HEALTH POLICY IN ACTION

Monoclonal antibodies treatments for COVID-19 have demonstrated significant potential curb severe symptoms of the virus if delivered early to patients in need. To help policy makers plan for the availability and distribution of these promising treatments, Duke-Margolis issued comprehensive overview of the critical near-term challenges facing patients, providers, and payers – including recommendations on how best to adapt timely testing and referral protocols, specialized infusion capacity, payment for administration, state-guided allocation to specialized infusion sites, and the overall supply of antibody treatments. A companion paper, “Right Patient, Right Time, Right Place: A Critical Challenge of COVID-19 Monoclonal Antibodies focuses on patient identification and prioritization, payment models, and additional evidence development needs.

Duke-Margolis has joined the COVID Collaborative, a diverse and comprehensive team of leading experts in health, education, and the economy. The Collaborative brings many of the nation’s leading experts in public health, education, and the economy together with associations representing state and local leaders to take unified action to stop the spread, crush the curve, and safely and sustainably reopen schools, businesses, and other places where Americans gather. The Collaborative partnered with The Ad Council on a $50 Million ad buy for a major vaccination education campaign. Find out more at covidcollaborative.us 

The nation is headed for its the most challenging period in this pandemic but better days are ahead, according to Center Director, Mark McClellan who headlined a Duke media briefing. He also addressed the upcoming holidays, vaccine distribution, the effectiveness of a new monoclonal antibody therapy, and when life may, finally, get back to some semblance of normalcy. Watch the briefing on YouTube or read more about it here.

In a recent Wall Street Journal article reporting on how the upcoming holidays are leading to higher demand and longer wait times for COVID-19 testing. Duke-Margolis Managing Associate Christina Silcox reminds us not to “put all of your eggs in the testing basket. Make sure you are protecting your loved ones in other ways as well.”

In a series of Wall Street Journal op-eds, Center Director Mark McClellan and former FDA Commissioner Scott Gottlieb discuss that best ways to mitigate COVID-19 spread at the local level; outline three steps policy makers should take to support opening schools more widely; and details a CDC national COVID registry to track information on vaccine use that will be connected with state vaccine registries, why collecting this data is important, and the urgency for the federal government to quickly establish these monitoring systems since most of the early vaccinations will be given to older patients covered by Medicare and to health-care workers.

A research study co-authored by Duke-Margolis Core Faculty Member Brystana Kaufman and Managing Associate Rebecca Whitaker on the impact of COVID-19 on high-risk rural populations and the stress that it is creating on rural hospitals was cited in coverage by the Wall Street Journal.

Graduate intern Sahil Sandhu, Research Director Robert Saunders, Core Faculty Member Charlene Wong and Center Director Mark McClellan co-authored “Health Equity Should Be A Key Value In Value-Based Payment And Delivery Reform” which details how the COVID-19 pandemic has hastened the need to prioritize health equity in value-based payment reform.

Senior Policy Fellow Hemi Tewarson commented on COVID-19 vaccine administration, state planning, and delivery in this Politico article and on the need for outreach and education, particularly in communities of color. Additionally, Tewarson was also interviewed by NBC Nightly News as part of a week-long special, “Race for a Vaccine”. Watch the full clip here. 

Core Faculty Member Aaron McKethan and Research Associate Hilary Campbell co-authored a series of briefs which model the impacts of COVID-19 in North Carolina. In the most recent brief, which examines geographic trends of COVID-19 incidence in North Carolina studied data from zip codes adjacent to major universities and found that there was “no obvious increase” in cases among other age groups beyond previously established patterns. Read more at in this article from The Chronicle. 

The N.C. Department of Health and Human Services recently allowed indoor visitation at long-term care facilities in North Carolina. In a viewpoint published with Emma Dries, a Duke public policy student, Duke Margolis Core Team Member Nathan Boucher reflects on the new state visitation guidelines and how to most effectively prevent the spread of illness while also considering the physical and emotional toll that separation can have on long-term care residents. 

Core Faculty Members Osondu Ogbuoji and Gavin Yamey co-authored a publication entitled “Reaffirming the Significance of Global Public Goods for Health: Global Solidarity in Response to COVID-19 and Future Shocks” which gained the attention of world leaders at this year’s G20 Summit. In a declaration prior to the summit, world leaders adopted the publication’s recommendations and language on GPGs, resilient health systems, UHC, and the future of the WHO. 

On December 7, 2020, Duke-Margolis Center for Health Policy will host a public webinar to showcase the Real-World Evidence Collaborative’s recent white paper that details a roadmap for developing real-world endpoints. A panel of experts will discuss key points from the white paper and offer insights about the future of real-world endpoint development. For more information and to register, click here. 

