Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 4 of 4
Full-Text Articles in Law
The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley
The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley
Articles
The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …
Unearthing The Lost History Of Seminole Rock, Amy J. Wildermuth, Sanne H. Knudsen
Unearthing The Lost History Of Seminole Rock, Amy J. Wildermuth, Sanne H. Knudsen
Articles
In 1945, the Supreme Court blessed a lesser known type of agency deference in Bowles v. Seminole Rock. Also known as Auer deference, it affords deference to agency interpretations of their own regulations. Courts regularly defer to agencies under this doctrine, regardless of where the interpretations first appear or how long-standing they are. Recently members of the Supreme Court have signaled a willingness to reconsider, and perhaps jettison, Seminole Rock. We agree. Seminole Rock has been widely accepted but surprisingly disconnected from any analysis of its origins and justifications. This Article — the first historical explication of Seminole …
Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley
Articles
Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
Articles
Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …