Health Law and Policy Commons^™

Foreword, Elizabeth Pendo

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi A. Walsh, Kari Baldwin, James M. Dubois

Saint Louis University Journal of Health Law & Policy

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

State Peer Review Laws As A Tool To Incentivize Reporting To Medical Boards, Nadia N. Sawicki

Saint Louis University Journal of Health Law & Policy

State medical boards have been stymied in their ability to take disciplinary action against physicians who engage in serious misconduct, in part because hospitals and other health care organizations rarely report such misconduct. This Article offers a proposal for incentivizing hospital reporting of physician misconduct, inspired by an existing but flawed model in the federal Health Care Quality Improvement Act. This Article proposes that state legislatures link state medical practice act reporting requirements with state laws establishing an evidentiary privilege for peer review activities.

Diversity From The Perspective Of Corporate Boards And Lawyer Disciplinary Boards, Lissa L. Broome, John M. Conley

Saint Louis University Journal of Health Law & Policy

This Article addresses the organizing question of this symposium—whether diversifying state medical boards (SMBs) would improve their effectiveness in disciplining doctors—by drawing on the comparable experiences of corporate boards of directors and lawyer disciplinary boards. Reexamining our own qualitative study of corporate board diversity conducted several years ago, we find that almost of all of the arguments for board diversity raised in the business literature or our own interviews also tend to support diversity on SMBs. Reviewing the legal profession’s experience with the diversity question on lawyer disciplinary boards, we find that many of these arguments have also been recognized, …

Contextualizing And Strengthening State Medical Board Responses To Physician Sexual Misconduct, Patricia A. King, Emily Gerard, Mark Staz, Eric M. Fish

Saint Louis University Journal of Health Law & Policy

As the instrument through which states regulate the professional conduct of medical practitioners, state medical boards play a critical role in addressing physician sexual misconduct. Sexual misconduct in the medical profession is particularly troubling given that physicians are often privy to the most intimate aspects of their patients’ lives. Patients place a profound trust in their physician, and the resulting relational dynamic may impact how a patient perceives or reacts to a physician’s conduct. State medical boards are often criticized for failing to respond appropriately to instances of sexual misconduct. However, some of these criticisms fail to consider historical attempts …

Finding The Cluster: Balancing Privacy And Public Health Amid The Covid-19 Pandemic, Jessie L. Bekker

Saint Louis University Journal of Health Law & Policy

More than 800,000 Americans have died and more than fifty-seven million sickened since March 2020 from the COVID-19 virus and its highly contagious variants. Public health officials urged the public to mask up, socially distance, and stay home in order to curb the virus’ spread in the early months of the pandemic before a vaccine was approved. Meanwhile, those same officials blocked access to valuable information pinpointing areas of disease concentration—“hotspots”—which could have alerted members of the public of locations to avoid. Those officials generally—and usually incorrectly—cited the Health Insurance Portability and Accountability Act (HIPAA) as grounds for …

Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous

Saint Louis University Journal of Health Law & Policy

Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

"Everybody Knows I'M Not Lazy": Medicaid Work Requirements And The Expressive Content Of Law, Kristen Underhill

Faculty Scholarship

In a first for the Medicaid program, the Department of Health and Human Services under President Trump allowed states to establish work requirements for program participants who are considered "able-bodied adults." These mandates were halted by litigation, and President Biden's administration is now in the process of withdrawing the waivers. But early experiences with Medicaid work requirements suggested that they can produce widespread losses of benefits. In addition to affecting access, work requirements and other conditions on public benefits can serve an expressive purpose: they provide a source of information about a state's values, goals, and beliefs about beneficiaries. Beneficiaries …

The Right To Mental Health In Yemen, Waleed Alhariri, Amanda Mcnally, Sarah Knuckey

Faculty Scholarship

Mental health issues are all too common consequences of conflict and atrocity crimes, often causing upwards of one-quarter of the post-conflict, post-atrocity population to suffer from physical and mental sequelae that linger long after weapons have been silenced. After more than six years of ongoing conflict, Yemen’s already weak health care system is on the brink of collapse, and population resilience has been severely stressed by indiscriminate attacks, airstrikes, torture, food insecurity, unemployment, cholera, and now the COVID-19 pandemic. This paper examines Yemen’s responsibilities regarding the right to mental health and details the few actions the government has taken to …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Skirting The Law: Medicaid Block Grants And Per-Capita Caps In A Pandemic, Laura D. Hermer

