Is the medicalization of poverty a rational and humane response to an intractable problem, or just the latest in a long series of ineffective and costly attempts to address the problem? Considerable ink has been spilled on the dispute, with each side marshalling heart-rending anecdotes to help make their case — along with the obligatory statistics and regression analyses. Rather than add more verbiage to that dispute, this article sketches out a framework for understanding the phenomenon of medicalization, along with a description of the demand-side and supply-side factors that have brought us to this pass.

The U.S. and Canadian health care systems are more similar than is commonly believed. This article debunks some of the powerful myths about these health care systems and opens up the discussion for greater policy learning from both sides of the border. Cross-border comparisons can yield a number of lessons from common policy challenges such as cost control, physician organization and payment, and the organization of health coverage and services for Native Americans and Indigenous Canadians.

Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid misuse and diversion in the United States. Pain specialists may be particularly well situated to address these issues. We describe an attempt to reverse the trend at an orthopedic surgical hospital by implementing a peri-operative assessment and treatment service which minimizes preoperative opioid use, when necessary implements addiction treatment, and encourages early tapering from opioids.

We design an agent based Monte Carlo model of antibiotics research and development (R&D) to explore the effects of the policy intervention known as Market Entry Reward (MER) on the likelihood that an antibiotic entering pre-clinical development reaches the market. By means of sensitivity analysis we explore the interaction between the MER and four key parameters: projected net revenues, R&D costs, venture capitalists discount rates, and large pharmaceutical organizations' financial thresholds. We show that improving revenues may be more efficient than reducing costs, and thus confirm that this pull-based policy intervention effectively stimulates antibiotics R&D.

In approximately the last 20 years, the self-protection capacity of many American Indian tribes has significantly increased to include the review of research requests by a tribally based IRB. While these tribal IRBs are trained using a curriculum derived from the Belmont Report, there is need to recognize the cultural specificity of the Belmont Report and its potential for conflict or inappropriateness when applied to populations with deep differences in cultural constructs compared to the majority population. However, recognition of the sometimes paradigmatically different culture of American Indian tribes compared to the U.S. culture at large seldom occurs. Moreover, significant and subtle factors of researchers' professional, organizational, and personal cultures that relate to the research enterprise are essentially never addressed by themselves or the tribal IRB. Nonetheless, tribal IRBs continue and serve as a procedural guide for investigators intending to conduct respectful research with American Indian populations.

There is much discourse and focus on the social determinants of health, but undergirding these multiple intersecting and interacting determinants are legal and political determinants that have operated at every level and impact the entire life continuum. The United States has long grappled with advancing health equity via public law and policy. Seventy years after the country was founded, lawmakers finally succeeded in passing the first comprehensive and inclusive law aimed at tackling the social determinants of health, but that effort was short-lived. Today the United States is faced with another fork in the road relative to the advancement of health equity. This article draws on lessons from history and law to argue that researchers, providers, payers, lawmakers and the legal community have a moral, economic and national security imperative to address not only the negative outcomes of health disparities, but also the imbalance of inputs resulting from laws and policies which fail to employ an equity lens.

Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.

No country has yet implemented a pilot to ensure access to or the innovation of new antibiotics for multi-drug infections. A team from national health agencies in Norway, with the support of the Innovative Medicine Initiative-funded project DRIVE-AB, designed a model suitable for the national context, including the selection of the antibiotics, the potential value, and the operational model.

“Medicalization” has been a contentious notion since its introduction centuries ago. While some scholars lamented a medical overreach into social domains, others hailed its promise for social justice advocacy. Against the backdrop of a growing commitment to health equity across the nation, this article reviews historical interpretations of medicalization, offers an application of the term to non-biologic risk factors for disease, and presents the case of housing the demonstrate the great potential of medicalizing poverty.

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal.

As part of a multifactorial approach to address weak incentives for innovative antimicrobial drug development, market entry rewards (MERs) are an emerging solution. Recently, the Duke-Margolis Center for Health Policy released the Priority Antimicrobial Value and Entry (PAVE) Award proposal, which combines a MER with payment reforms, transitioning from volume-based to “value-based” payments for antimicrobials. Here, the PAVE Award and similar MERs are reviewed, focusing on further refinement and avenues for implementation.

