Health Law and Policy Commons^™

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

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 …

Recognizing Women's Rights At Work: Health And Women Workers In Global Supply Chains, Erika R. George, Candace D. Gibson, Rebecca Sewall, David Wofford

Faculty Scholarship

The Guiding Principles mandate that businesses respect the human fights enshrined in the International Bill of Human Rights and in the International Labour Organization (ILO)'s Declaration on Fundamental Principles and Rights at Work. Due diligence processes and risk impact assessments are the main recommended means for ensuring compliance with companies' commitments to respect international human fights. Because OSH as a conceptual framework and regulatory order is not sufficient to identify the risk of health fights violations to women workers, we argue companies should not anchor their due diligence and risk assessment in OSH conventions and settle for a check-the-box solution …

Abortion In A Post-Truth Moment: A Response To Erwin Chemerinsky And Michele Goodwin, Aziza Ahmed

Faculty Scholarship

In Abortion: A Woman’s Private Choice, Erwin Chemerinsky and Michele Goodwin respond to the crisis of abortion rights in our current political moment. While preserving the right to abortion is an ongoing challenge for reproductive-justice advocates and lawyers, the arrival of a new Republican administration led by Donald Trump and a Republican majority in the House and Senate heightens these concerns. In the face of ongoing and new threats to abortion access, Chemerinsky and Goodwin argue that abortion should be treated as a woman’s private choice. I agree with Chemerinsky and Goodwin, as all supporters of abortion rights should. …

Decreasing Smoking But Increasing Stigma? Anti-Tobacco Campaigns, Public Health, And Cancer Care, Kristen E. Riley, Michael Ulrich, Heidi A. Hamann, Jamie S. Ostroff

Faculty Scholarship

Public health researchers, mental health clinicians, philosophers, and medical ethicists have questioned whether the public health benefits of large-scale anti-tobacco campaigns are justified in light of the potential for exacerbating stigma toward patients diagnosed with lung cancer. Although there is strong evidence for the public health benefits of antitobacco campaigns, there is a growing appreciation for the need to better attend to the unintended consequence of lung cancer stigma. We argue that there is an ethical burden for creators of public health campaigns to consider lung cancer stigma in the development and dissemination of hard-hitting anti-tobacco campaigns. We also contend …

Teaching The Law Of American Health Care, Elizabeth Weeks, Nicole Huberfeld, Kevin Outterson

Faculty Scholarship

In writing our casebook, The Law of American Health Care, we started from scratch, rethinking the topics to include and themes around which to organize them. Like many health law professors, we were schooled in and continued to propound the traditional themes of cost, quality, access, and choice. While those concerns certainly pervade many areas of health care law, our casebook's overarching themes emphasize different issues, namely: federalism, individual rights, fiduciary relationships, the modem administrative state, and market regulation. These new themes, we believe, better capture the range of issues and topics essential forthe new generation of health lawyers. When …

Nfib V. Sebelius At 5, Nicole Huberfeld

Faculty Scholarship

Keeping up with health care reform is like running up a mountain of sand - every time you reach the top, -the terrain starts shifting. In this talk, I offer a snapshot of where we are in implementing the Patient Protection and Affordable Care Act ("ACA") to aid in understanding the significance of NFIB v. Sebelius' at five. I will situate the ACA2 within historical patterns in American health care reform. I have been asked to discuss the key points of the NFIB decision, after which I will share some of the research that I have performed for the past …

The Economics Of Healthcare Rationing, Michael D. Frakes, Matthew B. Frank, Kyle Rozema

Faculty Scholarship

This article examines the economics of healthcare rationing. We begin with an overview of the various dimensions across which healthcare rationing operates, or at least has the potential to operate, in the first place. We then describe the types of economic analyses used in healthcare rationing decision-making, with particular reference to cost-benefit analysis and cost-effectiveness analysis. We also discuss healthcare rationing in practice, such as how economic analyses inform decisions regarding which services to cover, and conclude by discussing various practical and conceptual challenges that may arise with economic analyses and that span both economics and ethics.

Changing The Tax Code To Create Consumer-Driven Health Insurance Competition, Regina Herzlinger, Barak D. Richman

Faculty Scholarship

Because current tax laws exclude employer-paid health insurance premiums from employees’ taxable wages and income, employer-sponsored insurance remains the primary source of health insurance for most employed Americans. Economists have long blamed the employer-based insurance tax exclusion for inflating health care costs, and, more recently, for constraining income growth and exacerbating income inequality.

