Health Law and Policy Commons^™

Lessons Learned For The Independent Panel For Evidence For Action Against Amr From Previous International Science Panels: Stakeholder Views From The 2025 Lagos Workshop, Iruka N. Okeke, Anthony Mcdonnell, Ayodele A. Akinyele, Javier Guzman, Kevin Outterson

Faculty Scholarship

In September, 2024, the UN General Assembly assigned the Quadripartite Joint Secretariat on Antimicrobial Resistance (AMR) the task of establishing an Independent Panel for Evidence for Action against AMR (IPEA). To promote stakeholder views and input around the constitution and functioning of this Panel, which could feed into the Quadripartite Joint Secretariat’s consultation process, we independently commissioned seven papers to examine the lessons that could be learned from other high-level scientific panels. We then convened 85 stakeholders, primed with the background papers. The Workshop, held in Lagos, Nigeria in April, 2025, drew representation from around the world, particularly low-income or …

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Medical-Legal Partnership As Value-Based Primary Care: Interprofessional Teamwork For Health-Related Social Needs, Jin K. Park, Andrew F. Beck, Keegan D. Warren, William M. Sage

Faculty Scholarship

Today’s primary care physicians are being asked to address patients’ health-related social needs (HRSN) as part of their routine care practices. An aging population, with a growing complement of intersecting medical and social needs, increases this burden on primary care. Medical-legal partnerships (MLP) are interprofessional collaborations that combine clinical and legal expertise to address HRSN involving housing, public benefits, employment, and other domains remediable by civil legal assistance. A value-based approach to integrating MLP into the health system may help primary care practices more effectively address HRSN and, in turn, better balance revenue and expenses. At the practice and healthcare …

Access To Justice After Medina V Planned Parenthood South Atlantic, Daniel G. Aaron, Nicole Huberfeld

Faculty Scholarship

Access to justice is “the ability of all people to seek and obtain effective remedies through accessible, affordable, … and culturally competent institutions of justice.”¹ Historically, patients and physicians have worked together to protect the integrity of medical care as well as patients’ rights by challenging unlawful government actions in court. Yet the US Supreme Court recently issued decisions that may impede access to justice, potentially empowering federal, state, and local governments to interfere with evidence-based care. We explore constraints on access to justice that may arise after Medina v Planned Parenthood South Atlantic (PPSA) (606 US 357, 2025), …

Can Legal Knowledge Save Lives? A Randomized Experiment In Preventive Health Screenings, Christopher Robertson, Wendy Netter Epstein

Faculty Scholarship

While the U.S. healthcare system typically imposes significant out-of-pocket costs, the Affordable Care Act (ACA) requires full insurance coverage for certain preventive health services (PHS), including cancer screenings, without cost-sharing. Despite this policy, one in four eligible Americans remains unscreened for breast, colorectal, and cervical cancer, which increases their risk of premature death. We hypothesize that a lack of awareness about the ACA’s free care requirement contributes to this gap and that explicitly informing patients could increase screening uptake. Additionally, we investigate whether prior experiences with medical debt deter individuals from seeking even cost-free care, reflecting a spillover effect of …

Beyond Subsidies And Mandates: Testing A Simple Behavioral Mechanism To Drive Health Insurance Coverage, Wendy Netter Epstein, Hansoo Ko, Christopher Robertson, Kevin Wilson, David Yokum

Faculty Scholarship

Uninsured individuals face reduced access to care, financial risk, and higher mortality. Although public programs and private subsidies have lowered uninsurance, these mechanisms remain incomplete and politically unstable. We evaluate whether a low-cost outreach intervention can increase health insurance enrollment without altering plan prices. Using a randomized field experiment involving 16,477 uninsured Maryland households, we assigned households to a no-contact control or to receive email and postcard outreach featuring affordability messaging alone or combined with responsibility or community framings. Outreach increased qualified health plan enrollment by 0.699 percentage points and total coverage by 0.967 percentage points relative to control. The …

Transforming Blood Management Systems In Developing Countries Through Technological And Artificial Intelligence-Driven Innovations, Sandeep Bhargava, Shaun Aaron Abram, Srividhya Ragavan

Faculty Scholarship

It is critical to ensure the safe and quality supply of blood among various stakeholders; however, this remains a significant challenge in today’s world, especially in developing countries. These countries face severe problems, including blood shortages, fragmented regulatory frameworks, and inconsistent quality control measures. To tackle these challenges, countries like India are trying to implement the use of artificial intelligence (AI) and its derivative platforms to transform blood collection, testing, storage, and distribution by enabling interoperability, real-time compliance monitoring, automated donor screening, optimized inventory management, and advanced component separation. The article argues that developing countries must adopt both regulatory reform …

Priority Without Progress: The Fda's Neglected Tropical Disease Voucher Program After 18 Years, Maple Goh, Kevin Outterson, Aaron Kesselheim

Faculty Scholarship

Introduction: To incentivize drug and vaccine development for neglected tropical diseases (NTDs), US Congress created the Priority Review Voucher (PRV) program in 2007. Sponsors that obtain Food and Drug Administration (FDA) approval for an eligible product receive a voucher redeemable to accelerate review of another product.

