Health Law and Policy Commons^™

R-Egg-Ulation: A Call For Greater Regulation Of The Big Business Of Human Egg Harvesting, Danielle A. Vera

Michigan Journal of Gender & Law

When it comes to young healthy women “donating” their eggs, America has a regulation problem. This Note explains the science behind the harvesting of human eggs, focusing on potential egg donors, and describes the specific factors that make egg donation a unique type of transaction. It describes the current regulatory status of the assisted reproductive technology industry in the United States and highlights the ways in which this scheme fails to protect egg “donors.” This Note concludes with a call for comprehensive regulation of the assisted reproductive technology industry.

Minding Ps And Qs: The Political And Policy Questions Framing Health Care Spending, William M. Sage

Faculty Scholarship

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care …

No One Statute Should Have Too Much Power: How Electing Not To Amend 42 U.S.C § 1320(A)–7(B) May Frustrate The Purpose Of The Patient Protection And Affordable Care Act, Amber C. Dawson

University of Miami Business Law Review

The over breadth of the Federal Anti-Kickback statute as amended by the Patient Protection and Affordable Care Act (PPACA) holds dangerous implications for the future of the health care marketplace. When a statute permits criminal, civil and administrative punishment for an overbroad category of innocuous actions, such a statute must also take into account the specific, rather than general, intent of the actor, or the ensnaring of innocents is ultimately likely to result. Historically, the statute required a finding of specific intent to be found to uphold a violation of the statute. With the passing of Greber v. US and …

International Reciprocity: If A Drug Is Good Enough For Great Britain, It Should Be Good Enough For The United States, Nicole C. Perez

University of Miami Business Law Review

The pharmaceutical industry is one of the largest, and most lucrative, industries in the world, worth about one trillion U.S. dollars. Specifically, the United States accounts for more than one-third of the global pharmaceutical market with about 340 million dollars in sales. Not only is the pharmaceutical industry one of the biggest industries profit-wise, but it is also an industry that affects almost every single person in the world. In a nation where healthcare issues are always on the rise, ensuring that American citizens benefit from pharmacology is essential to improving the nation’s healthcare system. The Food and Drug Administration …

Informed Consent For The Use And Storage Of Residual Dried Blood Samples From State-Mandated Newborn Genetic Screening Programs, Tufik Y. Shayeb

Buffalo Law Review

No abstract provided.

Anti-Disruption Statutory Construction, Jonathan H. Adler

Cardozo Law Review

The article examines Chief Justice John Roberts' approach to statutory interpretation, characterizing it as a form of "Burkean minimalism." This approach prioritizes judicial restraint, avoiding disruptive outcomes and maintaining stability in the law, even if it requires departing from the plain meaning of statutory text. Roberts' decisions often reflect a pragmatic willingness to reinterpret statutes to prevent significant disruptions, uphold legislative enactments, and preserve constitutional harmony, rather than adhering strictly to textualist or doctrinal purity.

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley

Articles

Yet another bruising fight has erupted over health care reform. On September 9, 2016, the Obama administration offered to open settlement negotiations with health insurers that have sued the United States to recover billions of dollars that they claim they are owed. Congressional Republicans are incensed, believing that any settlement would illegally squander taxpayer dollars in a lastgasp effort to save the Affordable Care Act (ACA).

Program

Health Law & Policy Conferences

No abstract provided.

More Than Just A Toothache? N.C. Dental Leaves Medical Boards Vulnerable: A Look At Telemedicine Companies And Antitrust Challenges To State Prescription Drug Rules, Alexander R. Kalyniuk

William & Mary Business Law Review

Encouraged by technological advancements and favorable provisions within the Affordable Care Act, telemedicine companies that offer online doctor visits are thriving in the health care industry. Online doctor visits are a relatively new and cost-efficient method to provide medical care over long distances that do not require patients to step outside their homes. However, many state medical board scope-of-practice rules prohibit physicians from prescribing medications without an in-person physical examination of the patient, which impedes telemedicine companies from offering their online services in those states. To circumvent this barrier, telemedicine companies may have a prima facie case under § 1 …

The Heartbreak Of Not Making Automated External Defibrillators Available For Public Use, Samuel D. Hodge Jr., Daria Koscielniak

University of Miami Law Review

An automated external defibrillator (AED) is one of the greatest advancements in defibrillator technology in the past several decades. Its purpose is to treat sudden cardiac arrest, the leading cause of death in this country. An AED checks the heart’s rhythm and will dispatch an electric jolt when needed to reestablish the organ’s normal electrical pattern. The magic of this portable device is that anyone can use it and it is relatively inexpensive to purchase. Studies have shown that access to AEDs can improve the odds of surviving a cardiac arrhythmia outside of the hospital and the American Heart Association …

