Health Law and Policy Commons^™

Analytical Framework For Examining The Value Of Antibacterial Products, Kevin Outterson, Aylin Sertkaya, John T. Eyraud, Anna Birkenback, Calvin Franz, Nyssa Ackerley, Valerie Overton

Faculty Scholarship

Antibacterial resistance is a growing global problem. According to the most recent statistics from the Centers for Disease Control and Prevention (CDC), at least 2 million people acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat those infections in the United States alone. Of these, approximately 23,000 die as a result of drug-resistant infections. Even though estimates vary widely, the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively …

The Drug Quality And Security Act - Mind The Gaps, Kevin Outterson

Faculty Scholarship

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark.

Ahla Health Law Curriculum Manual, Kevin Outterson

Books

Despite being a significant segment of the economy, the discipline of health law is relatively new. This is particularly evident in many law schools where health law is still not represented by a full-time faculty member. Some of these schools either do not teach any courses in the area or rely primarily on adjuncts. For those unfamiliar with the discipline, it can be difficult to understand its content and breadth, which becomes a particular challenge to faculties that want to hire a health law professor for the first time, or for academic deans attempting to identify appropriately qualified adjuncts. Meanwhile, …

The Burden Of Deciding For Yourself: The Disutility Caused By Out-Of-Pocket Healthcare Spending, Christopher Robertson, David Yokum

Faculty Scholarship

As part of a larger "consumer-directed healthcare movement," cost-sharing mechanisms, such as copays and deductibles, cause patients to pay out of pocket for a portion of the costs of the healthcare they consume. Cost sharing is intended to reduce costs by changing consumption behavior, and it has been shown to be an effective though incomplete solution to the problem of unsustainable cost growth. It is controversial nonetheless. This Essay distinguishes three different normative problems with cost sharing (including underinsurance, deterrence of high-value care, and a tax on sickness), which can all be fixed through more precision in the design of …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

Money, Sex, And Religion – The Supreme Court's Aca Sequel, George J. Annas, Theodore W. Ruger, Jennifer Prah Ruger

Faculty Scholarship

The Supreme Court decision in the Hobby Lobby case is in many ways a sequel to the Court's 2012 decision on the constitutionality of the Affordable Care Act (ACA). The majority decision, written by Justice Samuel Alito, is a setback for both the ACA's foundational goal of access to universal health care and for women's health care specifically. The Court's ruling can be viewed as a direct consequence of our fragmented health care system, in which fundamental duties are incrementally delegated and imposed on a range of public and private actors. Our incremental, fragmented, and incomplete health insurance system means …

Allocating Responsibility For Health Care Decisions Under The United States Affordable Care Act, Wendy K. Mariner

Faculty Scholarship

This article summarizes the major elements of the ACA's insurance reforms and how they affect responsibility for making decisions about the health care that people receive. A key example of the difficulty of allocating decision making responsibility is the effort to define a minimum benefit package for insurance plans, called essential health benefits. While the ACA should achieve its goal of near-universal access to care, it leaves in place a multiplicity of processes and decision-makers for determining individual treatment. As a result, decisions about what care is provided are likely to remain, much as they are today, divided among government …

Hiv, Violence Against Women, And Criminal Law Interventions, Aziza Ahmed

Faculty Scholarship

The growing calls for the “securitization of body and property,”[ii] documented by Jonathan Simon in his book Governing Through Crime, illustrates a deep tension in our understanding of the role of criminal law as a tool for societal transformation.[iii] For some, including communities of color, the criminal legal system is a place where inequality flourishes;[iv] for others, including those feminists who have support criminal law interventions, it has become a tool to realize equality.[v] The Trafficking Victims Protection Act, reauthorized in 2013 as an amendment to the Violence Against Women Act (VAWA),[vi] relies heavily on the criminal law to obtain …

