Health Law and Policy Commons^™

How Can Law And Policy Advance Quality In Genomic Analysis And Interpretation For Clinical Care?, Ellen W. Clayton, Barbara J. Evans, Gail Javitt, Ralph Hull, Professor, University Of Minnesota Law School, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan

Vanderbilt Law School Faculty Publications

Delivering high quality care to patients depends on having accurate test results whose clinical implications are understood. While these requirements apply throughout medicine, the question of how best to ensure the quality of genetic tests used in clinical care, in particular, has vexed scientists and regulators alike for roughly two decades. Numerous federal advisory committees, expert scientific bodies, and professional societies have weighed in on the issue, proposed a variety of approaches, and identified a number of governmental and non-governmental entities to regulate the quality of single-gene tests. Over time, the understanding and clinical use of genetic tests have increased …

Online Pediatric Research: Addressing Consent, Assent, And Parental Permission, Ellen Wright Clayton, Kyle B. Brothers, Aaron J. Goldenberg

Vanderbilt Law School Faculty Publications

Research with children lags far behind research with adults, even though research conducted with pediatric participants is critical to developing scientific knowledge that can benefit children. This is particularly apparent in the realm of pharmaceuticals. In a recent study, physicians prescribed an off-label medication to children in 18.5% of pediatric ambulatory care visits. In 74.6% of these cases, the medication was prescribed to treat a condition for which it did not have FDA approval, and in 17.6% of cases the medication was approved for the condition but not in the child’s age group. This widespread practice of using unapproved, and …

The Evolving Federal Response To State Marijuana, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have launched a revolution in marijuana policy, creating a wide gap between state and federal marijuana law. While nearly every state has legalized marijuana in at least some circumstances, federal law continues to ban the substance outright. Nonetheless, the federal response to state reforms has been anything but static during this revolution. This Essay, based on my Distinguished Speaker Lecture at Delaware Law School, examines how the federal response to state marijuana reforms has evolved over time, from War, to Partial Truce, and, next (possibly) to Capitulation. It also illuminates the ways in which this shifting federal response …

Returning Results In The Genomic Era: Initial Experiences Of The Emerge Network, Ellen W. Clayton, Georgia L. Wiesner, Alanna K. Rahm, Et Al.

Vanderbilt Law School Faculty Publications

A goal of the 3rd phase of the Electronic Medical Records and Genomics (eMERGE3) Network was to examine the return of results (RoR) of actionable variants in more than 100 genes to consenting participants and their healthcare providers. Each of the 10 eMERGE sites developed plans for three essential elements of the RoR process: Disclosure to the participant, notification of the health care provider, and integration of results into the electronic health record (EHR). Procedures and protocols around these three elements were adapted as appropriate to individual site requirements and limitations. Detailed information about the RoR procedures at each site …

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

Risk Guideposts For A Safer Society: Introduction And Overview, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

This symposium issue of the Journal of Risk and Uncertainty addresses wide-ranging policy issues pertaining to risk regulation and the economic underpinnings of these efforts. One such intervention consists of policies to address informational market failures. Whether new information has a positive value is less obvious than economists often assume. When more stringent regulations are required, the structure and evaluation of these efforts often hinges on the value of a statistical life, or the VSL. This symposium reports estimates of the utility functions that generate these local risk-money tradeoffs as well as new estimates of the VSL using both stated-preference …

Utility Functions For Mild And Severe Health Risks, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

This article reviews economic evidence on health-dependent utility functions and presents new estimates of utility functions for cancer. Estimates of health-dependent utility functions have found that mild adverse health impacts can be treated as monetary equivalents. Severe health consequences also reduce utility levels but have an additional effect of altering the structure of utility functions by reducing the marginal utility of income. The implications of past studies are often misleading when they fail to account for income losses and medical expenses associated with serious ailments. This article’s estimates of the structure of utility functions for cancer indicate a substantially lower …

