Volume 22 (2013)

Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 22 (2013)

Issue 1, Winter 2013

Articles

The Curious Case of Trent Arsenault: Questioning FDA Regulatory Authority Over Private Sperm Donation
Author: Amber D. Abbasi 

Recent action by the Food & Drug Administration provides an opportunity to examine the federal government’s regulation of reproductive medicine. Generally, regulation focuses on contraception and abortion services. However, regulation entered a unique legal situation in the recent case of Trent Arsenault. Through a personal website, Mr. Arsenault offered semen donations to women on a purely private, uncompensated basis. The FDA subsequently ordered him to “cease manufacture” of sperm donations. The FDA’s exercise of new authority requires careful examination. This article examines the regulations that the FDA seeks to enforce against private sperm donors, their application in the Arsenault case, and the implications of expanding the government’s regulatory authority over individuals’ procreative decisions.

Ready or Not: Hospital Value-Based Purchasing Poised to Transform Healthcare Reimbursement Model and Introduce New Fraud Targets under the False Claims Act
Author: PollyBeth Hawk 

Value-based purchasing is central to the government’s mission to improve quality and achieve value for Medicare. Under PPACA, value-based purchasing programs will be used to incentivize quality improvement through payment reform. Value-based purchasing programs are based on the principle that providers will achieve better outcomes if their reimbursements are linked directly to their performance and, consequently health care will become more efficient and cost effective. This paper discusses the value-based purchasing template set forth by CMS in its Roadmap to Implementing VBP, as well as the required commitment to transparency as these changes occur. Moreover, value-based purchasing will be affected by the possibility of liability under the False Claims Act. The author explores the potential interplay between the False Claims Act and value-based purchasing programs.

A New Regulatory Strategy Against Smoking –Weekly Lotteries and Increasing Credit Balance as Incentives to Modify Behavior
Author: Gerrit M. Beckhaus 

Tobacco use continues to affect adversely a significant number of people, despite extensive tobacco control strategies in recent decades. This article discusses the impact of current regulatory approaches as well as the critical period of smoking initiation. The author argues that smoking is a modifiable behavior. Borrowing from behavior economics theories, this article explores the possibility of providing positive economic incentives to affect people’s choice regarding tobacco use. Focusing on the United States as a background, the proposed model takes a dual approach consisting of a weekly lottery as well as an account with an increasing credit balance than can only be accessed after a specific period of non-smoking.

Is Sugar the New Tobacco? How to Regulate Toxic Foods
Author: Barbara L. Atwell 

The average American diet is subject to both increasing scrutiny and criticism. In this article, the author focuses on the risks associated with excessive consumption of added sugar and what is to be done to address this public health problem. Obesity, heart disease, diabetes, and other chronic diseases have been linked to diets high in added sugar. These diseases both reduce quality of life and cost the healthcare system a considerable amount of money. Recently, attention has been drawn to the government’s role in regulating food choices. The author examines the evidence of health risks associated with added sugar and why, despite such evidence, the food industry perpetuates the problem. The author then explores whether added sugar ought to be a regulated substance, discussing the benefits and drawbacks of such regulation. A comparison can be drawn between proposed added sugar regulations and tobacco regulations. The author argues that many of the laws designed to discourage tobacco use should be applied to products with large quantities of added sugar. 

Hospital Value Based Purchasing and the Bundled Payment Initiative Under the Affordable Care Act: A Good Start, but is it Good Enough?
Author: Nita Garg

Health care reform discussions frequently center on improving quality while containing costs. The current reimbursement structure, and its reliance on fee for service payments, is often cited as negatively affecting these two goals.  This article discusses federal efforts to reform the health care system’s current fee-for-service reimbursement structure.  Two programs under PPACA, Hospital Value Based Purchasing and the Bundled Payment Initiative, aim to contain escalating costs while improving the quality of care provided. Both programs are Medicare-based and link reimbursement with outcomes rather than provision of services, thereby attempting to incentivize efficient, high quality care.  The Hospital Value Based Purchasing program does so by using a pay for performance model while the Bundled Payment Initiative uses an episodic payment model.  The author argues that the structure of these programs will be inadequate to accomplish the federal government’s stated goals. The programs should not be abandoned, but significant modifications may be necessary in order to avoid failure or unintended consequences.

Special Edition Guest Senior Editors: Lauren A. Burkhart, Julia J. Koestner, Ashley M. Votruba, Sandra Day O’Connor College of Law, Arizona State University

Issue 2, Special Edition 2013

Articles

Intervening at the Right Point in the Causal Pathways: Law, Policy, and the Devastating Impact of Pain Across the Globe
Author: Daniel S. Goldberg 

This essay examines pain across the globe to show how public health laws and policies targeted proximal or subsequent to the onset of disease are highly likely to be ineffective in meeting two paramount ethical goals of public health policy: absolute improvements in overall health and the compression of health inequities.  Drawing on a variety of social epidemiologic concepts, the article argues that the root causes of the inequitable distribution of global pain are the social, political, and economic conditions in which people in both global North and global South live and work.  The paper deploys the ample evidence suggesting that laws and policies targeted at the structural causes of ill health are much more likely to decrease pain prevalence and incidence and to compress global pain inequities.  Unfortunately, global law and policy efforts have focused overwhelmingly on the dispensation of medical treatment for pain.  Such efforts do not address the structural variables that represent fundamental causes of pain.  The paper concludes by proposing several alternative law and policy approaches that, by virtue of being targeted at structural and fundamental causes, are more likely to ameliorate global burdens of pain and compress inequities in its prevalence and in its outcomes.