Health Insurance Is Dead; Long Live Health Insurance, Wendy K. Mariner

Faculty Scholarship

Today, health insurance is no longer simply a class of insurance that covers risks to health, and it has not been so for many years. Health insurance has become a unique form of insurance — a mechanism to pay for healthcare that uses risk spreading as one of several pricing methods. The Affordable Care Act builds on this important payment function to create a complex social insurance system to finance healthcare for (almost) everyone. This article examines how the ACA draws on various conceptions of insurance to produce a quasi-social insurance system. This system poses new challenges to laws governing …

Medicaid Expansion As Completion Of The Great Society, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

A state’s decision whether to expand Medicaid has become a highly politicized issue, spawning countless news stories and on-going debate. However, this Essay takes a step back from that highly charged discourse and situates Medicaid expansion in its historical context. We reveal that this latest change universalizes the program, holding the power to finally realize President Johnson’s vision for the Great Society, almost fifty years later. Medicaid can be understood as a universal program for three reasons: (1) the percentage of thepopulation of children, pregnant women, and non-elderly adults it covers; (2) the degree to which Medicaid funds long-term care …

Dynamic Expansion, Nicole Huberfeld

Faculty Scholarship

Nearly one in four Americans will have medical care and costs covered by the Medicaid program when it has been expanded pursuant to the Patient Protection and Affordable Care Act (the ACA). National media outlets have been reporting that only about half of the states are participating in the Medicaid expansion; if the reports were true, millions of Americans would be left without insurance coverage, and many of the nation’s medically fragile citizens would not have access to consistent healthcare. Contrary to these reports, most states will participate in the Medicaid expansion in the near future. This claim is not …

Approval And Withdrawal Of New Antibiotics And Other Antiinfectives In The U.S., 1980-2009, Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio, Aaron S. Kesselheim

Faculty Scholarship

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibioticsintroduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes. Adjusted for these withdrawals, the net introduction of NME antibiotics is not as troubling of a trend. The reduction in NME antibiotics was partially offset by a surge in the introduction of NME antiretrovirals for HIV/AIDS and other drug classes (such as cardiovascular drugs) posted similar declines.

These data …

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

Limiting “Sugary Drinks” To Reduce Obesity — Who Decides?, Wendy K. Mariner, George J. Annas

Faculty Scholarship

When a judge struck down the New York City Board of Health's partial ban on selling “sugary drinks” in containers of more than 16 fluid ounces, the reaction was swift. The Portion Cap Rule was widely viewed as a signature accomplishment of Mayor Michael Bloomberg's third term as the “public health mayor,” and he vowed to appeal, saying, “I've got to defend my children, and yours, and do what's right to save lives. Obesity kills.” But the question before the judge was not about the health risks posed by obesity or even the relationship between obesity and access to large …

"At The Hospital There Are No Human Rights": Reproductive And Sexual Rights Violations Of Women Living With Hiv In Namibia, Aziza Ahmed

Faculty Scholarship

This report documents the ongoing stigma and discrimination of women living with HIV in Namibia, building on prior findings and investigations on the subject, such as the 2008 research conducted by the International Community of Women Living with HIV/AIDS (ICW) and the Namibian Women’s Health Network (NWHN). The report, based upon both desk research and a field mission, examines the human rights situation related to sexual and reproductive health of women living with HIV, including the gravity and ongoing nature of forced and coerced sterilizations in Namibia. The report also provides evidence of violations of informed consent in the context …

Did Legal Education Fail Health Reform? And How Health Law Can Help, Wendy K. Mariner

Faculty Scholarship

Arguments over the constitutionality of the Affordable Care Act illustrate the pervasiveness of health law issues in society. In court, arguments on both sides also demonstrated insufficient knowledge of the health care system and health insurance to identify and present useful arguments. Too many lawyers remained wedded to theories of constitutional law that have become disconnected from twenty-first century realities. Legal education may have something to answer for in this respect. This essay examines how legal education in health law may offer some valuable responses to ongoing critiques of legal education in general. The more law moves away from strict …

Plunging Into Endless Difficulties: Medicaid And Coercion In National Federation Of Independent Business V. Sebelius, Nicole Huberfeld, Elizabeth Weeks Leonard, Kevin Outterson

Faculty Scholarship

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes …

“Rugged Vaginas” And “Vulnerable Rectums”: The Sexual Identity, Epidemiology, And Law Of The Global Hiv Epidemic, Aziza Ahmed

