Health Law and Policy Commons^™

Medicare Mandates For Shared Decision Making With Patient Decision Aids: Linking Payment To Preference, Thaddeus Pope

Faculty Scholarship

Since 2015, the Centers for Medicare and Medicaid Services (CMS) has increasingly required shared decision making with evidence-based patient decision aids as an essential Medicare condition for payment. CMS is doing this because it recognizes that most healthcare is preference sensitive and value laden. So, whether treatment is “right” or “beneficial” for a patient is not only a matter of clinical expertise. It equally depends on the patient’s values, preferences, and goals. So, CMS wants to ensure that patients understand the risks, benefits, and alternatives to the healthcare that they receive and for which CMS pays. In short, under its …

The Supreme Court’S 2024–2025 Term: Eroding Public Health, Health Equity, And Access To Justice, Daniel G. Aaron, Wendy E. Parmet

Utah Law Faculty Scholarship

In this moment, the public health community can no longer afford the luxury of staying outside the arenas of politics and law. They must research empirically the impact of judicial decisions on health, treating the court’s decrees as a social determinant of health. They must also educate lawmakers on the impact of court decisions on people and patients, partner with policy and legal experts to inform the public about the important role that courts play in determining the health of individuals and communities, and attempt to combat the misinformation that muddles popular understandings of public health. Should we remain silent, …

Countering Workplace Wellness Bias Through Wellness-Legal Partnerships, Barbara Zabawa

Faculty Works

In the current United States economy, wellness is predominantly marketed to society’s privileged individuals, catering to a mostly white and high-income clientele. When marginalized communities encounter wellness services, such as in the workplace, they are faced with an Implicitly biased industry. These biases include an emphasis on individual behavior change without considering social determinants of health (SDOH), cultural appropriation of wellness activities for capitalistic gain, use of biased health measures like Body-Mass Index (BMI) and constant images of and expectations of achieving a stereotypical healthy body. The legal community must wake up to these biases and advocate for more equitable …

Health Care Corporatization As A Catalyst For Wellness Legal Partnerships, Barbara Zabawa

Faculty Works

The increasing presence of private equity investment in physician practices reveals that current health law practice sites such as in-house, corporate law firms, and Medical Legal Partnerships (MLPs) are ill equipped to address patient harm from health care corporatization. A new type of health law practice is needed to address the adverse impact health care corporatization is having on health care purchasers (primarily employers and patients) and physicians. I label this new health law practice the Wellness Legal Partnership (WLP), modeled after the Medical Legal Partnership (MLP). WLP lawyers can look to systems leadership theory, lawyer fiduciary duties, and health …

No More Wild West: The Need For Wellness Professional Standards, Barbara Zabawa

Faculty Works

The burgeoning wellness industry attracts a lot of practitioners who are largely unregulated. This “wild west” of wellness creates uncertainty for insurers, employers, consumers and practitioners as to what services and items wellness practitioners can offer, whether those practitioners are qualified and whether they behave in an ethical manner. Some guideposts for these wellness stakeholders would be welcome and may reduce consumer harm. Guideposts for wellness is especially crucial in a time when the Braidwood v. Becerra case threatens the delivery of preventive care services by the health care sector. As we have learned from the health care sector, the …

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

Artificial Intelligence And The Hipaa Privacy Rule: A Primer, Stacey A. Tovino

Faculty Articles

No abstract provided.

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Tackling The Next Public Health Crisis: Lessons Regarding Long-Term Care From The Covid Era, M. Sara Rosenthal, Keith R. Knapp, Laura Morton

Saint Louis University Journal of Health Law & Policy

This paper reviews multiple ethical and clinical issues during the COVID era affecting long-term care. The authors are members of one of many long-term care COVID task forces[1] that emerged in multiple jurisdictions to address a pandemic emergency. This paper applies the pandemic ethics literature that informed healthcare providers during COVID and recommends adjusting health messaging and communication that may shift responsiveness in the next public health crisis.

[1]. Kentucky Cabinet for Health and Family Services Long-Term Care Advisory Task Force (in alphabetical order): Muhammad Babar, MD, MBA, MSc, CMD, SNF medical director; Belinda Beard, BS, RN, Division Director, …

Between Private Equity And Housing Discrimination: The Long-Term Crisis In St. Louis And Beyond, Harold Braswell, Alexandra Mcnamee, Charitha Bodepudi

Saint Louis University Journal of Health Law & Policy

On 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 …

The Intersection Of Regulation, Quality Care Delivery, And Ethics And Compliance: Look Carefully Before Crossing!, David R. Hoffman, Ilene Warner-Maron

Saint Louis University Journal of Health Law & Policy

Quality 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, …

§1983 And The Federal Nursing Home Reform Act: A Perfect Fit, Sandra H. Johnson

Saint Louis University Journal of Health Law & Policy

The Supreme Court rarely takes a case involving federal quality standards for nursing home care, and that alone would make Health and Hospital Corporation of Marion County v. Talevski (Talevski) a significant case for those interested in long-term care. The Court’s decision in Talevski, however, reaches far beyond long-term care with implications for every federally funded program that relies on the states for administration, delivery of benefits, or enforcement of standards.

Much about the Talevski case signaled that a significant change in law may be coming. The plaintiff’s cause of action relied on a statutory instrument (§1983) frequently used by …

What Went Wrong? Identifying The Historical Roots Of Racial Disparities Among Older Adults In Nursing Facilities, Gelila Selassie

Saint Louis University Journal of Health Law & Policy

In early 2020, as the nation was just becoming familiar with COVID-19, over a million nursing facility residents were already experiencing crisis-level disasters. Extreme lockdowns, increased hospitalizations, and high mortality rates plagued nursing facilities earlier and far worse than the rest of the population. Data gradually showed that facilities with higher numbers of residents of color were facing particularly dire outcomes.

Although the severity of COVID-19 was surprising, the pandemic highlighted existing and long-standing problems with the country’s long-term care facilities. Many of the problems that led to the horrible disparities during COVID-19 are rooted in a wholly insufficient long-term …

The Layered Harms Of Nursing Home Segregation, Mary Crossley

Saint Louis University Journal of Health Law & Policy

This 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 …

Whose “Best Interests”? Concerns About The Use Of Fiduciary Framing In Long-Term Care Decisions, Jennifer L. Herbst

Saint Louis University Journal of Health Law & Policy

As 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, …

Birthdate Phaseout, Katharine B. Silbaugh

Faculty Scholarship

This article explores the Nicotine Free Generation (NFG) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: Prohibition, or a legal age-gate, such as 21 for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco, and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the 21 …

High Hopes, Clouded Realities: Minnesota's Cannabis Legalization And The Hidden Health Risks, Allison Crescimanno

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Green Dividends: A Case Study In Green Dividends And The Conditions For Private Ordering Solutions, Anne M. Tucker

Seattle University Law Review

This Essay introduces a novel private ordering solution to facilitate corporate investments in pro-social and environmental initiatives: Green dividends. Green dividends are an optional increase in shareholder dividends that are returned to the company to be reinvested in environmental initiatives or kept by a shareholder.

Green dividends pose an alternative to the current gridlocked debate that corporations can’t, won’t, shouldn’t, and shouldn’t even try to act in pro-social or environmental ways. Turning the common refrains on their head converts each narrative into an element for a successful private ordering solution: authority, accountability, shareholder buy-in, and government- backed enforcement. With Green …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Curing The Cancer Pledge: Three Legal Reforms To Support Employees With Cancer, Hannah R. Weiser, Elizabeth Brown

