Law Commons^™

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

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 …

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 …

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 …

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

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 …

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 …

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

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

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 …

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 …

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, …

Liberty, Justice, And Insurance For All: Re-Imagining The Employment-Based Health Insurance System, Carolyn V. Juárez

University of Michigan Journal of Law Reform

This Note examines the history of employment-based health insurance and the inherent historical limitations that have led to an erosion of health insurance coverage. Based on a review of several studies, this Note argues that the number of uninsured Americans has reached crisis proportions. State reform efforts, legislative proposals, and other proposed solutions have failed to repair the system. Nonetheless, this Note argues that employment-based health care is integral to the structure of national health care. Furthermore, health insurance coverage can be increased by combining employment-based health care with three reforms: large employer mandates, refundable tax credits, and purchasing pools. …

What Money Cannot Buy: A Legislative Response To C.Rac.K., Adam B. Wolf

University of Michigan Journal of Law Reform

Children Requiring a Caring Kommunity (C.R.A.C.K.) is an organization that pays current or former drug addicts $200 to be sterilized. While generating great public controversy, C.R.A.C.K. is expanding rapidly throughout the country. Its clients are disproportionately poor women of color, who are coerced by the offer of money into permanently relinquishing their reproductive rights. This Note argues that C.R.A.C.K. is a program of eugenical sterilization that cannot be tolerated. Moreover, C.R.A.C.K. further violates settled national public policy by offensively commodifying the ill-commodifiable, by demeaning women, and by starting down a slippery slope with devastating consequences. This Note proposes legislation that …

Accountable Managed Care: Should We Be Careful What We Wish For?, David A. Hyman

University of Michigan Journal of Law Reform

Managed care is exceedingly unpopular of late. Many people believe that the problem is managed care organizations (MCOs) are unaccountable. Indeed, for many people, the creation of tort-based accountability for MCOs is the touchstone for assessing legislative "reform." The case for tort-based accountability is actually quite complex, and the merits of tort-based accountability cannot be resolved with sound bites and bad anecdotes. Tort-based accountability has both costs and benefits, and little attention has been paid to the extent to which alternatives to tort-based accountability are found in existing institutional arrangements.

This Article systematically considers the extent to which alternatives to …

The Competitive Impact Of Small Group Health Insurance Reform Laws, Mark A. Hall

University of Michigan Journal of Law Reform

This Article reports on findings from an extensive study of small group health insurance market reforms in seven states, enacted during the early 1990s. After summarizing the content and purpose of these reforms, this evaluation focuses on the impact these reforms have had on the nature and degree of market competition. The principal findings are: (1) small group health insurance markets are highly competitive, both in price and in product innovation and diversity; (2) although some insurers have left some or all of these states in part because of these reforms, an ample number of active competitors remain, even in …

Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer

University of Michigan Journal of Law Reform

As American health care moves from a professionally dominated to a market-dominated model, concerns have been voiced that competition, once unleashed, will focus on price to the detriment of quality. Although quality has been extensively analyzed in health services research, the role of quality in competition policy has not been elucidated. While economists may theorize about non-price competition, courts in antitrust cases often follow simpler models of competition based on price and output, either ignoring quality as a competitive dimension or assuming that it will occur in tandem with price competition. This unsystematic approach is inadequate for the formulation of …

Fda Approved? A Critique Of The Artificial Insemination Industry In The United States, Karen M. Ginsberg

University of Michigan Journal of Law Reform

Artificial insemination by donor is becoming an increasingly popular means to achieving parenthood. While the majority of couples use artificial insemination to overcome fertility problems, many recipients use artificial insemination to avoid passing a genetic disease to their children. However, case studies reveal the inherent dangers of artificial insemination, namely the lack of proper screening methods to avoid passing genetic diseases to children born by artificial insemination. State-by-state regulation, federal guidelines, and private adjudication have all proven to be inadequate methods of regulating the artificial insemination industry. Ginsberg proposes federal regulation as the only means of achieving a safe artificial …

Regulating Viatical Settlements: Is The Invisible Hand Picking The Pockets Of The Terminally Ill?, Russell J. Herron

