Health Law and Policy Commons^™

Genomics Unbound: The Scientific And Legal Case Against Patents Based On Naturally Occurring Dna Sequences, Fazal Khan

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While there have been mixed opinions as to whether gene patents were dead in light of Prometheus,this Article argues that a proper understanding of patent law, genomics, and public policy concerns should lead to no other result. The primary focus of this piece is to rebut certain vested interests in the biotechnology industry and affirm the normative claim that gene patents improperly fetter genomics research and development. First, through the lens of the Myriad case, we will recount why there was such a strong public interest movement against recognizing such patents. Specifically, we will show how patents on naturally occurring …

Death Panels And The Rhetoric Of Rationing, Elizabeth Weeks Leonard

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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 …

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

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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 …

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

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No abstract provided.

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

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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 …

Prioritizing Abortion Access Over Abortion Safety In Pennsylvania, Randy Beck

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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 …

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

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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.

A "Common" Proposal, Stacey A. Tovino

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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 …

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

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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 …

Nfib V. Sebelius: Proportionality In The Exercise Of Congressional Power, David Orentlicher

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With its opinion on the constitutionality of the Affordable Care Act (ACA), the U.S. Supreme Court sparked much discussion regarding the implications of the case for other federal statutes. In particular, scholars have debated the significance of the Court's recognition of an anticoercion limit to the Spending Clause power.

When it recognized an anticoercion limit for the ACA's Medicaid expansion, the Court left considerable uncertainty as to the parameters of that limit. This essay sketches out one valuable and very plausible interpretation of the Court's new anticoercion principle. It also indicates how this new principle can address a long-standing problem …

Conflicts Of Interest In Medicine, Research, And Law: A Comparison, Stacey A. Tovino

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Several of the remarks and articles presented in this symposium have addressed conflicts of interest arising during the provision of legal counsel to individuals who are elderly, including specific conflicts of interest implicated by estate planning, retirement planning, and long-term care planning. Topics examined thus far include conflicts of interest with respect to the application of rules of confidentiality within state rules of professional conduct to elderly clients with impaired decision-making capacity; conflicts of interest involving representative payees for Social Security benefits; conflicts of interest in distributions when parents enter into marriages that are unprotected by law; and conflicts of …

The Fda’S Graphic Tobacco Warning And The First Amendment, David Orentlicher

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No abstract provided.

Deactivating Implanted Cardiac Devices: Euthanasia Or The Withdrawal Of Treatment?, David Orentlicher

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No abstract provided.

Concussion And Football: Failures To Respond By The Nfl And The Medical Profession, David Orentlicher

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No abstract provided.