The Pregnancy Penalty, Jennifer Bennett Shinall

Vanderbilt Law School Faculty Publications

Despite the renaissance of pregnancy-related scholarship over the past decade, 322 very little has been documented empirically regarding the status of pregnant women in the labor market. As such, scholars and advocates have been constrained in their ability to assess both the adequacy of current legislation and the relative urgency for new legislation. Furthermore, in the absence of labor market data, they have been limited in their ability to propose reform measures that can target the pregnant women most in need of assistance. This Article has taken an initial step towards filling these critical gaps in the literature, utilizing a …

A Systematic Literature Review Of Individuals' Perspectives On Privacy And Genetic Information In The United States, Ellen W. Clayton, Colin M. Halverson, Nila A. Sathe, Bradley A. Malin

Vanderbilt Law School Faculty Publications

Concerns about genetic privacy affect individuals' willingness to accept genetic testing in clinical care and to participate in genomics research. To learn what is already known about these views, we conducted a systematic review, which ultimately analyzed 53 studies involving the perspectives of 47,974 participants on real or hypothetical privacy issues related to human genetic data. Bibliographic databases included MEDLINE, Web of Knowledge, and Sociological Abstracts. Three investigators independently screened studies against predetermined criteria and assessed risk of bias. The picture of genetic privacy that emerges from this systematic literature review is complex and riddled with gaps. When asked specifically …

Approaches To Carrier Testing And Results Disclosure In Translational Genomics Research, Ellen Wright Clayton, Kathryn M. Porter, Et Al.

Vanderbilt Law School Faculty Publications

Background: Clinical genome and exome sequencing (CGES) is primarily used to address specific clinical concerns by detecting risk of future disease, clarifying diagnosis, or directing treatment. Additionally, CGES makes possible the disclosure of autosomal recessive and X-linked carrier results as additional secondary findings, and research about the impact of carrier results disclosure in this context is needed.

Methods: Representatives from 11 projects in the clinical sequencing exploratory research (CSER) consortium collected data from their projects using a structured survey. The survey focused on project characteristics, which variants were offered and/or disclosed to participants as carrier results, methods for carrier results …

Navigating The Research-Clinical Interface In Genomic Medicine: Analysis From The Cser Consortium, Ellen Wright Clayton, Susan M. Wolf, Laura M. Amendola, Et Al.

Vanderbilt Law School Faculty Publications

Purpose: The Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health– funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research–clinical interface. Methods: A CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research–clinical interface. Results: Survey responses described how studies approached the research–clinical interface, including in consent practices, recording …

The Net Effects Of Medical Malpractice Tort Reform On Health Insurance Losses, W. Kip Viscusi, Patricia H. Born, J. Bradley Karl

Vanderbilt Law School Faculty Publications

In this paper, we examine the influence of medical malpractice tort reform on the level of private health insurance company losses incurred. We employ a natural experiment framework centered on a series of tort reform measures enacted in Texas in 2003 that drastically altered the medical malpractice environment in the state. The results of a difference-in-differences analysis using a variety of comparison states, as well as a difference-in-difference-in-differences analysis, indicate that ameliorating medical malpractice risk has little effect on health insurance losses incurred by private health insurers.

Intersectional Complications Of Healthism, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

For Americans in the labor market with health conditions that fall outside the scope of the ADA, the rehabilitation Act, and GINA, antihealthism legislation, like the kind proposed by Roberts and Leonard, 9would unquestionably serve as a critical first step in increasing their legal protections in the workplace. Moreover, to the extent that such legislation would also operate outside the workplace, it could expand legal protections even for individuals who presently enjoy coverage by disability and genetic discrimination laws solely inside the workplace. Yet, as this article has argued, simple healthism-discriminatory animus based solely on health-may be surprisingly rare. Existing …

Public Attitudes Towards Consent And Data Sharing In Biobank Research, Ellen Wright Clayton, Saskia C. Sanderson, Kyle B. Brothers, Nathaniel D. Mercaldo, Other Contributers

