Health Policy Update: January 2022
Monthly Highlight:
The Milbank Memorial Fund’s second most read publication of 2021 is a Duke-Margolis publication by co-authors William Bleser, Rebecca Whitaker, James Zheng and Robert Saunders as well as former Duke-Margolis affiliated authors Hannah Crook (current PhD student, Vanderbilt) and Jasmine Masand (current Presidential Management Fellow at HHS Office of the Assistant Secretary for Financial Resources). Click here to read more about their paper and the see the entire Milbank top 10 publications. Congratulations to the entire team on their success!
COVID-19 RESPONSE:
HEALTH POLICY IN ACTION
GLOBAL

The COVID Global Accountability Platform (COVID GAP) co-hosted a convening on global vaccination challenges that brought together leaders from around the world to co-design and catalyze an accelerated pandemic response, particularly in low and middle-income countries. Led by Duke University and COVID Collaborative, COVID GAP partnered with the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), and Africa Centres for Disease Control and Prevention (Africa CDC) to hold this important convening, with support from The Rockefeller Foundation and the Bill & Melinda Gates Foundation. A key output of the meeting, the report, “From Airports to Arms” summarizes insights, recommendations, and learnings from national, regional, and global vaccination efforts to combat COVID over the past year, particularly those led by WHO and UNICEF through COVAX Country Readiness and Delivery activities and by Africa CDC and the African Union.

COVID GAP posts bi-weekly blogs that address in real time the global challenges to end the pandemic. Contact COVID GAP to learn more about its ongoing work.


Core Faculty Member Krishna Udayakumar commented on NPR about the challenges to meet the global target of having 40 percent of the world’s populations vaccinated by the end of 2021 and why the target was missed. Read the interview here.
NATIONAL
Duke-Margolis Center in partnership with Critical Path Institute (C-Path), Morningside Center for Innovative and Affordable Medicine, Intermountain Healthcare, Mayo Clinic, MITRE, UCI Health Affairs have announced the The Advancing Clinical Trials at the Point of Care (ACT@POC) coalition. The goal of this collaboration is to generate quality clinical research evidence in real time to better evaluate treatments and therapeutics, including those to treat COVID-19. The Coalition will engage a broader, more diverse group of patients and providers and develop digital health tools that make clinical trials simpler to run and more accessible to patients. Learn more about AOC@POC.
Prior to the Supreme Court’s January 13th decision regarding the Biden Administration’s vaccine requirements for health care workers, Mark McClellan, along with co-author Andy Slavitt, published an op-ed in the Washington Post entitled “We both led Medicare and Medicaid. Biden’s vaccine mandate for health-care workers must stand” where the two former leaders of CMS argue for the vaccine requirement for health-care workers. Read the full op-ed here.
After the Court’s decision to overturn the Biden Administration’s vaccination requirement for large business while keeping the health care worker mandate in effect, Director Mark McClellan commented in a CNN article saying, "One thing that will happen as a result of the requirement not going through in general for businesses--it's an opportunity to kind of take the volume down, or reduce the heat a little bit, and think about what are some other ways to engage and getting to more consensus locally on vaccinations." Read the full article.
As the Omicron variant became dominant throughout the US, it became statistically clear that treatments from Regeneron Pharmaceuticals and Eli Lilly and Co., used with success against the Delta variant, were ineffective in the fight against Omicron. Director Mark McClellan commented to NBCNews that “there’s not a medical justification based on the evidence on the Regeneron and Lilly products.” Read more from NBCNews “Patient beware: Some states are still pushing outdated Covid treatments.”
Duke-Margolis Faculty Fellow Nancy Allen LaPointe was quoted in the CNN article, ”Why changing the definition of 'fully vaccinated' could be difficult” where she provides clarification on what could be the distinction between being fully vaccinated and “up-to-date with the current recommendations.” Read more.
In partnership with The Rockefeller Foundation, Duke-Margolis co-authors Andrea Thoumi, Thomas Roades, Christina Silcox, and Mark McClellan published an issue brief, “Testing as an Alternative to Quarantining: Key Considerations and Best Practices for Implementing Test to Stay,” that focuses on a key COVID mitigation strategy for K-12 schools. Complementing guidance from the U.S. Centers for Disease Control and Prevention, the issue brief highlights case examples of Test to Stay programs from Illinois, Massachusetts, and North Carolina, which allow students who are close contacts of positive cases for COVID-19 to stay in school and undergo repeated testing, instead of quarantining at home. Read the full brief here.

