New Research
PHYSICIAN-LED ACOs SHOWING EARLY SUCCESS NEED MORE SUPPORT TO SUCCEED

Physician-led Accountable Care Organizations (ACOs) would benefit from more guidance and support from the Centers for Medicare & Medicaid Services, private insurers, and other sources to succeed in taking on greater financial risk for care and moving farther away from fee for service (FFS) payments, according to a new Duke-Margolis   report , developed with funding from the Robert Wood Johnson Foundation. 

This report is the latest in a series of Duke-Margolis  analyses ,which found that  all  types of ACOs are taking on greater financial risk and achieving net savings (on average) while improving care. Yet smaller physician ACOs (those with fewer than 10,000 beneficiaries and that mainly provide outpatient services) have had trouble staying in the program longer, despite notable successes in reducing costs and improving quality. “The goal is not to have more ACOs overall but to have more ACOs that deliver higher-value care,” said Robert Saunders, Duke-Margolis research director. “What’s needed is additional time or support for ultimately successful ACOs.” Read the  report .
SUBSCRIPTION MODEL CAN IMPROVE ACCESS TO LIFE-SAVING ANTIBIOTICS

A subscription model payment approach could help increase the development, availability, and appropriate use of priority antibiotics to combat rising levels of antimicrobial resistance, according to Duke-Margolis researchers in a new   Health Affairs  blog  and  issue brief . The CDC reports that nearly 3 million Americans contract antibiotic-resistant infections every year, and more than 35,000 people die as a result.

"Our current antibiotics are increasingly ineffective in combating infections, and few new drugs are being developed,“ said Monika Schneider, a Duke-Margolis managing associate, co-authored the work with Center Director Mark McClellan and Senior Research Assistant Nicholas Harrison, with the support of Wellcome Trust. "While public and private sector efforts are working to address the need for increased development of antibiotics, none of these initiatives has resolved the greatest barrier -- low expected manufacturer revenue and limited market opportunities for new drugs.”

A subscription model would pay set fees to manufacturers based on the availability of specific drugs, rather than paying based on the volume of the drugs actually used. “A subscription approach would more directly align antibiotic payments with public health goals, like appropriate use and stewardship, and with Medicare’s shift from volume- to value-based payments for other important components of medical care,” said Schneider. Read the  issue brief .
WRESTLING WITH PAYMENT AND ACCESS TO EARLY-STAGE ALZHEIMER'S DISEASE TREATMENT

Duke-Margolis published an  issue brief  and held a  webinar on Payment and Access to Treatments for Early-Stage Alzheimer’s Disease . Many new drugs on the horizon for Alzheimer’s are designed to treat very early stages of disease development, by modifying the disease course rather than treating symptoms. These drugs might enter the market with limited evidence about long-term outcomes, raising uncertainties for payers and patients, according to Duke-Margolis researchers. Their work covers the challenges associated with Alzheimer's diagnosis, potential treatment coverage, and payments, and describes how reforms to payment mechanisms can mitigate initial uncertainties about new drugs. Read the  issue brief  and view the  webinar .
News
"CERVICAL CANCER REVOLUTION" PROPOSAL AMONG TOP 100 FOR MacARTHUR $100 MILLION GRANT

Duke-Margolis Core Faculty member and Duke engineer, Nimmi Ramanujam's plan aims to close the cervical cancer inequity gap and catalyze a new model of women-centered health care. The John D. and Catherine T. MacArthur Foundation announced that her proposal was one of the highest-scoring proposals in its 100&Change competition for a single $100 million grant to help solve one of the world’s most critical social challenges. The proposal was designated among the Top 100 and will enter the next round of competition this spring.
Learn more about this  research
DUKE-MARGOLIS COMMENTS ON COVID-19

Director  Mark McClellan  addressed both the global economic impact of the coronavirus to date and lessons learned from pandemics on CNBC's "Squawk Box." Watch interview  here .

Duke-Margolis Core faculty member  Gavin Yamey  comments on inequities in countries' abilities to care for patients with, improve surveillance around the world, and ensure access to a future vaccine as a global public good on French 24. Watch the   interview .