Vanderbilt Law School Faculty Publications

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled …

The American Bar Association's Criminal Justice Mental Health Standards: Revisions For The Twenty-First Century, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In 1981, the American Bar Association ("ABA"), bolstered by a grant from the John D. and Catherine T. MacArthur Foundation, decided to develop standards for governing the involvement of persons with mental disabilities in the criminal justice system. To accomplish this task the ABA established six task forces, each focused on a different topic, and each composed of judges, prosecutors, defense attorneys, law professors, and mental health professionals well-known for their expertise about criminal mental health law. The result, promulgated in 1984 by the ABA's House of Delegates, was more than eighty black letter Criminal Justice Mental Health Standards, accompanied …

Health Insurance Mandates, Mammography, And Breast Cancer Diagnoses, Christopher K. Carpenter, Marianne P. Bitler

Vanderbilt Law School Faculty Publications

We examine the effects of state health insurance mandates requiring coverage of screening mammograms. We find evidence that mammography mandates significantly increased mammography screenings by 4.5-25 percent. Effects are larger for women with less than a high school degree in states that ban deductibles, a policy similar to a provision of federal health reform that eliminates cost-sharing for preventive care. We also find that mandates increased detection of early stage in-situ precancers. Finally, we find a substantial proportion of the increased screenings were attributable to mandates that are not consistent with 2014 recommendations of the American Cancer Society.

Unfulfilled Promises: Discrimination And The Denial Of Essential Health Benefits Under The Affordable Care Act, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

The passage of the ACA is a source of great pride for President Barack Obama's Administration, and the President undoubtedly hopes that the ACA will be his greatest legacy. 285 As a result, it is difficult to understand why, under his administration, HHS has relinquished its rulemaking authority to the states regarding the core guarantees of the Act. For the individuals living in states in which promised essential health benefits have not yet become a reality, HHS has offered a glimmer of hope. In 2012, the agency released a bulletin stating that it would "revisit" its approach of allowing states …

The Relationship Between The Markets For Health Insurance And Medical Malpractice Insurance, W. Kip Viscusi, J. Bradley Karl, Patricia H. Born

Vanderbilt Law School Faculty Publications

This article evaluates the interdependence of medical malpractice insurance markets and health insurance markets. Prior research has addressed the performance of these markets, individually, without specifically quantifying the extent to which they are linked. Increasing levels of health insurance losses could increase the scale of potential malpractice claims, boosting medical malpractice losses, or could embody an improvement in medical care quality, which will reduce malpractice losses. Our results for a state panel data set from 2002 to 2009 demonstrate that health insurance losses are negatively related to medical malpractice insurance losses. An additional dollar of health insurance losses is associated …

Risk Beliefs And Preferences For E-Cigarettes, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Drawing on evidence from a new nationally representative survey, this article examines several measures of risk beliefs for e-cigarettes. For both lung cancer mortality risks and total smoking mortality risks, respondents believe that e-cigarettes pose risks that are lower than the risks of conventional tobacco cigarettes. However, people greatly overestimate the risk levels of e-cigarettes compared with the actual risk levels. Risk beliefs for conventional cigarettes receive at least a two-thirds informational weight in the formation of e-cigarette risk beliefs. Public perceptions of nicotine levels of e-cigarettes are closer to the beliefs for conventional cigarettes than are their health risk …

The Fatality And Morbidity Components Of The Value Of Statistical Life, W. Kip Viscusi, Elissa Philip Gentry

Vanderbilt Law School Faculty Publications

The fatality risk–money tradeoff that is the value of a statistical life (VSL) may vary with the nature of the fatality event. While all fatalities involve loss of future life expectancy, the morbidity effects and their duration may differ. This article analyzes fatality risks accompanied by morbidity effects of different duration to disentangle the mortality and morbidity components of VSL using data from the Census of Fatal Occupational Injuries (CFOI). The VSL is comprised of the sum of the value of the fatality risk and the value of the morbidity risk. Labor market valuations of morbidity risks are positive, even …

Reference-Dependence Effects In Benefit Assessment: Beyond The Wta-Wtp Dichotomy And Wta-Wtp Ratios, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Willingness-to-pay (WTP) values and willingness-to-accept (WTA) values have received considerable attention, but the role of reference-dependence effects is more diverse. Policies involving cost and risk may have reference point effects with respect to both cost and risk, leading to four potential valuation measures. Experimental evidence for water quality policies suggests that the cost reference effects are particularly influential in that context. There is, however, no evidence of significant reference effects for labor market estimates of the value of a statistical life. Sound application of benefit values other than WTP measures requires pertinent empirical evidence and an assessment of the underlying …