Medication reconciliation for pediatric oncology patientparticipants enrolled in clinical trials often reveals the use of chemical complementary medicine alongside protocol therapeutic agents. Considering the blurry delineation between clinical ethics and research ethics, this paper demonstrates how complementary medicine-related protocol violations introduce ethical questions of who should be included and excluded from clinical trials and offers recommendations on how to manage physician-patient-family interactions around these challenging issues.

This article argues that correctional institutions violate the Eighth Amendment when they refuse to establish MAT programs and prevent doctors from exercising medical judgment to properly treat incarcerated people with OUD.

The next steps in health reform, like all such efforts before it, will have to engage the issue of American health care federalism – the relationship between the federal and state governments in the realm of health law and policy. Since its enactment in 2010, the Patient Protection and Affordable Care Act (ACA) has offered a robust example of modern federalism and revealed new complexities. This article recounts the findings of our five-year study of the federalist and nationalist features of ACA implementation. Contrary to the claims of ACA opponents that the law marked a federal “takeover,” the ACA's governance structures have advanced rather than suppressed state power. But we also found that the advances in state power occurred seemingly independently of the statute's structural arrangements; that is, the ACA's nationalist and federalist features both enhanced state power over health policy. These findings raise questions about whether cherished American federalism values are unique to federalist structures; they also raise the question of what exactly health care federalism is for, and why we continue to design health policy with federalism front and center. It is not clear that enhanced state power has brought better health policy. If it has not, is federalism for its own sake worth the trade-off?

Should Medicaid pay for supportive housing for homeless persons? After describing current limits on how states can use Medicaid funds to support housing, this article considers whether justice requires treating Medicaid recipients residing in nursing homes and Medicaid recipients needing supportive housing similarly.

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.

Health care costs and affordability are critical issues to consumers. Just as we assess the coverage impacts of a health reform proposal, we should be able to evaluate how the plan will constrain health care costs: its theory of cost control. This essay provides a framework to assess health reform plans on their theories of cost control, identifying the key policy tools to constrain health care costs organized in a two-by-two matrix across the following dimensions: price vs. utilization and public vs. private payers. It then applies the framework to the Affordable Care Act (ACA) and the Republican's 2017 legislative efforts to repeal and replace the ACA to identify their general theories of cost control, revealing on the plans' strengths, blind spots, and incoherence.

This article examines five different Medical-Legal Partnerships (MLPs) associated with Yale Law School in New Haven, Connecticut to illustrate how MLP addresses the social determinants of poor health. These MLPs address varied and distinct health and legal needs of unique patient populations, including: 1) children; 2) immigrants; 3) formerly incarcerated individuals; 4) patients with cancer in palliative care; and 5) veterans. The article charts a research agenda to create the evidence base for quality and evaluation metrics, capacity building, sustainability, and best practices; it also focuses specifically on a research agenda that identifies the value of the lawyers in MLP. Such a focus on the “L” has been lacking and is overdue.

This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.

The opioid epidemic has claimed the lives of more than 183,000 individuals since 1999 and is now the leading cause of accidental death in the United States. Meanwhile, rates of incarceration have quadrupled in recent decades, and drug use is the leading cause of incarceration. Medication-assisted treatment or MAT (i.e. methadone, buprenorphine) is the gold standard for treatment of opioid use disorder. Incarcerated individuals with opioid use disorder treated with methadone or buprenorphine have a lower risk of overdose, lower rates of hepatitis C transmission, and lower rates of re-incarceration. Despite evidence of improved outcomes, many jails and prisons do not offer MAT to individuals with opioid use disorder. This seems partly due to a scientifically unjustified preference for an abstinence-only treatment approach. The absence of MAT in prisons and jails results in poor outcomes for individuals and poses a public health threat to communities. Furthermore, it disproportionately harms poor communities and communities of color. Health care providers in prisons and jails have an ethical obligation to offer MAT to individuals with opioid use disorder to mitigate risk of infectious diseases, opioid overdose and health disparities associated with incarceration.