Methods: We reviewed the program’s public health impact by examining all 14 vouchers awarded for NTD products between 2007 and 2024, including the timing of FDA approval relative to World Health Organization (WHO) Prequalification, Essential Medicines List inclusion, first use in endemic countries, and voucher disposition.

Results: Eight (57%) achieved WHO …

Unwanted Medical Treatment Harms Patients: Taxonomy Of Healthcare Consent Infractions, Thaddeus Pope

Faculty Scholarship

Patients in the United States are subject to an ever-growing “avalanche” of unwanted medical treatment (UMT).  This is ethically, economically, and legally wrong. First, UMT constitutes a serious violation of patient autonomy and self-determination.  Second, it is waste (and often fraud or abuse) of scarce healthcare resources.  Third, but for rare exceptions, administering UMT contravenes settled legal rules and principles around consent and battery.

This article describe four types of unwanted medical treatment and how the law addresses (or fails to address) them.  The four types of UMT are (1) treatment over patient objections, (2) treatment with zero consent, (3) …

Spending Programs And The New Roberts Court, Nicole Huberfeld

Faculty Scholarship

The Supreme Court is poised to place new limits on Congress’s spending power at the urging of states vying for regulatory dominance, particularly in health care and public health. This article is the first to highlight and catalog the throughlines of argumentation, which sparked after states successfully challenged the ACA but have grown into opposing more than Medicaid’s cooperative federalism. This means federal and state programs that heavily rely on federal spending power are at risk, so studying this pattern is imperative. The article begins with a descriptive account of increasing spending power challenges, which make use of converging factors …

Corporate Childrearing, Katharine B. Silbaugh

Faculty Scholarship

With children influencing a trillion dollars in spending annually, corporations actively seek to shape children's identities in support of consumer culture and profit. Yet there are no scholarly treatments or theories of the legal relationship between children and corporations. Instead, scholars address individual industries such as food, social media, cosmetics, tobacco, or fashion, missing the structural role corporations play in children's identity formation. Family law evaluates child wellbeing interventions using a triangle to map the legal dynamics among child, parent, and state. This article adds corporations as fourth actors, reconceptualizing that triangle as a square. This square provides the first …

Health Truth To Power: Professional Collaboration To Bolster Trust Against Misinformation, William M. Sage, Keegan D. Warren

Faculty Scholarship

This Article is about health, leaving aside more general challenges to shared civic information today. The Article begins by surveying the principal challenges for health information in post-pandemic, arguably post-truth America, and then describes briefly the sources and limits of medical professional authority. Noting the double-edged sword of free speech guarantees under the U.S. Constitution, the Article continues by commenting on speaking truth to government, to industry, and to the crowd. Next, the Article considers the physicians’ role in speaking truth to power from the perspective of standard medical professional ethics and identity, comparing it to that of lawyers. Finally, …

Religious Riders And The Sherman Act, Bailey Sanders

Faculty Scholarship

Can corporations engage in anticompetitive behavior on the basis of religious belief? While the answer may seem like an obvious no, in fact this question has largely been overlooked. It has hovered at the margins of the debate over religious exemptions: Proponents of religious exemptions have essentially argued that there is no harm in providing such exemptions to businesses because a competitive market will ensure consumers who might be denied services or goods by a religious firm can still obtain those goods and services elsewhere. But what if religiously minded businesses act in ways that are specifically designed to limit …

The Effect Of Provider Diversity On Racial Health Disparities: Evidence From The Military, Michael Frakes, Jonathan Gruber

Faculty Scholarship

We assess the relationship between the racial diversity of medical providers and racial health disparities in the use of preventive care and in patient outcomes. We use unique data from the Military Health System, where we observe providers as patients so that we can identify their race, and where moves across bases change exposure to provider race in a plausibly exogenous fashion. We consider patients with four chronic, deadly, but manageable illnesses, where the relationship with the provider may have the most direct impact on health. We find striking evidence that provider racial diversity leads to reduced disparities in maintenance …

The Power And Peril Of The Aca's Universality At Fifteen, Nicole Huberfeld

Faculty Scholarship

As part of the symposium "15th Anniversary of the ACA: A Health Equity Review," this essay explores the ACA's mix of private law and public law provisions that rendered measurable improvements in health equity and health outcomes, especially for populations that experienced longstanding health disparities before its enactment.  Congress’s central objective was near-universal health insurance coverage, and the ACA employed a variety of mechanisms to reach that goal. The law’s health equity successes grew from establishing a principle of inclusion across federal statutes. This principle, which I have called “universality,” centered a human right to health approach: No longer would …

