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Pharmaceutical-Telehealth Confederacies
Full text linkAccess to prescription pharmaceuticals has historically been controlled by a physician’s pen. As a result, pharmaceutical companies spend billions of dollars on advertising and promotion to mitigate this barrier: first and primarily, to physicians and other prescribers, and more recently, to the general public through direct-to-consumer advertising. The success of these promotional efforts can be seen in greater prescribing of costly brand-name medicines, even in settings where lower-priced generic alternatives exist. Brand-name prescriptions now make up only 10% of all prescriptions written yet account for 87% of drug spending. Despite these substantial returns on investment, companies continue to seek opportunities to drive lucrative brand-name spending. In 2024, Eli Lilly & Co. and Pfizer, Inc., introduced direct-to-consumer services LillyDirectTM and PfizerForAllTM, aimed at largely circumventing the traditional role of physician-as-gatekeeper. LillyDirect and PfizerForAll engage in direct-to-consumer advertising, directing interested consumers to confederate telehealth companies and profiting when those telehealth prescribers in turn write prescriptions for the referring manufacturers’ costly brand-name drugs. These pharmaceutical-telehealth confederacies threaten patient safety and may increase health care costs by driving the inappropriate prescribing of costly drugs over cheaper alternatives. Four U.S. Senators inquired about the relationships between the two pharmaceutical companies and their telehealth groups to identify potential violations of the federal Anti-Kickback Statute (AKS). The U.S. Department of Health and Human Services Office of the Inspector General has also raised concerns regarding arrangements between physicians and telemedicine companies when providers are compensated for each prescription written. Likely by design, LillyDirect and PfizerForAll may evade AKS scrutiny by conducting transactions outside federal insurance programs. Yet the idea that drug companies can promote, prescribe, and dispense medications directly to patients with few gatekeepers and limited regulatory oversight seems inherently problematic. This Article evaluates the nature of these pharmaceutical-telehealth confederacies while offering solutions for reigning in their more egregious practices
Novel Ways of Creating Experiential ADR Problems
Full text linkIn legal education, experiential learning has become a vital tool for equipping students with the practical skills necessary for success in Alternative Dispute Resolution (ADR). This article explores three innovative methods for creating dynamic and realistic ADR problems: engaging teaching fellows to develop negotiation simulations, leveraging international LL.M. students to craft cross-cultural hypotheticals, and using artificial intelligence to generate customized exercises efficiently. Each approach offers unique benefits, from fostering deeper student investment in problem design to promoting comparative legal understanding and streamlining the creation of tailored learning experiences. By integrating these methods, educators can enhance student engagement, bridge the gap between theory and practice, and better prepare future legal professionals for the complexities of real-world dispute resolution
Teaching Client Counseling in the Shadow of Homelessness
Full text linkWorking with clients at risk of, or experiencing, homelessness teaches personal and professional humility like few other experiences in law school or the practice of law. Yet such sensitive work also provides an opportunity for law students to develop both a keener understanding of their own professional identity—with its capacities and limitations—and critical counseling skills.
