Health Law and Policy 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 …

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 …

Establishing New Legal Doctrine In Managed Care: A Model Of Judicial Response To Industrial Change, Peter D. Jacobson, Scott D. Pomfret

University of Michigan Journal of Law Reform

Courts are struggling with how to develop legal doctrine in challenges to the new managed care environment. In this Article, we examine how courts have responded in the past to new industries or radical transformations of existing industries. We analyze two historical antecedents, the emergence of railroads in the nineteenth century and mass production in the twentieth century, to explore how courts might react to the current transformation of the health care industry.

In doing so, we offer a model of how courts confront issues of developing legal doctrine, especially regarding liability, associated with nascent or dramatically transformed industries. Our …

Playing Doctor: Corporate Medical Practice And Medical Malpractice, E. Haavi Morreim

University of Michigan Journal of Law Reform

Although health plans once existed mainly to ensure that patients could pay for care, in recent years managed care organizations (MCOs) have attempted to limit expenditures by exercising significant influence over the kinds and levels of care provided. Some commentators argue that such influence constitutes the practice of medicine, and should subject MCOs to the same medical malpractice torts traditionally brought against physicians. Others hold that MCOs engage only in contract interpretation, and do not literally practice medicine.

This Article begins by arguing that traditional common law doctrines governing corporate practice of medicine do not precisely apply to the current …

Abusing The Patient: Medicare Fraud And Abuse And Hospital-Physician Incentive Plans, Kathryn A. Krecke

University of Michigan Journal of Law Reform

Part I provides a background discussion of the PPS, DRGs, and incentive plans. Part II focuses on the fraud and abuse provisions of the Medicare statute and argues that incentive plans violate the plain language · of the statute, which prohibits any knowing and willful remuneration for the inducement of referrals. Part III concentrates on the fraudulent and abusive practices that incentive plans encourage. The plans frustrate legislative intent because they encourage practices that subvert the cost-containment purposes of the PPS and have an adverse effect on patient care.