Faculty Scholarship

AIDS remains amongst the leading causes of death globally. Identity is the primary mode of understanding HIV and organizing in response to the HIV epidemic. In this Article, I examine how epidemiology and human rights activism co-produce ideas of identity and risk. I call this the "identity/risk narrative ": the commonsense understanding about an identity group's HIV risk. For example, epidemiology offers the biological narrative of risk: anal sex and the weak rectal lining make men who have sex with men more vulnerable to HIV; while the fragility of a woman's vaginal wall provides a biological foundation for women's vulnerability. …

Distributions Of Industry Payments To Massachusetts Physicians, Aaron S. Kesselheim, Christopher Robertson, Kent Siri, Puneet Batra, Jessica M. Franklin

Faculty Scholarship

Some states have mandated systematic public disclosure of payments made by drug- and device-makers to health care practitioners. We used Massachusetts data to characterize the distribution of payment types and the variation among medical specialties.

The 30 months’ of data included 32,227 reported payments to 11,734 Massachusetts physicians, for a total of $76.7 million. The most common form of payment was food. Compensation for bona fide services was the payment type with the highest value.

We found that 25% of currently licensed Massachusetts physicians received at least one payment during the study period. Prevalence ranged by specialties from pediatricians (12%) …

With Liberty And Access For Some: The Aca's Disconnectfor Women's Health, Nicole Huberfeld

Faculty Scholarship

The ACA denies to women the "basic security" of providing insurance for a procedure that statistics show one in three women will need during their reproductive lifetime. On one hand, the access-enhancing elements of the ACA are likely to help women, who earn lower wages, need more medical care, and live longer than men, to gain access to preventive and regular healthcare and to keep the insurance that they have. On the other hand, poor women and women of color will lose ground in access to abortion, because the ACA prevents insurance payment for abortions through both public and private …

Where There Is A Right, There Must Be A Remedy (Even In Medicaid), Nicole Huberfeld

Faculty Scholarship

The anticipated growth of Medicaid under the ACA will likely aggravate an ongoing dispute surrounding private enforcement of the Medicaid Act. The Medicaid Act does not provide a private right of action except when a person who is eligible for Medicaid is denied entry into the program. Nevertheless, historically, both Medicaid providers and beneficiaries have been able to protect their rights through 42 U.S.C. § 1983, which allows individuals to seek redress against states in federal court for violations of statutory or constitutional rights, or through the Supremacy Clause, which prevents states from enacting laws that violate superseding federal laws. …

Reframing Federalism — The Affordable Care Act (And Broccoli) In The Supreme Court, Wendy K. Mariner, Leonard H. Glantz, George J. Annas

Faculty Scholarship

The U.S. Supreme Court decision to uphold most of the Affordable Care Act (ACA), including the insurance-coverage requirement, allows historic reforms in the health care system to move forward. Because the justices were split four to four on whether the ACA was constitutional, Chief Justice John Roberts was able to write the lead opinion that commanded five votes for whatever outcome he determined was constitutional. The chief justice's leadership in upholding almost all of the ACA was unanticipated, as was much of his legal reasoning. It was widely assumed that the interpretation of the Commerce Clause by the Court would …

Post-Reform Medicaid Before The Court: Discordant Advocacy Reflects Conflicting Attitudes, Nicole Huberfeld

Faculty Scholarship

The Supreme Court will decide two major Medicaid cases this term that raise major questions about the program and the tensions it creates between the federal government and the states. The Court heard oral arguments on October 3d in Douglas v. Independent Living Center, a dispute between California and its Medicaid providers regarding reimbursement cuts due to California’s budget crisis. The Medicaid providers argue that these proposed cuts are so extreme as to violate federal law and thus the Supremacy Clause. Their contention hinges on the Equal Access Provision of the Medicaid Act, which commands states to pay healthcare providers …

Safeguarding The Safeguards: The Aca Litigation And The Extension Of Structural Protection To Non-Fundamental Liberties, Abigail Moncrieff

