Health Law and Policy Commons^™

Gone Too Far: Federal Regulation Of Health Care Attorneys, Stacey A. Tovino

Scholarly Works

Outside health care counsel frequently obtain medical records, billing records, health insurance claims records, and other records containing individually identifiable health information in the course of representing health industry clients in medical malpractice, licensure, certification, accreditation, fraud and abuse, peer review, and other civil, criminal, and administrative health law matters. This Article is the first to argue that state rules of professional conduct, not federal health information confidentiality regulations, should govern outside health care counsel’s use and disclosure of confidential client information, and that outside counsel should be excepted from direct federal regulation under the HIPAA Privacy Rule.

The Individual Mandate's Due Process Legality: A Kantian Explanation, And Why It Matters, Peter Brandon Bayer

Scholarly Works

In National Federation of Independent Business v. Sebelius, one of the most controversial decisions of this young century, an intensely divided Supreme Court upheld the Patient Protection and Affordable Care Act's most provocative feature-the Individual Mandate-under Congress's taxing power. In so doing, the Court rejected what appeared to be the Individual Mandate's more applicable constitutional premise-Congress's authority to regulate interstate commerce. Yet, neither the Constitution's Taxing Clause nor its Commerce Clause provide the ultimate answer as to whether Congress may regulate the multi-billion dollar healthcare market by compelling unwilling persons to buy private health insurance. The final determination of the …

A "Common" Proposal, Stacey A. Tovino

Scholarly Works

The Federal Policy for the Protection of Human Subjects (the “Common Rule”) is codified in separate regulations by seventeen federal departments and agencies, including the Department of Health and Human Services (HHS). HHS’s version of the Common Rule currently contains a basic policy for the protection of all human subjects, codified at Subpart A of the Common Rule, as well as special provisions governing human subjects research involving three sets of vulnerable populations, including pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). This Article proposes that HHS amend the Common Rule to add a …

A Response To Beyond Separation: Professor Copeland’S Ambitious Proposal For “Integrative” Federalism, Elizabeth Weeks

Scholarly Works

No abstract provided.

Plunging Into Endless Difficulties: Medicaid And Coercion In National Federation Of Independent Business V. Sebelius, Elizabeth Weeks Leonard, Nicole Huberfield, Kevin Outterson

Scholarly Works

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes …

Employers United: An Empirical Analysis Of Corporate Political Speech In The Wake Of The Affordable Care Act, Elizabeth Weeks Leonard, Susan Scholz, Raquel Meyer Alexander

Scholarly Works

Is the Patient Protection and Affordable Care Act (ACA) bad for business? Did the countries' most prominent companies game the Securities and Exchange Commission (SEC) disclosure process to make negative political statements about ObamaCare? Immediately following the ACA's enactment on March 23, 2010, a number of companies drew scrutiny for issuing SEC filings writing off millions – and in AT&T's case, one billion dollars – against expected earnings for 2010 alone, based on a single, discrete tax-law change in the ACA. Congressional and Administration officials accused the firms of being "irresponsible" and using "big numbers to exaggerate the health reform's …

Death Panels And The Rhetoric Of Rationing, Elizabeth Weeks Leonard

Scholarly Works

This essay offers an explanation for the United States' continued resistance to universal health care as grounded in two taboos: taxation and rationing. Even we were willing to pay more in taxes to directly subsidize the cost of medical care for those in need, rather than our current system of indirect subsidization through private insurance risk-pooling and cost-shifting, we still would face the unavoidable reality of resource limitations. Attempts to limit resource consumption, however, have been strongly opposed, as evidenced by the "death panels" controversy. Governor Palin's grossly erroneous characterization of the Patient Protection and Affordable Care Act (ACA) rendered …

Prioritizing Abortion Access Over Abortion Safety In Pennsylvania, Randy Beck

Scholarly Works

This conference was prompted by the prosecution of Dr. Kermit Gosnell, who ran an abortion clinic in Philadelphia, Pennsylvania. Dr. Gosnell was convicted in May of 2013 of charges arising from the killing of viable infants born in his clinic, the negligent death of an adult patient, and the systematic disregard of regulations governing the performance of abortions in Pennsylvania. One question proposed for our consideration is whether Dr. Gosnell is an “outlier,” a description offered by the National Abortion Federation following Gosnell’s indictment.

Presumably, one might want to know whether Gosnell was typical of abortion providers because it could …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Trips And Bits: An Essay On Compulsory Licenses, Expropriation, And International Arbitration, Peter B. Rutledge

Scholarly Works

This essay examines the potential for arbitration to resolve disputes between private companies and developing countries over the propriety of compulsory licenses. At bottom, my thesis is that arbitration supplies the medium through which to mediate the tension between the profit-seeking goals of private multinational companies and the development goals of foreign nations, especially in the developing world. The compulsory license debate raises a clash of fundamental interests between the patent holder, the patent holder’s state, and the host state. Arbitration can play an important role in balancing those interests, albeit a highly unusual one. Arbitration provides an essential forum …

Gene Patents No More? Deciphering The Meaning Of Prometheus, Fazal Khan, Lindsay Kessler

Scholarly Works

When Congress enacted the United States Patent Act in 1952, it specified that patentable subject matter included anything “under the sun that is made by man.” Three decades ago the United States Patent and Trademark Office (USPTO) issued the first gene patent and ushered in a brave new gold rush. Some genes are associated with specific diseases, so being able to identify these sequences is an essential first step for developing genomic diagnostic tests and therapies. The problem with gene patents is that they allow modern-day prospectors to cordon off access to naturally occurring DNA sequences and exclude others from …

Rights To Health Care In The United States: Inherently Unstable, David Orentlicher

Scholarly Works

No abstract provided.

Toward Acceptance Of Uterus Transplants, David Orentlicher

Scholarly Works

No abstract provided.

Insights From A National Conference: "Conflicts Of Interest In The Practice Of Medicine", David Orentlicher

Scholarly Works

No abstract provided.

Further Support For Mental Health Parity Law And Mandatory Mental Health And Substance Use Disorder Benefits, Stacey A. Tovino

Scholarly Works

In this Article, I provide additional support for my recent proposal* to extend federal mental health parity law and mandatory mental health and substance use disorder benefits to all public healthcare program beneficiaries and private health plan members. I begin by examining health-related doctrine outside the context of mental health insurance law, including disability discrimination law, civil rights and human rights law, health information confidentiality law, healthcare reform law, and child and adult health and welfare law, and I find that not one of these laws provides inferior legal protections or benefits for individuals with mental illness. I also analyze …

All Illnesses Are (Not) Created Equal: Reforming Federal Mental Health Insurance Law, Stacey A. Tovino

Scholarly Works

This Article is the second, and most important, installment in a three-part series that presents a comprehensive challenge to lingering legal distinctions between physical and mental illness. The basic impetus for this historical, medical, and legal project is a belief that there exists no rational or consistent method of distinguishing physical and mental illness in the context of health insurance law. The first installment in this series narrowly inquired as to whether a particular set of disorders, the postpartum mood disorders, are or should be classified as physical or mental illnesses in a range of health law contexts.* This second …

A Proposal For Comprehensive And Specific Essential Mental Health And Substance Use Disorder Benefits, Stacey A. Tovino

Scholarly Works

This Article analyzes the initial efforts of the Federal Department of Health and Human Services to implement the essential mental health and substance use disorder services benefit required by section 1302(b)(1)(E) of the Affordable Care Act and proposes the adoption of a comprehensive and specific essential mental health and substance use disorder benefit set. At a minimum, the benefit set should cover medically necessary and evidence-based inpatient and outpatient mental healthcare services, inpatient substance abuse detoxification services, inpatient and outpatient substance abuse rehabilitation services, emergency mental healthcare services, prescription drugs for mental health conditions, participation in psychiatric disease management programs, …

Human Dignity And Health Law: Personhood In Recent Bioethical Debates, Zachary R. Calo

Scholarly Works

This Article considers how the idea of human dignity has shaped, and been shaped by, recent bioethical debates, particularly concerning the issue of genetic engineering and enhancement. While the language of human dignity has long had a role in bioethics, the issue of genetic manipulation has raised anew fundamental questions about the nature of personhood and the meaning of dignity. Particular attention is given to Ronald Green’s “Babies by Design,” George Kateb's “Human Dignity,” Gilbert Meilaender's “Neither Beast Nor God: The Dignity of the Human Person,” Robert George's and Christopher Tollefsen's “Embryo: A Defense of Human Life,” Michael Sandel’s “The …

An Essay On Originalism And The 'Individual Mandate': Rounding Out The Government’S Case For Constitutionality, Dan T. Coenen

Scholarly Works

The Supreme Court now has under advisement the landmark federal health care law case. Much attention has focused on the law’s minimum coverage provision—or so-called “individual mandate” — and, in particular, its constitutionality under the Commerce Clause and the Necessary and Proper Clause. In a separate and much lengthier article, I offer two main observations about the arguments made to the Court on that issue. First, I show that the challengers of the minimum coverage provision emphasized originalist reasoning in their briefs and oral arguments, while the federal government did not. Second, I explain why — contrary to the impression …

