Health Law and Policy Commons^™

Beyond The Ethical Boundaries Of Solidarity: Increasing Vaccination Rates Through Mandatory Education To Solidarity, Nili Karako- Eyal Dr.

Texas A&M Law Review

Mandatory vaccination laws require children to be vaccinated against certain communicable diseases to attend school. These laws also provide exemptions to school vaccination requirements.1 All states exempt children from vaccination requirements for medical reasons, and most states also provide an exemption for religious and/or other personal reasons.2 Seven states include an educational component in their religious or philosophical exemption process, requiring that parents receive information regarding the benefits of vaccination and the risks of not being vaccinated.3 Of these seven states, five require that information regarding the social benefits of vaccination will be provided to parents.4

This type of legislation …

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …

Genetic Data Privacy Solutions In The Gdpr, Kristi Harbord

Texas A&M Law Review

The intersection of healthcare and technology is a rapidly growing area. One thriving field at this intersection involves obtaining, processing, and storing genetic data. While the benefits have been great, genetic information can reveal a great deal about individuals and their families. And the information that can be conveyed from genetic data appears limitless and is constantly growing and changing. Many entities have begun storing, processing, and sharing genetic data on a very large scale. This creates many privacy concerns that the current regulatory framework does not account for. The line between patient data and consumer data is blurred; many …

Robots Are Coming: A Discussion Of Choice-Of-Law Issues And Outcomes In Telesurgical Malpractice, Megan Cloud

Texas A&M Law Review

New technology frequently emerges that challenges the legal status quo. Early adopters must then grapple with uncertainty over how the law will apply to novel legal quandaries. There is no better example of this than in medicine; however, the health care field is notoriously risk averse. Despite this, the practice of medicine stands to gain tremendously from these technological advancements. One such advancement is the relatively new ability to perform robotic surgery in which the surgeon is remote from the patient. Widespread use of this technology would improve rural access to surgical care, as well as improve access to more …

Fifth Indifference: Clarifying The Fifth Circuit's Intent Standard For Damages Under Title Ii Of The Americans With Disabilities Act, Derek Warden

Texas A&M Law Review

The Americans with Disabilities Act prohibits discrimination against people with disabilities. Title II of the ADA applies to public entities. That same Title allows plaintiffs to obtain damages upon a showing that the discrimination was intentional. There are generally two possible standards of intent: (1) deliberate indifference or (2) animus. While most Circuit Courts expressly adopted the deliberate indifference model, the Fifth Circuit has not. Indeed, the Fifth Circuit has not adopted any standard and this has led to confusion. The confusion is not helped, moreover, by the sheer lack of justification offered by a number of the Circuit Courts …

If You Would Not Criminalize Poverty, Do Not Medicalize It, William M. Sage, Jennifer E. Laurin

Faculty Scholarship

American society tends to medicalize or criminalize social problems. Criminal justice reformers have made arguments for a positive role in the relief of poverty that are similar to those aired in healthcare today. The consequences of criminalizing poverty caution against its continued medicalization.

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …

Give Me Your Tired, Your Poor, Your Pregnant: The Jurisprudence Of Abortion Exceptionalism In Garza V. Hargan, Kaytlin L. Roholt

Texas A&M Law Review

Since a majority of Supreme Court justices created the abortion right in 1973, a troubling pattern has emerged: The Supreme Court has come to ignore—and even nullify—longstanding precedent and legal doctrines in the name of preserving and expanding the abortion right. And with a Supreme Court majority that is blithe to manipulate any doctrine or principle—no matter how deeply rooted in U.S. legal tradition—in the name of expansive abortion rights, it should come as no surprise that lower courts are following suit. Most recently, the D.C. Circuit fired up the “ad hoc nullification machine,” but this time, its victim of …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

Unlocking Exchanges, Brendan S. Maher

Faculty Scholarship

The fate of the Affordable Care Act is uncertain. Moreover, the nation is in an unusual state of political turmoil and may have no appetite for anything other than revolutionary changes to the ACA, if not its outright repeal. But press reports suggest even Republican officials formerly committed to its extirpation are now thinking instead about a measured path forward.

In any event, one fact about the ACA should not escape the attention of serious reformers: the legislation has already accomplished the difficult task of laying the ground work for a move away from employment-based (EB) insurance, a move scholars …

Error Disclosure Training And Organizational Culture, Jason M. Etchegaray, Thomas H. Gallagher, Sigall K. Bell, William M. Sage, Eric J. Thomas

Faculty Scholarship

Objective. Our primary objective was to determine whether, after training was offered to participants, those who indicated they had received error disclosure training previously were more likely to disclose a hypothetical error and have more positive perceptions of their organizational culture pertaining to error disclosure, safety, and teamwork.

