Volume 23 (2014)
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 23 (2014)
|
Editor-in-Chief: |
Publications Editor: |
Technical Production Editor: |
|
Marketing & Coordinating Editor: |
Symposium Editor: |
Advance Directive Editor: |
|
Senior Editors: Advance Directive Senior Editor: |
|
Senior Publications Editor: |
|
Members:
|
|
|
Issue 1, Winter 2014
Articles
Who Controls Our Continuing Medical Education?: The Shortcomings of the Current CME Regulation Regime and How to Reform It
Author: James J. Hennelly
Continuing medical education (CME) is intended to keep the knowledge and skills of health care professionals up to date so that they can provide the best possible care, improve patient outcomes, and protect patient safety. The current state of CME in the United States, however, is far from reaching that goal. Pharmaceutical and medical device companies have taken a lead role in financing the provision of and research for CME, raising concerns about conflicts of interest and whether some companies are using CME to influence health professionals to increase their market shares. This article highlights the various flaws in the way CME is conducted, financed, regulated, and evaluated. It first discusses the regulatory framework for CME activities, including the accreditation process and the history of the roles of the Food and Drug Administration and Department of Health and Human Services Office of Inspector General’s roles in ensuring independence and reliability in CME content. Next, this article focuses on the various shortcomings of the current regulatory schemes that seek to protect against undue industry influence in CME activity. Finally, this article provides recommendations for how to improve the CME programming framework to ensure accountability and independence for CME providers.
The Affordable Care Act and People Living With HIV/AIDS: A Roadmap To Better Health Outcomes
Author: Mark Bolin
Congress passed the Patient Protection and Affordable Care Act (PPACA) on March 23, 2010 with the intention of making comprehensive health care affordable for all Americans. For people living with HIV/AIDS, PPACA expands access to vital federal programs like Medicaid and institutes desperately needed consumer protections. By dramatically expanding the number of people living with HIV/AIDS who have access to health care, PPACA aims to improve health outcomes for people currently living with the disease while preventing its spread.
As the States and the Administration implement PPACA however, it has become clear that numerous obstacles to widespread viral suppression remain. Although PPACA contains dramatic reforms, the States possess substantial influence over their implementation. This has provided state actors with opportunities to sidetrack and dilute their impact. Furthermore, even if the States were completely compliant with PPACA’s provisions, the law would still fail to address important health care access issues for people living with HIV/AIDS.
In the public insurance market, legal challenges brought by protesting states have dramatically decreased the impact of the Medicaid expansion. Meanwhile, the law does nothing to address the longstanding problem of low Medicaid reimbursement rates, which has contributed to a shortage of participating physicians nationwide. In the private insurance market, PPACA institutes market reforms that include a requirement that insurance providers cover a basic level of health care. However, the Administration has ceded the authority to define what these requirements entail to the States, many of whom are openly hostile to PPACA’s implementation. Only when these issues have been addressed can PPACA begin to achieve its goal of comprehensive, affordable health care for not only people living with HIV/AIDS, but all Americans.
The Health Consequences of Sex Trafficking and Their Implications for Identifying Victims in Healthcare Facilities
Authors: Laura J. Lederer and Christopher A. Wetzel
This paper reports on focus groups conducted with 107 domestic victims of sex trafficking in which they discussed the health problems they experienced during trafficking. In addition, the project examined victims' interactions with various types of healthcare providers. The focus groups revealed that nearly all victims experienced serious physical and mental health problems while being trafficked, including serious communicable and other diseases, injuries resulting from violence, substance abuse, and reproductive health issues. The paper summarizes data about the health problems reported by significant numbers of survivors to present a fuller picture of the health consequences that victims of trafficking suffer. A majority of survivors sought healthcare at some point during the time they were trafficked. The paper also reports on the contact victims had with health care providers, including hospital emergency wards, urgent care clinics, neighborhood clinics, women's clinics, Planned Parenthood clinics, and general practitioners. Many providers were unaware of the fact that they were treating a trafficking victim, and unaware of the force, fraud, and coercion involved in trafficking. The paper discusses common physical and mental health symptoms and other warning signs that can assist medical professionals in recognizing possible trafficking victims. It also makes policy and program recommendations for medical care providers to enhance their roles as identifiers of trafficking victims. These recommendations include suggestions for interviewing possible victims and methods for helping victims obtain broader assistance, including criminal justice assistance where warranted. Other recommendations include mandatory training about trafficking in persons for healthcare providers, mandatory posting of the national trafficking hotline phone number and specialized resources to make available to victims.