Duke-Margolis Center researchers Brian Canter, Matt D’Ambrosio, Katie Greene, Morgan Romine, and Mark McClellan released an issue brief to assist policymakers and health system stakeholders in advance of the regulatory authorization of COVID-19 antivirals. The issue brief explores key issues and considerations in effectively and equitably deploying antiviral therapies, including identifying appropriate patient populations, implementing rapid “test-to-treat” strategies that maximize effectiveness, safeguarding equitable allocation to individuals and communities most at-risk of hospitalization and death, and initiating public outreach. Read the full brief here.
Duke-Margolis joined COVID Collaborative and nearly 90 other signatories in a letter to President Biden concerning the more than 167,000 children that have lost a parent or other in-home caregiver to COVID-19. The letter recommends that President Biden issue an Executive Order charging departments and agencies to shape a comprehensive response to support these children and families nationally, through states, tribal governments, and localities, drawing on or expanding existing programs and COVID relief funds while respecting tribal sovereignty. Read the full letter here.
STATE

Duke-Margolis co-authors John Bollinger, Katie Greene, Katie Huber, and Mark McClellan, in partnership with the National Academy for State Health Policy, published “Strategies to Increase COVID-19 Vaccination Rates in Medicaid Enrollees.” This report explores how states are tackling the challenge of identifying gaps in vaccine access among their Medicaid populations and provides examples of promising strategies to improve COVID-19 vaccination rates among Medicaid beneficiaries. Read the full report here.
RESEARCH
Achieving the JAMA Network’s “most read of the week,” Center faculty and researchers Rushina Cholera, David Anderson, Rebecca Whitaker, Janet Prvu Bettger, and Charlene Wong published “Medicaid Coverage Disruptions Among Children Enrolled in North Carolina Medicaid From 2016 to 2018,” which examines factors associated with coverage disruptions among children enrolled in North Carolina Medicaid from 2016 to 2018 and estimates the outcome of preventing such disruptions on medical expenditures. Findings reveal that large proportions of children enrolled in Medicaid continue to experience preventable coverage gaps that can have long-term negative health consequences and may lead to increased medical expenditures. Learn more.


Center co-authors Nitzan Arad, Beena Bhuiyan Khan, Elizabeth Staton, Hannah Graunke, Marianne Hamilton Lopez, and Mark McClellan summarize the National Coverage Analysis (NCA) proposed decision memo issued by the Centers for Medicare & Medicaid Services (CMS) for the use of monoclonal antibodies (mAbs) to treat Alzheimer’s disease (AD). Their analysis focuses on key questions that would be valuable for CMS to clarify and that should be the subject of comments during the comment period that closes on February 10, 2022. Read the issue brief here.

Governments and foundations have created incentives for drug and vaccine development for otherwise neglected diseases. Yet, the need for additional investment is needed as successful development of a new drug costs more than $1 billion dollars. Another powerful incentive could be the option for policy makers to enact a transferable exclusivity voucher program. In a new paper, “Design of a Transferable Exclusivity Voucher Program,” Duke-Margolis co-authors Beth Boyer and David Ridley describe the voucher program, detail four concerns raised about it, discuss how to address those concerns, and propose how to implement the program. Read more about the proposed program here.