Social Science Contributions To The Global Action Plan On Antimicrobial Resistance Management, Mathieu Poirier, Jaskeerat Singh, Isaac Weldon, Clare I. R. Chandler, Daniela Corno, Laura Valtere, Pedro Henrique D Batista, Daniel Carelli, Geneviève Boily-Larouche, Sonia Lewycka, Fiona Emdin, Kathleen Liddell, Timo Minssen, Ilaria Natali, Susan Nayiga, Iruka N. Okeke, Emmanuel Olamijuwon, Kevin Outterson, Julianne Piper, Kayla Strong, Jarnail Singh Thakur, Kednapa Thavorn, Maarten Van Der Heijden, A. M. Viens, Mary Wiktorowicz, Steven J. Hoffman

Faculty Scholarship

Social science research on antimicrobial resistance has gained traction in the last decade, employing a diverse set of theoretical perspectives to better understand topics ranging from antimicrobial stewardship to political coordination.4 As the action plan commitments will be updated in 2026, an opportunity exists to employ a broader social science scope to accelerate national antimicrobial resistance interventions.

In January 2025, the Global strategy lab convened leading antimicrobial resistance social scientists from a variety of disciplines to determine which new ways of understanding antimicrobial resistance could catalyse and incentivize action. Three conceptions stood out as important to revisions of the action …

Bridging The Fair Share Gap For Antibacterial Innovation: An Observational Analysis Of Antibacterial Revenues In The G7 And Eu27, Maple Goh, Matt Mcenany, Rachel Freeman, Max Newton, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

Background

Antimicrobial resistance (AMR) poses an important global health challenge, including insufficient investment in research and development. This study quantifies the required “fair share” contributions from the G7+EU27 countries for an effective set of pull incentives for antibacterial research and development.

Methods

Fair share targets within the G7+EU27 were calculated from GDP data and revenue targets from the literature, adjusted for inflation. Cefiderocol and ceftazidime-avibactam were selected as representative of key antibacterials. Revenues and volumes from IQVIA MIDAS data on these drugs were used to assess alignment with fair share targets. The study period was January 2015–December 2024.

Findings

The …

Whose Burden, Whose Benefit? Revisiting Ethical Trade-Offs In The Who Guidelines On Scaling Up Mass Azithromycin Administration, Maple Goh, A. M. Viens, Safura Abdool Karim, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

Author summary

• New evidence suggests that mass drug administration of azithromycin (MDAA) can significantly reduce childhood mortality in high-burden, low-resource settings, yet the World Health Organization’s (WHO) 2020 guidelines take a cautious approach due to concerns about antimicrobial resistance (AMR).
• While the WHO guidelines cite ethical principles, they insufficiently address key considerations, such as intergenerational justice, equitable burden sharing, and the structural determinants of health that shape infectious disease vulnerability.
• Global AMR policy often prioritizes conservation over access in ways that disproportionately burden low-income countries, despite high-income countries also bearing significant responsibility for the emergence and spread of AMR.
• A …

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Stakeholder Views On Lessons Learned For The Antimicrobial Resistance Panel From Previous International Science Panels [Version 1], Iruka N. Okeke, Ayodele A. Akinyele, Javier Guzman, Kevin Outterson

Faculty Scholarship

The United Nations General Assembly called in September 2024 for the establishment of an independent panel for actionable evidence against antimicrobial resistance (IPEA). The task of designing the panel was given to the Quadripartite Joint Secretariat (QJS) on Antimicrobial Resistance (AMR) with a delivery timeline of 15 months. To promote stakeholder thought and input around what this panel should look like and how it should work, which could feed into the QJS’s consultation process, we independently commissioned seven papers to examine lessons that could be learned from other high-level scientific panels. We then called a convening of stakeholders that were …

Mitigating Firearm Suicide With Trusted Messengers In Health Care, Michael Ulrich, Cassandra Devaney

Faculty Scholarship

Voluntary firearm safety actions avoid Second Amendment scrutiny, but rely on individuals recognizing their own risks. This could be aided by a network of healthcare professionals that have received proper training and information about all available tools to help prevent firearm-related suicide attempts, and combining the trust of clinicians and firearm owners could represent an opportunity to inform and educate in a manner that will engage patients.

