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 …

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

University of Michigan Journal of Law Reform

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

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 …

Increasing Consumer Power In The Grievance And Appeal Process For Medicare Hmo Enrollees, Kenneth J. Pippin

University of Michigan Journal of Law Reform

Federal law requires that Health Maintenance Organizations (HMOs) and Managed Care Organizations (MCOs) provide Medicare beneficiaries with specific grievance and appeal rights for challenging adverse decisions of these organizations. The Health Care Financing Administration (HCFA) is charged with enforcing these regulations. Currently, however, HCFA contracts with HMOs, allowing them to enroll Medicare beneficiaries despite the fact that many of the statutory and regulatory requirements are ignored by the Medicare HMOs. This is problematic because the elderly Medicare population may not be able to independently and adequately challenge the HMO's denial of care or reimbursement. Because HCFA has been reluctant and …

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 …

Clearing The Way For An Effective Federal-State Partnership In Health Reform, Eleanor D. Kinney

University of Michigan Journal of Law Reform

At century's end, states have assumed a very different role in the design, implementation, and operation of health service programs than they did twenty-five years ago. In the current volatile political atmosphere particularly at the federal level, states have taken up the mantle of healthcare reform in the final years of the 1990s. Yet there remain problems and difficulties with the current federal-state relationship in health reform. The critical question is whether states can successfully accomplish genuine reform given its politically charged, complex and costly nature. This question takes on particular significance for the most important reform-expanding coverage to the …

Managed Care Regulation: Can We Learn From Others? The Chilean Experience, Timothy Stoltzfus Jost

University of Michigan Journal of Law Reform

Because the United States relies on private insurance for financing health care to a much greater degree than do other nations, and because managed care as a form of private insurance is further developed in the United States than elsewhere, it is arguable that we have little to learn from other nations about managed care regulation. This Article tests this hypothesis with respect to Chile, a country where private insurance is widespread and managed care is emerging. It concludes that by studying the experience of other nations we might gain a larger perspective on the context of our concerns in …

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 …

Democratizing Hmo Regulation To Enforce The "Rule Of Rescue", Kent G. Rutter

University of Michigan Journal of Law Reform

Despite heightened public concern about HMOs, misguided regulatory measures have not guaranteed HMO patients access to the treatment options many consider vital. This Note recommends four changes to the current regulatory system that would preserve HMOs' ability to control health care costs while allowing patients and doctors, rather than lawmakers or HMO administrators, to set health care priorities.

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 …

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 …