We execute a simulation to test the effect of permitting employees to receive their employers’ premium contribution directly and then purchase health insurance themselves, using tax-free funds. Employees could deduct for income tax purposes the amount used for insurance and, if they spend less than the amount …

N.C. Medicaid Reform: A Bipartisan Path Forward, Barak D. Richman, Allison Rice

Faculty Scholarship

The North Carolina Medicaid program currently constitutes 32% of the state budget and provides insurance coverage to 18% of the state’s population. At the same time, 13% of North Carolinians remain uninsured, and even among the insured, significant health disparities persist across income, geography, education, and race.

The Duke University Bass Connections Medicaid Reform project gathered to consider how North Carolina could use its limited Medicaid dollars more effectively to reduce the incidence of poor health, improve access to healthcare, and reduce budgetary pressures on the state’s taxpayers.

This report is submitted to North Carolina’s policymakers and citizens. It assesses …

Creating A Data Resource: What Will It Take To Build A Medical Information Commons?, Patricia A. Deverka, Mary A. Majumder, Angela G. Villanueva, Margaret Anderson, Annette C. Bakker, Jessica Bardill, Eric Boerwinkle, Tania Bubela, Barbara J. Evans, Nanibaa’ A. Garrison, Richard A. Gibbs, Robert Gentleman, David Glazer, Melissa M. Goldstein, Hank Greely, Crane Harris, Bartha M. Knoppers, Barbara A. Koenig, Isaac S. Kohane, Salvatore La Rosa, John Mattison, Christopher J. O’Donnell, Arti K. Rai, Heidi L. Rehm, Laura L. Rodriguez, Robert Shelton, Tania Simoncelli, Sharon F. Terry, Michael S. Watson, John Wilbanks, Robert Cook-Deegan, Amy L. Mcguire

Faculty Scholarship

National and international public–private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable …

Overcoming The Legal And Regulatory Hurdles To Value-Based Payment Arrangements For Medical Products, Gregory W. Daniel, Thomas Barker, Arti K. Rai, Christian Springer, Marianne Hamilton Lopez, Jane Kalinina, Katie Greene, Jingyuan Qian, Mark B. Mcclellan

Faculty Scholarship

No abstract provided.

Minding Ps And Qs: The Political And Policy Questions Framing Health Care Spending, William M. Sage

Faculty Scholarship

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care …

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma E. Marouf

Faculty Scholarship

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised …

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 …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Dalia Deak, Kevin Outterson, John H. Powers, Aaron S. Kesselheim

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

Vaccines And Airline Travel: A Federal Role To Protect The Public Health, Christopher Robertson

Faculty Scholarship

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority — especially under the Commerce Clause — to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, John H. Rex, Kevin Outterson

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

Assembled Products: The Key To More Effective Competition And Antitrust Oversight In Health Care, William M. Sage

Faculty Scholarship

This Article argues that recent calls for antitrust enforcement to protect health insurers from hospital and physician consolidation are incomplete. The principal obstacle to effective competition in health care is not that one or the other party has too much bargaining power, but that they have been buying and selling the wrong things. Vigorous antitrust enforcement will benefit health care consumers only if it accounts for the competitive distortions caused by the sector’s long history of government regulation. Because of regulation, what pass for products in health care are typically small process steps and isolated components that can be assigned …

Regulating Employment-Based Anything, Brendan S. Maher

Faculty Scholarship

Benefit regulation has been called “the most consequential subject to which no one pays enough attention.” It exhausts judges, intimidates legislators, and scares off theorists. That need not be so. Reality is less complicated than advertised.

Governments often consider intervention if markets fail to make some socially desirable Good X — such as education, health care, home mortgages, or pensions, for example — sufficiently available. One obvious fix is for the government to provide the good itself. A less obvious intervention is for the government to regulate employment-based (EB) arrangements that provide Good X as a benefit to employees and …

An International Legal Framework To Address Antimicrobial Resistance, Steven J. Hoffman, Kevin Outterson, John-Arne Rottingen, Otto Cars, Charles Clift, Zain Rizvi, Fiona Rotberg, Göran Tomson, Anna Zorzet

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Health Care And The Myth Of Self-Reliance, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

Both pillars of the Affordable Care Act that are designed to facilitate universal coverage — the low-income tax subsidy and Medicaid expansion — have been subject to high-profile Supreme Court cases. While in King v. Burwell the Court saved the ACA’s low-income subsidy, in NFIB v. Sebelius the Court frustrated Medicaid expansion, at least temporarily. We argue that there is a deeper story about health care access for the poor. Drawing from the history of the American health care system, vulnerability theory, and demographic data, we demonstrate that all Americans lead subsidized lives and could find themselves quickly moving from …

Stopping Deceptive Health Claims: The Need For A Private Right Of Action Under Federal Law, Diane Hoffmann, Jack Schwartz

Faculty Scholarship

This is the accepted version of the article. The final published version is available at

https://journals.sagepub.com/doi/abs/10.1177/0098858816644715

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.