HEALTH POLICY IN ACTION

The end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023 will impact Americans’ free access to tests and diminish their ability to access early testing and prevent infectious disease spread, note authors of a new Duke-Margolis and COVID Collaborative report, “Testing for Respiratory Infections: Beyond the COVID-19 Public Health Emergency.” The authors, who briefed several federal agencies and the Administration, issued a set of recommendations to embed low-cost testing for those that need it most into national health policy and payment strategies to ensure that these diagnostic tools are accessible to the public long-term.

Read the full report here.

Duke-Margolis and CareJourney co-authored a comment letter in response to the Centers for Medicare & Medicaid Services’ 2024 Medicare Advantage (MA) and Part D Advance Notice. The comment letter notes that significant revisions proposed by CMS to risk adjustment policies for MA plans “did not seem to comport with the long-term goal of aligning risk adjustment methodologies across its accountable care programs and with the increasingly sophisticated and reliable electronic clinical data that are used to support care management and coordination for effective, whole-person care.”

Informed by results of rapid cycle analyses, Duke-Margolis and CareJourney concluded that the risk adjustment reforms as proposed have differential impact on racial and ethnic minorities and lower-income beneficiaries, who are more likely to have the conditions and complications involved in the reforms, and on the plans who disproportionately serve such beneficiaries. Duke-Margolis and CareJourney recommended that CMS should conduct further beneficiary impact analyses and seek further public input and begin the transition to a more sustainable risk adjustment strategy. Read the full comment letter here.

Duke-Margolis launched its Drug Supply Chain Resilience and Advanced Manufacturing Consortium to reduce the frequency and severity of drug shortages through policy solutions. Over 100 drugs are currently on the FDA drug shortage list, and these shortages can disrupt patient care, strain the health care workforce, and cost the health care system billions. The Consortium’s growing membership includes experts in supply chain, manufacturing, regulatory science, national security, and drug shortages from academia, private industry, governmental agencies (as observers), and additional relevant stakeholder groups, who will work in coordinated effort to promote a resilient drug supply chain with advanced manufacturing capabilities. Read the press release here.

Approximately one in three Americans, or over 110 million individuals, are on Medicaid or uninsured, and they often depend on the safety net: a network of national, state, and local health organizations that provide health care and social services to the nation’s historically underserved and under-resourced communities. A new, extensive Duke-Margolis report examines the relationship—and the challenges—between the safety net and accountable, value-based care models and provides a host of recommendations for action by federal agencies, states, and providers.

The report, with support from The Commonwealth Fund and Arnold Ventures, details policy reforms and technical design considerations to support safety net participation in accountable care models. Duke-Margolis proposes that safety net payers and funders—including states, federal agencies, and grant funders—create accountable funding streams that are simple, predicable, flexible, and explicitly tied to the goals of accountable care reforms. Read the full report here.

With North Carolina Governor Roy Cooper signing a Medicaid expansion bill into law, over 600,000 current uninsured North Carolinians are expected received health care coverage. The law builds on foundations Duke-Margolis laid in 2020, when the Center brought together both political parties to find common ground and discuss the need for state health care transformation.

“Two goals for Medicaid managed care transformation set by the NC General Assembly and NC DHHS are to improve health through whole-person and well-coordinated care and encourage smarter spending. NC DHHS has made great strides toward these goals in care reforms for children through initiatives like Integrated Care for Kids,” noted Duke-Margolis in a statement. “Through Medicaid expansion, more people—especially low-income adults—will gain access to this system of coordinated physical, behavioral health, and social needs care that enables them to stay healthy by accessing early interventions that keep costs down and improve well-being. Moreover, these reforms mean the state can better address health equity by going after social drivers of costly medical complications like food or housing insecurity through the Healthy Opportunities Pilots.”

The newly launched North Carolina State Transformation Collaborative has begun its work to improve the health of North Carolinians. A summary of the launch event and next steps for the initiative is available here.

COVID GAP released two Accountability Reports to discuss the latest in news surrounding the COVID-19 pandemic and two new blogs:

“UN High Level Pandemic Meeting Should Be Only the Beginning.” The article emphasizes the need for long-term political support for countering future health crises—read more about the potential impacts of this upcoming meeting here.

“COVID-19 Anguish Channeled into Survivor Support, Push for Better Pandemic Policies.” The article describes how the loss of loved ones to COVID-19 has created COVID Survivors for Change. Learn more about the organization and its impact here.

Duke-Margolis is a founding member of COVID GAP, which identifies key issues and recommendations for improving the pandemic response on a national and global level. Read the reports on their main site here.

Our second annual Health Policy Conference will gather stakeholders to discuss possible future directions for health policy and to reflect on progress made in the past year. More details on this hybrid event, including an agenda and speaker details, are coming soon. Join us in person at the Renaissance Hotel in Washington, DC, or virtually via Zoom. Registration is now open on the event webpage.

Duke-Margolis is hosting a webinar to discuss recent changes by the Centers for Medicare & Medicaid Services (CMS) to its risk adjustment methodology and future opportunities to improve the risk adjustment system. This webinar will present an overview of the current risk adjustment system, including how it works and the challenges it presents to transforming the payment system, and provide a brief analytical review of the recently proposed and finalized version of CMS policy reforms to risk adjustment. It will also explore short- and long-term policy opportunities to the improve the risk adjustment system beyond those CMS has already proposed. Learn more and register here.