This essay draws upon experiences gained in three distinct law school projects that work with clients at risk of, or experiencing, homelessness. After providing a brief overview of each project, the essay will explore methods used for training and supervising students during their counseling sessions, as well as techniques used for facilitating feedback and debriefing with students. The essay concludes by encouraging other instructors to include counseling housing-insecure clients into their courses, whether they teach a doctrinal or experiential class, given the benefits that accrue to students and clients alike
Between Private Equity and Housing Discrimination: The Long-Term Crisis in St. Louis and Beyond
Full text linkOn December 15, 2023, Northview Village, the largest skilled nursing facility in the Saint Louis region, closed abruptly, leading to the nighttime discharge of 170 residents. This emergency, while unique to that facility, is indicative of a broader crisis in both local and, to a significant extent, national nursing homes. This crisis has partly been catalyzed by the COVID-19 pandemic, but it rests on underlying factors that are unfortunately integral to the financing and operation of long-term care. This article will argue that understanding it requires situating long-term care at the intersection of two broader historical processes: the rise of private equity and the persistence of anti-Black housing discrimination. It will conclude by suggesting some strategies to address these trends in a way that might improve the situations of long-term care residents. Of particular importance is the need to include Black long-term care residents in future discussions of reparations for housing discrimination in St. Louis and elsewhere
The Layered Harms of Nursing Home Segregation
Full text linkThis Essay explores several dimensions of how segregation, separation, and shielding from view permit and contribute to the ethically problematic state of nursing home care in the United States. A quarter of a century ago, the Supreme Court recognized in the Olmstead decision that institutional care can function to segregate disabled people (whether young or old) from the richness of community life. Research over the past few decades confirms that racial segregation exists within the nursing home industry, and during the COVID-19 pandemic, the correlations between nursing homes’ racial makeup and their level of COVID fatalities were shocking. On another level, separating nursing home residents and those charged with caring for them from the community view increases opportunities for undetected neglect or abuse of residents. At the same time, that separation permits those living in the community to easily avert our attention from those harms. Concerns about abuse and neglect become more pointed when pressures from investors threaten to overwhelm a commitment to maximizing resident welfare, a phenomenon highlighted by researchers studying private equity ownership of nursing homes. Here, the hidden and opaque nature of ownership structures hinders attempts to regulate to improve the safety and quality of care. All these dimensions of segregation, separation, and shielding from view are particularly troubling considering the government’s dominant role in paying for nursing home care in the United States
Whose “Best Interests”? Concerns About the Use of Fiduciary Framing in Long-Term Care Decisions
Full text linkAs part of reimagining America’s long-term care system, this article will explain how today’s system is, in many ways, the logical extension of historical presumptions that are foundational to our understanding of family, medical, and organizational governance as “fiduciary” in nature. More specifically, much of our current language (operating in someone’s “best interests,” acting consistent with their “substituted judgment” if now incapacitated) and jurisprudence (parens patriae, trusts, guardianships, conservatorships, and corporate governance) descends from centuries of equity and law centered on the management of property, not people or health.
This legal framework is firmly rooted in English statutes, court opinions, organizational charters, and treatises that anticipated or addressed questions of incapacitated property owners and mismanagement of property and assets that are held in trust, whether in the form of an estate, trust, or corporation. Because of the “other-regarding” nature of these concerns, these matters have been overwhelmingly heard in courts of chancery and equity rather than courts of law (which were centered on the reasonable, autonomous man).
A look at this history highlights underlying presumptions of: (1) personal and family wealth (typically in the form of real property), (2) incapacitated people (or “objects of charity”) for whom feoffees, trustees, guardians, conservators, or directors make all decisions, and (3) unpaid, enslaved, or underpaid caregivers. These presumptions (and the fiduciary framework built upon them) encourage us to look past the day-to-day reality of those with long-term care needs and the millions of underpaid and unpaid caregivers who keep our neighbors, friends, and loved ones clean, clothed, fed, and engaged. We need to replace these antiquated tools with framing that more accurately reflects the reality of chronic illness and the need for sustainable caregiving
AMENDMENT 7 BALLOT CANDY AND THE SINGLE SUBJECT RULE: HOW THE LEGISLATIVE SUPERMAJORITY AMENDED THE STATE CONSTITUTION TO LIMIT VOTER CHOICE
Full text linkDuring the most recent general election, Missouri voters passed Amendment 7, a legislative ballot measure which erected bulwarks around an election process that limits voter choice. This article will discuss some of Missouri’s constitutional protections against deceptive ballot provision packages, specifically the single subject rule, as well as why they necessarily fall short of total efficacy. It does not argue for a more stringent application of the rules, because doing so would have implications for one of Missourians’ most powerful tools of direct democracy. The paper will examine Amendment 7 for its use of “ballot candy” that legislators successfully dangled to push unpopular rider provisions past unsuspecting voters and enticed them to undermine their own interests.https://scholarship.law.slu.edu/lawjournalonline/1130/thumbnail.jp
Work and Human Vocation in Catholic Social Teaching
Full text linkThis essay explores Catholic social teaching on work, focusing on how labor should enable humans to fulfill their vocation through experiences of dominion and communion. Drawing from papal encyclicals and theological anthropology, it examines how work becomes a means for humans to exercise their God-like faculties by intelligently shaping creation (dominion) and building rich relationships (communion). The essay argues that Catholic teaching offers distinctive contributions to contemporary workplace justice movements through its emphasis on two priorities: promoting worker-ownership and supporting family life. Worker-ownership, especially through cooperatives, enables labor to become an exercise of dominion, while family-centered policies make work a means of communion. Far from being peripheral concerns, these priorities follow inexorably from Catholic theological anthropology and offer concrete guidance for labor law and policy. The essay concludes that achieving more humane work arrangements requires not merely technical solutions but the moral conviction to establish and maintain systems that honor work’s proper place in God’s plan for human flourishing
The Intersection of Regulation, Quality Care Delivery, and Ethics and Compliance: Look Carefully Before Crossing!
