Health Policy Update: October 2022
Monthly Highlights:
North Carolina is in the midst of a major shift from fee-for-service to Medicaid managed care and other value-based care transformation efforts. As part of these reforms, North Carolina is required to integrate care for dual-eligible beneficiaries within five years of the Medicaid managed care launch. New Duke-Margolis recommendations urge the North Carolina Department of Health and Human Services (NC DHHS) to pursue the most comprehensive level of integration of the state’s Medicaid program with Medicare to ensure the 275,000 eligible North Carolinians have access to the “whole-person care” needed to address the diversity of their physical, behavioral and social care needs.

North Carolina Medicare-Medicaid Integration: Advancing Whole-Person Care,” co-authored by Duke-Margolis researchers and faculty Aparna Higgins, Brystana Kaufman, Corinna Sorenson, Montgomery Smith, Samantha Repka, and Mark Japinga, developed with support from a grant by Arnold Ventures, provides NC DHHS with pragmatic, evidence-based options for Medicare-Medicaid integration in the state. The report is accompanied by a practical guide for states interested in developing a tailored, evidence-based Medicare-Medicaid integration strategy. The Center hosted a webinar on in conjunction with the release of the report, presenting the proposed visions, goals, and potential integration options. Duke Daily featured a quote from Director Mark McClellan about this event, with was covered by the Associated Press and media around the country. Click here to read the full report and visit our event website to watch a recording of the webinar.
HEALTH POLICY IN ACTION
NATIONAL
Center Director Mark McClellan and fellow former FDA commissioner Scott Gottlieb penned a recent commentary published in JAMA Forum urging Congress to seize on the opportunity “to achieve long-awaited reforms that will modernize FDA’s regulation, promote innovation, and provide US consumers greater assurance that the products they use are safe and reliable.” Drs. McClellan and Gottlieb contend that the absence of reforms for dietary supplements, cosmetics, and diagnostic tests for patients—developed through a largely bipartisan process—from the final reauthorization of the FDA’s user fee programs is “a profound missed opportunity.” Read the full commentary here.
Duke-Margolis researchers Sherrie Wang, Frank McStay, Robert Saunders, David Muhlestein, William Bleser, Mark McClellan in a HealthAffairs Forefront blog discussed how the Medicare Shared Savings Program ACOs still perform well and continue to adapt to urgent patient needs but warn "this year’s results must continue to be interpreted with caution." Read the full article for their complete analysis.
GLOBAL
The COVID Global Accountability Platform (COVID GAP) released two updates in their ongoing series of Accountability Reports, which highlight and analyze recent developments; track progress toward national, regional, and global targets; and identify high-priority recommendations for a more effective, efficient, and equitable pandemic response and preparedness.

In addition to the ongoing Accountability Reports, COVID GAP has joined with the WHO, USAID, and the Johns Hopkins International Vaccine Access Center to conduct a systematic literature review on the COVID-19 vaccine roll-out and how integrating COVID-19 vaccination into immunization programs and primary health care and learning from experiences, best practices, and innovative solutions can support scaling and optimization of COVID-19 vaccine delivery. Learn more about this work here.
NEW GRANTS & UPCOMING RESEARCH
Duke-Margolis recently launched a new grant funded by The Commonwealth Fund, “Leveraging Value-Based Payments to Improve Drugs Spending, Utilization, and Equity.” This 15-month project aims to identify opportunities to better integrate medications into existing or new value-based payment (VBP) models with actionable use cases that demonstrate how to overcome existing policy barriers and technical challenges. This project will specifically gauge whether options have shown evidence or demonstrate promise for improved drug spending and/or reductions in total cost of care, and health disparities. Through a combination of literature scans, semi-structured interviews, and convening stakeholders, this project will generate needed, practical guidance on implementation and policy considerations. 
Duke-Margolis Core Faculty Member Frank Wharam was named principle investigator (PI) and Senior PI on two recently awarded grants. The first, a $2.7 million grant, concerns the impact of high deductible health plans and COVID-19 on alcohol use disorder treatment access, outcomes, and disparities. The second $2.5 million grant will investigate the impact of Medicare Part D opioid safety policies on disabled beneficiaries before and during the COVID-19 pandemic.
UPCOMING EVENTS
14th Annual Sentinel Initiative Public Workshop

November 15, 2022
1:00 – 5:00 PM ET

November 16, 2022
12:00 – 4:45 PM ET


On November 15-16, 2022, Duke-Margolis will host the 14th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the Food and Drug Administration (FDA). The workshop will be held as a virtual webinar and will provide an opportunity for attendees to discuss recent achievements and developments as well as engage with the broader community of patients, consumers, and scientific stakeholders.

The public workshop will feature a keynote from Dr. Patrizia Cavazzoni, Director for the Center for Drug Evaluation and Research (CDER). Participants will also hear from Sentinel Initiative leadership on a range of key issues, including recent studies and applications of Sentinel to protect and promote public health during the ongoing COVID-19 pandemic and emerging monkeypox public health emergency. Additional sessions will consider key progress made to fulfill Prescription Drug User Fee Act (PDUFA) commitments, advance innovation within Sentinel, and the development of partnerships to expand and extend important capabilities of the data network.

Click here to register and learn more about the workshop.
Health Policy Talks: The Evolution of the Health Care Movement: The Value Imperative

November 17, 2022
2:30 – 3:30 PM ET

After passage of the Affordable Care Act (ACA), the nation’s health care organizations, advocates, and stakeholershave spent years trying to recenter the national health care movement. Families across this nation continue to struggle with poor health outcomes and unaffordable health care costs that limit their opportunity to thrive economically. At the same time, COVID has shone a new light on how unequal the ability to be healthy is across America and how systemic racism and geographic disparities drive health inequities. Join Duke Law Alumnus, Duke-Margolis Advisory Board Member, and the President of Families USA Frederick Isasi, the Center’s November Distinguished Speaker who will address how more than a decade after passage of the ACA, a new imperative has emerged as central to moving the health of our nation forward—a serious, consumer driven movement to hold the health care sector accountable for costs and quality—a value imperative. This hybrid national event will be held in person at Duke’s Fuqua School of Business and also accessible virtually.

Click here to register and learn more about this newest installment of Health Policy Talks, the Duke-Margolis signature health policy speaker series.
PAST EVENTS
Challenges and Opportunities for REMS Integration, Innovation, and Modernization

October 11, 2022

The FDA requires Risk Evaluation and Mitigation Strategies (REMS) for certain medications to ensure that the benefits outweigh the risks. REMS requirements can be burdensome for prescribers, pharmacists, and patients, as they are completed often outside of standard clinical workflows, which can be costly and time-consuming and can create delays or barriers to medication access for patients. FDA has supported the development of a proof-of-concept prototype that will allow certain REMS activities to be integrated into standard health information technologies.

Duke-Margolis and FDA hosted a virtual public workshop soliciting feedback from key stakeholders on the REMS integration prototype. Speakers from FDA and MITRE provided an overview of the prototype’s aims, core functions, and role in FDA’s ongoing efforts to modernize REMS. Patients, prescribers, pharmacists, health system representatives, informaticists, and other key stakeholders participated in a series of moderated panel discussions that focused on how the prototype can address challenges associated with integrating REMS requirements into clinical workflows to facilitate safe medication use.
Health Policy Talks: Achieving Health Equity Through Health Care Transformation

October 17, 2022
2:00 – 3:00 PM ET

Duke-Margolis Distinguished Speaker Dora Hughes MD, MPH, Chief Medical Officer at the CMS Innovation Center, used storytelling and data to inform to the Duke community and a national audience about the impact of CMS innovation models to “improve health, quality of care outcomes, and reduce cost.” Early interim results of one such model, Accountable Health Communities, demonstrates its ability to serve as a bridge for clinical and community interventions for Medicaid patients and drive down emergency department visits by nine percent. Overall, however, Dr. Hughes noted that the Center’s models too often did not focus enough on health equity or were so narrowly focused on cost and quality that other transformative effects of a model were missed. Looking ahead, Dr. Hughes noted that the Center will develop new models that “embed health equity” and specifically evaluate these future models based on their impact on health equity.

“[W]e are forever grateful to have so many amazing partners, including the Duke-Margolis Center, who are really helping to inform and advance our work and advance our thinking,” she commented. “And we are looking forward to continuing partnership in the days ahead.”
EDUCATION
Student Accomplishments

Former Margolis Summer Intern Ishaan Brar received the 2022 Youth Voices for Change Award from The California Endowment for his work in recognizing the inequities in health care for the unhoused, undocumented and low-income residents in the Central Valley, and for forming the Healthy Community, which offers mobile pop-up clinics in Bakersfield, CA.



