fellow Andrea Thoumi and Policy Analyst for Health Equity Kamaria Kaalund presented at Workshop 7 of the Real-World Accelerator to Improve the Standard of Collection and Curation of Race and Ethnicity Data in Healthcare (RAISE). They shared insights from their research in collaboration with the Latinx Advocacy Team & Interdisciplinary Network for COVID-19 (LATIN-19) on innovative approaches in data collection to reduce health inequities within Latino/x communities. They highlighted lessons learned from previous research on COVID-19 vaccination and current research on increasing health insurance enrollment among Latino/x communities in North Carolina.

Andrea and Kamaria also joined Aaron Kamauu, Managing Director at Ikaika Health LLC, and Matt Veatch, Managing Director at Revesight Consulting, live on the Real World Wednesdays podcast to continue discussions of this work and the use of data to inform community-engaged interventions.

Duke Executive MBA Candidate and Graduate Student Research Associate Stephen Colvill spoke on a panel on Medication Supply Chain Quality and Safety at the 2023 IDN Summit conference. Alongside colleagues from Vizient, Children's Hospital Association, and Angels for Change, Stephen touched on emerging solutions for medication supply chain and quality issues, and improving patient access. The discussion frequently linked back to the recent launch of the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium, as it addresses the need for innovative policy solutions that promote a more resilient pharmaceutical supply chain.

Core Faculty Member Rushina Cholera will lead the evaluation of innovative health partnerships in a two-year, multi-partner project to increase access to food support through the Supplemental Nutrition Assistance Program (SNAP) in North Carolina. In collaboration with the North Carolina Department of Health and Human Services (NC DHHS), NC Medicaid, and the More In My Basket program, Rushina and Policy Analyst Greeshma James will evaluate a direct referral model for providing SNAP enrollment assistance to Medicaid-insured individuals who are eligible for but not currently receiving SNAP benefits. This work is part of a broader effort by NCDHHS to increase SNAP enrollment to serve 90 percent of eligible NC families and individuals by 2024. This project is funded by Share Our Strength and administered by the American Public Human Services Association.

Research Director Rachele Hendricks-Sturrup spoke at the following events this month to implement innovative strategies, such as the use of real-world evidence, to improve health on national and global levels:

Rachele also co-authored a white paper, “Data science and digital health in clinical development and operations: impact, challenges, and calls to action for the drug development ecosystem,” published and funded through the Medicines Development Modernization Initiative. The paper discusses how artificial intelligence and machine learning algorithms, digital health tools, and augmentation of randomized control data with real-world data can be applied to transform clinical development.

Assistant Research Director Trevan Locke and Rachele Hendricks-Sturrup presented at The National Academies’ Forum on Drug Discovery, Development, and Translation to highlight critical issues surrounding this topic. Learn more here.

Assistant Research Director Adam Aten and Rachele Hendricks-Sturrup will speak at ISPOR’s Real-World Evidence (RWE) Summit on May 7, 2023. ISPOR promotes health economics & outcome research, and their RWE Transparency Initiative aims to broaden RWE’s reach in health care. Learn more and register here.

Research Director Christina Silcox spoke at the Duke Office of Scientific Integrity’s “AI and Academic Research” meeting, which discussed regulatory challenges with artificial intelligence used in health and health care. Learn more here.

Core Faculty Member Mina Silberberg co-authored a paper, “A Community-Engaged Approach to Research Translation: The CIPHERS Project,” published in Johns Hopkins University’s Project MUSE. The CIPHERS project is a portfolio of research on the effect of paternal cannabis consumption on sperm epigenetics and implications for future generations, and this paper describes the research team’s approach to disseminating the results of that study to support changes in clinical practice, public health, and public policy.

David Anderson co-authored three recently published papers:

“Patient Cost Exposure and use of Preventive Care among ACA Compliant Individual Plans,” in Health Affairs addresses financial barriers surrounding preventive care service. Read it here.

“Plan Section, Enrollee Risk, and Health Spending on the Patient Protection and Affordable Care Act Individual Marketplaces, 2019,” in the Journal of the American Medical Association, here.

“Financial transaction costs reduce benefit take-up evidence from zero-premium health insurance plans in Colorado,” in the Journal of Health Economics, with funding from the National Institute of Health Care Management, investigates the impact of zero-premium health insurance plans. Read the paper here.

Core Faculty Member Nathan Boucher was awarded a grant by the Veterans Health Administration (VHA) National Center for Patient Safety. With this grant, Nathan will work to examine patient safety personnel use and quality of patient safety procedures across the VHA Health Care System.

Nathan co-authored a paper, funded by the Veterans Administration: “Frontline Clinician Appraisement of Research Engagement: ‘I feel out of touch with research.’” The article identifies barriers to frontline clinician engagement in research, and offers recommendations for improvement. Read more here.

ABC11 News quoted Core Faculty Member Gary Maslow in the article, “’Pivotal moment for action.’ Mental health crisis among teens mounts as stakeholders ask for help.” Gary urges immediate action and warns of long-term consequences as mental health crises in teens continue to rise.

Core Faculty Member Barak Richman was quoted in The News & Observer discussing the recent state bill that would affect millions of North Carolinians insured by Blue Cross. Learn more about the bill and read Barak’s comments in the article, “Legislature Needs to Go Slow on Far-Reaching Blue Cross NC Proposal.”

Research Director Rebecca Whitaker presented to the NC Business Group on Health’s Spring Forum on opportunities for employer engagement through the North Carolina State Transformation Collaborative, a public-private partnership to improve health for North Carolinians.

Senior Research Director Robert Saunders presented at a webinar hosted by the National Conference of State Legislatures on value-based health care and payment initiatives in North Carolina and promising practices to explore in other states.

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 with new ones added frequently. Click here to view all of our career opportunities.