University of Michigan Journal of Law Reform

The newly emerging viatical settlement industry has attracted considerable attention from both insurance regulators and advocates for the terminally ill. In a viatical settlement, a terminally ill person names a viatical settlement company as beneficiary under his life insurance policy in exchange for an immediate lump-sum cash payment of less than face value of the policy. To date, viatical settlement payments to people with AIDS (PWAs) have been disturbingly low as a percentage of the face value of PWA policies. This Note examines the few enacted viatical settlement regulations and the National Association of Insurance Commissioners' model regulations as they …

The Impact Of Public Abortion Funding Decisions On Lndigent Women: A Proposal To Reform State Statutory And Constitutional Abortion Funding Provisions, Carole A. Corns

University of Michigan Journal of Law Reform

This Note argues that state legislatures should relax funding restrictions on abortions for indigent women and proposes specific mechanisms to ensure the equal protection of indigent women in the abortion context. Part I briefly recounts the history of federal funding for abortions, from the liberal post-Roe funding scheme to the restrictive funding arrangements that have prevailed since the early 1980s. Part II surveys the existing literature and discusses patterns of state funding and the impact of funding restrictions on indigent women seeking abortions. This literature shows that the tightening of state funding policies subsequent to the federal Medicaid restrictions has …

The Medicare Rx: Prospective Pricing To Effect Cost Containment, H. Lynda Kugel

University of Michigan Journal of Law Reform

This Note analyzes the impact of changing hospital reimbursement while maintaining charge-based reimbursement for physicians on hospital-physician relationships and on cost and quality of care. This Note contends that if the stated goals of redirecting incentives and containing costs are to be realized, physicians must be drawn into the revised reimbursement scheme. An indirect, aggregate approach is advocated to maintain the integrity of the physician-patient relationship and to avoid a direct financial impact upon the physician regarding patient care decisions. Part I will briefly examine the reasons for changing hospital reimbursement from retrospective cost-based reimbursement to prospective fixed rates. Part …

Michigan's Nursing Home Reform Law, John D. Croll

University of Michigan Journal of Law Reform

This article examines Michigan's new nursing home reform law, which has been hailed as "landmark legislation" and as a model for the entire country. Part I examines the past failures of nursing home regulation and the need for reform. Part II analyzes the law's key provisions. Part III examines the weaknesses of certain enforcement measures. The article proposes the following improvements: (1) extension of the law's protection to residents of homes for the aged; (2) greater access to patients by approved organizations; (3) adoption of nurse-patient ratios; (4) improvement of inspection procedures; and (5) allowance for patients or their representatives …

Michigan's Revised Mental Health Code, William David Serwer

University of Michigan Journal of Law Reform

This note will evaluate the three chapters of the Michigan Code which present the most significant legislative attempts to safeguard the rights of the mentally ill. Chapter Four of the Code extends several traditional due process guarantees to the civil commitment process. By guaranteeing the right to adequate notice, the right to be present at the hearing, the right to be represented by counsel, and the right to notice of trial by jury, the Code offers better protection from unwarranted commitment. However, due to the difficulty of defining mental illness and accurately identifying those in need of treatment, the possibility …

New York's Revised Nursing Home Legislation, Michael G. Mcgee

University of Michigan Journal of Law Reform

This note undertakes an analysis of the extensive package of nursing home legislation recently enacted in New York. First, specific regulations will be examined in relation to problems they are designed to remedy. Next, the note critically appraises three key, innovative provisions, making recommendations for implementation or revision of each. Finally, the broad changes needed to bring about lasting improvement of nursing care are discussed and a summary of pending legislation is provided.

Mental Illness And Criminal Commitment In Michigan, Grant H. Morris

University of Michigan Journal of Law Reform

This article concentrates on one vital issue: to what extent are differences in treatment justified because of a mentally ill person's "criminal" involvement. While the article is primarily concerned with Michigan institutions and Michigan statutes, the discussion and the solutions proposed are in many respects applicable to all states of the Union. Not only must all states reevaluate their policies toward criminal commitment of the mentally ill in light of ever-changing medical and penal theory, but they must also consider the developing constitutional concepts in this area. These constitutional issues are raised here only to the extent necessary to alert …