2022 Summer Intern, Shamar Wilson was offered a position in Deloitte’s 2023 Strategy Summer Scholar program. In his application, Shamar emphasized the experiences he gained from Duke-Margolis and leveraged the knowledge he learned from his mentors, Rebecca Whitaker, Brianna Van Stekelenburg and Neil Rowen.

Margolis Scholar Eli Boone published a blog post in the Sanford Journal. The blog “On the Brink of Disaster: Medicaid Redetermination after the COVID-19 Public Health Emergency” reflects on the possible end of the COVID-19 public health emergency and why it is critical to understand what Medicaid redetermination is, how states are preparing, and what policy solutions exist to mitigate negative impacts. Click here to read more.



Margolis Scholar Nadia Bey was named to ProPublica’s Class of 2022 Emerging Reporters, one of eight students in the country to receive this honor. She will receive a stipend and mentorship from ProPublica’s staff as she begins to navigate a career in investigative journalism. Past Emerging Reporters have gone on to work at The New York Times, The Atlantic, THE CITY, Vox and other outlets.

Duke University’s Samuel Dubois Cook Center on Social Equity held a conference, “The Pandemic Divide: How COVID Increased Inequality in America,” where several Duke-Margolis team members presented their work. Click here for more information about the conference.


Academic Programs News and Recruitment

The recruitment for the Duke-Margolis Postdoctoral Associates is now open. Applications will be accepted now and until November 4. Click here for more information. Interested candidates can contact Marianne Hamilton-Lopez or Gabi Wurmitzer.

Duke-Margolis and Duke Family Medicine & Community Health are now accepting applications for the Health Equity and Primary Care Fellow. Click here for more information and to apply. Interested candidates can contact Andrea Thoumi or Brian Antono. The application window closes on November 15
PEOPLE
DUKE LEADERSHIP TRANSITIONS

Since its inception, Duke-Margolis has been championed by Duke University’s leaders, who have steadfastly voiced their support for the Center’s mission and work since 2016. President Vincent E. Price recently announced transition news of two key leader at Duke—and two instrumental supporters of Duke-Margolis—in the coming months. 

Provost Sally Kornbluth will be leaving Duke as its chief academic officer in January 2023 to become the 18th president of the Massachusetts Institute of Technology.

“Today is a great day not only for MIT—but also for Duke. I am thrilled for Sally as she pursues this well-deserved opportunity, and all of us can feel tremendous pride in her appointment,” said Dr. Price. “Provost Kornbluth has been a transformational figure at Duke, and President Kornbluth will be an extraordinary academic leader and administrator for MIT, a committed advocate for faculty, students, and staff, and a bold voice for innovation and inclusion in the academy.”

Chancellor A. Eugene Washington will be stepping down in June 2023 after eight years leading the Duke University Health System.

“Among Gene’s most profound contributions was his steady leadership through the COVID-19 pandemic. He led the rapid mobilization of our research, education, patient care and community health missions to equitably treat thousands of COVID-19 patients and safeguard public health locally and globally,” noted Dr. Price. “All of us can be proud of his tireless efforts to serve our community amidst these unprecedented challenges.”

As a community, Duke-Margolis will celebrate and show our deep appreciation to Drs. Kornbluth and Washington in the months ahead. In the meantime, please do reach out to congratulate them on their incredible careers at Duke and share best wishes for the next chapters ahead.
Deputy Director Gillian Sanders Schmidler is one of five Duke faculty members selected by Provost Sally Kornbluth to be Leadership Fellows in the inaugural Institute on Inquiry, Equity and Leadership in the Academic Department. Organized by the Ivy+ Faculty Advancement Network (FAN), the institute supports faculty leaders in examining academic routines, centering equity in policies and norms, and ultimately leading more inclusive departments. FAN is a consortium of national research universities collaborating to advance diversity and inclusion in the American professoriate.

Research Director Rebecca Whitaker presented at the NC Community Health Center Association Clinical Conference on Medicaid and value-based care updates and next steps with Elizabeth Kasper from the NC Department of Health and Human Services. During the session, attendees had an opportunity to share thoughts and areas of need to help advance high-value health care, health equity and the movement to alternative payment models in NC.
Duke-Margolis Center's Mark McClellan and Robert Saunders both will participate Health Evolution's Forum Roundtables. Mark will be participating in the Personalized Health Ecosystem roundtable and Rob will take part in the Value-Based Care for Specialized Populations event. Click here for more information.

Research Director Rachele Hendricks-Sturrup was quoted in a recent corporate profile of Verily published in STAT, commenting on the opportunities and challenges surrounding the use of real-world data. Read the piece here.


Duke-Margolis Researchers Maryam Nafie and Rachele Hendricks-Sturrup published a commentary entitled Practical Considerations and Recommendations for “a Revised Hippocratic Oath for the Era of Digital Health” in the Journal of Medical Internet Research. In the commentary, the authors offer further considerations for the proposed 21st-century revisions to the Hippocratic Oath, focusing on the shared goals and values of all digital health stakeholders and affirming patient choice, autonomy, and respect. Read their commentary here.




Duke-Margolis Health Equity Policy Fellow Andrea Thoumi has been appointed as Consulting Associate in Family Medicine and Community Health with the Duke Department of Family Medicine and Community Health. Congratulations on this appointment, Andrea!


Core Faculty Member Gavin Yamey has been named co-lead of a new two-year collaborative project with the Public Health Foundation of India on Rethinking Global Health Multilateralism. Gavin’s team will include researchers from Duke’s Center for Policy Impact in Global Health and Duke Global Health.

Research Director Christina Silcox was interviewed for an article published in MedTech Dive covering the use of software tools which can help physicians predict and detect illness and changes in a patient’s conditions. Read more about how the FDA has issued guidance that some of these tools should be regulated as medical devices.

Christina Silcox also participated in two conferences this month. She presented at IDWeek on the topic of “Testing for COVID-19 at Home: Challenges and Opportunities” and in ASU’s National COVID-19 Diagnostics Summit, as part of a panel called “At-Home Testing – Will it turn our world upside down?”
Center Director Mark McClellan will provide the closing remarks at this year’s LAN Summit taking place this November 9-10. This year’s event features appearances by CMS and CMMI leadership, the release of the 2022 APM Measurement Effort results, a discussion of the HEAT’s Social Risk Adjustment Guidance for APMs, and the announcement of the LAN’s 2030 APM Adoption Goals for Medicare, Medicaid, and commercial plans. More information and registration details can be found here.

Dr. McClellan will also be participating in a webinar entitled "Improving Health Equity: Bringing Clinical Trials to the Patients" on November 8. Click here for more information about the webinar and to register.
Core Faculty Member Barak Richman has been invited to deliver the keynote address for the Massachusetts Health Policy Commission’s Annual Health Care Cost Trends Hearing on November 2nd. His keynote will follow opening remarks by Massachusetts Governor Charlie Baker. Click here for more information and to live stream the address.



Duke University School of Medicine just announced that Monica Lemmon, Duke-Margolis Core Faculty member, has been named Associate Dean for Scientific Integrity in the Duke University School of Medicine. Congratulations, Monica, on this appointment!


Core Faculty Members Beth Shaz and Steven Patierno were featured in a recent article distributed by The Duke Daily discussing the Duke Cancer Institute’s (DCI)work on a new era of tools used to treat cancer that do not involve injecting poisons or using radiation. Read more about DCI’s work and the progress being made.
Team Welcomes
Martha Requard has joined the Center as an Executive Assistant, supporting Mark McClellan and the executive office. Martha comes to Duke-Margolis from UNC Health Strategic Execution & Core Business Transformation, where she provided executive support for three Vice Presidents responsible for the business enterprise and efforts to transform patient and employee experiences across 17 medical campuses to operate as one innovative business unit. She also previously served as the Executive Assistant for the Dean of the NC State University College of Education and the Executive Assistant for the Chair of the UNC Department of Ophthalmology.
Mira Gill rejoins the Center full-time as a Policy Analyst on the Biomedical Innovations team, focusing on the Center’s regulatory science activities. In August of 2022, Mira completed her Master of Science degree in physiology and biophysics at Georgetown University. She earned her degree while continued to work for the Center part-time as a research assistant. In her tenure with Duke-Margolis, Mira has contributed to the Center efforts related to regulatory decision-making, clinical trial design, data collection and aggregation, maternal health, substance use disorders, translational science, and real-world evidence.
Opportunities at Duke-Margolis Center for Health Policy
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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.