Lewis & Clark Law Review

The 2023 Super Bowl featured a short film about the #WorkingWithCancer Pledge, a business initiative supporting employees with cancer, to over 100 million viewers. This film highlighted the struggles of a disease that affects a shocking 50% of individuals. It also underscored the need for a broader and more impactful approach ensuring that people with cancer have as full and equitable opportunities to work as other employees. While cancer in the workplace is increasingly common, misconceptions and stigma surrounding cancer exacerbate the gaps in legal protections for both employees with cancer and their employers. Employees with cancer need better legal …

Middlemen At A Price: The Role Of State-Level Laws In Restricting Pharmacy Benefit Managers, Patrick W. Schrader

Lewis & Clark Law Review

Pharmacy Benefit Managers (PBMs) have evolved from simple third-party payors into powerful intermediaries controlling prescription drug access for over 289 million Americans. Operating with minimal federal oversight, just six PBMs dominate 96% of the market, employing practices that systematically increase drug costs while claiming to reduce them. This Comment examines four primary mechanisms through which PBMs exploit the pharmaceutical supply chain: rebate manipulation, spread pricing, step therapy requirements, and formulary control. Federal regulatory efforts remain nascent and ineffective. The Centers for Medicare and Medicaid Services requires only basic reporting without substantive restrictions. Proposed federal legislation has repeatedly stalled, leaving states …

The Legal Ramifications Of Israel’S Destruction Of Gaza’S Healthcare System, Serene Mistkawi

Lewis & Clark Law Review

This Comment argues that Israel’s attacks on the medical infrastructure of Gaza are a violation of international law because hospitals are protected zones and medical personnel are civilians. To Israel’s response that Hamas is attack-ing from hospitals, thereby rendering them legitimate targets, this Comment presents a number of responses: (1) there is little to no evidence that Hamas is doing this; (2) even if Hamas is doing this, the military gains from attacking hospitals are outweighed by the civilian deaths; (3) even if Hamas is doing this and there is significant military gain from attacking hospitals, the interna-tional rules have …

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

Cause Of Death? -- It's Probably Not What's Reported On The Death Certificate, Lauren R. Roth

Lewis & Clark Law Review

In the age of big data, this country has a data problem—inaccurate and incomplete information in death certificates. The problem has long been hidden by the numbers reported—as have the people whose deaths go uncounted, but the COVID-19 pandemic unveiled the scope of the issue. Since the beginning of the pandemic, “excess deaths” (i.e., any deaths above the number predicted by existing mortality models) have increased significantly. Most of these excess deaths are likely attributable to COVID-19 because the decedent was never tested for COVID-19 or it was one of multiple factors contributing to their death. Other deaths are uncounted …

Medication Abortion And The Mails: The Ghost Of Anthony Comstock Rides Again?, Lars Noah

UF Law Faculty Publications

Mail-order dispensing of the prescription drug mifepristone has become the latest flashpoint in this country’s long-running debate over abortion access. It also has brought back from the dead one of the oldest federal statutes to address that contentious subject. In their fight to limit access to a drug approved by the FDA one quarter of a century ago, abortion opponents have rediscovered the Comstock Act. Although amended on several occasions since 1873, Congress never managed to repeal or clarify its ambiguous language relating to abortion. On its narrowest reading, this provision would have no impact whatsoever on access to mifepristone; …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Cognitive Decline And The U.S. Presidency: The Case Of Joe Biden, Mark Fisher, Sandy Sanbar

Health Matrix: The Journal of Law-Medicine

This article examines the intersection of cognitive health, medical ethics, and constitutional governance through the lens of President Joe Biden’s medical history and recent cognitive performance. Highlighting the absence of formal neurocognitive testing protocols for presidential candidates and sitting Presidents, it raises critical questions about transparency, accountability, and the statutory and ethical obligations of medical professionals serving in political contexts. The paper discusses Biden’s stroke history, neurosurgical interventions, and subsequent lack of documented cognitive assessments, emphasizing the implications for public trust and the constitutional duty to ensure an executive fit for office. It advocates for the implementation of standardized, objective …

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …