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Articles 1 - 30 of 251

Full-Text Articles in Health Law and Policy

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen Apr 2019

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any ...


Abortion Talk, Clare Huntington Apr 2019

Abortion Talk, Clare Huntington

Michigan Law Review

Review of Carol Sanger's About Abortion: Terminating Pregnancy in Twenty-First-Century America.


Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams Oct 2018

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid ...


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs Sep 2018

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 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 ...


Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman Jun 2018

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then ...


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 ...


Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox May 2018

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common ...


Improving Generic Drug Approval At The Fda, Kathleen Craddock May 2018

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric ...


Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen May 2018

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these ...


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?


The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva Jan 2018

The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva

Michigan Journal of International Law

In the following, I outline the case against the international right to health care and explain why recognition of such a right is still necessary. The argument is explicitly limited to international human rights law and is primarily descriptive in nature, but I go on to explain the moral reasons to accept this account. Both the positive law and moral reasoning could be used in other health rights debates, but I do not attempt to make such claims here.

The structure of my work is as follows. I first outline three problems with recognizing an international right to health care ...


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 ...


Regulating Black-Box Medicine, W. Nicholson Price Ii Dec 2017

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they ...


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 ...


Prisoners With Disabilities, Margo Schlanger Nov 2017

Prisoners With Disabilities, Margo Schlanger

Book Chapters

A majority of American prisoners have at least one disability. So how jails and prisons deal with those prisoners’ needs is central to institutional safety and humaneness, and to reentry success or failure. In this chapter, I explain what current law requires of prison and jail officials, focusing on statutory and constitutional law mandating non-discrimination, accommodation, integration, and treatment. Jails and prisons have been very slow to learn the most general lesson of these strictures, which is that officials must individualize their assessment of and response to prisoners with disabilities. In addition, I look past current law to additional policies ...


The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah Nov 2017

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to ...


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.


The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos May 2017

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 ...


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 ...


A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider Apr 2017

A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider

Michigan Telecommunications & Technology Law Review

Human institutions and activities cannot avoid failures. Anxiety about them often provokes governments to try to prevent those failures. When that anxiety is vivid and urgent, government may do so without carefully asking whether regulation’s costs justify their benefits. Privacy and Accountability in Black Box Medicine admirably labors to bring discipline and rationality to thinking about an important development — the rise of “black-box medicine” — before it causes injuries regulation should have prevented and before it is impaired by improvident regulation. That is, Privacy and Accountability weighs the costs against the benefits of various forms of regulation across the many ...


Risk And Resilience In Health Data Infrastructure, Nicholson Price Mar 2017

Risk And Resilience In Health Data Infrastructure, Nicholson Price

Law & Economics Working Papers

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 ...


Unduly Burdening Women’S Health: How Lower Courts Are Undermining Whole Woman’S Health V. Hellerstedt, Litman M. Leah Jan 2017

Unduly Burdening Women’S Health: How Lower Courts Are Undermining Whole Woman’S Health V. Hellerstedt, Litman M. Leah

Michigan Law Review Online

At the end of the Supreme Court’s 2016 Term, the Court issued its decision in Whole Woman’s Health v. Hellerstedt. One of the more closely watched cases of that Term, Hellerstedt asked whether the Supreme Court would adhere to its prior decision in Planned Parenthood v. Casey, which reaffirmed that women have a constitutionally protected right to decide to end a pregnancy.

The state of Texas had not formally requested that the Court revisit Casey or the earlier decision Casey had affirmed, Roe v. Wade, in Hellerstedt. But that was what Texas was, in effect, asking the Court ...


Contemporary Practice Of The United States Relating To International Law, Daugirdas Kristina, Julian Davis Mortenson Jan 2017

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


The Fmla And Psychological Support: Courts Care About "Care" (And Employers Should, Too), Katherine Stallings Bailey Jan 2017

The Fmla And Psychological Support: Courts Care About "Care" (And Employers Should, Too), Katherine Stallings Bailey

Michigan Law Review

The Family and Medical Leave Act (“FMLA”) recognizes an employee’s right to take leave to care for a qualifying family member. In light of the Act’s remedial nature, the intended scope of the care provision is broad, but its definitional details are sparse. As a result of the attendant interpretive discretion afforded to courts, the Seventh Circuit announced its rejection of the requirement—first articulated by the Ninth Circuit—that care provided during travel be related to continuing medical treatment. A facial analysis of the resulting circuit split fails to appreciate the fundamental difference between the Seventh and ...


The Tax Definition Of "Medical Care:" A Critique Of The Startling Irs Arguments In O'Donnabhain V. Commissioner, Katherine Pratt Dec 2016

The Tax Definition Of "Medical Care:" A Critique Of The Startling Irs Arguments In O'Donnabhain V. Commissioner, Katherine Pratt

Michigan Journal of Gender & Law

This Article critiques the startling arguments made by the Internal Revenue Service (“IRS”) in O’Donnabhain v. Commissioner, a case in which the issue was whether a person diagnosed with gender identity disorder (“GID”) could take a federal tax deduction for the costs of male-to-female medical transition, including hormone treatment, genital surgery, and breast augmentation. Internal Revenue Code § 213 allows a deduction for the costs of “medical care,” which (1) includes costs incurred for “the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body,” but (2) generally excludes ...


R-Egg-Ulation: A Call For Greater Regulation Of The Big Business Of Human Egg Harvesting, Danielle A. Vera Dec 2016

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.


Black Health Matters: Disparities, Community Health, And Interest Convergence, Mary Crossley Oct 2016

Black Health Matters: Disparities, Community Health, And Interest Convergence, Mary Crossley

Michigan Journal of Race and Law

Health disparities represent a significant strand in the fabric of racial injustice in the United States, one that has proven exceptionally durable. Many millions of dollars have been invested in addressing racial disparities over the past three decades. Researchers have identified disparities, unpacked their causes, and tracked their trajectories, with only limited progress in narrowing the health gap between whites and racial and ethnic minorities. The implementation of the Affordable Care Act (ACA) and the movement toward value-based payment methods for health care may supply a new avenue for addressing disparities. This Article argues that the ACA’s requirement that ...


Nfib V. Sebelius And The Individual Mandate: Thoughts On The Tax/Regulation Distinction, Kyle D. Logue Jun 2016

Nfib V. Sebelius And The Individual Mandate: Thoughts On The Tax/Regulation Distinction, Kyle D. Logue

Michigan Business & Entrepreneurial Law Review

When Chief Justice John Roberts wrote the opinion of the Court in National Federation of Independent Businesses v. Sebelius (NFIB) explaining the constitutionality of the Affordable Care Act’s (ACA) minimum essential coverage provision (sometimes referred to as the individual mandate), he reasoned that the mandate—or, more precisely, the enforcement provision that accompanied the mandate (the Shared Responsibility Payment or SRP)—could be understood as a tax on the failure to purchase health insurance. According to this view, the enactment of the mandate and its accompanying enforcement provisions fell within Congress’s virtually unlimited power to “lay and collect ...