Health Law and Policy Commons^™

Alabama’S Ivf Immunity Law: A Constitutional License To Kill?, Dani Wasshausen

Washington and Lee Law Review

In today’s post-Dobbs world, states may freely define fetal “persons” and those fundamental rights afforded to them, but not without consequence. The Supreme Court of Alabama’s groundbreaking decision in LePage v. Center for Reproductive Medicine, P.C., holding that frozen embryos are “children” under the Wrongful Death of a Minor Act, led fertility clinics and services across the state to close. These in vitro fertilization (IVF) providers feared liability exposure because their standard practices—including embryonic fertilization, testing, cryopreservation, and transfer—inevitably result in damage or death to embryos. The Alabama Legislature swiftly responded by enacting a law granting broad civil and criminal …

Patients V. Profits: Addressing Private Equity’S Incursion On Healthcare, Michael Mccarthy

Washington and Lee Law Review

Between 2013 and 2023, private-equity-sponsored investment funds spent one trillion dollars on healthcare acquisitions, targeting hospitals, physician practices, and specialty providers. This Note examines the growing role of private equity in the US healthcare system and its implications for cost, quality, and competition.

ring struggling hospitals and medical practices much-needed capital and managerial expertise. In practice, however, prevalent private equity practices often create moral hazards by prioritizing short-term financial gains over long-term community health. Their reliance on debt, short investment horizons, and consolidation strategies can translate into higher prices, compromised care, and anticompetitive behavior. Mounting empirical studies reinforce these concerns, …

The Indian Pharmacopoeia: Enabling Open Access And Crafting A ‘Sovereign Function Exception’ For Government Works, Aparajita Lath

National Law School Journal

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain …

Good Faith Estimates And The No Surprises Act, Stuart L. Segelnick Dds, Ms

The New York State Dental Journal

Federal law requires dentists to be up front with self-pay patients about the cost of their treatment. Surprises may lead to penalties.

The No Surprises Act (NSA) went into effect on Jan. 1, 2022. This is a federal law that applies to all health-care providers, including dentists. The law gives certain rights to patients to help protect them from receiving surprise medical bills. These surprises usually occur when a person has no control over who treats them, such as during an emergency or when they are treated unknowingly by an out-of-network provider.

What To Know About Release Of Information, Authorization, And Records Requests, Jennifer Cosey

The Journal of the Michigan Dental Association

This article clarifies HIPAA regulations regarding the disclosure of protected health information (PHI). It distinguishes between a "Right of Access" request, where a patient directly seeks their own record (no authorization needed), and an "Authorization," which is required for disclosures beyond treatment, payment, or health care operations, or to third parties for ongoing access. The author details activities permissible without authorization, such as coordination of care, billing, and quality improvement. Specific examples are provided for situations requiring authorization, like disclosing PHI to attorneys or for marketing. The article also outlines seven essential elements for a HIPAA-compliant authorization form

Dentistry And The Law: What Ever Happened To The Ban On Covenants Not To Compete?, Daniel Schulte Jd

The Journal of the Michigan Dental Association

The Federal Trade Commission's (FTC) rule banning most employee non-competition agreements remains held up, despite a scheduled September 2024 effective date, due to ongoing court challenges with conflicting decisions. Recent changes at the FTC, including the appointment of a new chair (Andrew Ferguson) who previously opposed the ban, suggest a potential reversal or non-enforcement by the current Trump administration. While motions have been filed to hold appeals in abeyance, the FTC's formation of a new Joint Labor Task Force complicates the outlook, indicating continued focus on antitrust issues in the labor market. A clear outcome or timeline for the ban …

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Purdue’S Side Effects: Using Due Process To Realign Mass Tort Bankruptcies, William A. Organek

BYU Law Review

In Harrington v. Purdue Pharma, the United States Supreme Court held that victims of the opioid crisis could not be forced to release their independent claims against the Sacklers, who owned and controlled Purdue, without the victims’ consent. Such releases had become a controversial mainstay of mass tort bankruptcy filings. Yet Purdue was decided on narrow, textualist grounds, leaving as a side effect many seemingly disparate and difficult questions unanswered. This Article argues that Purdue and its open issues should be analyzed through a broader due process lens in tension with some aspects of current bankruptcy practice but consistent with …

Kebijakan Cukai Konsumsi Minuman Berpemanis Dalam Kemasan (Mbdk) Dalam Mengendalikan Masalah Kesehatan: Tinjauan Literatur Sistematis Dan Meta Analisis, Risky Kusuma Hartono, Fitria Aryani Susanti