Millennium Development Goal 5, Human Rights, and Maternal Health in Africa: Possibilities, Constraints, and Future Prospects
Author: Dr. Obiajulu Nnamuchi
Millennium Development Goal 5 (MDG 5) holds particular significance for Africa in that it incentivizes countries in the region to: first, look beyond their shores to strategies being implemented by others to improve maternal health and wellbeing of women within their respective jurisdictions; and, second, incorporate transferable best practices into their national initiatives. But the process is dangerously dangling on the precipice of being overrun by seemingly insuperable factors, evident in continuing deterioration of women’s health throughout the region. Proceeding on the premise that maternal health is a human right, the violation of which inevitably bequeaths catastrophic consequences upon women and children, this paper argues that the status quo in all the countries in the region is indefensible and desperately in need of reversal. This paper provides an analytical framework for exploring current implementation challenges and identifies specific interventions within and outside the health sector that must be incorporated into country policies, strategies, and plans of action as fundamental to positioning Africa on a sustainable track toward the MDG.
Vol. 23 Issue 2, Special Edition 2014
Articles
Flipped the Light Switch: New Perspectives on Default to Donation for Organs and Tissues
Authors: Daniel G. Orenstein and Layne M. Bettini
The decision to donate organs and tissues after death is a complex choice, implicating numerous ethical, moral, legal, and other values. However, it is also a simple one in that it has two mutually-exclusive options (consent or decline). As with other such binary decisions, the legal “default” that applies when no affirmative choice is made provides an important framework. Other scholars have robustly analyzed the possibility of increasing solid organ donation by transitioning to a system of presumed consent and the potential concerns for individual autonomy that would be associated with such a system. Less attention, however, has been paid to the potential impacts in two other respects: (1) cadaveric ocular and tissue donation, and (2) donor families. While the existing U.S. system does an excellent job procuring solid organs for transplant – even in the current opt-in structure – there is comparatively much more room for improvement in ocular and tissue procurement rates. Additionally, presumed consent offers several benefits to donor families who, under the current system, are suddenly thrust into decision-making roles under exceedingly difficult circumstances. A properly structured presumed consent system would not significantly affect the donation decision directly – much as the initial position of a light switch does not affect one’s choice to light a room. However, the public health benefits a change to the default rule could be significant if it successfully fosters a culture that supports donation and views it as the norm, rather than the exception.
The Legal Anatomy of Product Bans to Protect the Public’s Health
Authors: James G. Hodge, Jr. and Megan Scanlon
Products that present significant health risks to individuals or populations are routinely banned in the U.S. However, some products that negatively impact health remain available commercially despite efforts to ban their sale or possession. Underlying public health powers to ban products are multiple, countervailing law, policy, and ethics arguments that sometimes thwart public health efforts. Using product bans in furtherance of the public’s health is predicated on successfully identifying and navigating these arguments. Lacking a definitive assessment of such product bans, this article assesses the “legal anatomy” for identifying and implementing bans that are effective, and avoiding those that are not.
The Expansion of Newborn Screening: Implications for Public Health and Policy
Authors: Leila Barraza and Lauren Burkhart
Newborn Screening Programs have proven to be a successful model of public health intervention. Shortly after birth, a blood sample is taken from the heel of newborn babies and tested for certain conditions. Analysis of the newborn’s genome is used at the present time only for confirmation of a positive test from a newborn screen. Whole Genome Sequencing (WGS) of newborns as a routine procedure, however, is the next progression in the development of newborn screening programs. This article examines the history of current newborn screening programs and looks beyond into the potential for expansion into WGS as a newborn screening method. Benefits from WGS of newborns could reap enormous benefits for public health research for disease prevention and health promotion. Expansion into new scientific areas is never easy and will require a consideration of ethical and legal constructs and changes in state statutory law. This article looks at policy considerations that will necessarily be examined and addressed for a shift from the current blood spot program to a WGS approach.
ACA Implementation: The Court Challenges Continue
Authors: Jane Perkins and Dipti Singh
This article provides an overview of litigation related to Supreme Court’s upholding of the constitutionality of the Patient Protection and Affordable Care Act (ACA) by identifying three “rounds” of litigation that have emerged. Round One involves litigation that culminated in the 2012 Supreme Court ruling. Almost uniformly, that litigation sought to repeal the ACA in its entirety. The second round of litigation, comprised of cases filed since the 2012 decision and dominated by cases seeking to curtail an ACA requirement for health insurers to cover contraception without cost sharing. Notably, there have been a large number of such cases (approaching 100, to date), and the Supreme Court has agreed to decide whether for-profit businesses have religious rights entitling them to an exemption from the contraceptive coverage requirement. Finally, the emerging Round Three of litigation seeks to enforce the ACA so that its benefits can be realized.
