In the September 2019 Issue of the Quarterly

This issue of the Quarterly features opinion pieces from several of our contributing writers as well as invited commentaries from noted guest authors on a broad range of issues:

• Lawrence Gostin’s assessment of the World Health Organization’s Global Action Plan to promote the health of refugees and migrants reveals serious inadequacies and inequities among nations. He calls for member states to share the burden of providing needed services on a more equal and fair basis.
• A stated goal of the new “Primary Cares Initiative” of the Centers for Medicare and Medicaid Services (CMS) is the transformation of primary care delivery from a fee‐for‐service driven enterprise to one involving value‐based payment. In a guest opinion, K. John McConnell appraises the initiative’s two‐part design—Primary Care First and Direct Contracting—and raises questions regarding its ability to catalyze wide reform.
• In addition to focusing on primary care, CMS also has tried to transform hospital care by promoting patient safety in its hospital payment policies. Yet, despite efforts to penalize hospitals for poor safety performance, Gail Wilensky notes that patient safety issues continue to plague American hospitals, and she ponders whether low‐scoring hospitals are receiving the assistance they need to improve their performance.
• Paula Lantz examines the recent spate of state laws restricting abortion and urges policymakers to document the impact of such laws, arguing that it is in society’s best interests to produce nonbiased, valid estimates of the death and morbidity toll from these policies.
• Harold Pollack poignantly describes the plight of pregnant and parenting women struggling with opioid addiction, and cautions against repeating the harmful, stigmatizing media coverage that marked the crack epidemic 25 years ago. He argues that journalists and researchers have a responsibility to approach the opioid challenges with evidence‐based optimism that we can employ realistic interventions to help those affected.
• Controversy has long surrounded the issue of human gene patent eligibility, but proposals now before Congress to relax current restrictions raise new questions and pose a threat to public health. In a guest opinion, Jacob Sherkow reviews recent case law, including decisions by the Supreme Court, and appraises their potential implications for both public health and future medical innovation.

We are pleased to introduce the Milbank Quarterly Classics, a series of landmark articles published by the journal over the course of its 97‐year history. Each article in the series has withstood the test of time, representing an important contribution to the field at the time of publication, and serving today as a still‐relevant guidepost for contemporary policymakers and practitioners. We intend to post Classic articles on the Fund’s website at three‐month intervals. For each Classic article, commentaries by noted scholars pointing out the key lessons relevant to the current policy environment will appear in the journal, along with a web link to the Classic. The first in the series is a 1996 article by Edward Wagner, Brian Austin, and Michael Von Korff, “Organizing Care for Patients with Chronic Illness.” In separate commentaries, Edward Wagner and Donald Berwick discuss the chronic care model’s widespread adoption and reflect on its role in health care delivery after more than two decades as the gold standard for managing chronically ill patients.

Readers also may be interested in new original research by Russell Glasgow and colleagues. In “An Adaptive, Contextual, Technology‐Aided Support (ACTS) System for Chronic Illness Self‐Management,” they build upon the legacy of the chronic care model to create an integrated, patient‐directed system that takes greater account of a patient’s life context and home/primary care/work‐setting supports.

Accountable Care Organizations (ACOs) typically employ patient engagement strategies in their adult primary care practices, but little is known about the relation of these strategies to patient‐reported outcomes. In “Linking Practice Adoption of Patient Engagement Strategies and Relational Coordination to Patient‐Reported Outcomes in Accountable Care Organizations,” Hector Rodriguez and colleagues find no differential improvements in outcomes among patients of practices with high vs. low adoption of patient engagement strategies or among patients of practices with high vs. low relational coordination. Their findings suggest that ACOs may need to invest more heavily in collecting, monitoring, and analyzing patient‐reported outcome data to ensure that adoption and implementation of patient engagement strategies lead to improved functioning among patients.

Racism is a fundamental cause of health inequities and disease, and cultural systems historically have shaped racial inequities. In “Culture, Race, and Health: Implications for Racial Inequities and Population Health,” Courtney Cogburn examines the influence of cultural barriers and assets in shaping racial inequities in health. She observes that a lack of shared conceptual grounding and language regarding cultural threats to health has hindered the identification and measurement of cultural processes and that building a culture of health to achieve health equity requires meaningful assessment of cultural racism to obtain insights into how population health may eradicate racial disparities in health.

The current crisis of worldwide antibiotic resistance demands policy reforms both locally and globally. Insight into different regulatory systems can inform decision‐making regarding the market entry of new drugs that promotes access while minimizing the risk of antimicrobial resistance. In “Less is More: Norwegian Drug Regulation, Antibiotic Policy, and the ‘Need Clause,’” Bard Hobæk and Anne Lie employ the Norwegian drug regulatory procedures as an example of how national drug regulators can promote innovation of new drugs that meet public health needs by accepting only drugs that add therapeutic value.

Three separate articles pertain to different aspects of Food and Drug Administration (FDA) policies and decision‐making:

• In “Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015,” Audrey Zhang and colleagues examine public documents from advisory committees that provide the FDA with external scientific counsel on potential agency actions and regulatory decision‐making. They find that the FDA disagrees with advisory committee recommendations only 22% of the time and, in most cases, the FDA is less likely to enact new product approvals, supplemental indications, and safety actions.
• In “Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency,” Matthew Herder reports findings from interviews with FDA leaders regarding postmarket requirements (PMRs) for new drugs. His analysis reveals that insufficient resources and coordination within the agency, inadequate legal authorities, and the political economy of withdrawing an approved indication in the face of opposition from companies and patients, all contribute to observed shortcomings in the FDA’s use and enforcement of PMRs.
• Finally, in “FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost‐Effectiveness Analysis,” Brendan Collins and colleagues use microsimulation methods to assess the cost‐effectiveness of meeting voluntary sodium reduction targets set by the FDA, finding that achievement of long‐term targets could produce substantial 20‐year health gains in US food system workers. They conclude that the benefits of implementing FDA voluntary sodium targets extend to food companies and food system workers, with the value of health gains and health care cost savings outweighing the costs of reformulating incentives.

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