Jurnal Ekonomi Kesehatan Indonesia

Globally, the consumption of sugar-sweetened beverages (SSBs) has increased by nearly 16%. The imposition of taxes on sugary drinks is considered one of the strategic measures to control diseases associated with their consumption. This study aims to conduct a meta-analysis of the correlation between SSB taxation and health issues. The systematic review and meta-analysis were carried out following the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines. Literature from various countries published since January 1, 2014, was collected using databases such as Google Scholar, PubMed, and Science Direct. The meta-analysis process was performed using a funnel plot. A …

The Impact Of The Chevron Ruling On Medicare, Sana Sherali

DePaul Journal of Health Care Law

The Supreme Court’s historic decision to overturn the Chevron doctrine in June 2024 received national attention due to its implications for how much power agencies will hold in the years to come. The Chevron doctrine originally comes from the Supreme Court’s 1984 decision in Chevron, U.S.A., Inc. v. Natural Resources Defense Council.Chevron addressed the requirements imposed on states by The Clean Air Act Amendments of 1977. This decision set the precedent that if federal legislation is unclear or leaves an administrative gap, courts have to follow the regulatory agency’s interpretation of the law, as long as the interpretation is …

Heterogeneity In Hospital Consolidation, Christina Depasquale

DePaul Journal of Health Care Law

This paper examines the heterogeneity between two types of hospital consolidations—mergers and system-joinings. I examine changes in admissions, employment outcomes, beds in different medical units, surgeries, costs, case mix, and discharges. I find that hospital mergers and system-joiners are fundamentally different among almost all outcomes examined. Additionally, I extend my analysis by examining those hospitals that, at the time of consolidation, are closer to either their fellow merging hospital or a fellow system-member hospital. I find no meaningful correlation between distance and outcomes.

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

Lost Without A Cause: The Sixth Circuit’S But-For Standard For False Claims Act Violations Harms Healthcare Fraud Enforcement, Margo Chapin

Villanova Law Review (1956 - )

No abstract provided.

Vandy Earns Top Prize In Auwcl National Health Law Writing Competition, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Nicholle Vandy, a rising 3L from Knox, Ind., has become the first Indiana University Maurer School of Law student to earn top honors at the American University Washington College of Law National Health Writing Competition.

Vandy’s paper, “True Man, Captive Mother: Abortion as a Fundamental Self-Defense Right,” was named the winning entry of the 10th annual competition, which encourages law students from across the country to write scholarly papers on current topics of interest relevant to health, food, and/or drug law.

Presentations: Pennsylvania's Environmental Rights Amendment And Environmental Justice, Samantha Phillps Beers, John C. Dernbach, Emma H. Bast, Margaret O. Murphy

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Climate Change And Digital Nations: Harnessing The Metaverse To Perpetuate Small Island Statehood, Nicole Bessette

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Education In Advance Care Planning: A Novel Equity-Based, Interprofessional Service-Learning Approach, Dorothy Yam, Sriya Kudaravalli, Elizabeth A. Mulvaney, Leslie Scheunemann, Grace W. Orsatti

Journal of Innovation in Health Sciences Education

Introduction: Despite health sciences graduate schools emphasizing service-learning and interprofessionalism, they often struggle to integrate these values into the curricula effectively. Advance care planning is inherently interdisciplinary and presents an opportunity to address equity gaps through service-learning. This report describes a novel interdisciplinary service-learning initiative for graduate student trainees, focused on advance care planning in underserved communities.

Methods: After targeted training, teams of medical, law, and social work students, and professionals from their respective fields, took part in two Life Planning Fairs in historically underserved neighborhoods in Pittsburgh, Pennsylvania. Using a form developed by the Allegheny County Bar Association …

Why Medicaid Is Addressing Homelessness With Section 1115 Waivers: A Critical Examination Of The United States' Federalist Mental Health System, Joshua Haas

Washington Law Review

Housing and health care are deeply interconnected, and their systemic relationship profoundly affects individual and societal well-being. Inadequate funding has undermined the American mental health system for decades, leading to gaps in care that have caused lasting harm to vulnerable individuals and society as a whole. This Comment examines the historical connections between homelessness and the American mental health system. It explores the benefits and criticisms of the United States’ federalist approach to health care, particularly focusing on Medicaid and its “section 1115 waivers,” which grant states flexibility to develop innovative, state-specific Medicaid programs. Recently, states began to utilize section …

Regulating Healthcare Coverage Algorithms, Jennifer D. Oliva

Indiana Law Journal

American healthcare facilities and providers increasingly rely on algorithmic tools to support clinical decision-making, standards of care, and institutional practices related to patient diagnosis and treatment. This development has been characterized as both “promising” and “peril[ous].” Healthcare algorithms are intended to improve and standardize healthcare decision-making, but they also are capable of exacerbating bias and discrimination and, thus, contributing to the delivery of inequitable care for already disadvantaged groups.