Faculty Scholarship

To what extent can an administration abridge Medicaid’s entitlement status by administrative fiat? In the final year of the Trump administration, just before the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) sought to push the outer bounds of this question by announcing the Healthy Adult Opportunity (HAO) initiative. It invited states to submit § 1115 demonstration applications to cover individuals not eligible for Medicaid benefits under the state’ s Medicaid plan—meaning, in many cases, the Affordable Care Act’s (ACA’s) Medicaid expansion population. Spending on those populations would be capped, not by purporting to waive federal law regarding …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

The Aoc In The Age Of Covid - Pandemic Preparedness Planning In The Federal Courts, Zoe Niesel

Faculty Articles

The 2020 COVID-19 pandemic created a crisis for American society—and the federal courts were not exempt. Court facilities came to a grinding halt, cases were postponed, and judiciary employees adopted work-from-home practices. Having court operations impacted by a pandemic was not a new phenomenon, but the size, scope, and technological lift of the COVID-19 pandemic was certainly unique.

Against this background, this Article examines the history and future of pandemic preparedness planning in the federal court system and seeks to capture some of the lessons learned from initial federal court transitions to pandemic operations in 2020. The Article begins by …

Tort Immunity In The Pandemic, Betsy J. Grey, Samantha Orwoll

Indiana Law Journal

The Covid-19 pandemic set off a public health emergency that quickly brought doctors and other health care providers to the front line, while shuttering businesses throughout the United States. In response to the emergency, the federal and state governments rapidly created broad protections from tort liability for health care providers. To encourage businesses to reopen, some states have also provided liability protection for businesses from personal injury suits brought by patrons and employees. Congress is considering similar protections for businesses as it contemplates further aid packages. Some industries, like nursing homes and universities, are lobbying for specific immunity. This Essay …

Just Plain Dumb?: How Digital Contact Tracing Apps Could’Ve Worked Better (And Why They Never Got The Chance), Brian E. Ray

Law Faculty Articles and Essays

This essay describes how the privacy debate that emerged over digital contact tracing and Google’s and Apple’s decisions to strictly limit apps permitted to use their platforms resulted in undercutting their potential usefulness as a tool to combat the pandemic while still failing to engender trust in these tools as intended.

A 'Public' Journey Through Covid-19: Donald Trump, Twitter, And The Secrecy Of U.S. Presidents’ Health, Mark Fenster

UF Law Faculty Publications

Donald Trump ignored numerous governance norms in his one term as U.S. President, especially those that prescribe disclosure of official and personal financial information. His brief period of illness from COVID-19, which he broadcast to the world via his Twitter account, revealed the complexity of Trump’s relationship to the concept and norms of transparency that presume information’s necessity for a functional and accountable state. At the same time that Trump offered little in the way of coherent and authoritative information about his health, he also provided an enormous amount of seemingly “inside” and direct accounts of the progress of his …

Sex Discrimination In Healthcare: Section 1557 And Lgbtq Rights After Bostock, Amy Post, Ashley Stephens, Valarie K. Blake

Law Faculty Scholarship

Section 1557 of the Affordable Care Act (“ACA”) banned sex discrimination in health care. In June of 2020, however, the Trump administration finalized a rule that explicitly removed sexual orientation and gender identity from Section 1557’s safeguards. That same month, the Supreme Court held that sexual orientation and gender identity discrimination are forms of sex discrimination for purposes of Title VII employment discrimination in Bostock v. Clayton County. Following the Court’s decision in Bostock, this Article argues that sex discrimination under Section 1557 necessarily encompasses gender identity and sexual orientation discrimination.

Equality And Sufficiency In Health Care Reform, Gabriel Scheffler

Articles

Most Americans believe that health care is a right, not a privilege. Yet debates over health care reform frequently fail to distinguish between two distinct conceptions of the right to health care: one which focuses on sufficient access to health care-what I refer to as the Right to a Decent Minimum-and a second which focuses on equality in access to health care what I refer to as the Right to Equal Access. These two conceptions of the right to health care in turn support two distinct categories of proposals for expanding health insurance coverage. The Right to Equal Access justifies …