Faculty Scholarship

As the lawsuits challenging the Patient Protection and Affordable Care Act (ACA) have evolved, one feature of the litigation has proven especially rankling to the legal academy: the incorporation of substantive libertarian concerns into structural federalism analysis. The breadth and depth of scholarly criticism on this point is surprising, however, given that judges today frequently choose indirect methods for protecting substantive constitutional values, including structural and process-based methods of the kinds at issue in the ACA litigation. Indeed, indirection in the protection of constitutional liberties is a well-known and well-theorized strategy, which one scholar recently termed “semisubstantive review” and another …

The Affordable Care Act And Health Promotion: The Role Of Insurance In Defining Responsibility For Health Risks And Costs, Wendy K. Mariner

Faculty Scholarship

This article examines whether insurance is an appropriate mechanism for improving individual health or reducing the cost of health care for payers. The Affordable Care Act contains implicit standards for allocating responsibility for health, especially in provisions encouraging health promotion and wellness programs. A summary of the accumulating evidence of the effects of such programs suggests that wellness programs have been somewhat more effective in making people feel better than in reducing costs. Health promotion should be encouraged, because health is valuable for its own sake. Insurance is not well suited to improve health or manage behavioral risks to health; …

Brief Of Amici Curiae Jewish Alliance For Law, Social Action (Jalsa), Jewish Council On Urban Affairs (Jcua), Jewish Social Policy Action Network (Jspan), New England Jewish Labor Committee (Jlc), And Professor Abigail R. Moncrieff In Support, Abigail Moncrieff, Andrew Fischer

Faculty Scholarship

The minimum coverage provision does not require individuals to purchase any unique product or service but rather requires a standardized financial contribution to the national healthcare infrastructure from all legal residents who are able to pay – a kind of requirement that has never been found unduly or even unusually restrictive of individual liberty.

Amici Curiae Brief In Support Of Petitioners Urging Reversal On The Minimum Coverage Provision Issue, Department Of Health And Human Services V. State Of Florida, Wendy Parmet, Lorianne Sainsbury-Wong

Faculty Scholarship

This amicus brief was filed before the Supreme Court in the Affordable Care Act (ACA) litigation on behalf of Health Care for All and other Massachusetts organizations that have been involved in the implementation of Massachusetts’ health 2006 health reform legislation. The brief argues that Massachusetts’ health reform law, upon which the ACA is modeled, has been very effective in expanding insurance coverage within the State, but it required substantial federal support, through a Medicaid waiver, to achieve its success. In addition the Commonwealth’s experience illustrates that the health insurance and health care markets are inherently interstate commerce and that …

Brief Amici Curiae Of Prescription Policy Choices, Professors Of Law, And Professors Of Health Policy In Support Of Petitioners On The Minimum Coverage Provision In Department Of Health & Human Services V. State Of Florida, Abigail Moncrieff, Kevin Outterson, Kyle Thomson, David Arnold, Julia Grace Mirabella, Wang Hao

Faculty Scholarship

One purpose of the individual mandate is to eliminate the market for self-insured healthcare transactions. It is well-established in this Court’s precedent that the elimination of an interstate commercial market is a constitutionally legitimate end for Congress to pursue under the Commerce Clause. Under the Necessary and Proper Clause, Congress may use any reasonably adapted means to accomplish constitutionally legitimate ends. The individual mandate is not only reasonably adapted but is quite elegant as a means of eliminating the market for self-insured healthcare transactions. The provision effectively encourages individuals to shift from the inefficient market for self-insured care to its …

A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson

Faculty Scholarship

The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.

The Politics Of Medicaid, Nicole Huberfeld

Faculty Scholarship

Medicaid is the word on everyone's lips, not only because of the budgetary crisis many states are suffering, but also because the Supreme Court will decide two major cases regarding Medicaid this term, each of which has the potential to significantly alter the course of this long-standing safety net as well as the constitutional principles undergirding the program. Medicaid is a federal program that was intended to mainstream the very poor into the healthcare system by providing states with matching federal funds for particular expenditures on and provision of medical care. Without Medicaid, tens of millions of Americans would be …