Innovative manufacturing technologies have the potential to improve the manufacture of pharmaceuticals and bring benefits to patients. Duke-Margolis, under a cooperative agreement with the U.S. Food and Drug Administration (FDA), will host a hybrid workshop focused on regulatory strategies to support the utilization of innovative manufacturing technologies for drugs and biological products. Attend in person at the National Press Club in Washington, DC, or virtually via Zoom. Learn more and register here.

Drug-resistant infections and antimicrobial resistance are a major global public health threat. Duke-Margolis hosted a webinar to discuss how to identify and answer clinical questions with antibiotic use data, as well as policy approaches to improve data capture for antibiotic use. Learn more here.

Duke-Margolis, in cooperation with the FDA, hosted a virtual workshop to discuss how negative controls could support new methodological approaches for casual inference in the Sentinel Initiative. The use of real-world evidence (RWE) to address scientific and regulatory questions at the FDA has increased, but evaluation of RWE for regulatory use depends on a robust causal inference framework. The discussion at this workshop will inform the development of a series of methods demonstration projects aimed at informing this framework.

Click here to learn more.

Neonatal research faces unique challenges, and finding relevant, clinically meaningful outcomes from neonatal studies is often difficult. Duke-Margolis’s hybrid event aimed to promote discussion of conducting effective clinical trials in neonates, and to foster collaboration among researchers, clinicians, industry, and regulators in neonatal therapeutics. The event took place virtually via Zoom as well as in-person in Washington, D.C. Further details and a recording can be found here.

The FDA and Duke-Margolis hosted a public workshop to convene key stakeholders to discuss the priorities for the development of digital health technologies (DHTs) for use in clinical trials. This virtual meeting explored the challenges and opportunities related to the use of DHTs in clinical trials during the drug development process. Learn more about the workshop here.

Join us at the Fortin Foundation Bass Connections Showcase to celebrate the accomplishments of our 2022-2023 Bass Connections Health Policy and Innovation project teams. This annual event includes an open floor session featuring posters and interactive displays, lightning talks, awards, and a reception.

The 2023 showcase takes place on April 19, from 3:30 – 6:00 PM ET. Learn more here.

Research Director Christina Silcox spoke at the following events this past month:

Core Faculty Member John Purakal received a Presidential Award, one of the highest honors for Duke faculty and staff, for his work on developing a social needs screening program.

Research Director Rachele Hendricks-Sturrup co-authored several papers:

“A survey of United States adult privacy perspectives and willingness to share real-world data,” was published in the Journal of Clinical and Translational Science to address privacy surrounding real-world data. Read the paper here.

“An Assessment of Perspectives and Concerns Among Research Participants of Childbearing Age Regarding the Health-Relatedness of Data, Online Data Privacy, and Donating Data to Researchers: Survey Study,” was published in Journal of Medical Internet Research: Read the paper here.

“Evidence on Real-World Data and Real-World Evidence As a Driver for Precision Medicine Implementation in Pharmacy Practice,” was published in Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy. Read it here.

A new brief from FastCures, “Community-Based Infrastructure for Inclusive Research: Engaging the Private Sector,” quotes Mark McClellan and features Duke-Margolis’s Advancing Clinical Trials at the Point of Care (ACT@POC) coalition. Read the brief here.

Mark McClellan will be the keynote speaker in an in-person conference, “A Prescription for the Future of Drug Pricing,” hosted by the University of Pennsylvania’s Leonard Davis Institute of Health Economics (Penn LDI) on Friday, May 5^th from 9:00 AM - 2:30 PM ET. The conference will address new and pending policy changes surrounding drug pricing, and discuss public and private sector innovations. Learn more and register here.

Mark McClellan also provided the keynote address at the Healthcare Supply Chain Association's 2023 National Pharmacy Forum, and Stephen Colvill moderated the opening panel discussion titled "Pharmaceutical Supply Chain and the Path Forward.” In their remarks, they discussed promising policy solutions to address drug shortages. Learn more about the forum here.

Core Faculty Member Nathan Boucher will join the North Carolina Medical Journal in July 2023 as a new Scientific Editor. The journal was founded in 1849 and features research on topics that are relevant to North Carolinians’ health. Learn more about the journal here.

Robert Saunders brought Duke students to Capitol Hill to meet with congressional staff as part of a class based in the Fuqua School of Business. His class involves students in practical discussions with key health policy experts, including Duke-Margolis staff, federal agencies, private sector organizations, and others.

Core Faculty Member Krishna Udayakumar emphasized the need for global access to COVID-19 treatments in The Standard’s article, “New Covid-19 pill delivered to high-risk patients in four African countries.” Read it here.

Core Faculty Member Gary Maslow was quoted in wbur’s article, “Why mental health is declining for teenage girls in the U.S.” Read the story here.

Assistant Research Director Frank McStay discussed CMS’ CY 2024 Medicare Advantage Advance Notice on March 14 as part of a panel from America’s Physicians Groups. In particular, the panel discussed proposed changes to CMS’ risk adjustment methodology.

Gerrit Hamre, MA, is a new Research Director in Medical Product Development and Regulatory Policy at the Center. Gerrit has worked for nearly 20 years in the pharmaceutical industry with a focus on clinical research, regulatory, and commercial roles. Central to much of his career work is extensive internal and external stakeholder engagement to advance innovative, evidence-based healthcare solutions. He has often worked in the drug development and approval environment. Highlights of Gerrit’s career so far have included his work in the Food and Drug Administration’s Office of Legislation and as a Peace Corps Volunteer in South Africa. Welcome, Gerrit!

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.