Health Law and Policy Commons^™

The Death Of Private Practice: How The Rising Cost Of Healthcare Is Destroying Physician Autonomy, Oliver Owaid

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the past two decades, the number of physicians in private practice has dropped dramatically. This trend is the result of the financial pressure imposed by the federal government in response to the skyrocketing cost of healthcare. Physicians, frustrated by stagnant reimbursement rates in conjunction with increased administrative costs and overhead, are choosing hospital staff employment in favor of private practice. This trend is to the detriment of the physician, the taxpayers, and, most importantly, the patients. Patients treated in hospital outpatient settings have worse outcomes than those treated in private practice. In addition, hospital procedures cost both the government …

Abuse Of The Hatch-Waxman Act: Mylan's Ability To Monopolize Reflects Weaknesses, Kieran Meagher

Brooklyn Journal of Corporate, Financial & Commercial Law

The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is intended to lower the average price paid by consumers for prescription drugs. The Hatch-Waxman Act attempts to do so by simplifying the application process for generic drug manufacturers, allowing generic drug applications to circumvent the lengthy FDA testing and approval process that brand-name manufacturers must undergo. Though the Hatch-Waxman Act has successfully created a clear path to the market for generic drugs, it contains loopholes that allow brand name and generic companies to engage in practices aimed at maximizing monopoly profits, effectively …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Recognizing Women's Rights At Work: Health And Women Workers In Global Supply Chains, Erika R. George, Candace D. Gibson, Rebecca Sewall, David Wofford

Faculty Scholarship

The Guiding Principles mandate that businesses respect the human fights enshrined in the International Bill of Human Rights and in the International Labour Organization (ILO)'s Declaration on Fundamental Principles and Rights at Work. Due diligence processes and risk impact assessments are the main recommended means for ensuring compliance with companies' commitments to respect international human fights. Because OSH as a conceptual framework and regulatory order is not sufficient to identify the risk of health fights violations to women workers, we argue companies should not anchor their due diligence and risk assessment in OSH conventions and settle for a check-the-box solution …

Abortion In A Post-Truth Moment: A Response To Erwin Chemerinsky And Michele Goodwin, Aziza Ahmed

Faculty Scholarship

In Abortion: A Woman’s Private Choice, Erwin Chemerinsky and Michele Goodwin respond to the crisis of abortion rights in our current political moment. While preserving the right to abortion is an ongoing challenge for reproductive-justice advocates and lawyers, the arrival of a new Republican administration led by Donald Trump and a Republican majority in the House and Senate heightens these concerns. In the face of ongoing and new threats to abortion access, Chemerinsky and Goodwin argue that abortion should be treated as a woman’s private choice. I agree with Chemerinsky and Goodwin, as all supporters of abortion rights should. …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

Decreasing Smoking But Increasing Stigma? Anti-Tobacco Campaigns, Public Health, And Cancer Care, Kristen E. Riley, Michael Ulrich, Heidi A. Hamann, Jamie S. Ostroff

Faculty Scholarship

Public health researchers, mental health clinicians, philosophers, and medical ethicists have questioned whether the public health benefits of large-scale anti-tobacco campaigns are justified in light of the potential for exacerbating stigma toward patients diagnosed with lung cancer. Although there is strong evidence for the public health benefits of antitobacco campaigns, there is a growing appreciation for the need to better attend to the unintended consequence of lung cancer stigma. We argue that there is an ethical burden for creators of public health campaigns to consider lung cancer stigma in the development and dissemination of hard-hitting anti-tobacco campaigns. We also contend …

Teaching The Law Of American Health Care, Elizabeth Weeks, Nicole Huberfeld, Kevin Outterson

Faculty Scholarship

In writing our casebook, The Law of American Health Care, we started from scratch, rethinking the topics to include and themes around which to organize them. Like many health law professors, we were schooled in and continued to propound the traditional themes of cost, quality, access, and choice. While those concerns certainly pervade many areas of health care law, our casebook's overarching themes emphasize different issues, namely: federalism, individual rights, fiduciary relationships, the modem administrative state, and market regulation. These new themes, we believe, better capture the range of issues and topics essential forthe new generation of health lawyers. When …

Nfib V. Sebelius At 5, Nicole Huberfeld

Faculty Scholarship

Keeping up with health care reform is like running up a mountain of sand - every time you reach the top, -the terrain starts shifting. In this talk, I offer a snapshot of where we are in implementing the Patient Protection and Affordable Care Act ("ACA") to aid in understanding the significance of NFIB v. Sebelius' at five. I will situate the ACA2 within historical patterns in American health care reform. I have been asked to discuss the key points of the NFIB decision, after which I will share some of the research that I have performed for the past …

Medical Malpractice And The Mind-Blowing Hypocrisy Of Obamacare Repeal, Joanne Doroshow

Other Publications

No abstract provided.

The Fmla And Psychological Support: Courts Care About "Care" (And Employers Should, Too), Katherine Stallings Bailey

Michigan Law Review

The Family and Medical Leave Act (“FMLA”) recognizes an employee’s right to take leave to care for a qualifying family member. In light of the Act’s remedial nature, the intended scope of the care provision is broad, but its definitional details are sparse. As a result of the attendant interpretive discretion afforded to courts, the Seventh Circuit announced its rejection of the requirement—first articulated by the Ninth Circuit—that care provided during travel be related to continuing medical treatment. A facial analysis of the resulting circuit split fails to appreciate the fundamental difference between the Seventh and Ninth Circuits’ considerations: the …

Certificate Of Need In The Post-Affordable Care Act Era, Emily Whelan Parento

Kentucky Law Journal

Certifcate of need ("CON") programs were conceived approximately fifty years ago as supply constraint mechanisms for healthcare services, in an environment that is essentially unrecognizable today. Every aspect of the healthcare landscape has changed dramatically, particularly in the years since the enactment of the Affordable Care Act. The historical rationales in support of CON programs have been vigorously questioned by scholars across disciplines, roundly criticized by the federal government, and largely disproven by research. Yet the status quo persists with thirty-five states retaining CON laws, due in large part to a combination of entrenched interests and polrical inertia that prevents …

Implementing Medicaid Health Homes To Provide Medication Assisted Treatment To Opioid Dependent Medicaid Beneficiaries, Page M. Smith

Kentucky Law Journal

No abstract provided.

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Big Pharma Worms Its Way Into Congress’ Medical Malpractice Bill, Joanne Doroshow

Other Publications

No abstract provided.

Why Some Religious Accommodations For Mandatory Vaccinations Violate The Establishment Clause, Hillel Y. Levin

Scholarly Works

All states require parents to inoculate their children against deadly diseases prior to enrolling them in public schools, but the vast majority of states also allow parents to opt out on religious grounds. This religious accommodation imposes potentially grave costs on the children of non-vaccinating parents and on those who cannot be immunized. The Establishment Clause prohibits religious accommodations that impose such costs on third parties in some cases, but not in all. This presents a difficult line-drawing problem. The Supreme Court has offered little guidance, and scholars are divided.

This Article addresses the problem of religious accommodations that impose …

Teaching The Law Of American Health Care, Elizabeth Weeks, Nicole Huberfeld, Kevin Outterson

Scholarly Works

In writing our casebook, The Law of American Health Care, we started from scratch, rethinking the topics to include and themes around which to organize them. Like many health law professors, we were schooled in and continued to propound the traditional themes of cost, quality, access, and choice. While those concerns certainly pervade many areas of health care law, our casebook's overarching themes emphasize different issues, namely: federalism, individual rights, fiduciary relationships, the modem administrative state, and market regulation. These new themes, we believe, better capture the range of issues and topics essential for the new generation of health lawyers. …

Adjudicating Religious Sincerity, Nathan Chapman

Scholarly Works

Recent disputes about the “contraception mandate” under the Affordable Care Act and about the provision of goods and services for same-sex weddings have drawn attention to the law of religious accommodations. So far, however, one of the requirements of a religious accommodation claim has escaped sustained scholarly attention: a claimant must be sincere. Historically, scholars have contested this requirement on the ground that adjudicating religious sincerity requires government officials to delve too deeply into religious questions, something the Establishment Clause forbids. Until recently, however, the doctrine was fairly clear: though the government may not evaluate the objective accuracy or plausibility …

An Expressive Theory Of Privacy Intrusions, Craig Konnoth

Publications

The harms of privacy intrusions are numerous. They include discrimination, reputational harm, and chilling effects on speech, thought, and behavior. However, scholarship has yet to fully recognize a kind of privacy harm that this article terms "expressive."

