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Articles 31 - 60 of 117
Full-Text Articles in Law
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Articles
A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.
Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii
Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii
Articles
Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …
Shadow Health Records Meet New Data Privacy Laws, W. Nicholson Price Ii, Margot E. Kaminski, Timo Minssen, Kayte Spector-Bagdady
Shadow Health Records Meet New Data Privacy Laws, W. Nicholson Price Ii, Margot E. Kaminski, Timo Minssen, Kayte Spector-Bagdady
Articles
Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space …
Privacy In The Age Of Medical Big Data, W. Nicholson Price Ii, I. Glenn Cohen
Privacy In The Age Of Medical Big Data, W. Nicholson Price Ii, I. Glenn Cohen
Articles
Big data has become the ubiquitous watch word of medical innovation. The rapid development of machine-learning techniques and artificial intelligence in particular has promised to revolutionize medical practice from the allocation of resources to the diagnosis of complex diseases. But with big data comes big risks and challenges, among them significant questions about patient privacy. Here, we outline the legal and ethical challenges big data brings to patient privacy. We discuss, among other topics, how best to conceive of health privacy; the importance of equity, consent, and patient governance in data collection; discrimination in data uses; and how to handle …
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar
Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar
Articles
In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …
Are Medicaid Work Requirements Legal?, Nicholas Bagley
Are Medicaid Work Requirements Legal?, Nicholas Bagley
Articles
On January 12, 2018, the Centers for Medicare & Medicaid Services (CMS) approved a waiver allowing Kentucky to impose a work requirement on some nondisabled Medicaid beneficiaries. Similar waivers are sure to follow. Supporters see work requirements as a spur to force the idle poor to work; opponents see the requirements as a covert means of withholding medical care from vulnerable people. Setting the policy debate aside, however, are work requirements legal?
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Articles
In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …
Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii
Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii
Articles
Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and stationary patients, the system works—sometimes. But when care is fragmented, fragmented data often result. Fragmented data create risks both to individual patients and to the system. For patients, fragmentation creates risks in care based on incomplete or incorrect information, and may also lead to privacy risks from a patched together system. For the system, data fragmentation hinders efforts to improve efficiency …
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Articles
Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …
Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley
Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley
Articles
Though congressional efforts to repeal and replace the Affordable Care Act (ACA) seem to have stalled, the Trump administration retains broad executive authority to reshape the health care landscape. Perhaps the most consequential choices that the administration will make pertain to Medicaid, which today covers more than 1 in 5 Americans. Much has been made of proposals to introduce work requirements or cost sharing to the program. But another decision of arguably greater long-term significance has been overlooked: whether to allow “partial expansions” pursuant to a state Medicaid waiver. Arkansas has already submitted a waiver request for a partial expansion, …
The Dubious Empirical And Legal Foundations Of Wellness Programs, Adrianna Mcintyre, Nicholas Bagley, Austin Frakt, Aaron Carroll
The Dubious Empirical And Legal Foundations Of Wellness Programs, Adrianna Mcintyre, Nicholas Bagley, Austin Frakt, Aaron Carroll
Articles
The article offers information on the dubious empirical and legal foundations of workplace wellness programs in the U.S. Topics discussed include enactment of Affordable Care Act for expanding the scope of incentives availas; analysis of financial incentives offered to the employees for encouraging their participation in wellness programs; and targeting incentives specifically toward individuals diagnosed with chronic diseases.