Methods. Across a 3-year span, all clinical faculty from six health institutions (four medical schools, one cancer center, and one health science center) in The University of Texas System were offered the opportunity to anonymously complete an electronic survey focused on measuring error disclosure culture, safety culture, teamwork culture, and intention to …

Antitrust As Disruptive Innovation In Health Care: Can Limiting State Action Immunity Help Save A Trillion Dollars?, William M. Sage, David A. Hyman

Faculty Scholarship

On February 25, 2015, the United States Supreme Court ruled in North Carolina State Board of Dental Examiners v. FTC that state licensing boards controlled by market participants are subject to federal antitrust law unless they are “actively supervised” by the state itself. The ruling may sound narrow and technical, but the significance of the case can be inferred from the number and prominence of the amici curiae who lined up to support the North Carolina State Board of Dental Examiners (“North Carolina Board”)—first when the Federal Trade Commission’s (“FTC”) internal enforcement action was appealed to the United States Court …

Some Thoughts On "Healthism" And Employee Benefits In The Age Of Trump, Brendan S. Maher

Faculty Scholarship

I look forward to the publication of HEALTHISM: HEALTH STATUS DISCRIMINATION AND THE LAW (hereinafter Healthism), by Jessica L. Roberts of the University of Houston Law Center and Elizabeth Weeks Leonard of the University of Georgia Law School.

On November 4, 2016, at the invitation of Professors Roberts and Weeks, I participated in a conference in which the discussants commented on Roberts and Weeks' forthcoming book and shared thoughts about the relevance of that work to various related fields. What follows here is somewhat different than those comments-although the general themes are the sameand is so in part because, four …

Fracking Health Care: How To Safely De-Medicalize America And Recover Trapped Value For Its People, William M. Sage

Faculty Scholarship

The wealth trapped within American health care is simultaneously a tragedy and a miracle. It is a tragedy because stagnating wages, widening disparities in income, ballooning deficits, and stunted investments in education and social services make such medical profligacy shameful. It is a miracle because it still exists, whereas other U.S. economic resources of similar magnitude have already been dissipated by global market forces without addressing any of the aforementioned failings – indeed, sometimes having contributed to them. It therefore can be released and used.

It is time to “frack the health care system” and innovate the de-medicalization of America. …

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 …

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 …

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 …

When Biopharma Meets Software: Bioinformatics At The Patent Office, Saurabh Vishnubhakat, Arti K. Rai

Faculty Scholarship

Scholars have spilled much ink questioning patent quality. Complaints encompass concern about incoming applications, examination by the U.S. Patent and Trademark Office (“USPTO”), and the USPTO’s ultimate output. The literature and some empirical data also suggest, however, that applications, examination, and output may differ considerably based on technology. Most notably, although definitions of patent quality are contested, quality in the biopharmaceutical industry is often considered substantially higher than that in information and communications technology (ICT) industries.

This Article presents the first empirical examination of what happens when the two fields are combined. Specifically, it analyzes the creation and early history …

Compelling Interests And Contraception, Neil S. Siegel, Reva Siegel

Faculty Scholarship

On the eve of Griswold v. Connecticut’s fiftieth anniversary, employers are bringing challenges under the Religious Freedom Restoration Act (RFRA) to federal laws requiring them to include contraception in the health insurance benefits that they offer their employees. In Burwell v. Hobby Lobby Stores, five Justices asserted that the government has compelling interests in ensuring employees access to contraception, but did not discuss those interests in any detail. In what follows, we clarify those interests by connecting discussion in the Hobby Lobby opinions and the federal government’s briefs to related cases on compelling interests and individual rights in the areas …

Contraception As A Sex Equality Right, Neil S. Siegel, Reva B. Siegel

Faculty Scholarship

Challenges to federal law requiring insurance coverage of contraception are occurring on the eve of the 50th Anniversary of the U.S. Supreme Court’s decision in Griswold v. Connecticut. It is a good time to reflect on the values served by protecting women’s access to contraception.

In 1965, the Court ruled in Griswold that a law criminalizing the use of contraception violated the privacy of the marriage relationship. Griswoldoffered women the most significant constitutional protection since the Nineteenth Amendment gave women the right to vote, constitutional protection as important as the cases prohibiting sex discrimination that the Court would …

Our 'Patchwork' Health Care System: Melodic Variations, Counterpoint, And The Future Role Of Physicians, William M. Sage

Faculty Scholarship

This Foreword to a forthcoming symposium on the "patchwork" health care system to be published in the Houston Journal of Health Law & Policy considers whether current reactions to fragmentation in health care represent minor variations on a longstanding theme in US health policy or offer a more substantial counterpoint to that theme. The theme is this: that perfect physicians should be allowed to control health care even if safeguards are needed in practice because real physicians are not perfect. The Foreword previews four scholarly articles featured in the published symposium. It concludes that, while all the articles present original …