Depending on where the search is taking place and who the actors involved are--a teacher in a school, the police on the street, a food inspector in a restaurant--victims and observers might infer different messages from the search. The search marks the importance of certain societal values such as law enforcement or food safety. It can also send messages about certain groups by …

Can Right To Health Help Policy Makers To Address Maternal Mortality?: A Short Communication, Sumera Aziz Ali, Nadir Suhail, Savera Aziz Ali

Community Health Sciences

No abstract provided.

Teaching Health Law From A Social-Ecological Perspective, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

I started teaching health law relatively recently-in the fall of 2010, just after the Affordable Care Act ("ACA") was enacted, but before much of it had been implemented. This timing has been a blessing because I started with a fresh slate rather than adding the ACA on top of a previously developed course. It has also been a curse, but ultimately I appreciate that I started teaching the course at a time when the ACA was under constant threat. The ever-evolving nature of health law means that health law teachers must always bear in mind a goal that applies to …

Teenage Pregnancy, Parenting, And Abortion: Legal Limits On Adolescents' Reproductive Rights, Maya Manian

Scholarly Articles in Law Reviews & Journals

As numerous scholars have noted, the law takes a strikingly incoherent approach to adolescent reproduction. States overwhelmingly allow a teenage girl to independently consent to pregnancy care and medical treatment for her child, and even to give up her child for adoption, all without notice to her parents, but require parental notice or consent for abortion. This chapter argues that this oft-noted contradiction in the law on teenage reproductive decision-making is in fact not as contradictory as it first appears. A closer look at the law's apparently conflicting approaches to teenage abortion and teenage childbirth exposes common ground that scholars …

Tobacco, Denormalization, Anti-Healthism, And Health Justice, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

Patent Protection For Microbial Technologies, Jacob S. Sherkow

Articles & Chapters

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies—both scienti cally and commercially—depend, in part, on the patent regime available for each, and researchers’ willingness to enforce those patents against others.

God Said To Abraham/Kill Me A Son: Why The Insanity Defense And The Incompetency Status Are Compatible With And Required By The Convention On The Rights Of Persons With Disabilities And Basic Principles Of Therapeutic Jurisprudence, Michael L. Perlin

Articles & Chapters

Interpretations of the General Comments to the Convention on the Rights of Persons with Disabilities (CRPD) — that command the abolition of the insanity defense and the incompetency status — make no theoretical or conceptual sense, disregard the history of how society has treated persons with serious mental disabilities who are charged with crime, and will lead to predictable torture of this population in prison, at the hands of both prison guards and other prisoners. Such interpretation also flies in the face of every precept of therapeutic jurisprudence. Support of this position exhibits a startling lack of understanding of the …

Using Taxes To Support Multiple Health Insurance Risk Pools, David Gamage, Darien Shanske

Articles by Maurer Faculty

In most markets, it is considered desirable for consumers to have more choices. But health insurance regulation is different. When it comes to health insurance, giving consumers more choices can result in the market collapsing — leaving the sickest and most needy consumers without any good choices at all. To mitigate this problem, the Affordable Care Act’s Exchanges were designed around maintaining a single exchange-based risk pool. However, one problem with this approach taken by the Affordable Care Act is that the regulations designed to maintain the single exchange-based risk pool have the side effect of limiting some potentially positive …

Disparities In Private Health Insurance Coverage Of Skilled Care, Stacey A. Tovino

Faculty Articles

This article compares and contrasts public and private health insurance coverage of skilled medical rehabilitation, including cognitive rehabilitation, physical therapy, occupational therapy, speech-language pathology, and skilled nursing services (collectively, skilled care). As background, prior scholars writing in this area have focused on Medicare coverage of skilled care and have challenged coverage determinations limiting Medicare coverage to beneficiaries who are able to demonstrate improvement in their conditions within a specific period of time (the Improvement Standard). By and large, these scholars have applauded the settlement agreement approved on 24 January 2013, by the U.S. District Court for the District of Vermont …

The Hipaa Privacy Rule And The Eu Gdpr: Illustrative Comparisons, Stacey A. Tovino

Faculty Articles

In this Article, Professor Tovino compares and contrasts three illustrative concepts and rights in the Privacy Rule and/or the GDPR, including the concepts of authorization and consent, the rights of amendment and rectification, and the right to erasure. Identified similarities reflect the core values of HHS and the EU with respect to maintaining the confidentiality and privacy of personal data and protected health information, respectively. Identified differences reflect the Privacy Rule's original, narrow focus on health industry participants and individually identifiable health information compared to the GDPR's broad focus on data controllers and personal data. Other differences reflect, perhaps, the …