RESEARCH

Core Faculty Members Matt Maciejewski and Virginia Wang along with Duke-Margolis Intern Judy Zhong coauthored “Fragmentation of care as a barrier to optimal ESKD management” which outlines the role of care fragmentation in the delivery of optimal end‐stage kidney disease care and identifies research gaps in the evidence across the continuum of care. Read the full article here.

Three national health policy leaders are joining the Duke-Margolis Advisory Board. Please join us in welcoming Michelle McMurray-Health, Rebekah Gee, and Esther Krofan who will provide essential leadership, guidance, and support to further the Center’s mission, strategic goals, and operational activities.

Rebekah Gee, MD, CEO Health Care Services for LSU Health—an obstetrician/gynecologist, Dr. Gee is the former Secretary of the Louisiana Department of Health, where her leadership resulted in over 500,000 Louisianans becoming newly insured under Louisiana’s Medicaid expansion, and many receiving much needed primary and preventive health care. Her Medicaid expansion dashboard to measure access to healthcare services became a national model. She is a national leader in tackling pharmaceutical pricing, including spearheading an innovative effort for a subscription model for drug access to eliminate hepatitis C in Louisiana.

Esther Krofah, MPP, Executive Director of FasterCures, a center of the Milken Institute—a Duke alumna and former GlaxoSmithKline director of public policy, Ms. Krofah led Federal engagement on broad health care policy issues, including leadership in improving vaccinations and care for people living with HIV. She has served as the deputy director of HHS’ Office of Health Reform, leading the development of regulatory priorities, including the health insurance marketplaces. Prior to HHS, Ms. Krofah served as a program director at the National Governors Association, working directly with governors' health policy advisors, state Medicaid directors, and state health commissioners on health insurance, health workforce, and Medicaid coverage issues.

Michelle McMurray-Heath, MD, PhD, President and CEO, BIO—a Duke alumna, physician, and molecular immunologist, Dr. McMurray-Heath led a Johnson & Johnson (J&J) global clinical and regulatory team of 900 with responsibilities in 150 countries and was instrumental in bringing the company’s incubator, JLabs, to Washington, DC. Prior to her time at J&J, Dr. McMurray-Heath was a key science policy leader in government, serving as associate science director of the FDA’s Center for Devices and Radiological Health under Commissioner Peggy Hamburg. In that role, she championed clinical trial evolution, the use of real-world evidence in product evaluation, and an embrace of the patient’s voice in health research so new medical products deliver outcomes that matter to them.

“The Duke Health Policy Center Advisory Board is a key source of important insights and strategic advice to our whole Duke team,” said Duke-Margolis Founder Dr. Robert Margolis. “The addition of these three distinguished women to our Board adds meaningful and diverse views that will serve to further advance the important work of the Center. A warm welcome to Michelle, Esther and Rebekah.”

“This is a crucial moment for Duke-Margolis and the nation to hear from these distinguished experts on public health, state health care reform, and biomedical innovation to protect and safe lives. We are honored to have them join the Duke-Margolis team,” said Dr. Mark McClellan, director of Duke-Margolis.

Center Senior Research Assistant Nicholas Harrison and Research Associate Sarah Sheehan released a summary from a two 2019 FDA convenings entitled “Characterizing the FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle.” Read the full summary here.

In early November, the Supreme Court heard arguments for the third time in ten years regarding the constitutional nature of the Affordable Care Act. Core Faculty Member Nathan Boucher discussed what's at stake if it's struck down in this interview by WRAL’s Lena Tillett. Boucher continued his discussion of the ACA and issues surrounding pre-existing conditions, including COVID-19 in a Pew’s Stateline blogpost, “COVID-19 ‘Long-Haulers’ Worry About Coverage, Costs.” “There may come a period in which people are going to have to prove that COVID is the reason for their heart issue or lung disease and not just that they’re getting older.” The post received additional attention when NY Senator Kirsten Gillibrand entered the article into the Congressional record.

Senior Policy Fellow Hemi Tewarson participated in a webinar produced by The National Institute for Health Care Management’s entitled, “The Future of the COVID-19 Response: The New Administration, Vaccines, and the Health Care System” where she discussed COVID-19 response at the state level, including policy and plans for reducing transmission, equitable vaccine distribution, and plans for further vaccine development, distribution, and vaccine hesitancy. Watch her presentation here. 

Managing Associate William Bleser was featured on the most recent episode of Ask the Expert, a series from Penn State’s Center for Health Care and Policy Research. Bleser provided insight into the COVID-19 vaccine distribution plans and the FDA’s process in the United States for testing vaccine candidates to determine their efficacy and effectiveness. Listen to the podcast here. 

Policy Fellow Morgan Romine has transitioned to the new role as the Center’s Chief of Staff, where he will serve to provide strategic support to advance the Center’s impact and the well-being of the Duke-Margolis research staff, coordinate the Senior Research Team and provide input to the Center leadership, and serve as a communications bridge across the Center and with external collaborators and stakeholders, including Congressional offices.