In light of the Center for Medicaid and CHIP Services’ strategic refresh, Duke-Margolis researchers Montgomery Smith, Jonathan Gonzalez-Smith, William Bleser, and Robert Saunders co-authored a brief providing guidance on ways to increase access to home-based care for people with complex health and social needs entitled “Policy Agenda Brief on Opportunities for Expanding Home-Based Care within the Center for Medicaid and CHIP Services and State-Based Programs.” Access the brief here.
Core Faculty Member Megan Shepherd-Banigan examines whether persons with cognitive impairment (PwCI) reported occurrence of, and whether PwCI-care partner agreement about advance care planning (ACP), discussions are associated with completion of advance directives in her newest article, “Making the Informal Formal: Discussing and Completing Advance Care Plans in Care Dyads with Cognitive Impairment” published in SAGE Journals. Read her research here.
Duke-Margolis Core Faculty Member Nathan Boucher co-authored “Parents of Children with Newly Diagnosed Disorders of Sex Development Identify Major Concerns: A Qualitative Study” published in Urology. The article looks to develop a conceptual framework to understand and define the impact of Disorders of Sex Development (DSD) diagnosis and management from the perspective of parents of recently diagnosed children. Read the article here.

Nathan Boucher was also the senior author of, “‘That little bit of time’: Transition-to-Hospice Perspectives from Hospice Staff and Bereaved Family.” The findings demonstrate a need to improve the hospice admissions process and better support terminally ill patients and their families. Read the full article in Innovations in Aging.
Health Equity Policy Fellow Andrea Thoumi and Core Faculty Member Osondu Ogbuoji published the study, “Is value-based payment for healthcare feasible under Ghana’s National Health Insurance Scheme?” which explores stakeholder perceptions of the feasibility of value-based payment for health care in Ghana in Health Research Policy and Systems. This work shows that VBP could be a feasible policy option in Ghana if implementation challenges are addressed. Read the full study.
UPCOMING EVENTS
Leveraging Payment Reforms to Transform and Expand Home-Based Care for People with Complex Health Needs

February 17, 2022
1:00 – 3:00 PM ET

Home-based care is an untapped resource to provide care to millions of people in the United States who are unable to access or have difficulty obtaining care. On February 17, 2022, Duke-Margolis Center for Health Policy is hosting a webinar to discuss opportunities to expand home-based care for people with complex health and social needs. The event will explore immediate policy opportunities to increase home-based care at both the federal and state level, including pathways to use value-based payment models to further expand access to home-based care services. The webinar will include a panel with national experts as well as a conversation with a CMS Innovation Center representative to identify key actions in the public and private sector to strengthen and scale home-based care. For more information and to register click here.

This webinar and project are supported by The Commonwealth Fund, The SCAN Foundation, and The John A. Hartford Foundation.
PAST EVENTS
Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling
The US Food & Drug Administration (FDA) helps to ensure that prescribing information (PI) communicates essential drug interaction (DI) information as part of the FDA's public health mission to assure the safe and effective use of drugs marketed in the US. To obtain input on how to best communicate DI information in PI, including the DRUG INTERACTIONS section, the FDA and Duke-Margolis convened a stakeholder workshop in October 2019 and a follow-on meeting in December 2019. Meeting participants included academic physicians, retail and clinical pharmacists, nurse practitioners, academic researchers, drug database publishers, drug developers, informaticists, and representatives from the FDA. This workshop summary presents participant feedback from these meetings.
Understanding Bias and Fairness in AI-enabled Healthcare Software
On December 17, 2021 Duke-Margolis hosted a meeting to discuss ways in which bias can affect artificial intelligence (AI) in healthcare software and how to promote fairness in artificial intelligence software, including methods to detect and mitigate bias throughout the development process. Speakers at the meeting also discussed whether AI itself can play a role in reducing existing biases in the health care setting. Materials are available here.
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC)
In cooperation with the FDA, Duke-Margolis Center for Health Policy brought together a diverse group of experts to discuss what is needed to support successful Niemann-Pick Type C clinical trial endpoint development and selection. The workshop, largely scientific in nature workshop, also heard the perspectives of patients and caregivers because, ultimately, patients and their families are at the heart of this issue. FDA has opened a comment docket for those who would like to provide information or feedback to the agency related to this workshop. The docket will be open for comment until April 25. For additional information, including workshop recordings (coming soon), visit the workshop’s webpage.
PEOPLE
Andrea Thoumi and Keren Hendel received awards from Academy Health Disparities Interest Group for their demonstrated commitment to promoting health equity. Read their recent Health Affairs blog on strategies to bridge the health equity gap and improve access to COVID-19 testing, vaccination, and other services in Durham, NC. Keren received the Student Op-Ed Competition Award for her piece on investing in mobile health care solutions to reduce health inequities (publication forthcoming). Andrea received the Early-Stage Distinguished Investigator Award for her leadership to embed health equity across Center priorities, mentorship of students, and key research activities in mitigating health inequities among marginalized and minoritized populations in the US and abroad through health policy. Join us in congratulating Andrea and Keren for this recognition!