Complementarity in Public Health Systems: Using Redundancy as a Tool of Public Health Governance
Authors: Lance Gable & Benjamin Mason Meier  

Redundant systems exist throughout legal systems and permeate public health governance. Scholars, lawmakers, and policy-makers often consider this redundancy to be a pernicious indicator of inefficiency and waste in public health systems, and seek reforms to minimize or eliminate overlapping institutions. Yet redundancy has countervailing values that may overcome these concerns. Analyzing the benefits of overlapping networks of governance, this article explores the positive aspects of complementarity in public health law as a tool to expand capacity and systemic resiliency; augment innovation in policy and practice; promote accountability and transparency; and foster the development of normative and procedural harmonization and consistency conducive to improving public health.

Enhancing Communication Between Scientists, Government Officials, and the Lay Public: Advancing Science and Protecting the Public’s Welfare through Better Multi-Stakeholder Interfacing
Authors: Clark J. Lee, Patrick P. Rose & Earl Stoddard III

In December 2011, the National Science Advisory Board for Biosecurity (“NSABB”) controversially recommended that two studies funded by the National Institutes of Health (“NIH”) on the H5N1 virus be published in redacted format. While the NSABB ultimately endorsed full publication of the scientific papers, the episode highlighted the friction that sometimes exists between public welfare and scientific progress. Some local and state governments have successfully engaged the scientific community to bridge the lack of public understanding regarding scientific research and its value in advancing public welfare. This article discusses how such efforts can be encouraged as a matter of law and public policy to promote public health.

Making a Positive Impact: Striking a Balance Between Legislative Reach and Road Safety
Authors: Diana M. Bowman, Michael P. Fitzharris & Ray Bingham

Worldwide, road traffic crashes result in the death of over 1.24 million citizens per annum, with estimates suggesting that by 2020, road crashes will be the third leading cause of disease and injury worldwide. In recognition of this increasing global burden of road traffic crashes, the United Nations declared 2011 through 2020 to be the Road Safety Decade of Action. Legislation and evidence-based policy frameworks have been identified as key mechanisms in driving reductions in this global “road toll.”
The aim of this article is to examine the competing interests and tensions at play in promoting road safety through legislated public health policy instruments. This includes the balancing of express and implied civil liberties against the public health need of injury control. Given the central role of regulation in driving advances in road safety and the current momentum for global action, this article argues that a global Framework Convention on Road Safety should be implemented under the treaty-making power of the World Health Organization as a means of advancing road safety action beyond 2020.

Federal Funds for Syringe Exchange Programs: A Necessary Component Toward Achieving an AIDS-Free Generation
Authors: Rachel L. Hulkower & Leslie E. Wolf

The United States government has declared the goal of an AIDS-free generation a “policy imperative,” calling for investment in evidence-based prevention measures.  Ironically, U.S. policy forbids investment in one prevention measure with strong evidence of effectiveness.  Needle and syringe exchange programs (“SEPs”) significantly reduce HIV transmission due to injection drug use, one of the most common modes of HIV transmission in the United States.  This article argues that the ban on SEP funding represents a significant barrier to the President’s stated goal of achieving an AIDS-free generation.  Without federal support, states have been unwilling or unable to consistently support SEPs.  Accordingly, the federal government must act in unequivocal support for SEPs as part of a comprehensive HIV prevention program, and provide funding to facilitate prevention services for injection drug users.  Only with decisive federal funding and guidance can an AIDS-free generation be realized.

Clarifying Liability for After-Hours Community Use of School Recreational Facilities
Authors: John O. Spengler, Natasha Frost, Daniel P. Connaughton & J. David Prince

The obesity epidemic has prompted policy guidance directed at the state and local levels to encourage physical activity.  Policies that promote community access to school recreational facilities during non-school hours (“shared use”) are of particular importance.  The American Heart Association (“AHA”) advocates for shared use in furtherance of the Institute of Medicine’s recommendation to adopt legislative policies, where necessary, to address liability issues that might prevent the sharing of school recreational facilities.  The AHA and Public Health Law Center developed policy guidance in the form of sample legislation for individual states to use as a starting point in developing policies to eliminate or reduce barriers to shared use.  The policy guidance includes: (1) findings; (2) purpose; (3) definitions; (4) liability provisions; (5) liability exceptions; and (6) implementation.  Advocates and policy makers can use the AHA policy guidance to make informed decisions about school shared use legislation.

