HEALTH POLICY IN ACTION

Duke-Margolis, in collaboration Rockefeller Foundation and John Hopkins University, released “Risk Assessment and Testing Considerations for Reducing SARS-CoV-2 Transmission in K-12 Schools.” The report is designed to provide schools across the country with testing and screening protocols to assist in a safer re-opening process. “Safer school re-openings have importance far beyond the academic benefits of in-person instruction,” says co-author and Duke-Margolis Managing Associate Christina Silcox. “These testing and screening protocols have the potential to allow schools to use rapid testing in combination with appropriate mitigation measures in order to re-open safely and stay open, by preventing outbreaks that would otherwise cause closures.” She continued in MedPage Today that testing is just one part of a "Swiss cheese method of risk reduction. So, you layer all these slices, all these different mitigation techniques" including hand washing, physical distancing, mask-wearing, and assessing facilities' ventilation, "and that makes a more solid, more resilient, mitigation strategy overall."

Duke-Margolis released two issue briefs the FDA approval process of COVID-19 vaccines, and their fair and equitable distribution. COVID-19 Vaccines: Ensuring Regulatory and Scientific Integrity During the Approval Process outlines the critical, transparent steps that should be met throughout the clinical development and the FDA regulatory review process to ensure that Americans can trust that an eventual vaccine has been rigorously studied and approved. A prime example of how this process played out in the FDA vaccine advisory committee meeting, a crucial public deliberation designed to provide career staff at the agency with insight and recommendations from outside, independent experts about potential vaccines.

Scientific standards and safeguards outlined in the issue brief will be a cornerstone for communicating with the public about an eventual vaccine’s safety and efficacy – just one plank of the unprecedented vaccine distribution and access plans outlined in the second issue brief, COVID-19 Vaccines: Planning for Equitable Distribution and Access.

Core Faculty Member Catherine Wong co-authored a JAMA Health Forum article, “The COVID-19 ‘Return-to-Learning’ Natural Experiment” which provides considerations for researchers seeking to partner with K-12 schools to ensure that ongoing decisions about children, schools, and COVID-19 are based on science, not speculation.

Core Faculty Members Nathan Boucher and Courtney Van Houtven contemplate older adults, post-incarceration and their long-term care service and supports, with special consideration of the COVID-19 pandemic in their co-authored article published in the Journal of the American Medical Directors Association, “Older Adults Post-Incarceration: Restructuring Long-Term Services and Supports in the Time of COVID-19”.

In two Wall Street Journal op-eds, Duke-Margolis Center Director Mark McClellan and former FDA Commissioner Scott Gottlieb outline the potential of monoclonal antibody treatment for COVID-19,, the timeline for use, and address whether the treatment might be the bridge to a vaccine. The co-authors state in the October 8th op-ed that FDA should and will weigh the benefits of the therapy against the risks and judge the application on the scientific merits, hopefully without political interference.” Drs. McClellan and Gottlieb discuss in their October 18^th op-ed, the various scenarios for delivery of infusion treatment of these antibodies, including home delivery and states and hospitals working to provide special administration sites.  

The Journal of General Internal Medicine published research by Duke-Margolis and Duke Population Health Sciences, “Comparing Associations of State Reopening Strategies with COVID-19 Burden.” Co-authors Brystana Kaufman, Rebecca Whitaker, Nirosha Mahendraratnam Lederer, and Mark McClellan, this study explored the differences in excess cases and death in states both with tight virus mitigation efforts and those states whose efforts are more lax. The research points to excess deaths rates that are eight times higher in those states whose mitigation efforts, including mask usage, are more lenient. Read the study.

Core Faculty Member Aaron McKethan, weighed in on the North Carolina Treasurer plans to reduce the payment amounts to hospitals caring for the nearly three-quarters of a million employees under the State’s health insurance plan. “The hospitals have very strong political clout in North Carolina, and increasingly so as they get bigger. They are huge sources of employment. If anything, COVID has reinforced and strengthened them — the job of wagging your finger at hospitals over their prices has gotten harder.” Read the full article here.

Center Director Mark McClellan joined Neill McNeill on his NEWSmakers segment to discuss COVID-19 vaccines and the challenges that North Carolina is facing., Read and watch the interview here. Mark also spoke with North Carolina Health News regarding the safety and timeline of a vaccine. Read the full article here. He addressed states efforts to establish their own vaccine safety review boards in addition to that of the FDA in Politico.

San Antonio Business Journal interviewed Center Deputy Director, Policy, Marta Wosinska regarding reopening of bars in Texas. “We are seeing an upswing in cases and more recently hospitalizations in the majority of states. Mask wearing, testing and appropriate distancing will remain our main defenses against the virus for months to come.” Read more here. APN News also quoted Dr. Wosinka for their piece detailing the Duke-Margolis’ partnership in the CovidExitStrategy.org project. Read more here.

Research Director, Global Health Andrea Thoumi  at Duke Margolis published a commentary for The United Nations Association-UK “COVID-19 has threatened to overwhelm health systems worldwide. What lessons can we learn about how to achieve ‘good health and well-being for all’?” where she investigates the challenges that the pandemic has made for health inequities as well as the future of health financing and what strategies may be available to strengthen health systems and make them more equitable to all populations.

Core Faculty Members Gavin Yamey, Osondu Ogbuoji, and coauthors published “Reaffirming the significance of global public good for health: solidarity in response to COVID-19 and future shocks addressing global systemic and structural health inequities.

Core Faculty Member Gavin Yamey co-authored the editorial “Political interference in public health science during covid-19” discussing the rejection of science by certain leaders around world. 

Duke-Margolis hosted the 12^th Annual Sentinel Initiative Public Workshop featuring a keynote address by Acting Director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni and fireside chat with the U.S. Food and Drug Administration’s (FDA) Deputy Principal Commissioner Dr. Amy Abernethy and Center Director Mark McClellan. Numerous expert panelists provided insightful presentations on key Sentinel Initiative developments, milestones, and strategic aims. Discussion also highlighted numerous studies conducted within the Sentinel Initiative as part of the U.S. FDA’s efforts to protect and promote public health during the COVID-19 pandemic. View the event.   

RESEARCH

Core Faculty Member Courtney Van Houtven co-authored, “Association of Medicaid Expansion Under the Patient Protection and Affordable Care Act with Use of Long-term Care.” In this study, ACA-funded Medicaid expansion was associated with an increase in any long-term care use among newly eligible low-income, middle-aged adults, suggesting that the population covered by the Medicaid expansion may have had unmet long-term care needs before expansion. Read the study.

Dave Anderson co-authored a report “Association Between Effectiveness of Care Quality Ratings and Insurer Characteristics in the Health Insurance Marketplaces” in the Journal of General Internal Medicine that discussing non-profit vs for profit insurers and the relationship associated with the effectiveness of care quality ratings.

Christina Silcox, Susan Dentzer, and David Bates co-authored “AI-Enabled Clinical Decision Support Software: A “Trust and Value Checklist” for Clinicians,” an editor’s pick in NEJM Catalyst. The article presents a “trust and value checklist” for clinicians using AI-enabled clinical decision support systems. 

Core Faculty Member Matthew Maciejewski co-authored “Patient-Reported Social and Behavioral Determinants of Health and Estimated Risk of Hospitalization in High-Risk Veterans Affairs Patients” that examines the association between patient-reported social determinants of health and risk for VA admission. Dr. Maciejewski has also been named Principle Investigator for the NIA-funded U.S. Deprescribing Research Network that will be conducting feasibility studies over the next two years to prepare for future deprescribing evaluations and intervention studies. A Duke cohort is expected to be developed as one of the five sites in the network.

Core Faculty Members Virginia Wang and Matthew L. Maciejewski co-authored “Association of VA Payment Reform for Dialysis with Spending, Access to Care, and Outcomes for Veterans with ESKD” concluding that VA policies to standardize payment and establish national dialysis contracts increased the value of VA–financed community dialysis care by reducing reimbursement without compromising access to care or survival.

Team members from both Duke-Margolis and Duke University School of Medicine co-authored the article “Children and the Opioid Epidemic: Age-Stratified Exposures and Harms” highlighting the importance of addressing early opioid exposures. Team members included Kelby W. Brown, Kayla Carlisle, Sudha R. Raman, Peter Shrader, Megan Jiao, Michael J. Smith, Lisa M. Einhorn, Charlene A. Wong

Mark McClellan and Charlene Wong aimed to identify needed capabilities and potential solutions for implementing pediatric accountable health communities (AHCs) in their co-authored article “Pediatric accountable health communities: Insights on needed capabilities and potential solutions”

Core Faculty member Janet Prvu Bettger was selected as a Healthy Longevity Global Competition Catalyst Awardee from among more than 1,500 innovators for her work with Musculoskeletal pain in Tanzania.

Virginia Wang has been named co-investigator on two Department of Veterans Affairs (VA) Health Services Research and Development-funded studies: 1) CKD Cascade of Care (C3) Initiative to improve identification and staging of chronic kidney disease in the Veterans Health Administration and 2) Patterns, Processes, and Outcomes of Kidney and Liver Transplantation in an Era of Enhanced Community Care for Veterans. This study will assess the impact of the VA Mission Act’s expansion of organ transplantation on access and outcomes of Veterans receiving liver and kidney transplant services.

Michel Landry has joined the Center as a Core Faculty Member. A health policy and health services researcher, his area of study is the policy implications of the gap between available supply (financial and human resources) and increasing demand for rehabilitation and health services across the continuum of care. He lectures widely on the policy and political dynamics of rehabilitation and disability, and is a provocative advocate for the moral, ethical and economic necessity to ensure accessible and affordable rehabilitation services across the continuum of high, middle and low-income countries. Dr. Landry completed his Master of Business Administration at Duke University's Fuqua School of Business in December 2019. 

Duke-Margolis Founder Bob Margolis joined Don Crane on the APG on American Healthcare podcast. Their conversation reflected upon Bob’s career, what he has learned, and why he thinks it might be time for a national health care czar. Listen to the podcast here.

Center Research Director Andrea Thoumi now will serve as its new Health Equity Policy Fellow. In this new role for the Center, Andrea will advance the Center’s aim to incorporate health equity across our research portfolio. Her initial focus will be to work closely with Duke-Margolis research staff and faculty members to integrate the Center’s anti-racism and equity goals into relevant, existing projects; to identify and help develop mission-aligned collaborations across Duke on policy reforms in health equity; and to work with the education team to support and expand the Center’s academic offerings in this vital area. Andrea led the Center’s team to identify opportunities to advance health equity, anti-racism and health disparities research and serves on the Duke-Margolis Anti-Racism and Equity Committee. 

Elaine Chhean has joined Duke-Margolis as a research associate, working with Visiting Senior Health Policy Fellow Hemi Tewarson on the Center’s growing state health policy portfolio, and with Research Director Robert Saunders on payment and delivery reform. Most recently a senior policy analyst at the National Governor’s Association in the Health Division of its Center for Best Practices, Elaine provided technical assistance to state leaders and projects addressing Medicaid, behavioral health, COVID-19 testing, health equity, and school health and safety. 

Katie Huber has joined the Duke-Margolis as a senior research assistant working on the payment and delivery reform. A 2020 graduate of UNC-Chapel Hill’s Gillings School of Global Public, Katie worked on adolescent health studies for the Carolina Population Center and improvements to children’s mental health in Durham County for Duke Integrated Pediatric Mental Health.  

Alec Lintz, a Duke alumnus (Public Policy), returns to the University as a research assistant on the Duke-Margolis team. Alec will work on legal and regulatory issues related to value-based for medical products. Most recently a corporate banking analyst at KeyBank in Cleveland, Alec completed internships with the White House, Senator Ron Portman, and the American Continental Group. 

Nirosha Mahendraratnam Lederer presented at the SCOPE webinar on “Emerging trends in the expanded use of real-world evidence across the life sciences industry. Where is the industry going?” and at the 3^rd Annual Real-World Data & Life Sciences Analytics Congress. Additionally she was interviewed for ISPOR’s Values & Outcomes Spotlight article, “Unlocking the Promise of Real-World Evidence” 

Mark McClellan and Marianne Hamilton Lopez participated in the Precision Medicine Leaders’ Summit – RTP/Population Health, on providing the keynote address and presenting on Policy Challenges and Opportunities with Precision Health Innovation, respectively.

Research Director, Robert Saunders , moderated a panel, “Using the Patient Voice to Drive Systemic Change” at The Alliance for Health Policy’s 2020 Annual Signature Series. This panel addressed how to collect and operationalize patient feedback to create patient-centered care at a systems level. View the event. 

Center Managing Associate Christina Silcox addressed the Connected Health Initiative’s “Good Machine Learning Practices Discussion & Feedback Session.”