Full text linkQuality and compliant care delivery in nursing homes remains elusive. Four main interests are currently misaligned, thereby putting nursing home residents at risk of harm. Without a clearly defined commitment to quality and compliant care and alignment of these interests, nursing home residents will remain vulnerable to severe harm.
The first key interest concerns nursing home ownership and management. Currently, over seventy percent of nursing homes are owned by for-profit entities. Previous ownership models, including non-profit, religious-based, and county-owned facilities, have largely closed or transitioned to for-profit entities. The shift in ownership significantly impacts quality and compliant care delivery. Unfortunately, the consolidation of ownership has not led to improvements in care quality.
The next interest relates to the regulatory system governing nursing homes. This paper will briefly review the history of regulation and enforcement activity (or lack thereof), its effectiveness in terms of focus and uniformity, and its impact on quality and compliant care delivery and resident protection. While increased regulation is a common response to complaints about quality, improvements in care delivery are rarely driven solely by regulation. The inspection process is highly subjective and often overlooks major health and safety issues, significantly affecting residents’ quality of care and life.
The third main interest is the nursing home’s operations, particularly in terms of staffing. This includes the numbers of nursing employees, their education, competencies, recruitment, and turnover. Multiple studies have demonstrated the relationship between quality of care and the sufficiency of nursing staff. A lack of a sufficient number of competent staff in nursing homes has been shown to increase the risk of harm, including falls, pressure injuries, elopements, medication errors, and other serious adverse outcomes.
The fourth key interest concerns nursing home residents and their families. As individuals transition from a home or hospital setting, they and their families often have reasonable expectations regarding care delivery but lack the knowledge or power to select a quality facility. Hospital discharge planners are often unfamiliar with the recommended nursing home, placing uninformed consumers at risk. The incentive to discharge hospitalized patients “sicker and quicker” forces families to accept a transfer to the first available bed. Although it would be highly beneficial for consumers to be knowledgeable regarding the continuum of older adult services (adult day care, Home and Community-Based Services through the Area Agency on Aging, home health care, and hospice), many are unaware of these alternatives to skilled nursing facility (SNF) placement. Planning for the future, including having knowledge of area SNFs, is often neglected until a healthcare crisis arises, requiring hospitalization and post-acute admission. Additionally, the Medicare.gov website, designed to improve consumer behavior through the “Five Star” rating process, remains underutilized by older adults and their families.
This paper proposes changes to the regulatory system, emphasizing important systemic issues that identify care failures. It will suggest enhanced protocols for consumer education and discuss how effective ethics and compliance programs can improve staff performance, increase resident safety, and enhance quality care delivery. The paper will use case examples focusing on pressure injuries as a mechanism to identify and remediate care delivery failures from both an internal and external quality assurance and performance improvement perspective
