Health Policy Update: June 2023
A MESSAGE FROM DUKE
In response to the Supreme Court’s recent decision regarding race-conscious admissions plans in higher education, Duke-Margolis re-emphasizes our commitment to advancing equity in all we do.

“Duke’s position continues to be that diversity is absolutely vital to our educational mission—everyone in our community, and the work they do, benefits from differing perspectives, opinions, and life experiences,” says Vincent E. Price, President of Duke University. “We remain steadfastly committed to cultivating a racially and socially equitable Duke to the fullest extent permitted by the law.”
MONTHLY HIGHLIGHT
Spotlight on our Duke-Margolis Education Program Faculty Directors
The future of health policy relies on the next generation, and Duke-Margolis prepares and engages future health care leaders through our commitment to Education and Workforce Development. Meet the Faculty Directors at Duke-Margolis, who each lead a key part of the Center’s education efforts:
Nathan Boucher, Associate Research Professor at the Sanford School of Public Policy
Nathan directs the Undergraduate Health Policy Certificate, which educates students in evidence-based health policy analysis, development, and implementation. The certificate is a joint effort between Duke-Margolis and the Sanford School of Public Policy and aims to prepare students to address leading health and health care challenges at all levels.

“Health policy challenges have aspects related to many different areas, such as education and social policy. That is why I enjoy introducing students to health policy—many of their interests and emerging skills will likely play a role in health policy solutions.”
Kate Bundorf, J. Alexander McMahon Distinguished Professor of Health Policy and Management at the Sanford School of Public Policy
Kate directs the Margolis Scholars Program, designed for students with a strong commitment to a career in health policy and management as well as the desire to take on a leadership role to improve health policy.

“The Margolis Scholars Program is geared toward students who are passionate about health policy and includes students ranging from PhD candidate to undergraduates from multiple Duke schools and departments. The interdisciplinary health policy community created by Scholars and Margolis faculty and staff is the best part of the Margolis Scholars Program! I can’t wait for our incoming Scholars to join our community this fall.”
Beth Gifford, Associate Research Professor at the Sanford School of Public Policy
Beth directs the Bass Connections Health Policy and Innovation Theme. Bass Connections brings together interdisciplinary Duke research teams to address various societal challenges through their projects, which fall under key thematic areas, including Health Policy and Innovation.

“Bass Connections is giving students, staff, faculty, and community partners a vehicle to expand team science. Student engagement and enthusiasm is a resource that helps energize and expand the reach of many research teams.”
Marianne Hamilton Lopez, Senior Research Director of Biomedical Innovation and Adjunct Associate Professor at Duke-Margolis



Marianne directs the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program, which offers a variety of opportunities for early-career researchers and clinicians to strengthen their knowledge and experience in health policy.

“The postdocs and affiliated fellows are smart, inquisitive, and represent various disciplines and experiences. They take advantage of all the new opportunities offered by Duke-Margolis as they build the foundation of their careers in health policy.”
Dev Sangvai, President of Duke Regional Hospital, Vice President for Duke Population Health Management of Duke University Health System, Professor of Family Medicine, Pediatrics, and Psychiatry at Duke University School of Medicine, and Professor in the Program of Education at Duke University Arts & Sciences
Dev directs the Duke-Margolis Summer Experience Program, an internship program that offers undergraduate and graduate students the opportunity to contribute to a variety of projects and gain professional experience within the field of health policy.

“Our Summer Experience Interns are problem solvers and solution-oriented. What I really enjoy about this program is that it helps them understand how policy is as much a process as it is an outcome through which solutions are generated. By understanding how to shape policy, interns are learning essential skills to shape the future of health care. Their thinking is bold, no problem is too big to solve, and their optimism is infectious!”
Corinna Sorenson, Assistant Professor in Population Health Sciences at Duke University School of Medicine, Assistant Professor at Sanford School of Public Policy, Associate of the Duke Initiative for Science & Society
Corinna directs Undergraduate and Graduate Studies at Duke-Margolis and is the Senior Advisor and Founding Director of the Margolis Scholars Program. The Center provides a range of opportunities for students of varied backgrounds and levels of experience to learn from and work alongside faculty, staff, and external partners. Corinna is also leading an initiative to create a core competency framework in health policy, which will inform the Center's educational approach.

