Health Law and Policy Commons^™

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.

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 …

Improving The Transparency Of Legal Measurement In Health Policy Evaluation—A Guide For Researchers, Reviewers, And Editors, Benjamin A. Barsky, Alina Schnake-Mahl, Cason D. Schmit, Scott Burris

Faculty Scholarship

Advances in quantitative research methods have led to acceptance that well-designed observational studies can enable causal inferences about the effects of policy interventions on health. Indeed, JAMA recently announced exploring a range of study designs for which causal interpretations may be made in JAMA Network journals. This development is welcome for research on the potential health effects of laws—including statutes, regulations, executive orders, formal agency guidance, and other documents that purport to require compliance with rules or standards—given that they are rarely amenable to evaluation using experimental methods. As researchers, reviewers, and editors refine criteria for assessing the appropriateness of …

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 …

Birth On Mother Earth: Mitigating The Maternal Health Crisis, Jill C. Engle

Faculty Scholarship

Maternal health outcomes in the U.S. are remarkably poor, especially when compared to those in other industrialized countries. For example, our maternal death rate is more than twice that of Canada’s. Women of color in the U.S. suffer maternal morbidity and mortality at rates considerably higher than white women. Indigenous women experience the worst maternal health outcomes of all. Yet, most maternal deaths and injuries are preventable. Furthermore, rates of maternal harm, including death, are lower when midwives and similar birthing attendants are involved. This Article is the first to fully explore the unique skillset of traditional birth attendants (TBAs). …

Recent Changes In Discretionary Denials Of Drug Patent Challenges, S. Sean Tu, Arti K. Rai, Aaron S. Kesselheim

Faculty Scholarship

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of “discretionary denials,” invoking a new “settled expectations” rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes …

Imperfect Access: Structural Barriers And External Threats To Preventive Care, Dorit Rubenstein Reiss, Richard H. Hughes Iv

Faculty Scholarship

Access to healthcare in the United States is often partial and inequitable. This is due in large part to a highly fragmented public-private system of providing health insurance coverage to its citizens. Yet, through incremental policy developments, the United States provides more comprehensive preventive care coverage across both public and private sources of coverage than in other areas of healthcare. Moreover, it has developed safety net programs intended to gap-fill access for those without insurance coverage. This is not surprising; like other countries, the United States realize that in addition to being just and equitable, broader access to prevention has …

Moral Politics Theory Applied To Abortion: Utopias, Dystopias, And Dobbs, Susan Ayres

Faculty Scholarship

This article examines Moral Politics Theory (MPT) as a way to understand current tensions in the US concerning reproductive justice. MPT, as developed and researched for over thirty years by cognitive scientist, George Lakoff, provides a way to explain differences in political worldviews. According to Lakoff’s research in Moral Politics and Don’t Think of an Elephant!, conservatives tend to hold a strict-father model, and progressives hold a nurturant-parent model. People in the political middle tend to endorse both models; Lakoff labels those in the middle as “biconceptuals,” and discusses how this group is most susceptible to persuasion because metaphors frame …

The United States Healthcare System: From Medicare To Post-Pandemic Health Policy, William M. Sage

Faculty Scholarship

My purpose in this essay is to comment on national health policy in the United States over the past sixty years.  My conclusions are less optimistic than what I had hoped when I began my teaching and research career in the 1990s to be able to say in 2025.  In particular, the successful expansion of publicly supported health coverage via the passage of the Affordable Care Act (“ACA” or “Obamacare”) in 2010 seems to have triggered -- though I hesitate to say that it caused – a backsliding from broader commitments to clinical performance, population health, and social solidarity that …

The Ninth Circuit’S Nod To Anti-Vaccine Advocates, Richard H. Hughes Iv, Dorit R. Reiss

Faculty Scholarship

On June 7, 2024, a three-judge panel of the Ninth Circuit issued a decision that, while it did not go as far as anti-vaccine activists claimed, clearly drew on anti-vaccine tropes, and suggested a retreat from important public health precedents.