Monitoring the Law: Court Watch Programs in Maryland
Author: Megan Griest
Traditionally, domestic violence has been treated as a women’s issue, not the public health problem it is. This national problem affects the health and well-being of people across all demographics of this country. The Maryland court system is failing victims of domestic violence. In some cases, these victims do not report the crime to the police out of fear of repercussions from the abuser; in other cases, a lack of trust in the criminal justice system alienates victims. Throughout the process, victims may feel alone and unprotected. One way the state could address this issue is by more widely implementing court watch programs, which train volunteers to observe judicial behavior in court and complete a record of the case and behavior of judges, bailiffs and other court staff. Program administrators then compile these records and typically prepare a report discussing the consistency of the judges’ behavior, best practices observed, and recommendations for improvement, to disseminate to judges in that jurisdiction. This article discusses domestic violence as a public health concern and the need for policy change within the court system. Then it discusses how the current system is failing domestic violence victims in Maryland and reviews court watch programs as a potential solution to increase the consistency of judicial behavior and provide increased protections to victims in domestic violence cases.
Priorities in Public Health Law: A Practice-Based Analysis of Trends in the Legal Needs of Public Health Professionals
Authors: Caty Schmitter and Jennifer A. Bernstein
The Network for Public Health Law (Network) works to address public health legal issues may be able to contribute relevant information gained through their program activities. Through its activities assisting public health professionals with legal questions, the Network has compiled a considerable amount of data on the needs of these professionals. This article is a report summarizing the results of a detailed analysis of this data and identifies trends among requests submitted to the Network from public health professionals in an effort to build on past reviews of Network activities, identify opportunities for further analysis and contribute to the expanding body of research that will inform public health law’s priorities moving forward. The report provides background on the Network, including its purpose and activities, its relevance to a discussion of the legal needs of public health professionals and several limitations in the Network's existing data set which have prevented more complex analysis. It then lays out the goals of a new study of Network data and describes the methods which were used to collect, prepare and analyze data for the purposes of this study. The report then describes the results of the study and highlights trends in requests submitted to the Network across a number of factors. Finally, it discusses potential explanatory factors and implications for several key trends. These findings will facilitate public health professionals being able to make use of law and policy to promote the public’s health.
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 23 (2014)
|
Editor-in-Chief: |
Publications Editor: |
Technical Production Editor: |
|
Marketing & Coordinating Editor: |
Symposium Editor: |
Advance Directive Editor: |
|
Senior Editors: Advance Directive Senior Editor: |
|
Senior Publications Editor: |
|
Members:
|
|
|
Issue 1, Winter 2014
Articles
Who Controls Our Continuing Medical Education?: The Shortcomings of the Current CME Regulation Regime and How to Reform It
Author: James J. Hennelly
Continuing medical education (CME) is intended to keep the knowledge and skills of health care professionals up to date so that they can provide the best possible care, improve patient outcomes, and protect patient safety. The current state of CME in the United States, however, is far from reaching that goal. Pharmaceutical and medical device companies have taken a lead role in financing the provision of and research for CME, raising concerns about conflicts of interest and whether some companies are using CME to influence health professionals to increase their market shares. This article highlights the various flaws in the way CME is conducted, financed, regulated, and evaluated. It first discusses the regulatory framework for CME activities, including the accreditation process and the history of the roles of the Food and Drug Administration and Department of Health and Human Services Office of Inspector General’s roles in ensuring independence and reliability in CME content. Next, this article focuses on the various shortcomings of the current regulatory schemes that seek to protect against undue industry influence in CME activity. Finally, this article provides recommendations for how to improve the CME programming framework to ensure accountability and independence for CME providers.
The Affordable Care Act and People Living With HIV/AIDS: A Roadmap To Better Health Outcomes
Author: Mark Bolin
Congress passed the Patient Protection and Affordable Care Act (PPACA) on March 23, 2010 with the intention of making comprehensive health care affordable for all Americans. For people living with HIV/AIDS, PPACA expands access to vital federal programs like Medicaid and institutes desperately needed consumer protections. By dramatically expanding the number of people living with HIV/AIDS who have access to health care, PPACA aims to improve health outcomes for people currently living with the disease while preventing its spread.
As the States and the Administration implement PPACA however, it has become clear that numerous obstacles to widespread viral suppression remain. Although PPACA contains dramatic reforms, the States possess substantial influence over their implementation. This has provided state actors with opportunities to sidetrack and dilute their impact. Furthermore, even if the States were completely compliant with PPACA’s provisions, the law would still fail to address important health care access issues for people living with HIV/AIDS.
In the public insurance market, legal challenges brought by protesting states have dramatically decreased the impact of the Medicaid expansion. Meanwhile, the law does nothing to address the longstanding problem of low Medicaid reimbursement rates, which has contributed to a shortage of participating physicians nationwide. In the private insurance market, PPACA institutes market reforms that include a requirement that insurance providers cover a basic level of health care. However, the Administration has ceded the authority to define what these requirements entail to the States, many of whom are openly hostile to PPACA’s implementation. Only when these issues have been addressed can PPACA begin to achieve its goal of comprehensive, affordable health care for not only people living with HIV/AIDS, but all Americans.
The Health Consequences of Sex Trafficking and Their Implications for Identifying Victims in Healthcare Facilities
Authors: Laura J. Lederer and Christopher A. Wetzel
This paper reports on focus groups conducted with 107 domestic victims of sex trafficking in which they discussed the health problems they experienced during trafficking. In addition, the project examined victims' interactions with various types of healthcare providers. The focus groups revealed that nearly all victims experienced serious physical and mental health problems while being trafficked, including serious communicable and other diseases, injuries resulting from violence, substance abuse, and reproductive health issues. The paper summarizes data about the health problems reported by significant numbers of survivors to present a fuller picture of the health consequences that victims of trafficking suffer. A majority of survivors sought healthcare at some point during the time they were trafficked. The paper also reports on the contact victims had with health care providers, including hospital emergency wards, urgent care clinics, neighborhood clinics, women's clinics, Planned Parenthood clinics, and general practitioners. Many providers were unaware of the fact that they were treating a trafficking victim, and unaware of the force, fraud, and coercion involved in trafficking. The paper discusses common physical and mental health symptoms and other warning signs that can assist medical professionals in recognizing possible trafficking victims. It also makes policy and program recommendations for medical care providers to enhance their roles as identifiers of trafficking victims. These recommendations include suggestions for interviewing possible victims and methods for helping victims obtain broader assistance, including criminal justice assistance where warranted. Other recommendations include mandatory training about trafficking in persons for healthcare providers, mandatory posting of the national trafficking hotline phone number and specialized resources to make available to victims.
Millennium Development Goal 5, Human Rights, and Maternal Health in Africa: Possibilities, Constraints, and Future Prospects
Author: Dr. Obiajulu Nnamuchi
Millennium Development Goal 5 (MDG 5) holds particular significance for Africa in that it incentivizes countries in the region to: first, look beyond their shores to strategies being implemented by others to improve maternal health and wellbeing of women within their respective jurisdictions; and, second, incorporate transferable best practices into their national initiatives. But the process is dangerously dangling on the precipice of being overrun by seemingly insuperable factors, evident in continuing deterioration of women’s health throughout the region. Proceeding on the premise that maternal health is a human right, the violation of which inevitably bequeaths catastrophic consequences upon women and children, this paper argues that the status quo in all the countries in the region is indefensible and desperately in need of reversal. This paper provides an analytical framework for exploring current implementation challenges and identifies specific interventions within and outside the health sector that must be incorporated into country policies, strategies, and plans of action as fundamental to positioning Africa on a sustainable track toward the MDG.
Vol. 23 Issue 2, Special Edition 2014
Articles
Flipped the Light Switch: New Perspectives on Default to Donation for Organs and Tissues
Authors: Daniel G. Orenstein and Layne M. Bettini
The decision to donate organs and tissues after death is a complex choice, implicating numerous ethical, moral, legal, and other values. However, it is also a simple one in that it has two mutually-exclusive options (consent or decline). As with other such binary decisions, the legal “default” that applies when no affirmative choice is made provides an important framework. Other scholars have robustly analyzed the possibility of increasing solid organ donation by transitioning to a system of presumed consent and the potential concerns for individual autonomy that would be associated with such a system. Less attention, however, has been paid to the potential impacts in two other respects: (1) cadaveric ocular and tissue donation, and (2) donor families. While the existing U.S. system does an excellent job procuring solid organs for transplant – even in the current opt-in structure – there is comparatively much more room for improvement in ocular and tissue procurement rates. Additionally, presumed consent offers several benefits to donor families who, under the current system, are suddenly thrust into decision-making roles under exceedingly difficult circumstances. A properly structured presumed consent system would not significantly affect the donation decision directly – much as the initial position of a light switch does not affect one’s choice to light a room. However, the public health benefits a change to the default rule could be significant if it successfully fosters a culture that supports donation and views it as the norm, rather than the exception.