“Duke-Margolis is deeply committed to equipping tomorrow’s health policy leaders with the knowledge, skills, and attributes required to drive meaningful change in health, health equity, and health care value. The health policy core competency framework we are currently developing encapsulates that mission and vision. It’s exciting to create a resource that will benefit students, health policy education and training programs, and the field more broadly. I’m thrilled with the interest and input we’ve received around this work to date and look forward to incorporating the framework across the Center’s programs and sharing it with the health policy community at large!”
Andrea Thoumi, Health Equity Policy Fellow, Adjunct Assistant Professor at Duke-Margolis, Consulting Associate at the Department of Family Medicine and Community Health


Andrea directs Health Equity Education, which aims to equip future health leaders with the knowledge and skills to address racial and ethnic health inequities and to contribute to professional settings that are anti-racist and equitable.

“The best part about the Health Equity Education program is getting to work with passionate and innovative postdoctoral and fellowship scholars who are building authentic, community-based partnerships to mitigate structural inequities through policy change.”
HEALTH POLICY IN ACTION
Drug Repurposing

At the start of an emerging pandemic or health threat, drug repurposing stands as the first line of defense against a new threat and serves as an essential complement to de novo drug development efforts. Therefore, drug repurposing is a critical component of pandemic preparedness, and requires an efficient, supportive ecosystem to facilitate efforts. A Duke-Margolis white paper identifies three necessary components of building a drug repurposing ecosystem and highlights outstanding research questions. Read the paper here.
AI In Drug Development
Despite the advances of artificial intelligence and machine learning (AI/ML) in health care and drug development, many challenges surrounding their use must be addressed. Duke-Margolis and the Food and Drug Administration (FDA) held a December 2022 workshop, “Understanding AI/ML in the Drug Development Lifecycle,” to explore these issues. A summary of the discussion provides an overview of technical challenges, areas of needed regulatory clarity, and priorities for future development of AI/ML tools and their use throughout the drug development lifecycle. This effort is part Duke-Margolis’ ongoing work in Artificial Intelligence in Health Care. Learn more and read the summary on the workshop’s webpage.
Advancing North Carolina Healthy Opportunities Pilots
North Carolina's Healthy Opportunities Pilots (NC HOP) program is designed to help pay for and deliver services to address unmet social needs in three regions across North Carolina. Duke-Margolis team members Will Bleser, Katie Huber, Rebecca Whitaker, and Yolande Pokam Tchuisseu hosted a regional convening in Wilmington, NC, in partnership with Community Care of the Lower Cape Fear and the Cape Fear Healthy Opportunities Pilot (Cape Fear HOP). This in-person convening was the first of three regional meetings designed to share successes and challenges, and to support the implementation of NC HOP and other statewide efforts to address social needs. More than 70 stakeholders involved in all parts of the region’s Pilots attended, including leaders from NC Department of Health and Human Services (NC DHHS) and local and statewide stakeholders involved in addressing social needs. The event was supported by the Kate B. Reynolds Charitable Trust. Find out more about this project here.  
Duke-Margolis Strongly Represented at AcademyHealth
AcademyHealth’s 2023 Annual Research Meeting featured panels and presentations from a number of Duke-Margolis researchers, who showcased recent and upcoming work across the Center’s health policy portfolio. The conference is designed to convene researchers in health, health care, and policy to share their work with a broader audience.
Will Bleser presented on the Healthy Opportunities Pilot Program in North Carolina, and moderated a panel on the advancement of health equity in value-based payment design and implementation.
Andrea Thoumi, Kamaria Kaalund, and Gaby Plasencia presented their poster on increasing insurance enrollment among Latinx populations in North Carolina.

Sherrie Wang discussed the importance of cross-sector alignment in designing value-based payment models for safety net models, as well as implications for forthcoming Centers for Medicare & Medicaid Services’ (CMS) models, such as Making Care Primary. Her poster presentation drew from a recent Duke-Margolis publication.