Center Director Mark McClellan joined a bipartisan group of former FDA Commissioners in a letter supporting the nomination Dr. Califf’s to return as Commissioner of Food and Drugs ahead of his confirmation hearing in the Senate HELP Committee. On January 14th, Dr. Califf’s nomination passed the Senate HELP Committee and will now be taken up for a vote by the full Senate. A date for the Senate’s vote on confirmation has not been set.


The Robert Wood Johnson Foundation announced 14 new grants under their Health Data for Action program. Duke-Margolis Core Faculty Member Virginia Wang was selected as one of these 14 grantees for her project, “Examining Medicare Reliance After Implementation of Medicare Payment Reform and the ACA Marketplace” Read more about the Health Data for Action program and the awarded projects on the AcademyHealth website.
Digital Policy Health Fellow Christina Silcox participated in a number of panels and presentations in recent months. At the end of 2021, she moderated a panel ANSI’s “Data Standardization as Building Blocks for AI in Healthcare” meeting, called “Data quality, data measurement, and data management needs in healthcare AI,” which discussed stakeholder requirements for the use of data and other standards throughout the phases of AI-enabled software products’ life cycle. This month, she spoke at ONC’s Artificial Intelligence Showcase on Duke-Margolis’s work on “Building Equitable and Trustworthy AI.” She also took part in the US Department of Education’s “COVID Testing in K-12: A ‘How To’ Webinar”, to help schools and districts start or strengthen their school-based COVID-19 testing program.
Center Director Mark McClellan presented a keynote address at JP Morgan’s 40th Annual Health Care Conference. The health care investment symposium connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
Duke-Margolis Core Faculty Member Frank Wharam was named an Expertscape World Expert in Deductibles and Coinsurance. Expertscape’s rankings are recognized in medical and scientific communities worldwide because the objective results are based on peer-reviewed publications in scientific journals.
TEAM MEMBER WELCOMES
Christina Bush is a new Policy Analyst with the Biomedical Innovation team, where she will focus on medical technology diffusion and medical product payment. A Duke alumna, Christina formerly served as the Worksite Wellness Program Coordinator for MountainWise, implementing wellness programs to increase access to clinical services and health resources for underserved populations across North Carolina’s western region. Christina also has worked in various clinical settings and as a Master’s student at UNC Gillings School of Public Health, she conducted clinical research at an Asheville-based free medical clinic. She studied topics including health disparities and inequities, barriers to healthcare access, insurance coverage gaps, the medical needs of uninsured populations, and the healthcare safety net. Christina holds a Bachelor’s degree in Public Policy from Duke and a Master of Public Health degree from UNC Gillings School of Global Public Health.


Eric Shipley has joined the DC office to work with Chief of Staff Morgan Romine and the Duke in DC and the Duke-Margolis communications team to manage the DC office and its in-house events as well as provide additional administrative support to members of the Center’s Executive team. Eric has worked in facilities, office, and property management for a host of national and international entities, including The Brattle Group, Marriott International, Bank of America, and Cushman Wakefield.
Sabine Sussman, MPH, is a new Policy Analyst with the Biomedical Innovation team, where she will focus on medical technology payment policy, coverage and access. Sabine comes to Duke-Margolis from Palladium International, where she served as a health financing and policy analyst. In this role, she provided technical support for private sector engagement and health financing sustainability projects funded by USAID and the Global Fund through literature reviews, policy research, stakeholder engagement, and consultant management. Prior to that she interned at Children's HealthWatch in Boston. Sabine earned both her Master’s in Public Health and her Bachelor’s in Community Health and Child Study & Human Development from Tufts University.
Opportunities at Duke-Margolis Center for Health Policy
4 New Positions Added This Month!
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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 and new positions have been posted this week! Click here to view all of our career opportunities.