Duke-Robert J. Margolis, MD, Institute for Health Policy

Duke-Robert J. Margolis, MD, Institute for Health Policy Duke University's Institute for Health Policy with offices on Duke's Durham campus and in Washington, D

A draft agenda is now available for our upcoming event! On October 14, we are exploring the future of accountable care a...
09/10/2026

A draft agenda is now available for our upcoming event! On October 14, we are exploring the future of accountable care at the Ronald Reagan Building in Washington, DC with policy and health care experts. Accountable care is now a permanent part of the Medicare landscape, but its future impact will depend on the modernization of the data, technology, and payment infrastructure that supports it. A free networking reception will follow the event—we invite you to join us in-person to connect with your peers. Space is limited! Learn more about the topics of discussion and register today: https://duke.is/b/9kxj

The fourth event in the FDA's Rare Disease Innovation, Science, and Exploration (RISE) workshop series will explore stat...
09/09/2026

The fourth event in the FDA's Rare Disease Innovation, Science, and Exploration (RISE) workshop series will explore statistical considerations for rare disease investigations. Join us on September 29 as we convene this hybrid event with the FDA Rare Disease Innovation Hub! Topics will include the role of randomization and blinding, strategies for enhancing efficiency, and factors specific to medical devices. Discussions will explore these statistical considerations with the goal of identifying efficient approaches that maintain scientific rigor and produce meaningful results for rare disease product development. Learn more and register here: https://duke.is/2/z3fw

A new public event has been announced! As 2027 approaches, accountable care is entering a new phase of evolution. While ...
09/03/2026

A new public event has been announced! As 2027 approaches, accountable care is entering a new phase of evolution. While the model has largely proven more effective than traditional fee-for-service payment, there is less agreement on what comes next. Join us in DC next month for an event that will explore progress in accountable care to-date and opportunities to leverage evidence that can accelerate accountable care: https://duke.is/b/9kxj

TOMORROW: Join us for the Innovation in Quantitative Medicine Summit, starting at 12pm ET! We are co-convening this virt...
08/31/2026

TOMORROW: Join us for the Innovation in Quantitative Medicine Summit, starting at 12pm ET! We are co-convening this virtual event with the FDA's Quantitative Medicine Center of Excellence to inform the establishment of the Quantitative Medicine Innovation Network (QMIN). The QMIN will bring together academic institutions, industry sponsors, contract research organizations, regulators, and patient advocates in a sustained, cross-sector collaboration to advance the science and regulatory application of quantitative medicine with the goal of fundamentally transforming drug development and clinical care. Learn more and register here: https://duke.is/8/4p56

Don't miss your chance to register for this upcoming event! The Food and Drug Administration (FDA) is hosting a public w...
08/21/2026

Don't miss your chance to register for this upcoming event! The Food and Drug Administration (FDA) is hosting a public workshop, convened by Duke-Margolis under a cooperative agreement with the FDA, to gather expert speakers to discuss challenges and opportunities to advance the use of digitally-derived endpoints in clinical trials for drug and biological products. To learn more about the speakers and topics of discussion, check out the agenda on the event webpage: https://duke.is/4/7rtf

A draft agenda is now available for our upcoming workshop on statistical considerations for rare disease investigations....
08/19/2026

A draft agenda is now available for our upcoming workshop on statistical considerations for rare disease investigations. Statistical considerations affect every aspect of drug development, testing, and review, including clinical trial design and measuring product effectiveness; understanding the role of statistical review is important for sponsors, patients, and disease advocates alike. All members of the rare disease community, regardless of prior familiarity with statistical approaches, are encouraged to attend: https://duke.is/2/z3fw

The Health Care Payment Learning & Action Network (HCPLAN) has released a new Patient Empowerment Guidebook, which was d...
08/17/2026

The Health Care Payment Learning & Action Network (HCPLAN) has released a new Patient Empowerment Guidebook, which was developed for providers, health plans, employers, and community-based organizations to help make care more affordable, ensure patients can access the services they need, and allow patients to navigate the health care system with confidence. It highlights real-world examples and implementation guidance to help organizations move from awareness to action.

“A recent increase of technology-based solutions holds promise to help patients and caregivers to better manage the health care journey they are working on together,” said Duke-Margolis Director Mark McClellan, who also co-chairs the Executive Forum at the HCPLAN. “However, with barriers like siloed data, consents, and administrative and billing burden, an opportunity exists to guide stakeholders to help patients navigate these challenges. The Patient Empowerment Guidebook meets that opportunity, informed by a wealth of perspectives across the health care industry at the HCPLAN.”

Read the guidebook here: http://bit.ly/45BpKtD

Check out our latest policy brief, which examines state Medicaid program and drug manufacturer perspectives on the Medic...
08/10/2026

Check out our latest policy brief, which examines state Medicaid program and drug manufacturer perspectives on the Medicaid Multiple Best Prices (MMBP) pathway. Among the states interviewed, none had implemented a value-based purchasing arrangement through MMBP. Stakeholders identified challenges involving state capacity, contract design, data and outcome measurement, and unresolved legal and regulatory issues. Read the findings and potential strategies for making the pathway a more feasible contracting option for Medicaid: https://duke.is/j/gce3

Policy Brief Evaluating the Medicaid Multiple Best Prices Provision as a Pathway for Value-Based Purchasing Published date July 31, 2026 Topics Drug Pricing and Competition Policy, Coverage and Payment Policy View Publication (PDF) This policy brief examines stakeholder perspectives on the Medicaid....

On September 1, Duke-Margolis and the U.S. Food and Drug Administration's Quantitative Medicine Center of Excellence are...
08/06/2026

On September 1, Duke-Margolis and the U.S. Food and Drug Administration's Quantitative Medicine Center of Excellence are co-convening a virtual event to inform the establishment of the Quantitative Medicine Innovation Network. A draft agenda is now available! Learn more about the topics of discussion and register here: https://duke.is/8/4p56

Join us for the next event in the Rare Disease Innovation, Science, and Exploration (RISE) workshop series, "RISE to the...
08/05/2026

Join us for the next event in the Rare Disease Innovation, Science, and Exploration (RISE) workshop series, "RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations," on September 29, 2026. Duke-Margolis and the FDA Rare Disease Innovation Hub are co-convening this hybrid workshop to explore statistical considerations in the design, conduct, and analysis of clinical investigations for rare disease medical products. All members of the rare disease community, regardless of prior familiarity with statistical approaches, are encouraged to attend. Learn more and register here: https://duke.is/2/z3fw

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