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Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

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 ...


Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar May 2018

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 ...


Are Medicaid Work Requirements Legal?, Nicholas Bagley Mar 2018

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?


Researching Colorado Health Law, Kerri Rowe Jan 2018

Researching Colorado Health Law, Kerri Rowe

Articles

No abstract provided.


Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii Dec 2017

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 ...


Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii Nov 2017

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 ...


Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley Sep 2017

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 Jul 2017

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.


Federalism And The End Of Obamacare, Nicholas Bagley Apr 2017

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 ...


Three Words And The Future Of The Affordable Care Act, Nicholas Bagley Oct 2015

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 ...


No Good Options: Picking Up The Pieces After King V. Burwell, Nicholas Bagley, David K. Jones Apr 2015

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 Jan 2015

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 ...


Toward A Structural Theory Of Implicit Racial And Ethnic Bias In Health Care, Dayna Bowen Matthew Jan 2015

Toward A Structural Theory Of Implicit Racial And Ethnic Bias In Health Care, Dayna Bowen Matthew

Articles

No abstract provided.


Health Care, Title Vi, And Racism's New Normal, Dayna Bowen Matthew Jan 2014

Health Care, Title Vi, And Racism's New Normal, Dayna Bowen Matthew

Articles

No abstract provided.


Taxing The Platypygous, James J. White Jan 2013

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at ...


Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider Sep 2012

Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today’s health policy watchword. This article evaluates consumerism and the regulatory ...


Why It's Called The Affordable Care Act, Nicholas Bagley, Jill R. Horwitz Jan 2011

Why It's Called The Affordable Care Act, Nicholas Bagley, Jill R. Horwitz

Articles

The Patient Protection and Affordable Care Act of 2010 (“ACA”) raises numerous policy and legal issues, but none have attracted as much attention from lawyers as Section 1501. This provision, titled “Maintenance of Mini-mum Essential Coverage,” but better known as the “individual mandate,” requires most Americans to obtain health insurance for themselves and their dependents by 2014. We are dismayed that the narrow issue of the mandate and the narrower issue of free riding have garnered so much attention when our nation’s health-care system suffers from countless problems. By improving quality, controlling costs, and extending coverage to the uninsured ...


The Unaffordable Health Care Act - A Reponse To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn Jan 2011

The Unaffordable Health Care Act - A Reponse To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn

Articles

The Patient Protection and Affordable Care Act of 2010 has stirred considerable controversy. In the public debate over the program, many of its proponents have defended it by focusing on what is sometimes called the “free-rider” problem. In a prior article, we contended that the free-rider problem has been greatly exaggerated and was not a significant factor in the congressional decision to adopt the Act. We maintained that the free-rider issue is a red herring advanced to trigger an emotional attraction to the Act and distract attention from the actual issues that favor and disfavor its adoption. In a recently ...


Free Rider: A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn Jan 2011

Free Rider: A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn

Articles

Section 1501 of the Patient Protection and Affordable Care Act added section 5000A to the Internal Revenue Code to require most individuals in the United States, beginning in the year 2014, to purchase an established minimum level of medical insurance. This requirement, which is enforced by a penalty imposed on those who fail to comply, is sometimes referred to as the “individual mandate.” The individual mandate is one element of a vast change to the provision of medical care that Congress implemented in 2010. The individual mandate has proved to be controversial and has been the subject of a number ...


Rural Hospital Ownership: Medical Service Provision, Market Mix, And Spillover Effects, Jill R. Horwitz, Austin Nichols Jan 2011

Rural Hospital Ownership: Medical Service Provision, Market Mix, And Spillover Effects, Jill R. Horwitz, Austin Nichols

Articles

Objective. To test whether nonprofit, for-profit, or government hospital ownership affects medical service provision in rural hospital markets, either directly or through the spillover effects of ownership mix. Data Sources/Study Setting. Data are from the American Hospital Association, U.S. Census, CMS Healthcare Cost Report Information System and Prospective Payment System Minimum Data File, and primary data collection for geographic coordinates. The sample includes all nonfederal, general medical, and surgical hospitals located outside of metropolitan statistical areas and within the continental United States from 1988 to 2005. Study Design. We estimate multivariate regression models to examine the effects of ...


When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider Feb 2009

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's watchword. This Article evaluates this ideal ...


The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall Jan 2009

The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory ...