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Do Bans On Conversion Therapy Impose A Governmental "Orthodoxy" About Sex And Gender?, Linda C. Mcclain

Faculty Scholarship

In Part I, this Essay evaluates how orthodoxy arguments featured in Mr. Tingley’s challenge to Washington’s ban on conversion therapy. Part II offers a preliminary analysis of Chiles v. Salazar, ⁴² which the Court will hear during its 2025-2026 Term. I illustrate how the arguments made against Washington’s law by Chiles and her amici draw from the anti-orthodoxy and marketplace of ideas rhetoric found not only in Justice Thomas’s Tingley dissent and his NIFLA opinion but also in Justice Gorsuch’s majority opinion in the 303 Creative decision.⁴³ Woven together with these speech arguments are appeals to the Court’s …

Sexual And Reproductive Health & Rights: Advances And Setbacks, Aziza Ahmed, Alicia Ely Yamin, Sofia Gruskin

Faculty Scholarship

This article first describes shifts in human rights law that have led to improvements in the realization of sexual and reproductive health and rights (SRHR) over the last decade. The article does so, however, with careful attention to the structural factors beyond formal legal mechanisms that may undermine the ability of governments, even with the best of intentions, to fully develop the necessary robust health and justice systems. Second, this article considers two additional factors: the political economy factors that enable or limit the ability of States to realize SRHR, as well as the growing evidence base that supports positive …

Innovative Mechanisms For Marketing Health Insurance: An Experimental Field Test (Results From Colorado), Wendy Netter Epstein, Christopher Robertson, David Yokum, Hansoo Ko, Kevin Wilson

Faculty Scholarship

We hypothesize that marketing messages using a generosity framing have the potential to draw healthy persons into the insurance pool, thereby improving access and health outcomes and lowering premiums, but without removing choice or requiring substantial government action. The dependent variable for our field experiment is whether or not recipients of the marketing campaigns enroll in health insurance via the participating exchanges or in Medicaid.

Reclaiming Abortion As A Moral—And Religious—Decision, Linda C. Mcclain

Faculty Scholarship

Elizabeth Sepper, Free Exercise of Abortion, 49 BYU L. Rev. 177 (2023).

In 1973, before the Supreme Court decided Roe v. Wade, two members of a group of clergy committed to helping women receive abortion care stated: “every woman must possess the freedom, guaranteed by the U.S. Constitution, to follow her religious conscience in the determination of whether she will or will not bear a child.”1 Religious supporters of abortion access also cited the Establishment Clause: states were adopting, in a religiously diverse nation, a religious view about when life begins and how to value fetal and maternal life. …

Celebrating 70 Years Of Health Law At Bu, Christopher Robertson, Elizabeth Mccuskey, Aziza Ahmed, Dionne Lomax, Kathryn Zeiler, Dianne Mccarthy, Laura Stephens, Michael Ulrich, Lawrence Vernaglia, Danielle Pelfrey Duryea, Nicole Huberfeld, Kevin Outterson

Faculty Scholarship

This essay celebrates the BU Health Law Program upon its 70th anniversary, offering reflections on the founders of the program, Fran Miller, George Annas, and Wendy Mariner (“FGW,” endearingly), and their contributions to the field.

Current faculty offer reflections, including: Several speak to scholarly research, including Elizabeth McCuskey on health care finance, Aziza Ahmed on human rights, Dionne Lomax on antitrust, Christopher Robertson on trust, and Kathy Zeiler on the marketplace. Other contributors speak to the student experience, with Dianne McCarthy on mentorship, Laura Stephens on demanding excellence, Michael Ulrich on teaching, and Larry Vernaglia on merging law and public …

Public Funds, Public Functions, Private Actors: The Cognitive Dissonance Of Us Health Law, William M. Sage

Faculty Scholarship

This chapter begins with the evolution of American medicine from a “sovereign” self-regulating profession focused on direct patient service to a large industry that serves the social sector but that, because of its professional heritage, receives extensive public subsidies without equivalent public accountability. Next, the chapter identifies regulatory dynamics in American health care governance that structurally discourage movement from the prevailing, if dissonant, private law framework to one explicitly grounded in public law. The chapter concludes by highlighting the challenges and opportunities inherent in a private law approach to what is intuitively a public law domain.

Medicare Mandates For Shared Decision Making With Patient Decision Aids: Linking Payment To Preference, Thaddeus Pope

Faculty Scholarship

Since 2015, the Centers for Medicare and Medicaid Services (CMS) has increasingly required shared decision making with evidence-based patient decision aids as an essential Medicare condition for payment. CMS is doing this because it recognizes that most healthcare is preference sensitive and value laden. So, whether treatment is “right” or “beneficial” for a patient is not only a matter of clinical expertise. It equally depends on the patient’s values, preferences, and goals. So, CMS wants to ensure that patients understand the risks, benefits, and alternatives to the healthcare that they receive and for which CMS pays. In short, under its …

Birthdate Phaseout, Katharine B. Silbaugh

Faculty Scholarship

This article explores the Nicotine Free Generation (NFG) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: Prohibition, or a legal age-gate, such as 21 for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco, and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the 21 …