Duke-Margolis faculty, researchers, alumni, and students participants, included:

View the interactive agenda here to learn more about the conference’s content.
POLICY IMPACT
Medicare-Medicaid Dual Eligibles
In a JAMA Health Forum article, “Medicaid Utilization & Spending Among North Carolina Dual Eligibles Varies By Subgroup,” Duke-Margolis researchers Brystana Kaufman, Aparna Higgins, Rebecca Whitaker, Don Taylor, Kate Bundorf, and Courtney Van Houtven, share high-level findings of an original study about health care use and spending for North Carolina’s population eligible for both Medicare and Medicaid. Read the study here.
Cost of Care
Fast Company covered research from Caroline Sloan and Peter Ubel in the article, “Study: Even with insurance, many patients with diabetes turn to GoFundMe to offset high cost of care.” In the article, Caroline comments on the hidden costs of living with a chronic illness like diabetes. Read the original study here in the Annals of Internal Medicine.
Alzheimer's Disease
Inside Health Policy’s article, “CMS Plans Agency-Led Registry For Fully Approved Alzheimer’s Drugs,” mentions the recent Duke-Margolis policy brief that outlined suggestions for implementing registry requirement without minimizing access to Alzheimer’s disease amyloid-targeting monoclonal antibodies. Read the policy brief here.

In related coverage, Reuters quoted Mark McCellan in, “US to require patient data for payment of Leqembi, similar Alzheimer’s drugs,” and discussed Medicare health plan’s decision to limit reimbursement for certain drugs that treat Alzheimer’s disease. Read more about the effects of this decision here.
RWE
The Evidence Base reported on Mark McClellan’s keynote at the inaugural GetReal conference, where he discussed advancing real-world data and evidence in global contexts. The article took a deep dive into Mark’s session as part of their series on summarizing the findings of the conference. Read the article here, and learn more about the conference here.
Value-Based Payment
The American Bar Association cites Duke-Margolis work in a recent article, “The Reverse Robin Hood Effect of Value-Based Payment.” The referenced pieces included a two-part paper published on Health Affairs Forefront, which addresses the CMS Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) program. Read part one here, and part two here.
UPCOMING EVENTS
Advancing Representative Enrollment in Clinical Trials

July 18, 2023
12:00 – 4:00 PM ET
This public meeting will explore challenges to achieving representative enrollment in clinical trials. Topics discussed will include opportunities to synthesize best practices where possible and identify policy levers for achieving measurable change. We will also explore learnings and examples from the current clinical trial landscape with an eye towards improving clinical trial conduct across a broad range of clinical sites and locations by advancing pragmatic trial principles. Panel discussions will focus on critically examining actionable steps various stakeholders can take to advance the mission of representative trial enrollment.

Learn more and register here.
PAST EVENTS
Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development
This two-day event illustrated challenges and opportunities in rare disease endpoint development, introduced stakeholders to the Rare Disease Endpoint Advancement (RDEA) Pilot Program, and highlighted how the RDEA Pilot Program is structured to support sponsors who may encounter challenges with endpoint development. Attendees heard from a variety of speakers about rare disease endpoint examples to gain a better understanding of endpoint development challenges and opportunities. Workshop programming facilitated a shared understanding of the RDEA Pilot Program’s purpose and structure, including key features of the program, such as sponsor disclosure requirements. This event served 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 watch the recordings here.
Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches
Innovative manufacturing approaches and technologies can increase drug manufacturing agility, reduce susceptibility to drug shortages, and improve measurement and control of product quality, ultimately ensuring that patients have safe and effective drugs in adequate quantities, when they are needed. Through a series of presentations and panel discussions, speakers covered FDA’s ongoing work to support the adoption of innovative manufacturing and laid out recommendations for future regulatory strategy in this space.

This workshop was hosted under a cooperative agreement with the FDA. The workshop materials, including the full slide deck and recording, can be found here.
EDUCATION
Duke Summer Research Showcase
Duke-Margolis summer interns will join students from 12 programs across Duke who will present their work at the Duke Summer Research Showcase. This event is presented by the Duke Undergraduate Research Support Office and the Duke Office of Undergraduate Research as part of their ongoing efforts to promote student research. Join us at Penn Pavilion between 10:00 AM – 12:00 PM ET on July 28 to meet our students and learn more about their summer research. Learn more here.

Participating programs:
PEOPLE
President Biden appointed former NC DHHS Secretary Mandy Cohen as the new director for the Centers for Disease Control and Prevention. In one Politico article covering this news, Mark McClellan commended the choice and highlighted Mandy’s merits as a leader in public health. A few other sources also picked up Mark’s comments on Mandy, including an article by The Daily News & Observer and one by the Arkansas Democrat-Gazette. These two articles also featured Core Faculty member Adrian Hernandez, who shared his thoughts on what Mandy’s top priorities as Director should be. While Mandy held her position at NC DHHS, Duke-Margolis worked closely with her and her office to support the state’s efforts to expand Medicaid and advance other health reforms. Most recently, she was the co-author of the Duke-Margolis paper, “The Future of Public Health: Public Health 3.0 and Accountable Population Health.”
Triangle Business Journal selected Core Faculty member John Purakal to receive their 40 Under 40 Leadership Award for 2023, an award that recognizes outstanding professionals under the age of 40 for their contributions to their organizations and to the community. Learn more here.

John also co-authored a paper, “Assessment of Emergency Department Health Care Providers’ Readiness for Managing Intimate Partner Violence and Correlation With Perceived Cultural Competence,” published in the Journal of Emergency Nursing. This research investigated the emergency department’s capability to detect and respond to intimate partner violence. Read the study’s findings here.
Mark McClellan spoke at the Health Care Payment Learning & Action Network (HCP LAN)’s 2023 Spring Series, “Primary Care’s Role in Advancing High-Quality Accountable Care.” Mark offered opening remarks and also moderated a panel on Aligning Local Approaches to Accountable Care. Learn more about the event here.

The Hill op-ed, “Antimicrobial resistance will be worse than COVID—we have to act now,” co-authored by Mark McClellan, discussed the rising crisis of antimicrobial resistance and urged policymakers, health care providers, public health agencies, and pharmaceutical companies alike to take action. Read more here.
Assistant Research Director Frank McStay served on two panels during America’s Physician Groups’ 2023 Spring Conference. The first panel focused on Medicare financial benchmarking, while the second discussed Medicare’s risk adjustment system. Both panels explored short- and long-term opportunities to improve the current systems in place, relative to CMS’ strategic goal to have 100 percent of Medicare Advantage and Traditional Medicare beneficiaries in accountable care relationships by 2030. Learn more about the conference here.

Frank also joined AHIP 2023 for their panel on Advancing Value-Based Payment Models at the State Level. He discussed the importance of state innovation as it relates to value-based care and current state innovations that are top-of-mind for the industry. Learn more about the event here.


Core Faculty member Gavin Yamey co-authored an article in STAT, “When should hospitals require masks?” to discuss the costs and benefits of keeping certain public health measures in place even as the COVID-19 pandemic is declining. Read more here.
Research Director Rachele Hendricks-Sturrup and Assistant Research Director Trevan Locke presented research around real-world evidence (RWE) the DIA 2023 Global Annual Meeting). Rachele spoke on the latest progress in RWE use and acceptance, and Trevan explored the use of pragmatic and point of care clinical trial approaches for generating evidence. Speakers at DIA also celebrated the Duke-Margolis RWE Collaborative and the GetReal Institute as “communities of practice.” Learn more about the event here.


Core Faculty member Don Taylor commented on the public policy issue of home health in The Boston Globe’s article, “Finding a home health aide to care for sick loved ones shouldn’t be this hard. (Not here.)” The article critiqued the home health care sector for lack of staff and regulation—read more here.




Assistant Research Director Will Bleser was quoted in MDedge’s article, “Primary care’s per-person costs for addressing social needs not covered by federal funding.” Will commented on a recent study of the costs to address social needs, and highlighted the promise of Medicaid as a resource for these needs. Read more here.
Core Faculty member Matt Maciejewski co-authored three papers, funded by Veterans Affairs Health Services Research and Development Service, that study COVID-19 infection and vaccine effectiveness:

“Effectiveness of COVID-19 Treatment with Nirmatrelvir-Ritonavir or Molnupiravir among U.S. Veterans: target trial emulation studies with one-month and six-month outcomes,” in Annals of Internal Medicine. Read it here.

“Adverse outcomes of SARS-CoV-2 infection with delta and omicron variants in vaccinated versus unvaccinated US veterans: retrospective cohort study,” published in the British Medical Journal. Read it here.




Core Faculty member Gary Maslow pressed the importance of anxiety screening through a number of articles, including one from NBC News. The article commented on a recent U.S. Preventive Services Task Force that reported adults under 65 should be screened for anxiety—read more here.


The Atlantic quoted Stephen Colvill in their article, “The Cancer-Drug Shortage Is Different.” The article discussed the supply-chain problems that affect the manufacturing of medications to treat cancer and explored potential solutions. Read more here.



Research Associate Dave Anderson was quoted in NC Health News’ article, “’Unwinding’ could undermine Medicaid expansion in North Carolina,” to comment on the timing of Medicaid eligibility expansion and who might fall through the cracks. Read the article here.
Opportunities at Duke-Margolis Center for Health Policy
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.