The Legal Anatomy of Product Bans to Protect the Public’s Health
Authors: James G. Hodge, Jr. and Megan Scanlon
Products that present significant health risks to individuals or populations are routinely banned in the U.S. However, some products that negatively impact health remain available commercially despite efforts to ban their sale or possession. Underlying public health powers to ban products are multiple, countervailing law, policy, and ethics arguments that sometimes thwart public health efforts. Using product bans in furtherance of the public’s health is predicated on successfully identifying and navigating these arguments. Lacking a definitive assessment of such product bans, this article assesses the “legal anatomy” for identifying and implementing bans that are effective, and avoiding those that are not.
The Expansion of Newborn Screening: Implications for Public Health and Policy
Authors: Leila Barraza and Lauren Burkhart
Newborn Screening Programs have proven to be a successful model of public health intervention. Shortly after birth, a blood sample is taken from the heel of newborn babies and tested for certain conditions. Analysis of the newborn’s genome is used at the present time only for confirmation of a positive test from a newborn screen. Whole Genome Sequencing (WGS) of newborns as a routine procedure, however, is the next progression in the development of newborn screening programs. This article examines the history of current newborn screening programs and looks beyond into the potential for expansion into WGS as a newborn screening method. Benefits from WGS of newborns could reap enormous benefits for public health research for disease prevention and health promotion. Expansion into new scientific areas is never easy and will require a consideration of ethical and legal constructs and changes in state statutory law. This article looks at policy considerations that will necessarily be examined and addressed for a shift from the current blood spot program to a WGS approach.
ACA Implementation: The Court Challenges Continue
Authors: Jane Perkins and Dipti Singh
This article provides an overview of litigation related to Supreme Court’s upholding of the constitutionality of the Patient Protection and Affordable Care Act (ACA) by identifying three “rounds” of litigation that have emerged. Round One involves litigation that culminated in the 2012 Supreme Court ruling. Almost uniformly, that litigation sought to repeal the ACA in its entirety. The second round of litigation, comprised of cases filed since the 2012 decision and dominated by cases seeking to curtail an ACA requirement for health insurers to cover contraception without cost sharing. Notably, there have been a large number of such cases (approaching 100, to date), and the Supreme Court has agreed to decide whether for-profit businesses have religious rights entitling them to an exemption from the contraceptive coverage requirement. Finally, the emerging Round Three of litigation seeks to enforce the ACA so that its benefits can be realized.
Monitoring the Law: Court Watch Programs in Maryland
Author: Megan Griest
Traditionally, domestic violence has been treated as a women’s issue, not the public health problem it is. This national problem affects the health and well-being of people across all demographics of this country. The Maryland court system is failing victims of domestic violence. In some cases, these victims do not report the crime to the police out of fear of repercussions from the abuser; in other cases, a lack of trust in the criminal justice system alienates victims. Throughout the process, victims may feel alone and unprotected. One way the state could address this issue is by more widely implementing court watch programs, which train volunteers to observe judicial behavior in court and complete a record of the case and behavior of judges, bailiffs and other court staff. Program administrators then compile these records and typically prepare a report discussing the consistency of the judges’ behavior, best practices observed, and recommendations for improvement, to disseminate to judges in that jurisdiction. This article discusses domestic violence as a public health concern and the need for policy change within the court system. Then it discusses how the current system is failing domestic violence victims in Maryland and reviews court watch programs as a potential solution to increase the consistency of judicial behavior and provide increased protections to victims in domestic violence cases.
Priorities in Public Health Law: A Practice-Based Analysis of Trends in the Legal Needs of Public Health Professionals
Authors: Caty Schmitter and Jennifer A. Bernstein
The Network for Public Health Law (Network) works to address public health legal issues may be able to contribute relevant information gained through their program activities. Through its activities assisting public health professionals with legal questions, the Network has compiled a considerable amount of data on the needs of these professionals. This article is a report summarizing the results of a detailed analysis of this data and identifies trends among requests submitted to the Network from public health professionals in an effort to build on past reviews of Network activities, identify opportunities for further analysis and contribute to the expanding body of research that will inform public health law’s priorities moving forward. The report provides background on the Network, including its purpose and activities, its relevance to a discussion of the legal needs of public health professionals and several limitations in the Network's existing data set which have prevented more complex analysis. It then lays out the goals of a new study of Network data and describes the methods which were used to collect, prepare and analyze data for the purposes of this study. The report then describes the results of the study and highlights trends in requests submitted to the Network across a number of factors. Finally, it discusses potential explanatory factors and implications for several key trends. These findings will facilitate public health professionals being able to make use of law and policy to promote the public’s health.