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Full-Text Articles in Law
The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds
The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds
Articles
Incarcerated people are excluded from Medicaid coverage due to a provision in the Social Security Act Amendments of 1965 known as the Medicaid Inmate Exclusion Policy (“MIEP”). This Article argues for the elimination of the MIEP as an anachronistic remnant of an earlier era prior to the massive growth of the U.S. incarcerated population and the expansion of Medicaid eligibility under the Patient Protection and Affordable Care Act of 2010. It explores three reasons for eliminating the MIEP. First, the inclusion of incarcerated populations in Medicaid coverage would signify the final erasure from the Medicaid regime of the istinction between …
The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos
The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos
Articles
Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
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 …
Constitutional Cohesion And The Right To Public Health, James G. Hodge Jr., Daniel Aaron, Haley R. Augur, Ashley Cheff, Joseph Daval, Drew Hensley
Constitutional Cohesion And The Right To Public Health, James G. Hodge Jr., Daniel Aaron, Haley R. Augur, Ashley Cheff, Joseph Daval, Drew Hensley
University of Michigan Journal of Law Reform
Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally are realities of our existing constitutional infrastructure. In essence, there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and malfeasance). Structural …
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
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
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 about …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
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 products. This Note …
Regulating Black-Box Medicine, W. Nicholson Price Ii
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 …
Prisoners With Disabilities, Margo Schlanger
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 …
Spending Medicare’S Dollars Wisely: Taking Aim At Hospitals’ Cultures Of Overtreatment, Jessica Mantel
Spending Medicare’S Dollars Wisely: Taking Aim At Hospitals’ Cultures Of Overtreatment, Jessica Mantel
University of Michigan Journal of Law Reform
With Medicare’s rising costs threatening the country’s fiscal health, policymakers have focused their attention on a primary cause of Medicare’s high price tag—the overtreatment of patients. Guided by professional norms that demand they do “everything possible” for their patients, physicians frequently order additional diagnostic tests, perform more procedures, utilize costly technologies, and provide more inpatient care. Much of this care, however, does not improve Medicare patients’ health, but only increases Medicare spending. Reducing the overtreatment of patients requires aligning physicians’ interests with the government’s goal of spending Medicare’s dollars wisely. Toward that end, recent Medicare payment reforms establish a range …
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 …
Medicine As A Public Calling, Nicholas Bagley
Medicine As A Public Calling, Nicholas Bagley
Michigan Law Review
The debate over how to tame private medical spending tends to pit advocates of government-provided insurance—a single-payer scheme—against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century— and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not …
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 …
Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah
Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah
University of Michigan Journal of Law Reform
Brain death is different from the traditional, biological conception of death. Although there is no possibility of a meaningful recovery, considerable scientific evidence shows that neurological and other functions persist in patients accurately diagnosed as brain dead. Elsewhere with others, I have argued that brain death should be understood as an unacknowledged status legal fiction. A legal fiction arises when the law treats something as true, though it is known to be false or not known to be true, for a particular legal purpose (like the fiction that corporations are persons). Moving towards greater transparency, it is legally and ethically …
For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley
For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley
University of Michigan Journal of Law Reform Caveat
This football season, millions of Americans enjoying their favorite pastime might feel pangs of a guilty conscience. Years of scientific research into the long-term neurological effects of tackle football and a recent settlement between the National Football League (NFL) and thousands of retired NFL players have made football-related traumatic brain injuries (TBI) a topic of national conversation. Current and former NFL players and even President Obama have participated in the conversation, saying that they would hesitate to let their sons play the game for fear of possible brain injury. Because research has uncovered signs of permanent brain damage in players …
The Fourth Trimester, Saru M. Matambanadzo
The Fourth Trimester, Saru M. Matambanadzo
University of Michigan Journal of Law Reform
This Article introduces a new conceptual framework to the legal literature on pregnancy and pregnancy discrimination: the fourth trimester. The concept of a fourth trimester, drawn from maternal nursing and midwifery, refers to the crucial three to six month period after birth when many of the physical, psychological, emotional, and social effects of pregnancy continue. Giving this concept legal relevance extends the scope of pregnancy beyond the narrow period defined by conception, gestation, and birth and acknowledges that pregnancy is a relational process, not an individual event. In the United States, however, antidiscrimination law has failed to acknowledge the demands …
An Insurance Structure To Encourage Investment In Preventative Health Care, Nicholas Georgakopoulos
An Insurance Structure To Encourage Investment In Preventative Health Care, Nicholas Georgakopoulos
University of Michigan Journal of Law Reform
The incentives for investments in Americans' health are poorly aligned. Health insurers are not sufficiently motivated to invest for the long term. The structure of health insurance does not compensate insurers for investments in lasting health, such as measures preventing chronic disease. If an American changes insurers, the new insurer reaps the benefits of the good health the prior insurer's investment produced. This Essay explores insurers' incentives to invest in health, illustrates how those incentives fail, explores possible improvements, and shows that subsequent insurers should have an obligation to compensate the prior insurer for the averted expenses of expected diseases …
Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley
Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley
Articles