A Promise Realized? A Critical Review Of Accountable Care Organizations Since The Enactment Of The Affordable Care Act, Jean Phillip Shami

University of Miami Law Review

As the six-year anniversary of the passage of the Affordable Care Act (“ACA”) comes to a close, a critical review of one of the key inventions of the ACA—Accountable Care Organizations (“ACOs”)—is timely as part of the greater narrative around affordable, quality health care in America. This Comment begins with a discussion of the statutory creation, philosophy and vision, and organizational structure of ACOs in the context of the passage of the ACA in 2010. Then, it will critically review ACOs from three perspectives based on the ACO model’s mission to provide better care for more people at a lower …

A Comprehensive Review Of The 2016 Asha Code Of Ethics, Robin L. Edge Ph.D., Ccc-Slp, Bess Sirmon-Taylor Ph.D., Ccc-Slp, Raul F. Prezas Ph.D., Ccc-Slp

Journal of Human Services: Training, Research, and Practice

The American Speech-Language-Hearing Association (ASHA) initially implemented a Code of Ethics in 1952, and has periodically revisited the content of the document with revisions to reflect the expanding scope of practice within speech-language pathology and audiology and to clarify certain concepts. Code revision is a cyclical mandated task of the ASHA Board of Ethics conducted to assure accuracy, currency, and completeness of this most important document (Solomon-Rice & O’Rourke, 2016). The current version of the Code of Ethics (2016) was modified from the previous version (2010r), with an updated preamble, definitions of related vocabulary, and re-organized language in the principles. …

The Next Who Director-General’S Highest Priority: A Global Treaty On The Human Right To Health, Lawrence O. Gostin, Eric A. Friedman, Paulo Buss, Mushtaque Chowdhury, Anand Grover, Mark Heywood, Churnrurtai Kanchanachitra, Gabriel Leung, Judith Mackay, Precious Matsoso, Sigrun Mogedal, Joia S. Mukherjee, Francis Omaswa, Joy Phumaphi, K. Srinath Reddy, Mirta Roses Periago, Joe Thomas, Oyewale Tomori, Miriam Were, Debrework Zewdie

Georgetown Law Faculty Publications and Other Works

Amidst the many challenges facing the next WHO Director-General, the new WHO head should find WHO’s foremost priority in its most important constitutional pillar: the right to health. The centerpiece of this endeavor should be leadership on the Framework Convention on Global Health (FCGH), the proposed global treaty based in the right to health and aimed at national and global health equity. The treaty would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right …

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Community Health Centers And Medicaid Payment Reform: Emerging Lessons From Medicaid Expansion States, Peter Shin, Jessica Sharac, Zoe Barber, Sara J. Rosenbaum

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Community health centers represent a major source of primary health care for the nation’s Medicaid beneficiaries. Because the Federally Qualified Health Center (FQHC) payment system is encounter-based, health centers and Medicaid agencies in ACA expansion states are actively pursuing payment reforms that will enable health centers to adopt strategies that can more effectively respond to the considerable and complex health and social needs of people served by health centers, and more efficiently address the surging volume of patient care. In five expansion states whose alternative payment experiments are underway, health centers and Medicaid agencies are testing payment alternatives, such as …

Health It Security: An Examination Of Modern Challenges In Maintaining Hipaa And Hitech Compliance, Andrew S. Miller, Bryson R. Payne

KSU Proceedings on Cybersecurity Education, Research and Practice

This work describes an undergraduate honors research project into some of the challenges modern healthcare providers face in maintaining compliance with the Health Insurance Portability and Accountability Act (HIPAA) and HITECH (Health Information Technology for Economic and Clinical Health) Act. An overview of the pertinent sections of both the HIPAA and HITECH Acts regarding health information security is provided, along with a discussion of traditionally weak points in information security, including: people susceptible to social engineering, software that is not or cannot be regularly updated, and targeted attacks (including advanced persistent threats, or APTs). Further, the paper examines potential violations …

A Nurse's Face: The Burqa In The Hospital, Lucas Newbill

North Carolina Central Law Review

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Fall 2016

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Law And Health Care Newsletter, Vol. 24, No. 1, Fall 2016

Law & Health Care Newsletter

No abstract provided.

Rethinking Body Property, Kara W. Swanson

Florida State University Law Review

Body products, including blood, gametes, and kidneys, are a routine part of contemporary medicine. They are also controversial. There is a strong preference for donated gifts, based on an intuition that gifts are pure, altruistic, and healthy, and that purchased products (commodities) are tainted, exploitative, and dangerous. Law and policy reflect this dichotomy, preventing market exchanges either by declaring body products non-property or banning sales by the supplying body. Yet with growing scarcity leading to injustice in the allocation and harvesting of body products, calls to allow sales have been increasing, motivating proposals to increase supplies by compensating bone marrow …