The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos
The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos
Articles
It seems that everybody loves workplace wellness programs. The Chamber of Commerce has firmly endorsed those progarms, as have other business groups. So has President Obama, and even liberal firebrands like former Senator Tom Harkin. And why not? After all, what's not to like about programs that encourage people to adopt healthy habits like exercise, nutritious eating, and quitting smoking? The proponents of these programs speak passionately, and with evident good intentions, about reducing the crushing burden that chronic disease places on individuals, families, communities, and the economy as a whole. What's not to like? Plenty. Workplace wellness programs are …
Federalism And The End Of Obamacare, Nicholas Bagley
Federalism And The End Of Obamacare, Nicholas Bagley
Articles
Federalism has become a watchword in the acrimonious debate over a possible replacement for the Affordable Care Act (ACA). Missing from that debate, however, is a theoretically grounded and empirically informed understanding of how best to allocate power between the federal government and the states. For health reform, the conventional arguments in favor of a national solution have little resonance: federal intervention will not avoid a race to the bottom, prevent externalities, or protect minority groups from state discrimination. Instead, federal action is necessary to overcome the states’ fiscal limitations: their inability to deficit-spend and the constraints that federal law …
Contemporary Practice Of The United States Relating To International Law, Daugirdas Kristina, Julian Davis Mortenson
Contemporary Practice Of The United States Relating To International Law, Daugirdas Kristina, Julian Davis Mortenson
Articles
In this section: • Congress Overrides Obama’s Veto to Pass Justice Against Sponsors of Terrorism Act • U.S. Federal Court of Appeals Upholds United Nations’ Immunity in Case Related to Cholera in Haiti • U.S.-Russian Agreements on Syria Break Down as the Syrian Conflict Continues • Russia Suspends Bilateral Agreement with United States on Disposal of Weapons-Grade Plutonium • The United States Makes Payment to Family of Italian Killed in CIA Air Strike • United States Ratifies Hague Convention on the International Recovery of Child Support and Other Forms of Family Maintenance
Regulating Secrecy, W. Nicholson Price Ii
Regulating Secrecy, W. Nicholson Price Ii
Articles
Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …
Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley
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).
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Articles
Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
Articles
Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …
Legal Limits And The Implementation Of The Affordable Care Act, Nicholas Bagley
Legal Limits And The Implementation Of The Affordable Care Act, Nicholas Bagley
Articles
Accusations of illegality have dogged the Obama Administration's efforts to implement the Affordable Care Act (ACA), the most ambitious piece of social legislation since the advent of Medicare and Medicaid. Some of the accusations have merit; indeed, it would be surprising if they did not. Even as the ACA's rollout has exposed unanticipated difficulties in the statutory design, congressional antipathy to health reform has precluded looking to the legislature to iron out those difficulties. To secure his principal achievement, President Obama has repeatedly tested the limits of executive authority in implementing the ACA. Six years after its enactment and two …
Transparency And The Supreme Court—Can Employers Refuse To Disclose How Much They Pay For Health Care?, Nicholas Bagley, Christopher Koller
Transparency And The Supreme Court—Can Employers Refuse To Disclose How Much They Pay For Health Care?, Nicholas Bagley, Christopher Koller
Articles
For decades, the prices that hospitals and physicians charge private insurers have been treated as trade secrets. Even though inflated prices are an enormous reason why health care is so much more expensive in the United States than in other countries, we have only a hazy picture of what those prices actually are.
Three Words And The Future Of The Affordable Care Act, Nicholas Bagley
Three Words And The Future Of The Affordable Care Act, Nicholas Bagley
Articles
As an essential part of its effort to achieve near universal coverage, the Affordable Care Act (ACA) extends sizable tax credits to most people who buy insurance on the newly established health care exchanges. Yet several lawsuits have been filed challenging the availability of those tax credits in the thirty-four states that refused to set up their own exchanges. The lawsuits are premised on a strained interpretation of the ACA that, if accepted, would make a hash of other provisions of the statute and undermine its effort to extend coverage to the uninsured. The courts should reject this latest effort …
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …
Protection Or Harm? Suppressing Substance-Use Data, Austin B. Frakt, Nicholas Bagley
Protection Or Harm? Suppressing Substance-Use Data, Austin B. Frakt, Nicholas Bagley
Articles
What if it were impossible to closely study a disease affecting 1 in 11 Americans over 11 years of age — a disease that’s associated with more than 60,000 deaths in the United States each year, that tears families apart, and that costs society hundreds of billions of dollars? What if the affected population included vulnerable and underserved patients and those more likely than most Americans to have costly and deadly communicable diseases, including HIV–AIDS? What if we could not thoroughly evaluate policies designed to reduce costs or improve care for such patients?