None Of The Laws But One, Neil S. Siegel

Faculty Scholarship

This Symposium contribution explores differences in how congressional Republicans responded to Medicare and how they responded to the Patient Protection and Affordable Care Act (ACA). Given the narrowness of the constitutional challenges to the ACA that congressional Republicans promoted and the many federal taxes, expenditures, and regulations that they support, this Article rejects the suggestion that today's Republicans in Congress generally possess a narrow view of the constitutional scope of federal power. The Article instead argues that congressional Republicans then and now-and the two parties in Congress today-fracture less over the constitutional expanse of congressional authority and more over the …

Putting Insurance Reform In The Aca's Rear-View Mirror, William M. Sage

Faculty Scholarship

This Commentary acknowledges and applauds efforts to understand the mechanisms of insurance reform contained in the ACA and to evaluate their success or failure. But the Commentary’s principal purpose is to examine the pros and cons of connecting insurance reform to health care and health—the pen and the french fry—and to convey the importance to the country of moving beyond insurance reform as quickly as possible. The Commentary begins by describing the potential synergies among the three health policy domains and offering reasons why the ACA sought to make simultaneous changes. It then identifies the vulnerabilities that are revealed in …

The Affordable Care Act, Remedy, And Litigation Reform, Brendan S. Maher

Faculty Scholarship

The Patient Protection and Affordable Care Act of 2010 (“ACA”) rewrote the law of private health insurance. How the ACA rewrote the law of civil remedies, however, is — to date — a question largely unexamined by scholars. Courts everywhere, including the United States Supreme Court, will soon confront this important issue.

This Article offers a foundational treatment of the ACA on remedy. It predicts a series of flashpoints over which litigation reform battles will be fought. It identifies several themes that will animate those conflicts and trigger others. It explains how judicial construction of the statute’s functional predecessor, the …

Reverse Payments, Perverse Incentives, Murat C. Mungan

Faculty Scholarship

Issuing and enforcing prescription drug patents requires courts and legislatures to strike a delicate balance. A patent gives drug manufacturers a legal, if temporary, monopoly on sales of a drug; this encourages manufacturers to engage in costly research and development of new medicines. But not all patents issued by the Patent Office are ultimately deemed valid – generic drug manufacturers can infringe the patent, and, when sued, attack its validity in court on a variety of grounds, including obviousness. In recent years, patent holders have begun to settle these suits (which they initiated) by paying the alleged infringer. Not surprisingly, …

Not The Power To Destroy: An Effects Theory Of The Tax Power, Robert D. Cooter, Neil S. Siegel

Faculty Scholarship

The Supreme Court’s “new federalism” decisions impose modest limits on the regulatory authority of Congress under the Commerce Clause. According to those decisions, the Commerce Clause empowers Congress to use penalties to regulate interstate commerce, but not to regulate noncommercial conduct. What prevents Congress from penalizing non-commercial conduct by calling a penalty a tax and invoking the Taxing Clause? The only obstacle is the distinction between a penalty and a tax for purposes of Article I, Section 8. In National Federation of Independent Business v. Sebelius (NFIB), the Court considered whether the minimum coverage provision in the Patient Protection and …

The New Textualism, Progressive Constitutionalism, And Abortion Rights: A Reply To Jeffrey Rosen, Neil S. Siegel

Faculty Scholarship

In this Essay, I offer a few thoughts in response to Jeffrey Rosen's contribution to this symposium on Jack Balkin's "Living Originalism". I will first focus on what he writes about the "new textualism." I will then reply to what he intimates about the continuing validity of Roe v. Wade. In short, I will argue that Rosen offers progressives little reason to accept the new textualism or to reject Roe in the name of legal fidelity.

If the abortion right is ultra vires because a lack of decisive warrant in text, structure, and history trumps mediating equality principles and legal …

Equality Arguments For Abortion Rights, Neil S. Siegel, Reva B. Siegel

Faculty Scholarship

Roe v. Wade grounds constitutional protections for women’s decision wheth­er to end a pregnancy in the Due Process Clauses. But in the four decades since Roe, the U.S. Supreme Court has come to recognize the abortion right as an equality right as well as a liberty right. In this Essay, we describe some distinctive features of equality arguments for abortion rights. We then show how, over time, the Court and individual Justices have begun to employ equal­ity arguments in analyzing the constitutionality of abortion restrictions. These arguments first appear inside of substantive due process case law, and then as claims …

Enough About The Constitution: How States Can Regulate Health Insurance Under The Aca, Brendan S. Maher, Radha A. Pathak

Faculty Scholarship

Last term, the United States Supreme Court upheld the constitutionality of the Affordable Care Act in a landmark decision. It is a forceful reminder that America’s oldest question — how power should be shared between federal and state sovereigns — retains powerful political salience. Critics have reflexively attacked the decision as an assault on states’ rights, while supporters have celebrated the result. Regrettably, insufficient attention has been paid to how, in actuality, health care regulatory authority has been and will be divided between federal and state governments. In this Article, we fill that gap. To do so, we apply “federalism-in-fact,” …