Affordable Care Act Litigation: The Standing Paradox, Elizabeth Weeks Leonard

Scholarly Works

The Patient Protection and Affordable Care Act (ACA) litigation presents a standing paradox. In the current posture, it appears that states lack standing to challenge the federal law on behalf of individuals, while individuals possess standing to challenge the federal law on behalf of states. This Article contends that there is no principled reason for this asymmetry and argues that standing doctrine should apply as liberally to states as individuals, assuming states allege the constitutional minimum requirements for standing and especially where the legal challenge turns on allocation of power between the federal government and states. The Article proceeds by …

The Rhetoric Hits The Road: State Resistance To Affordable Care Act Implementation, Elizabeth Weeks Leonard

Scholarly Works

This paper provides an update and reanalysis of my previously published article, Rhetorical Federalism: The Value of State-Based Dissent to Federal Health Reform, 93 Hofstra Law Review 111 (2010). In Rhetorical Federalism, I made an affirmative case for the widespread trend of state resistance to the then-recently enacted Patient Protection and Affordable Care Act of 2010 (ACA). Before and immediately after ACA’s enactment, a significant number of states engaged in various forms of objection to the new federal Act, including but not limited to lawsuits challenging the constitutionality of the individual insurance mandate. My article focused on five targets of …

It’S An Art Not A Science: State-Mandated Insurance Coverage Of Assisted Reproductive Technologies And Legal Implications For Gay And Unmarried Persons, Valarie K. Blake

Scholarly Works

Assisted reproductive technology (ART) has made it possible for a wealth of individuals, who would otherwise be unable, to create families and become parents. Traditionally, most people think of infertile couples as the beneficiaries of such technology, but ART has special and important implications for gay and/or unmarried persons as well. Dubbed the “structurally infertile,” this latter group is highly dependent on ART for their family planning needs. Despite the growth in popularity of ART for both the medically and structurally infertile, ART continues to be a mainly private-payer enterprise, reserved for those individuals who have the expendable income to …

Using Payroll Deduction To Shelter Individual Health Insurance From Income Tax, David Orentlicher

Scholarly Works

In this article, Professor Orentlicher and his colleagues assess the impact of state laws requiring or encouraging employers to establish ‘‘section 125’’ cafeteria plans that shelter employees’ premium contributions from tax.

Can Congress Make You Buy Broccoli? And Why It Doesn’T Matter, David Orentlicher

Scholarly Works

No abstract provided.

The Commerical Speech Doctrine In Health Regulation: The Clash Between The Public Interest In A Robust First Amendment And The Public Interest In Effective Protection From Harm, David Orentlicher

Scholarly Works

No abstract provided.

Controlling Health Care Costs Through Public, Transparent Processes: The Conflict Between The Morally Right And The Socially Feasible, David Orentlicher

Scholarly Works

No abstract provided.

Constitutional Challenges To The Health Care Mandate: Based In Politics, Not Law, David Orentlicher

Scholarly Works

No abstract provided.

Reforming State Mental Health Parity Law, Stacey A. Tovino

Scholarly Works

This Article is the final installment in a three-part project that presents a comprehensive challenge to lingering legal distinctions between physical and mental illness in the context of health insurance. The first installment in this series narrowly inquired as to whether the postpartum mood disorders should be classified as physical or mental illnesses in a range of health law contexts, including the context of health insurance. The second installment was broader in scope and challenged a number of federal provisions that allow publicly- and privately-funded health care programs and plans to provide mental health insurance benefits that are less comprehensive …

Can You Really Keep Your Health Care Plan? The Limits Of Grandfathering Under The Affordable Care Act, Elizabeth Weeks Leonard

Scholarly Works

This article examines the rhetoric and reality of President Obama's repeated hallmark promise during federal health reform that "you can keep your health plan," as one example of the Administration's equivocal stance toward deregulation. Although rhetorically supporting the popular preference for decreased government involvement in health care, the Obama Administration, in several instances, has achieved significant re-regulation through the intricacies of executive branch rule-making. The Affordable Care Act's "grandfather rule" (Section 1251, "Preservation of Right to Maintain Existing Coverage") purports to uphold the "you can keep your health plan" promise. But the regulatory requirements for plans to retain grandfathered status …

Rhetorical Federalism: The Value Of State-Based Dissent To Federal Health Reform, Elizabeth Weeks Leonard

Scholarly Works

This Article makes the affirmative case for the widespread trend of state resistance to the recently enacted, comprehensive federal health reform law, the Patient Protection and Affordable Care Act of 2010, or ACA. A significant number of states have engaged in various forms of objection to the new federal laws, including filing lawsuits against the federal government, enacting laws providing that ACA will not apply to residents of the state, and refusing to cooperate with implementing the new laws. This Article identifies reasons why those actions should not be disregarded simply as Tea Party antics or election-year gamesmanship but instead …