The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider Oct 2008

The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider

Articles

Medicine is a Profession on which physicians rely for their livelihood and patients for their lives. If physicians do not charge for services, they cannot survive. If patients cannot afford those services, they cannot survive. No wonder many physicians have long agreed that fees are “one of the most difficult problems . . . between patient and physician.” For years comprehensive insurance subdued this problem, but currently widespread underinsurance and consumer-directed health care are reviving it. Even as the ranks of the uninsured continue to increase,the latest hope for controlling medical costs requires insured patients to pay for much more care out-of ...


(Debate) Medicare: Did The Devil Make Us Do It?, Jill R. Horwitz, D. A. Hyman Jan 2008

(Debate) Medicare: Did The Devil Make Us Do It?, Jill R. Horwitz, D. A. Hyman

Articles

In this lively and creative debate, Professors David Hyman and Jill Horwitz argue about the virtues and vices of the federal Medicare program. As some predict a bleak future for the American’s government’s ability (or inability) to continue paying for Medicare as the population ages, this debate shows that there is genuine disagreement about the severity of the problem. In his Opening Statement, Professor Hyman offers a satirical letter to the Devil from one of his demonic servants, describes the Medicare program through the lens of the seven deadly sins. Arguing that Medicare’s faults are represented in ...


Does Nonprofit Ownership Matter?, Jill R. Horwitz Jan 2007

Does Nonprofit Ownership Matter?, Jill R. Horwitz

Articles

In recent years, policymakers have increasingly questioned whether nonprofit institutions, particularly hospitals, merit tax exemption. They argue that nonprofit hospitals differ little from their for-profit counterparts in the provision of charity care and, therefore, should either lose their tax-exempt status or adhere to new, strict, and specific requirements to provide free services for the poor. In this Article, I present evidence that hospital ownership-whether it is for-profit, nonprofit, or government owned-has a significant effect on the mix of medical services it offers. Despite notoriously weak enforcement mechanisms, nonprofit hospitals act in the public interest by providing services that are unlikely ...


After Autonomy, Carl E. Schneider Apr 2006

After Autonomy, Carl E. Schneider

Articles

Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl ...


Hipaa-Cracy, Carl E. Schneider Jan 2006

Hipaa-Cracy, Carl E. Schneider

Articles

The Department of Health and Human Services has recently been exercising its authority under the (wittily named) "administrative simplification" part of the Health Insurance Portability and Accountability Act to regulate the confidentiality of medical records. I love the goal; I loathe the means. The benefits are obscure; the costs are onerous. Putatively, the regulations protect my autonomy; practically, they ensnarl me in red tape and hijack my money for services I dislike. HIPAA (a misnomer-HIPAA is the statute, not the regulations) is too lengthy, labile, complex, confused, unfinished, and unclear to be summarized intelligibly or reliably. (Brevis esse laboro, obscurus ...


Hard Cases And The Politics Of Righteousness, Carl E. Schneider May 2005

Hard Cases And The Politics Of Righteousness, Carl E. Schneider

Articles

The law of bioethics has been the law of cases. Interpreting the common law and the Constitution, judges have written the law of informed consent, abortion, and assisted suicide. Reacting to causes célèbres, legislatures have written the law of advance directives and end of life decisions. The long, sad death of Terri Schiavo eclipsed even the long, sad deaths of Karen Ann Quinlan and Nancy Beth Cruzan in the duration and strength of the attention and passions it evoked. What are Schiavo’s lessons? Hard cases, lawyers say, make bad law. Why? First, hard cases are atypical cases. They present ...


Where Is The "There" In Health Law? Can It Become A Coherent Field?, Mark A. Hall, Carl E. Schneider Jan 2004

Where Is The "There" In Health Law? Can It Become A Coherent Field?, Mark A. Hall, Carl E. Schneider

Articles

Gerturde Stein complained of Oakland, "There is no there there." Churchill complained of his pudding that "it has no theme." And everybody complains of health law that it lacks an organizing principle. Health law scholars bemoan the "pathologies" of health law and its contradictory and competing "paradigms'. which form a "chaotic, dysfunctional patchwork." But it should not surprise us that any field which grows by accretion lacks a unifying idea or animating concern. And health law certainly grew by accretion. It began in the 1960s, when the Law-Medicine Center was established, concerned with medical proof in litigation, physicians' malpractice, and ...


Why We Need The Independent Sector: The Behavior, Law, And Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz Jan 2003

Why We Need The Independent Sector: The Behavior, Law, And Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz

Articles

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made ...