Law Commons^™

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …

Hacking Or Hatching The Skinny Label: How The Federal Circuit’S Decision In Gsk V. Teva Threatens Generics And Induced Infringement, Kayla Mccallum

Texas A&M Journal of Property Law

This Note focuses on the recent precedential decision handed down by the Federal Circuit in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which impacts “one of the greatest public health inventions of the 21st century”: generic drugs. An invention that rose to prominence when former President Ronald Reagan signed into law the Hatch-Waxman Act (“the Act”), formally known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Act aimed to increase competition between brand-name and generic manufacturers while balancing two seemingly opposing interests: (1) encourage and reward innovation by pioneer drug companies and (2) increase access …

A Response To Rules Of Medical Necessity, Brendan S. Maher

Faculty Scholarship

Professors Monahan and Schwarcz’s recent Article in the Iowa Law Review, Rules of Medical Necessity, is a must-read for multiple audiences. In this short Response, I informally describe health insurance, and—using that perspective—describe and comment on why Rules of Medical Necessity is a piece of work that not only deserves attention from experts in the field, but is also one that casual readers should choose first when attempting to understand how health insurance works in theory and practice.

What The Pandemic Taught Us: The Health Care System We Have Is Not The System We Hoped We Had, William M. Sage

Faculty Scholarship

The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community.

Why this happened is clearly important. But that it happened is …

Adding Principle To Pragmatism: The Transformative Potential Of "Medicare-For-All" In Post-Pandemic Health Reform, William M. Sage

Faculty Scholarship

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Age,” the Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy, and identifies professional and political barriers to more sweeping reform. It focuses on four aspects of health policy that have become apparent: simultaneous inefficiency and injustice in medical care, neglect of the …

Following The Money: The Aca’S Fiscal-Political Economy And Lessons For Future Health Care Reform, William M. Sage, Timothy M. Westmoreland

Faculty Scholarship

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship …

Mandatory Legal Malpractice Insurance: Exposing Lawyers' Blind Spots, Susan Saab Fortney

Faculty Scholarship

The legal landscape for lawyers’ professional liability in the United States is changing. In 2018, Idaho implemented a new rule requiring that lawyers carry legal malpractice insurance. The adoption of the Idaho rule was the first move in forty years by a state to require legal malpractice insurance since Oregon mandated lawyer participation in a malpractice insurance regime. Over the last two years, a few states have considered whether their jurisdictions should join Oregon and Idaho in requiring malpractice insurance for lawyers in private practice. To help inform the discussion, the article examines different positions taken in the debate on …

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.

Cross-Subsidies: Government's Hidden Pocketbook, John Brooks, Brian Galle, Brendan S. Maher

Faculty Scholarship

Governments can use regulation to pay for public goods out of the pockets of consumers, rather than taxpayers. For example, the Affordable Care Act underwrites care for women and the infirm through higher insurance premium payments by healthy men. Building on a classic article from Richard Posner, we show that these “cross-subsidies” between consumers are a common feature of modern law, ranging from telecommunications to intellectual property to employee benefits.

Critics of the ACA, and even some of its supporters, argue that taxes would be a better choice. Taxes are said to be more transparent, and to fit better with …

Regulatory Fracture Plugging: Managing Risks To Water From Shale Development, Caroline Cecot

Texas A&M Law Review

Debates about the desirability of widespread shale development have highlighted outstanding uncertainty about its health, safety, and environmental impacts—most prominently, its water-contamination risks—and the ability of current institutions to deal with these impacts. States, the primary regulators of oil and gas extraction, face pressure from the energy industry, local communities, and, in some cases, the federal government to strike the right balance between energy production and the health and safety of individuals and the environment—an elusive balance given the ongoing risk uncertainty. This dynamic is not especially unique to fracking, or even oil and gas extraction; instead, this dynamic, characterized …

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. …

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 …

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 …

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 …

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,” …

Health Insurance And Federalism-In-Fact, Radha A. Pathak, Brendan S. Maher

Faculty Scholarship

The constitutional legitimacy of the Patient Protection and Affordable Care Act (“ACA”) received substantial attention. Less examined has been the legislation’s sub-constitutional effect on the regulatory power that states can and might exercise. Regarding a state's ability to promulgate "sickness rules," (those legal rules pertaining to the conditions or treatment an insurance policy covers) and "non-sickness" rules (those legal rules pertaining to insurance other than sickness rules), we scrutinize the ACA itself and contrast it with the other most significant statute governing private health insurance, the Employee Retirement Income Security Act of 1974 (“ERISA”). The authors would like to thank …

Some Thoughts On Health Care Exchanges: Choice, Defaults, And The Unconnected, Brendan S. Maher

Faculty Scholarship

One feature of the ACA that appealed to observers across the political spectrum was the creation of health insurance “exchanges.” Among other things, exchanges are intended to aid consumers in making simple and transparent choices regarding the purchase of health insurance. This Article considers how exchanges might benefit from the use of “default” options — both online and off. Given the significant number of Americans that have limited or no Internet access, offline defaults may be an attractive way to promote coverage of the “unconnected.”

The Benefits Of Opt-In Federalism, Brendan S. Maher

Faculty Scholarship

The Affordable Care Act (“ACA”) is a controversial and historic statute that mandates people make insurance bargains. Unacknowledged is an innovative mechanism ACA uses to select the law that governs those bargains: opt-in federalism.

Opt-in federalism – in which individuals choose between federal and state rules – is a promising theoretical means to make and choose law. This Article explains why, and concludes that the appeal of opt-in federalism is independent of ACA. Whatever the statute’s constitutional fate, future policymakers should consider opt-in federalist approaches to answer fundamental but exceedingly difficult questions of health and retirement law.

