Law Commons^™

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …

Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck

Faculty Publications

Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.

Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …

Specialty Drugs And The Health Care Cost Crisis, Isaac ("Zack") D. Buck

Scholarly Works

Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.

Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel Juhas Suddarth

Law Faculty Publications

Health care costs are on the rise. In 1960, the United States spent $9 billion on hospital care. Since then, hospital related spending has grown exponentially. In 2015, the United States spent over $1 trillion on hospital care, with $359.9 billion of those payments coming from the federal Medicare program for the aged and disabled. Researchers have long tried to understand the exact causes of rising health care costs. While many have closely examined the costs associated with population demographics, medical innovation, prescription drug costs, overutilization of services, and fraud or abuse, there is one driving force that does not …

Further Support For Mental Health Parity Law And Mandatory Mental Health And Substance Use Disorder Benefits, Stacey A. Tovino

Scholarly Works

In this Article, I provide additional support for my recent proposal* to extend federal mental health parity law and mandatory mental health and substance use disorder benefits to all public healthcare program beneficiaries and private health plan members. I begin by examining health-related doctrine outside the context of mental health insurance law, including disability discrimination law, civil rights and human rights law, health information confidentiality law, healthcare reform law, and child and adult health and welfare law, and I find that not one of these laws provides inferior legal protections or benefits for individuals with mental illness. I also analyze …

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …

The Pragmatist’S Guide To Comparative Effectiveness Research, Amitabh Chandra, Anupam B. Jena, Jonathan Skinner

Dartmouth Scholarship

No abstract provided.

Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski

Faculty Publications

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act’s significant initiatives that aims to improve treatment outcomes and lower health care costs. This Article takes CER a step further and suggests a novel clinical application for it. The Article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients’ conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the …

Trust And Betrayal In The Medical Marketplace, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues in this Comment that disingenuity as first resort is an unwise approach to the conflict between our ex ante and our later, illness-endangered selves. Not only does rationing by tacit deceit raise a host of moral problems, it will not work, over the long haul, because markets reward deceit's unmasking. The honesty about clinical limit-setting that some bioethicists urge may not be fully within our reach. But more candor is possible than we now achieve, and the more conscious we are about decisions to impose limits, the more inclined we will be to accept them without experiencing …

Exploitation Of The Elite: A Case For Physician Unionization, Dionne L. Koller

All Faculty Scholarship

Our intuition tells us that physicians are elites, and therefore they cannot be exploited. Relying on this intuition, we adopt policies which attempt to provide a health care system that gives first-quality care, at the lowest prices, delivered through a “free-market” system. As the key gatekeepers to health care, physicians are thus caught in the middle. Top-notch American health care costs money and for-profit MCOs must watch their bottom line. Rationing, therefore, is key. The issue is, assuming we have decided that free-market health care is the solution, how much should physicians have to sacrifice in the name of the …

Fax: Fighting For Quality Health Care, September 23, 1996, Clinton Gore 96

Saffy Collection - All Textual Materials

A fax sent to disseminate information about the President Clinton fighting for healthy families through Health Insurance Reform Act (Kassembaum-Kennedy Bill), Family and Medical Leave Act, Childhood Immunization Initiative, Women Infants and Children Program (WIC), and other health care initiatives.

Elder Law In The Nineties, Peter J. Strauss

Articles & Chapters

The need to reconsider estate planning, placing a greater emphasis on life planning, is the theme of Peter J Strauss's essay. He provides an overview of the status of the elderly in the United States and reminds the reader that the legal profession has not yet adequately addressed the needs of this segment of the population. The life planning components are discussed and corporations are urged to attend to such employee planning needs so as to enhance productivity at work and to improve the quality of their employees' lives.