Notwithstanding its obvious importance, Medicare is almost invisible in the legal literature. Part of the reason is that administrative law scholars typically train their attention on the sources of external control over agencies’ exercise of the vast discretion that Congress so often delegates to them. Medicare’s administrators, however, wield considerably less policy discretion than the agencies that feature prominently in the legal commentary. Traditional administrative law thus yields slim insight into Medicare’s operation. But questions about external control do not—or at least they should not—exhaust the field. An old and often disregarded tradition in administrative law focuses not on external …
Family Caregiving And The Law Of Succession: A Proposal, Thomas P. Gallanis, Josephine Gittler
Family Caregiving And The Law Of Succession: A Proposal, Thomas P. Gallanis, Josephine Gittler
University of Michigan Journal of Law Reform
As the American population ages, the need for long-term care, already great, will become even greater. Some of this care is paid for by government programs, such as Medicaid, and by individual long-term care insurance policies. But the combination of the public fisc and private insurance are, and will continue to be, insufficient to pay for all of the care our seniors and adults with disabilities need. The provision of care in a family residence by one or more family members is an important component of our health care delivery system and must be supported and encouraged by public policy …
The Tangled Thicket Of Health Care Reform: The Judicial System In Action, Gene Magidenko
The Tangled Thicket Of Health Care Reform: The Judicial System In Action, Gene Magidenko
University of Michigan Journal of Law Reform Caveat
On March 23, 2010, after a lengthy political debate on health care reform, President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. A week later, he signed the Health Care and Education Reconciliation Act of 2010, which amended certain provisions of PPACA. But far from ending the intense national debate on the issue, these enactments opened a new front of battle in the federal courts that will almost certainly make its way to the United States Supreme Court. Much of this litigation focuses on § 1501 of PPACA, which contains the controversial individual mandate requiring …
Re-Thinking Health Insurance, Hans Biebl
Re-Thinking Health Insurance, Hans Biebl
University of Michigan Journal of Law Reform Caveat
In May 2009, while promoting the legislation that would become the Patient Protection and Affordable Care Act (PPACA), President Obama said that rising health care costs threatened the balance sheets of both the federal government and private enterprise. He noted that any increase in health care spending consumes funds that “companies could be using to innovate and to grow, making it harder for them to compete around the world.” Despite the rancorous debate that surrounded this health care legislation and which culminated with the Supreme Court’s decision in National Federation of Independent Businesses, the PPACA was not a radical piece …
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci
Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci
University of Michigan Journal of Law Reform
The denial of Medicaid coverage for augmentative communication devices, despite an existing legal framework that mandates the opposite result, raises fundamental questions about what independence means for people with disabilities. This situation, compounded by the barriers in the Medicaid administrative appeal process encountered by such beneficiaries, invites new approaches to the delivery of civil legal services, such as medical-legal partnerships (MLPs). MLPs are formalized arrangements that bring lawyers into a healthcare setting to provide specialist consultations when patients experience legal problems that affect health. While there is an emerging scholarship on MLPs, this Article offers the first in-depth analysis of …
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
University of Michigan Journal of Law Reform
Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …
Rural Hospital Ownership: Medical Service Provision, Market Mix, And Spillover Effects, Jill R. Horwitz, Austin Nichols
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 (1) hospital …
Crisis On Campus: Student Access To Health Care, Bryan A. Liang
Crisis On Campus: Student Access To Health Care, Bryan A. Liang
University of Michigan Journal of Law Reform
College-aged adults are an overrepresented group in the uninsured population of the United States, and traditionally underserved minorities are disproportionately affected. Students with private health insurance are often functionally uninsured as well, since most schools refuse to accept this traditionally elite calling card on campus. Consequently, the large uninsured and functionally uninsured populations often rely on school-sponsored health insurance plans for access to care. These plans have uneven coverage, limited benefits, exclusions and high co-pays and deductibles, and provide little health care security for their beneficiaries. Further, schools and insurance companies have profited substantially from these student plans, raising the …
Reconstructing The Individual Mandate As An Escrow Account, Gregg D. Polsky
Reconstructing The Individual Mandate As An Escrow Account, Gregg D. Polsky
Michigan Law Review First Impressions
The recent health care reform law's most controversial provision is the individual mandate, which imposes a fine on individuals who fail to obtain a minimum level of health insurance coverage. Many object to this policy, arguing that the government shouldn't force individuals to purchase health insurance. Others believe that the mandate is a necessary component to health care reform. What has been missed in the discussion is that Congress could restructure the individual mandate to avoid the requirement that individuals purchase health insurance while still fulfilling its principal function. The principal purpose of the mandate is not to require individuals …
Risky Ventures: The Impact Of Irs Health Care Joint Venture Policy, Roger P. Meyers
Risky Ventures: The Impact Of Irs Health Care Joint Venture Policy, Roger P. Meyers
University of Michigan Journal of Law Reform
IRS oversight of joint ventures between exempt and for-profit organizations has undergone substantial change over the past thirty years. This change has important consequences for the health care industry, where joint ventures have grown increasingly common. In the face of unclear guidance and aggressive enforcement of exemption-policing tools such as the private benefit doctrine and the control test, a hospital risks revocation of its tax-exempt status, or liability for unrelated business income tax, when it engages in a joint venture directly. It may be able to eliminate this risk by operating the same joint venture through a for-profit subsidiary; however, …
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Michigan Journal of Gender & Law
In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …