Law Commons^™

Why Money Is Well Spent On Time, Michael Ulrich

Faculty Scholarship

There are a few reasons why incentivizing clinicians to spend more time with patients can improve health outcomes. Doing so affords clinicians time to assess social determinants’ influences on their patients’ health experiences; offers opportunities to identify and respond to patients’ loneliness; and helps motivate patients’ trust in health care, strengthen patient-clinician relationships, and bolster patients’ adherence to clinicians’ recommendations.

Border Babies — Medical Ethics And Human Rights In Immigrant Detention Centers, Sondra S. Crosby, George J. Annas

Faculty Scholarship

Providing decent medical care for families in U.S. detention centers near the Mexican border has become exceedingly difficult over the past 2 years. Trauma was inflicted on migrants to deter others from attempting to enter the United States. A cornerstone of deterrence was the “zero tolerance” policy that forcibly separated children from their parents at the border. Photographs of children confined in cages horrified Americans, who demanded that the policy be rescinded. It was, but family separations continue and have been made even worse by the Migrant Protection Protocol (MPP) — which the U.S. Supreme Court will most likely review …

What Federalism Means For The Us Response To Coronavirus Disease 2019, Sarah H. Gordon, Nicole Huberfeld, David K. Jones

Faculty Scholarship

The rapid spread of novel coronavirus disease 2019 (COVID-19) across the United States has been met with a decentralized and piecemeal response led primarily by governors, mayors, and local health departments. This disjointed response is no accident. Federalism, or the division of power between a national government and states, is a fundamental feature of US public health authority.¹ In this pandemic, US public health federalism assures that the coronavirus response depends on zip code. A global pandemic has no respect for geographic boundaries, laying bare the weaknesses of federalism in the face of a crisis.

Epilogue: Health Care, Federalism, And Democratic Values, Nicole Huberfeld

Faculty Scholarship

Is the United States experiencing a “crisis of democracy in health care”? This symposium's central question can only begin to be addressed here. The answer depends, in part, on where we look and how we measure democracy.

Democracy is a complex ideal often said to be promoted by federalism. In health care, each level of government exercises power because federalism is a default choice in health reform efforts. This default enables state governments and the federal government to create, enforce, and adjudicate health law and policy - democratic operations at the national and the subnational levels. But on each democratic …

Federalism In Health Care Reform, Nicole Huberfeld

Faculty Scholarship

Throughout American history, protecting states’ rights within federal health reform laws has served purposes other than the needs of the poor, such as excluding those deemed undeserving of assistance, the “able-bodied.” This chapter explores the role of federalism in health reform, paying particular attention to the importance of universality in programs meant to aid the poor, such as Medicaid. American federalism is dynamic, involving separate state negotiations with the federal government rather than the fixed dual sovereignty imagined by the Supreme Court. Such negotiations lead to variability, which in health care may lower the baseline for reform-resistant states and thus …

Big Waiver Under Statutory Sabotage, Elizabeth Mccuskey

Faculty Scholarship

The Affordable Care Act's State Innovation waiver allows federal agencies to suspend the most controversial parts of the statute for states to pursue alternative paths, while keeping the federal funding provided by the statute. This "big waiver" provision has the potential to enable states to pursue transformative health reforms, while preserving the affordability and universal coverage aims of the federal statute. Big waivers like this one carry theoretical promise, which largely depends on the strength of the federal statute's baseline infrastructure. This Essay considers early implementation of the State Innovation waiver as a test for big waiver theory - and …

Can Work Be Required In The Medicaid Program, Nicole Huberfeld

Faculty Scholarship

On January 11, 2018, a new policy encouraging states to develop work requirements in their Medicaid programs was issued by the Centers for Medicare and Medicaid Services (CMS).1 Under this policy, states can require nonelderly, nondisabled adults to work or engage in community service to qualify for Medicaid coverage, unless they are deemed medically frail or have a substance use disorder. States will be permitted to require detailed reporting on work status, decide who will be exempt from these requirements, and impose lockout periods for those who do not comply. For example, Kentucky’s newly approved program requires at least …

Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson

Faculty Scholarship

In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a non-financial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health‐related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

The Picture Begins To Assert Itself: Rules Of Construction For Essential Health Benefits In Health Insurance Plans Subject To The Affordable Care Act, Wendy K. Mariner

Faculty Scholarship

As the ACA shifts the function of health insurance from voluntary contract to a means of financing health care, it poses some challenges to traditional doctrines for interpreting health plan provisions. This article explores whether and how the doctrine of reasonable expectations and rules of statutory interpretation might apply to Essential Health Benefits coverage. A functional approach linking the two into a doctrine of reasonable statutory expectations could move us toward developing more consistent rules of interpretation within a more realistic conception of contemporary health insurance.

Women And Children Last — The Predictable Effects Of Proposed Federal Funding Cuts, Wendy K. Mariner, George J. Annas

Faculty Scholarship

"Women and children last” might as well be the refrain of the current U.S. Congress's new health care budget cutters. We have seen similar efforts before. In the mid-1990s, managed care organizations tried to save money by limiting hospitalization benefits for new mothers and their infants to 24 hours after a vaginal delivery and 48 hours after a cesarean section. As with current Congressional proposals, financial savings were seen as more important than the health of women and children. Because only women get pregnant and give birth, restricting access to reproductive health care is discriminatory on its face and undermines …

Can Congress Make You Buy Broccoli? And Why That's A Hard Question, Wendy K. Mariner, George J. Annas, Leonard H. Glantz

Faculty Scholarship

The continuing uncertainty over the constitutionality of the Affordable Care Act (ACA), illustrated by conflicting trial court rulings and scholarly commentaries, raises the question of why this constitutional question is so hard to answer. There are at least four reasons.

Health Insurance Politics In Federal Court, Wendy K. Mariner, George J. Annas

Faculty Scholarship

Having been outmaneuvered in Congress with the passage of the Patient Protection and Affordable Care Act (“Affordable Care Act,” or ACA), Republicans have taken their case to federal court, arguing that the law's key provision, the individual mandate to purchase health insurance, is unconstitutional. This argument has been made most prominently by attorneys general from 20 states in a Florida federal court and by the Commonwealth of Virginia in a Virginia federal court. In early August, federal district court judge Henry Hudson decided that the Virginia challenge deserves a hearing,1 thereby giving the constitutional argument an aura of respectability …

Social Solidarity And Personal Responsibility In Health Reform, Wendy K. Mariner

Faculty Scholarship

In the United States, calls to expand access to health care, when not simply ignored, typically result in bills or legislation to reform health insurance. We are in the midst of just such a cycle today. Several states have adopted reform laws to make insurance available to most of their residents.' Presidential candidates are offering their own proposals for the nation's health care system.² Former Treasury Secretary Paul O'Neill even declared that health care should be a right, adding that wealthier people should help pay for those who will never be able to afford their own care.' Most Americans …

Reviews In Medical Ethics: Stumbling On Options: A Review Of Readings In Comparative Health Law & Ethics, Frances H. Miller

Faculty Scholarship

Thanks to a series of storms sweeping up the eastern seaboard for three days, I found myself with four fivehour flight delays and two completely unrelated books in my briefcase. One of the books was the second edition of Professor Tim Jost's Readings in Comparative Health Law & Ethics,' which I was reviewing for this publication. The second was Daniel Gilbert's Stumbling on Happiness,² which someone - no doubt thinking I could use a little wisdom on the subject - had given me for my birthday. I did not mind the delays, for they gave me time …

Why Don’T Doctors & Lawyers (Strangers In The Night) Get Their Act Together?, Frances H. Miller