No Good Options: Picking Up The Pieces After King V. Burwell, Nicholas Bagley, David K. Jones
No Good Options: Picking Up The Pieces After King V. Burwell, Nicholas Bagley, David K. Jones
Articles
If the Supreme Court rules against the government in King v. Burwell, insurance subsidies available under the Affordable Care Act (ACA) will evaporate in the thirty-four states that have refused to establish their own health-care exchanges. The pain could be felt within weeks. Without subsidies, an estimated eight or nine million people stand to lose their health coverage. Because sicker people will retain coverage at a much higher rate than healthier people, insurance premiums in the individual market will surge by as much as fifty percent. Policymakers will come under intense pressure to mitigate the fallout from a government loss …
Predicting The Fallout From King V. Burwell - Exchanges And The Aca, Nicholas Bagley, David K. Jones, Timothy Stoltzfus Jost
Predicting The Fallout From King V. Burwell - Exchanges And The Aca, Nicholas Bagley, David K. Jones, Timothy Stoltzfus Jost
Articles
The U.S. Supreme Court's surprise announcement on November 7 that it would hear King v. Burwell struck fear in the hearts of supporters of the Affordable Cara Act (ACA). At stake is the legality of an Internal Revenue Service (IRS) rule extending tax credits to the 4.5 million people who bought their health plans in the 34 states that declined to establish their own health insurance exchanges under the ACA. The case hinges on enigmatic statutory language that seems to link the amount of tax credits to a health plan purchased "through an Exchange established by the State." According to …
The Legality Of Delaying Key Elements Of The Aca., Nicholas Bagley
The Legality Of Delaying Key Elements Of The Aca., Nicholas Bagley
Articles
Under the Affordable Care Act (ACA), the employer mandate — the requirement that most employers offer health insurance to their workers or pay a tax penalty — was scheduled to go into effect on January 1, 2014. Last summer, however, the Obama administration announced that it was delaying the mandate for a year. The administration has now extended the delay for midsize firms until 2016.
Long-Term Financial Burden Of Breast Cancer: Experiences Of A Diverse Cohort Of Survivors Identified Through Population-Based Registries, Reshma Jagsi, John A.E. Pottow, Kent A. Griffith, Cathy Bradley, Ann S. Hamilton, John Graff Rutgers University, Steven J. Katz, Sarah T. Hawley
Long-Term Financial Burden Of Breast Cancer: Experiences Of A Diverse Cohort Of Survivors Identified Through Population-Based Registries, Reshma Jagsi, John A.E. Pottow, Kent A. Griffith, Cathy Bradley, Ann S. Hamilton, John Graff Rutgers University, Steven J. Katz, Sarah T. Hawley
Articles
Purpose: To evaluate the financial experiences of a racially and ethnically diverse cohort of long-term breast cancer survivors (17% African American, 40% Latina) identified through population-based registries. Methods: Longitudinal study of women diagnosed with nonmetastatic breast cancer in 2005 to 2007 and reported to the SEER registries of metropolitan Los Angeles and Detroit. We surveyed 3,133 women approximately 9 months after diagnosis and 4 years later. Multivariable models evaluated correlates of self-reported decline in financial status attributed to breast cancer and of experiencing at least one type of privation (economically motivated treatment nonadherence and broader hardships related to medical expenses). …
Essential Health Benefits And The Affordable Care Act: Law And Process, Nicholas Bagley, Helen Levy
Essential Health Benefits And The Affordable Care Act: Law And Process, Nicholas Bagley, Helen Levy
Articles
Starting in 2014, the Affordable Care Act (ACA) will require private insurance plans sold in the individual and small-group markets to cover a roster of "essential health benefits." Precisely which benefits should count as essential, however, was left to the discretion of the Department of Health and Human Services (HHS). The matter was both important and controversial. Nonetheless, HHS announced its policy by posting on the Internet a thirteen-page bulletin stating that it would allow each state to define essential benefits for itself. On both substance and procedure, the move was surprising. The state-by-state approach departed from the uniform, federal …