Local Governments and the Food System: Innovative Approaches to Public Health Law and Policy
Authors: Lainie Rutkow, Jennifer L. Pomeranz & Sarah O. Rodman

Law plays a powerful role in protecting the health of populations, especially as new challenges emerge such as obesity and chronic diseases associated with unhealthy diets.  Numerous novel uses of the law have been identified to address these challenges and create a healthier, more sustainable food system.  Because local governments are often viewed as policy innovators, it is particularly important to understand successes and obstacles they have faced when regulating food system industries to promote public health goals.  This article provides a brief overview of the legal infrastructure within which local governments operate.  It then analyzes food industry efforts to challenge local governmental regulation through litigation.  Next, it considers how speech rights may curb local governments’ regulatory efforts.  It subsequently examines the impact of preemption on regulation by local governments.  The article concludes with a discussion of how local governments can promote innovative public health law and policy responses to redress potentially harmful industry actions within the food system.

Issue 3, Summer 2013

Articles

The Road to Universal Health Coverage in Mexico: From Charity to Social Protection in Health
Authors: Octavio Gómez-Dantés, Julio Frenk & Ignacio Ibarra

In this paper, the authors analyze the evolution of the Mexican legal framework that culminated in the creation of the System of Social Protection in Health (SSPH) and its operative branch, Popular Health Insurance or Seguro Popular.  This insurance scheme extended health care coverage with financial protection to all Mexicans citizens in 2012.  First, we discuss the nature of social rights, including the right to health care.  The authors then describe the evolution of the contents of the legal instruments (the Constitution, the social security laws and the General Health Law) that supported the transition in Mexico from health care as the subject of charity to health care as a labor right and then as a social or citizen right.  Finally, the authors discuss how the creation of the SSPH established the regulatory and financial conditions to guarantee the exercise of the right to the protection of health.  There are three lessons of the evolution of the framework that gave legal support to the expansion of health coverage in Mexico.  First, the introduction of the right to the protection of health into the Mexican Constitution in 1983 identified UHC as an achievable vision.  Second, the establishment of the SSPH placed access to comprehensive health care outside of the public assistance realm, guaranteeing its justiciability and establishing the rules to assure its financial sustainability. Finally, the recent Mexican reform illustrates the potential to expand coverage with financial protection to reach the poor and non-salaried workers by decoupling access to social protection in health from salaried employment and transforming it into a right of citizenship.

Duty to Warn of the Risk of HIV/AIDS Infection in Africa: An Appropriate Legal Response?
Authors: Dr. Obiajulu Nnamuchi & Dr. Remigius N. Nwabueze  

The central concern of this paper is to determine whether a physician who competently diagnosed an African female patient of HIV/AIDS infection has a legal obligation to disclose the test result to the patient’s husband or partner. The paper argues that although most western jurisdictions have settled in favor of disclosure, this is not a sufficient warrant for adopting a similar regime in Africa. It advocates an Africentric response, one that focuses squarely on the vulnerable circumstances of women in Africa and the havoc that would be wrought in these women’s lives and well-being by the imposition of a mandatory disclosure framework.

Prosecutions of Pharmaceutical Companies for Off-Label Marketing: Fueled By Government’s Desire to Modify Corporate Conduct or Pursuit of a Lucrative Revenue Stream?
Authors: Lise T. Spacapan & Jill M. Hutchison  

Every year, health care fraud and abuse places a significant financial strain on the federal government.  This article specifically discusses fraud and abuse cases involving pharmaceutical companies that allegedly promote their products for off-label purposes, which are not approved by the United States Food and Drug Administration.  First, the authors provide a discussion of the applicable federal regulations under the Federal Food, Drug and Cosmetic Act.  Next, the authors look at the Department of Justice’s enforcement of regulatory violations and call into question the DOJ’s aggressive approach.  The authors then provide several examples of government prosecutions and spotlight some of the fundamental challenges to those prosecutions.  The authors then discuss the added financial costs following DOJ scrutiny and the relevant health policy issues that are implicated.  In conclusion, the authors question whether these current trends in government conduct actually benefit the public or simply generate a substantial revenue stream.

Dear Doctor Letters: Lessons in Statutory Interpretation, Preemption, Proximate Causation, and Subsequent-Remedial Measures
Authors: James W. Huston, Ellen Nudelman Adler & Joanna L. Simon 

In this article, the authors discuss the current use and the potential legal implications of Dear Doctor letters.  Dear Doctor letters are used to communicate important information between pharmaceutical manufacturers and the professionals who prescribe and administer drugs.  This article first discusses the applicable FDA regulations and guidance material, including the standards for when, how, and to whom Dear Doctor letters should be issued.  Next, the article reviews the extent to which federal preemption principles apply to Dear Doctor letters as outlined by the Supreme Court in the landmark case Pliva v. Mensing.  The article then analyzes the role of Dear Doctor letters in litigation in a post-Mensing world, including whether Dear Doctor letters can be used to show causation and whether Dear Doctor letters are admissible evidence at trial.  The article concludes with practical tips related to sending out Dear Doctor letters.