This Article explains the decision and the way in which it can undermine public health law. In short, the decision is problematic in two ways. First, it accepts claims that are untrue on their face. By ignoring the evidence and facts provided by public health authorities and experts, the opinion demonstrates further erosion of the high deference to expertise embodied …

Transplantation And Immortality: A Selective History Of Boston University’S Center For Health Law, Ethics & Human Rights, George J. Annas

Faculty Scholarship

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later …

Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation, Srividhya Ragavan

Faculty Scholarship

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best …

China, The Trips Waiver, And The Global Pandemic Response, Peter K. Yu

Faculty Scholarship

This chapter identifies three distinct reasons why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. It also recounts the country’s more assertive position in the run-up to the adoption of the Ministerial Decision on the waiver. Drawing eight lessons from the international debate on the waiver and the subsequent Ministerial Decision, the chapter offers insights into the future role China can or will play in future international policy debates at the intersection of intellectual property and public health, including during the next pandemic.

Just Fix The Damn Payment System!, Frances H. Miller

Faculty Scholarship

This piece takes as a given that we are stuck with our fragmented, inefficient, multi-payor health care system for at least the short run. It then analyzes the deficiencies of three payment mechanisms whereby regulators (including Congress) have invited private sector providers to help ameliorate perceived problems. The first concerns an inadequate supply of nursing home beds in the early ‘70s, the next focuses on Medicare Advantage as a supposedly superior cost containment alternative to traditional Medicare, and the final one involves the ‘devil’s bargain’ struck with the pharmaceutical industry to get prescription drug coverage added to Medicare. All three …

Health Law And Democracy, Wendy K. Mariner

Faculty Scholarship

Current political divisions are destabilizing existing laws affecting the health field. Major changes in the field of health law have one thing in common: changes in who holds political power ‒ Congress and state legislatures, governors, presidents, judges, and agency officials. The laws that structure financial, economic, educational, and health care systems, environmental conditions, and civil society are primarily the product of elections that populate our political institutions. These structural determinants of health in turn create laws that influence how ‒ and how well ‒ we live and whether our society functions fairly under the rule of law. Thus, who …

Intellectual Property, Genetic Resources, And Associated Traditional Knowledge, N.S. Gopalakrishnan, Srividhya Ragavan, Narendran Thiruthy

Faculty Scholarship

The recently concluded WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge mandates disclosure requirements in patent applications, thereby creating an obligation to attribute the use of genetic resources and traditional knowledge. The WIPO member countries thus have an opportunity to modify their national patent laws, so that they can effectively control genetic resources and traditional knowledge. This article examines the choices that the biodiversity-rich countries have when designing their national legal systems to implement the treaty.

Common Measures Of Vaccination Intention Generate Substantially Different Estimates That Can Reduce Predictive Validity, Jessica Fishman, K. Aleks Schaefer, Daniel Scheitrum, Christopher Robertson, Dolores Albarracin

Faculty Scholarship

Surveys often estimate vaccination intentions using dichotomous ("Yes"/"No") or trichotomous ("Yes," "Unsure," "No") response options presented in different orders. Do survey results depend on these variations? This controlled experiment randomized participants to dichotomous or trichotomous measures of vaccine intentions (with “Yes” and “No” options presented in different orders). Intentions were measured separately for COVID-19, its booster, and influenza vaccines. Among a sample of U.S. adults (N = 4,764), estimates of vaccine intention varied as much as 37.5 ± 17.4 percentage points as a function of the dichotomous or trichotomous response set. Among participants who had not received the COVID-19 vaccine, …

Reducing Disparities Through Online Accessibility Information, Benjamin A. Barsky, Michael Ashley Stein, Lisa I. Iezzoni

Faculty Scholarship

Over the coming decades, physicians in the US can expect to see more patients with disabilities as medical advances extend the lives of persons with complex congenital or early-onset conditions and as the population ages with a higher incidence of multimorbidities and functional impairments. As reported by the Centers for Disease Control and Prevention, the overall age-adjusted disability prevalence in 2021 among adults aged 18 years or older was 27.2%, with estimates of 12.1% for mobility disability, 6.1% for hearing disability, and 4.8%for vision disability. In 2021, however, only 63.2%of persons with any disability aged 18 to 44 years reported …

Why Mlp Legal Care Should Be Financed As Health Care, William M. Sage, Keegan D. Warren

Faculty Scholarship

Medical-legal partnership (MLP) integrates the unique expertise of lawyers into collaborative clinical environments. MLP teams meet the needs of individual patients while also detecting structural problems at the root of health inequities and advancing solutions at the institutional, community, and system levels. Yet MLPs today operate in limited settings and survive on scant budgets. Expanding their impact requires secure funding. Financing MLPs as health care can do the following: (1) help address inequity at the point of care; (2) enable expert diagnosis and treatment of nonmedical drivers of health; (3) enhance team-based practice in health care organizations; (4) offer another …

The Limits Of Immigrant Resilience, Huyen Pham, Natalie C. Cook, Ernesto Amaral, Raymond Robertson, Suojin Wang

Faculty Scholarship

Economists have identified important adaptations that immigrant workers have made to weather economic crises. During times of economic contraction, immigrant workers have moved across industries or geographical locations, downshifted to part-time work, and accepted lower wages to stay employed. Evidence from the Great Recession (2007–2009) shows the benefits of that economic resilience: immigrant workers were more likely than native-born workers to remain continuously employed, to have shorter periods of unemployment when they lost their jobs, and to regain jobs more quickly in the recovery period. Of course, these adaptations had significant personal costs for immigrant workers and their families, but …

Changes In Revenues Associated With Antimicrobial Reimbursement Reforms In Germany, Matt Mcenany, Kevin Outterson

Faculty Scholarship

Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives—financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy …

The States' Hodgepodge Of Physician Licensure Regulations, Tara Sklar, Christopher Robertson

Faculty Scholarship

The end of the federal COVID-19 public health emergency (PHE) on May 11, 2023, marked a pivotal shift in the landscape of telehealth regulation in the US. Kwan, Jolin, and Shachar analyze the implications of this transition by exposing inconsistencies in access to care. We agree that we now face a “convoluted patchwork of permanent and temporary changes to telehealth law and policy.”

Development Of An Online Tool To Support Financial And Legal Planning In Dementia, Irene Tessaro, Sarah M. Hooper, Denise Watt, David Menestres, David Farrell

Faculty Scholarship

Objective: To develop, assess, and refine an online educational tool, Plan for Clarity, to support financial and legal planning in dementia.

Methods: A Delphi mixed-method study with three rounds of anonymous review by lay and professional stakeholders was designed to reach consensus about the content of the online tool and explore the socio-cultural and behavioral factors that could affect access and use.

Results: Consensus showed that the online tool covered key information, knowledge, and communication skills for financial and legal planning. Study themes: 1) the online tool had to be easy to navigate with relevant, easily understood …

Implementing An Eu Pull Incentive For Antimicrobial Innovation And Access: Blueprint For Action, Michael Anderson, Adrian Towse, Kevin Outterson, Elias Mossialos

Faculty Scholarship

In June, 2023, the Council of the EU published a recommendation that the European Commission should contribute to the design and governance of an EU cross-country pull incentive to stimulate antimicrobial innovation and access. In this Personal View, we discuss six key considerations to support the implementation of the new pull incentive—ie, the size of the potential pull incentive and possible contributions of the member states, design of the incentive model, interplay of the new pull incentive with the proposed revisions of the EU pharmaceutical legislation, roles and responsibilities of both the EU and member states, balance between pull and …

Perspectives On The Constitution Of The War On Drugs: A Collection Of Posts From The Balkinization Blog, Douglas A. Berman, Rachel Barkow, Louis Michael Seidman, Kimani Paul-Emile, Jennifer D. Oliva, Shaun Ossei-Owusu, Katherine Shaw, Paul Butler, David E. Pozen

Faculty Scholarship

This collection of essays provides extended commentary from multiple law professors on David Pozen’s 2024 book, The Constitution of the War on Drugs. Pozen’s book provides a rich and astute perspective on a wide array of dynamic legal, political, and social stories at the intersection of constitutional jurisprudence and drug policy. The work is the first book in Oxford University Press’s Inalienable Rights series to be fully open access. Yale Law Professor Jack Balkin, recognizing the book engaged many historical and cutting-edge issues in the fields of constitutional law, criminal law and health law, invited professors in these fields …

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

Employer-Sponsored Reproduction, Valarie K. Blake, Elizabeth Mccuskey

Faculty Scholarship

This Article interrogates the current and future role of employer-sponsored health insurance in reproductive choice, revealing the magnitude of impact that employers’ insurance coverage choices have on Americans’ access to reproductive care, as well as the legal infrastructure that prioritizes employer choice over individual autonomy.

Over half the population depends on employers for health insurance. The laws regulating those plans grant employers discretion in what services to cover, with exceptionally wide latitude for employers’ choices about reproductive care services, like abortion, contraception, infertility, and pre-exposure prophylaxis (PrEP). In their role as health care funders, employers pursue their own economic interests, …