Center Deputy Director, Policy,  Marta Wosinska  informed a recent Tradeoffs  podcast   on the causes of medical supply and device shortages.
OPENING UP WHILE LOCKING DOWN: BUILDING THE DIGITAL PLATFORM FOR CARE DELIVERY REFORM

Duke-Margolis and Blue Cross NC held its fourth in an acclaimed campus-based and nationally livestreamed speaker series with thought leaders in health policy. Aneesh Chopra, the nation's first chief technology officer, commented on the promise of health IT to improve health and health care. Binge watch the series   here .
RWE's ROLE IN ASSESSING DRUG EFFECTIVENESS

Duke-Margolis Managing Associate   Nirosha Mahendraratnam Lederer   addressed the role of Real-World Evidence (RWE) for clinical trial stakeholders in an interview with Clinical Research News. Draft guidance expected to be issued by the end of 2021 should shed light on the three key issues outlined in the agency’s  Framework  for FDA’s Real-World Evidence Program: what makes RWD fit for use, how to generate RWE to provide adequate scientific evidence to address regulatory questions of interest, and how to ensure the conduct of the study meets regulatory requirements (e.g., study monitoring and data collection). 

Both the framework and guidance are mandates of the 21st Century Cures  Act  and the sixth Prescription Drug User Fee Act ( PDUFA VI ), and make the use of RWD and RWE for effectiveness decision-making an FDA priority, according to Nirosha. Read the interview  here .
People


DENTZER COMMENTS ON NC AND FEDERAL HEALTH POLICY TRANSFORMATION EFFORTS

Duke-Margolis Senior Policy Fellow  Susan Dentzer  addresses the potential of health care transformation at the state level at the North Carolina Institute of Medicine Legislative Health Policy Fellows Program, and at the national level at the American Health Association CEO Roundtable.
Upcoming Events

EMPLOYER LEADERSHIP IN IMPROVING HEALTH CARE VALUE

March 4, 2020 @ Geneen Auditorium, Fuqua Business School and live streamed

Can employers do more to help their employees get access to affordable care from high-quality providers, and can they do more to support physicians and other providers in delivering high-quality care?

Embold Health Founder and CEO, Daniel Stein, MD, MBA, will explore what employers, such as Walmart, are doing to address these questions and how Embold is supporting these efforts through innovative data and analytic approaches. Join us! Registe here .
INNOVATIONS IN HEALTH CARE
2020 ANNUAL FORUM

March 15-17, 2020
Watergate Hotel
Washington, DC

The IiH 2020 Annual Forum brings together experts in engage sessions that will cover:
 
  • Digital & Mental Health
  • Investing in Women-led Enterprises
  • Maternal and Child Health Innovation
  • The Future of Primary Care
  • Access to Healthcare
  • The Role of Data Science in Driving Value in Healthcare

View the  agenda and  register today!
INCLUDING PREGNANT WOMEN SAFELY IN CLINICAL TRIALS

April 16, 2020 - 9:00 am to 5:00 pm
National Press Club, W ashington, DC

The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration (FDA), is convening this public meeting to discuss the need for clinical research in pregnant women as well as scientific and ethical considerations for the inclusion of this complex population in clinical trials. The meeting will explore topics including:

  • Regulatory, scientific, and ethical considerations for the enrollment of pregnant women in clinical research, as articulated in existing FDA Guidance;
  • Priority areas of unmet need for clinical data collection and therapeutic development in obstetrics;
  • Characteristics of a standard nonclinical program designed to assess the safety of a product in the antenatal period; and,
  • Clinical trial designs for studies enrolling pregnant women to evaluate the safety and efficacy of therapeutics for chronic or acute medical conditions that require treatment during pregnancy.

Register   here.
12th Annual Sentinel Initiative Public Workshop

April 20, 2020 - 9:00 am to April 21, 2020 - 4:45 pm
Washington, DC

The Sentinel Initiative, an active medical product surveillance system, was established in response to the Food and Drug Administration (FDA) Amendments Act of 2007 and has become one of the Agency’s premier evidence generation platforms. The 12th Annual Sentinel Initiative Public Workshop is being convened by Duke-Margolis under a cooperative agreement with the FDA. The workshop provides an opportunity to discuss recent achievements and engage with the broader community of patients, consumers, and scientific stakeholders.]

The agenda, speaker bios and meeting materials can be accessed using a mobile application called  Guidebook  that is available for iOS and Android platforms. Attendees are encouraged to download the application.

DAY 1, Sentinel Annual Public Workshop, April 20, 2020
Featuring a keynote by Dr. Patrizia Cavazzoni from FDA and numerous expert panelists who will provide updates on major system developments, milestones, and strategic aims.

DAY 2, Innovation Day and Sentinel System Public Training, April 21, 2020
Featuring a morning session with presentations from key leadership and experts from the new Sentinel Innovation Center, followed by an afternoon session consisting of didactic training on the new capabilities in maternal health and pregnancy in Sentinel, including the new mother-infant data linkage.

Meeting materials will be posted on this event web page in advance of the workshop. The webcast for Day 1 and Day 2 will go live once the workshops begins. 

Register   here .