Faculty Scholarship

Health care in America is an expensive, complicated, inefficient, tangled mess – everybody says so. Patients decry its complexity, health care executives bemoan its lack of coherence, physicians plead for universal coverage to simplify their lives so they can just get on with taking care of patients, and everyone complains about health care costs. The best health care in the world is theoretically available here, but we deliver and pay for it in some of the world’s worst ways. Occam’s razor (“Among competing hypotheses, favor the simplest one”) is of little help here. There are no simple hypotheses – everything …

Trusting Doctors: Tricky Business When It Comes To Clinical Trials, Frances H. Miller

Faculty Scholarship

This article examines the troublesome ethical dilemmas arising out of physician conflicts of interest in the context of research on human beings. It focuses on the inevitable conflict between the objectives of clinical investigators and those of their human subjects to illuminate subtle divergences of interest in doctor-patient relationships that patients often do not recognize - or want to believe. Once perceived, however, these potentially corroding conflicts can stun research subjects and their families, and leave them feeling deeply betrayed by their clinicians. The article concludes that a researcher's substantial financial conflicts constitute material information which, absent compelling circumstances, the …

Health Care, Technology And Federalism, Kevin Outterson

Faculty Scholarship

The regulation of health care has traditionally been the province of the states, most often grounded in the police power. In Colonial times, this division of responsibility was a rational response to the technological level of the eighteenth century, although even in the youth of the Republic some health and safety regulation required national and international action. With the growth of distancecompression technology, the increase in mobility of goods and services, and a significant federal financial role in health care, the grip of the police power on the regulation of health care has been weakened. Discussion of the police power …

Slouching Toward Managed Care Liability: Reflections On Doctrinal Boundaries, Paradigm Shifts, And Incremental Reform, Wendy K. Mariner

Faculty Scholarship

Following the seemingly endless debate over managed care liability, I cannot suppress thoughts of Yeats’s poem, “The Second Coming.” It is not the wellknown phrase, “Things fall apart; the centre cannot hold,” that comes to mind; although that could describe the feeling of a health-care system unraveling. The poem’s depiction of lost innocence — “The best lack all conviction, while the worst/Are full of passionate intensity” — does not allude to the legislature, the industry, the public, or the medical or legal profession. What resonates is the poem’s evocation of humanity’s cyclical history of expectation and disappointment, with ideas as …

What Recourse?—Liability For Managed Care Decisions And The Employee Retirement Income Security Act, Wendy K. Mariner

Faculty Scholarship

Should managed-care organizations be accountable to patients injured by the company's negligence or wrongdoing? The general rule is that all organizations, including managed-care organizations, are legally liable for causing personal injury as a result of their own negligence or the negligence of their employees or agents.1-4 However, as most observers of the U.S. health care system know by now, there is an exception to this basic legal rule of accountability. The Employee Retirement Income Security Act of 1974 (ERISA) has been interpreted to grant health benefit plans provided by employers or unions (and the managed-care organizations that sell or …

Standards Of Care And Standard Form Contracts: Distinguishing Patient Rights And Consumer Rights In Managed Care, Wendy K. Mariner

Faculty Scholarship

There is hardly a legislature in the country that is not currently debating the issue of patient rights in managed care. Not surprisingly, legislators, as well as reporters covering the debate, have called upon George J. Annas, Edward R. Utley Professor of Health Law and Chair of the Health Law Department at Boston University, for information and advice. Professor Annas has earned the title of "father of patient rights" for his decades of research, writing, and advocacy on behalf of individuals who need health care and deserve justice.