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

Contextualizing Gay‐Straight Alliances: Student, Advisor And Structural Factors Related To Positive Youth Development Among Members, Matthew P. Shaw

Vanderbilt Law School Faculty Publications

Gay-straight alliances (GSAs) may promote resilience. Yet, what GSA components predict well-being? Among 146 youth and advisors in 13 GSAs (58% lesbian, gay, bisexual, or questioning; 64% White; 38% received free/reduced-cost lunch), student (demographics, victimization, attendance frequency, leadership, support, control), advisor (years served, training, control), and contextual factors (overall support or advocacy, outside support for the GSA) that predicted purpose, mastery, and self-esteem were tested. In multilevel models, GSA support predicted all outcomes. Racial/ethnic minority youth reported greater well-being, yet lower support. Youth in GSAs whose advisors served longer and perceived more control and were in more supportive school contexts …

Addressing The Ethical Challenges In Genetic Testing And Sequencing Of Children, Ellen Wright Clayton, Laurence B. Mccullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf

Vanderbilt Law School Faculty Publications

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recom-mendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium’s PediatricsWorking Group compared these recommendations, focusing on operational and ethical issues specific to decision making forchildren. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locusof decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or come to different butcompatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways.AAP/ACMG analyzes risks and benefits …

Changing The Costs: A Rational Choice Perspective On African Americans' Healthcare Consumption Decisions, Nicole Langston

Vanderbilt Law School Faculty Publications

This paper makes the case for racial disparities in the consumption of healthcare and advocates for a large-scale cost-benefit change for healthcare practitioners and the African American community to ensure efficient consumption of healthcare by African American patients. Part I explores the history of African Americans and the healthcare system, arguing the history of this interaction fuels many of the present-day decisions not to consume healthcare.

Part II explores the current racial differences in healthcare treatment and outcomes for African Americans in order to lay the framework for racially disparate treatment in America's healthcare system.

Part III of this paper …

Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad

Vanderbilt Law School Faculty Publications

Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care …

Recommendations For Returning Genomic Incidental Findings? We Need To Talk!, Ellen Wright Clayton, Wylie Burke, Armand H. Matheny Antommaria, Et Al.

Vanderbilt Law School Faculty Publications

The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated …

The Benefits Of Mortality Risk Reduction: Happiness Surveys Vs. The Value Of A Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

A principal component of many benefit-cost analyses (BCAs) of health, safety, and environmental regulations is the valuation of the fatality risk effects of the underlying policy. Government agencies currently value these expected effects using estimates of the value of a statistical life (VSL), that is, the tradeoff rate between money and very small risks of death. This measure corresponds to BCA's theoretically appropriate benefits measure, which is society's willingness to pay for the risk reduction. Here, I will review the VSL approach, compare it to suggested alternatives that use happiness measures of well-being, and address some of the misunderstandings that …

Patient Awareness And Approval For An Opt-Out Genomic Biorepository, Ellen Wright Clayton, Kyle B. Brothers, Matthew J. Westbrook, M. Francis Wright, John A. Myers, Daniel R. Morrison, Jennifer L. Madison, Jill M. Pulley

Vanderbilt Law School Faculty Publications

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository. Materials & methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA). Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%. Conclusion: These …

What’S To Know? Puzzles In The Literature On The Value Of Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Notwithstanding the general acceptance of the value of statistical life (VSL) estimates for policy assessment purposes, several important unresolved issues remain. First, the results from revealed preference studies are systematically higher than those from stated preference studies, potentially limiting the usefulness of stated preference studies in generalizing the VSL estimates to different populations and kinds of risks. Second, extrapolating the results of meta-analyses to project the VSL for different population groups requires that such generalization be reflective of the underlying economic content of what average VSL estimates reflect. Third, government agencies within and across countries place differing emphasis on types …