Erisa & Uncertainty, Brendan S. Maher, Peter K. Stris

Faculty Scholarship

In the United States, retirement income and health insurance are largely provided through private promises made incident to employment. These “benefit promises” are governed by a statute called ERISA, which many healthcare and pension scholars argue is the cause of fundamental problems with our nation’s health and retirement policy. Inevitably, however, they advance narrowly tailored proposals to amend the statute. This occurs because of the widely-held view that reform should leave undisturbed the underlying core of the statute. This Article develops a theory of ERISA designed to illustrate the unavoidable need for structural reform.

Creating A Paternalistic Market For Legal Rules Affecting The Benefit Promise, Brendan S. Maher

Faculty Scholarship

Notwithstanding the fact that ERISA was enacted to protect employee benefits, courts have narrowly construed the relief available when benefits are denied, out of concern that a stronger remedy would be too costly for the system to bear. Judges, I argue, are ill-equipped to make this policy judgment. Instead, a regulated, subsidized, paternalistic market should be created to permit the benefit players themselves to choose and price the strength of the remedy they desire. This is a superior means to reach the right level of remedial strength for the most players. To protect against undesirably weak remedial options being selected, …

Dances With Elephants: Administrative Resolution Of Medical Injury Claims By Medicare Beneficiaries, Eleanor D. Kinney, William M. Sage

Faculty Scholarship

In our judgment, Hoffmann and Rowthorn's research clearly demonstrates that the QIO-based complaint review process does not provide genuine relief to beneficiaries. People who complain typically want an explanation of their bad experience, compensation for harm they may have suffered, and assurance that future experiences will be better for themselves and for others. Medicare beneficiaries, however, receive minimal information about the resolution of their complaints and no substantive relief whatsoever.

As Hoffmann and Rowthorn point out, several reform proposals are now before Congress, including moving the beneficiary complaint function from QIOs to new "Medicare Provider Review Organizations." It is not …

Resolving Medical Malpractice Claims In The Medicare Program: Can It Be Done?, Eleanor D. Kinney, William M. Sage

Faculty Scholarship

There is increasing interest in an integrated approach to patient safety and medical liability among policymakers. We have proposed Medicareled malpractice reform that would provide Medicare beneficiaries with better safety, improved communication in the event of error, preservation of therapeutic relationships, timely settlement, and fair compensation at a lower administrative cost. Disputes in the reformed system would be adjudicated by Medicare's existing administrative appeals system that would work together with Medicare's quality improvement regulation and payment policy to reduce errors and compensate injured patients.

Despite the laudable rationale for Medicare-led malpractice reform, important issues attend the constitutional and statutory authority …

Public Medical Malpractice Insurance: An Analysis Of State-Operated Patient Compensation Funds, Frank A. Sloan, Carrie A. Mathews, Christopher J. Conover, William M. Sage

Faculty Scholarship

Compared to major tort and insurance reforms, PCFs have received virtually no attention by scholars. With an exception or two, they are not a major focus of public policy debate either. Because they are small organizations and there have been lengthy periods in which medical malpractice markets are quiescent, they have not attracted much scrutiny. Given a lack of quantitative evidence, our evaluation depended on qualitative evidence. Yet PCFs address the fundamental issues of medical malpractice that have led to reoccurring crises in the availability of medical malpractice insurance coverage and in its premiums for such coverage. As such, PCFs …

Medical Malpractice Insurance And The Emperor's Clothes, William M. Sage

Faculty Scholarship

Tom Baker and Mark Geistfeld's contributions to this Symposium offer detailed and persuasive analyses of medical malpractice insurance. Their principal contribution to the malpractice reform debate, however, is simple: confirming that liability insurers should not be left to their own devices between malpractice crises or appeased during crisis periods. Instead, liability insurance must be consciously designed to help the health care system work toward its core goals of high quality, broad access, and affordable cost.

In 2000, the IOM issued a follow-up report to its earlier indictment of medical error, calling upon the health care system to become safe, effective, …

Managed Care’S Crimea: Medical Necessity, Therapeutic Benefit, And The Goals Of Administrative Process In Health Insurance, William M. Sage

Faculty Scholarship

This Essay explores the concept of medical necessity as it has evolved in the judicial and administrative oversight of managed care. The goals of the Essay are to illustrate the range of plausible rationales for establishing administrative procedures to govern medical necessity disputes, and to demonstrate the difficulty of incorporating into those procedures the most important professional and social responsibilities of managed care in today’s health care system. Part I of the Essay explains the ideological and practical significance of medical necessity as managed care has evolved. Part II examines medical necessity as a legal problem, and questions whether current …

Judicial Opinions Involving Health Insurance Coverage: Trompe L'Oeil Or Window On The World?, William M. Sage

Faculty Scholarship

This essay offers a few thoughts about using judicial decisions as the dataset for research into health insurance coverage. Part I offers a general overview of insurance coverage law. Part II considers why students of health insurance coverage gravitate toward studying published opinions. Part III then discusses what is wrong with the approach, and suggests alternatives. Finally, Part IV turns to what may be right with the approach, concluding that judicial opinions in coverage litigation may reveal the functionality (or dysfunctionality) of the coverage process in managed care. Although the basic critique which the essay presents applies to areas other …

Enterprise Liability And The Emerging Managed Health Care System, William M. Sage

Faculty Scholarship

“Enterprise medical liability” is a term used to describe a system in which health care organizations bear responsibility for medical malpractice in addition to or instead of individual health professionals. Enterprise liability is in many senses a natural outgrowth of the increasing dependence of medical practice on institutional resources and expertise. Proposals for enterprise liability surfaced briefly from the academic literature into the political spotlight during the 1993-94 health care reform debate. At that time, objections to the concept as a basis for medical malpractice liability, even in a restructured health care system, were nearly universal.

Just five years later, …