Today, however, one might ask whether patient rights are compatible with managed …

Medical Discipline In The 21st Century: Can Purchasers Do It?, Frances H. Miller

Faculty Scholarship

Millenia prompt reflection about change, both past and future. Tons of newsprint have already been devoted to documenting the astonishing developments in medicine during the past century, and to speculating about what breakthroughs to expect in the next one.¹ Health economists generally accept that these changes, particularly advances in technology, have been the dominant factor propelling U.S. health care costs into the stratosphere over the past hundred years.' Analysts by the score have also examined the myriad ways in which this nation's health care delivery system has been (and must continue to be) transformed to cope with these expensive …

State Regulation Of Managed Care And The Employee Retirement Income Security Act, Wendy K. Mariner

Faculty Scholarship

The federal Employee Retirement Income Security Act (ERISA)1 is the federal law that governs employee-benefit plans offered by private employers and unions. ERISA has long hindered state efforts to expand access to health care, because it prohibits states from requiring all employers to offer benefits to their employees.2 States have shifted their attention from seeking universal insurance coverage for health care to regulating the benefits of people who already have health insurance. Reports describing how some managed-care organizations limit the care provided to their enrollees have prompted a rash of legislative efforts intended to protect patients from receiving …

Business Vs. Medical Ethics: Conflicting Standards For Managed Care, Wendy K. Mariner

Faculty Scholarship

The increased competition for a share of the market of insured patients, which arose in the wake of failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations. Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient care, are of special concern because they can create incentives to withhold beneficial care from patients. Of course, fee-for-service (FFS) medical practice creates incentives to provide unnecessary services, and managed care can avoid that type of harm. Still, as Edmund Pellegrino has noted, …

Working And Poor: The Increasingly Popular Practice Of Excluding Disabled Employees From Health Care Coverage, Maria O'Brien

Faculty Scholarship

One might think, since passage of the Americans With Disabilities Act of 1990 (ADA),' that the employment story for disabled employees or would-be disabled employees was cheerful, or at least improving. This may be true in so far as obtaining and retaining employment is concerned;' however, the ADA, because it permits employers and third-party insurers to continue to utilize traditional risk management techniques, has resulted in reduced or (in some cases) non-existent employee benefits for the disabled. At the same time, more and more employers are opting to self-insure under the Employee Retirement Income Security Act of 1974 (ERISA),3 in …

The Empire Of Death: How Culture And Economics Affect Informed Consent In The U.S., The U.K., And Japan, George J. Annas, Frances H. Miller

Faculty Scholarship

Historically, most Americans have treated health care as a private commodity whose price, and therefore availability, is primarily determined by market forces. In such a context, the law not unsurprisingly places a high premium on information disclosure by physicians. Personal autonomy-an individual's power to choose among medical options-enjoys its most zealous protection under U.S. jurisprudence.⁷ The dominant U.S. version of informed consent is grounded on principles of patient/consumer autonomy, and seems to enhance market choice. But a strong theme of collectivism now runs through some discussions of U.S. health policy.⁸ President Clinton was elected at least in part …

Problems With Employer-Provided Health Insurance — The Employee Retirement Income Security Act And Health Care Reform, Wendy K. Mariner

Faculty Scholarship

Health care reform is in the wind. As the nation prepares for a new presidential term, a more equitable and cost-effective health care system is beginning to sound inevitable.1 But the shape of that system remains a matter of debate. Employer-provided health insurance is the cornerstone of several national proposals for reform.2 3 4 5 6 The Bush administration's preference for tax credits rested on the assumption that most employers would continue to provide health insurance to their employees. President-elect Bill Clinton's proposal relies on insurance reform to enable small businesses to buy affordable private health insurance. Lawmakers …

Risky Business: Setting Public Health Policy For Hiv-Infected Health Care Professionals, George J. Annas

Faculty Scholarship

In JULY 1991, THE UNITED STATES SENATE VOTED 81 to 18 to impose a $10,000 fine and a ten-year jail sentence on any HTV-infected physicians who treated patients without disclosing their HIV status. Senator Jesse Helms, the sponsor of the measure, explained his rationale: “Let the punishment fit the crime. . . . I believe in horsewhipping. I feel that strongly about it” (Tolchin 1991). Later, Senator Helms wrote that HIV-infected physicians who practice medicine “should be treated no better than the criminal who guns down a helpless victim on the street” (Helms 1991). In his article he explained that …