Health Law and Policy Commons^™

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).

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 tax-exempt …

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 taxes.” This tax-based interpretation …

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 …

Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price

Law & Economics Working Papers

Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …

Productivity And Affinity In The Age Of Dignity, Stephen Lee

Michigan Law Review

This Review proceeds as follows. Part I summarizes The Age of Dignity. Part II explains how this segment of immigrant workers challenges the productivity/affinity binary that dominates immigration law’s formal migration rules. Part III shows how this binary sets up dual migration streams, both of which could account for future flows of care workers. As Part III shows, the example of the eldercare industry nicely illustrates how the employment based and family-based migration systems simply represent two different ways of filling labor needs. I then conclude.

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 …

The Affordable Care Act, Experience Rating, And The Problem Of Non-Vaccination, Eric Esshaki

University of Michigan Journal of Law Reform Caveat

Polio, the whooping cough, and the mumps, among many other communicable diseases, were once prevalent in communities within the developed world and killed millions of people.1 The advent of vaccinations contained or eradicated several of these diseases.2 However, these diseases still exist in the environment3 and are making a comeback in the United States.4 Their persistence is directly attributable to the rising trend among parents refusing to vaccinate their children.5 One proposed solution to this problem is to hold parents liable in tort when others are harmed by their failure to vaccinate. Another proposed solution argues that parents should pay …

Shared Responsibility Regulation Model For Cross-Border Reproductive Transactions, Sharon Bassan

Michigan Journal of International Law

The term “cross-border reproductive transactions” refers to the movement of tens of thousands of people, who travel from one country to purchase reproductive services from suppliers in other countries, in order to have a child.2 It is estimated that between eleven and fourteen thousand patients in Europe alone engage in this practice annually.3 Historically, the phrase ‘medical tourism’ used to refer to the travel of patients from less-affluent countries seeking better healthcare in countries with superior healthcare standards. Today, the journey is just as likely to flow in the opposite direction, as patients travel from industrialized to less affluent countries …

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 …

Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii

Michigan Telecommunications & Technology Law Review

Black-box medicine—the use of big data and sophisticated machine-learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, …

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.

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

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

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 …

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

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

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 …

King V. Burwell: Brief For Professors Thomas W. Merrill, Gillian E. Metzger, Abbe R. Gluck, And Nicholas Bagley As Amici Curiae Supporting Respondents, Nicholas Bagley

Appellate Briefs

The Amici teach and write about federalism, constitutional law, and legislation. Amici submit this brief in the hope that its analysis of the federalism issues in this case will be of value to the Court.

The parties to this case have set forth two opposing interpretations of the Exchange provisions of the Patient Protection and Affordable Care Act (ACA), Pub. L. No. 111-148, 124 Stat. 119. Under petitioners' interpretation, federal taxpayer subsidies are available only to those who purchase insurance on Exchanges that are set up by the States and are not available to those who do so on HHS-facilitated …

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 …

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 …

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

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

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 …

Multipolarity, Intellectual Property, And The Internationalization Of Public Health Law, Sam F. Halabi

Michigan Journal of International Law

The cause of global health today is arguably the most influential human rights movement ever seen, mobilizing vast flows of direct and indirect aid to the developing world to fight disease and build health care infrastructure; prompting the establishment of international organizations like UNAIDS and the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund); including global health as a priority in major diplomatic summits; and driving the formation and implementation of international agreements to address global health threats. Champions of this movement claim that the diverse and influential state and non-state actors participating in the development of the …

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

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). …

Keynote Remarks At The University Of Michigan Environmental Law And Public Health Conference, Gina Mccarthy

Michigan Journal of Environmental & Administrative Law

The following are the prepared remarks delivered at the University of Michigan Law School’s 2013 Environmental Law and Public Health Conference on September 26, 2013.

Protecting Human Health And Stewarding The Environment: An Essay Exploring Values In U.S. Environmental Protection Law, Tracy Bach

Michigan Journal of Environmental & Administrative Law

The purpose of this conference is to explore “the relationship between environmental protection and public health and how it should inform our efforts to become better stewards of the environment.” No one would disagree with the assertion that during the last forty years of federal environmental protection, air and water quality have improved and led to concomitant improvements in human health. Exploring the contours of this “relationship,” Environmental Protection Agency (EPA) Administrator Gina McCarthy said in her keynote speech that “[t]he thing is, the word ‘relationship’ is too neutral. The link between the health of our planet and the health …

Environmental Law, Public Health, And The Values Conundrum, David M. Uhlmann

Michigan Journal of Environmental & Administrative Law

In September 1996, when I was nearing the end of my sixth year as a Justice Department environmental crimes prosecutor, one of my colleagues sent me an email that there was a “good-sounding RCRA [Resource Conservation and Recovery Act] knowing endangerment case developing in Idaho.” A twenty-year-old man named Scott Dominguez had collapsed inside a storage tank at an Idaho fertilizer manufacturing facility called Evergreen Resources. Mr. Dominguez could not be rescued for nearly an hour, because firefighters who responded to the scene did not know what was in the tank and what safety precautions they needed to take before …