Federal laws that protect workers from insurance discrimination and infringement of health privacy include exceptions for wellness programs that are "voluntary" and "reasonably designed" to improve health. Initially, these exceptions were intended to give employers the flexibility to create innovative wellness programs that would appeal to workers, increase productivity, and protect the workforce from preventable health conditions.
Yet a detailed look at the scientific literature reveals that wellness program efficacy is quite disputed, and even highly touted examples of program success have been shown to be unreliable. Meanwhile, the latest administrative regulations on wellness programs were vacated by a district court in January 2019, leaving the legal scope of wellness programs in flux. The U.S. District Court of Connecticut now has a case before it that could start a national overhaul of these programs.
In this Article, we give a scientific and legal overview of wellness programs and explain why wellness programs are a source of ethical controversy. Given the unsteady evidence on wellness programs' benefits and their real potential risks, we argue that more should be done to regulate their scope and design. A robust interpretation of the relevant statutes would help protect workers in the face of indecisive evidence. To this end, we conclude with an attempt to resolve the widespread disagreement over the terms "voluntary" and "reasonable design" with the goal of providing courts and regulators with a more workable framework to apply.
INTRODUCTION I. THE DUBIOUS EVIDENCE ON PROGRAM BENEFITS A. Early Enthusiasm B. Reassessing the Evidence II. INTENSIFYING CONCERNS ABOUT PROGRAM RISKS A. Risks of Health Screenings B. Risks of Financial Incentives C. Additional Risks D. Balancing Risks and Benefits III. A LACK OF SUBSTANTIVE DIRECTION FROM THE LAW A. Federal Statutes and Regulations 1. HIPAA and ACA: The Reasonable Design Criterion 2. ADA and GINA: The Voluntariness Criterion 3. Regulatory Confusion B. Judicial Treatment IV. A CONCEPTUAL PATH FORWARD A. Voluntariness 1. Adequate Information 2. Noncoercion a. The Moralized Approach b. The Value-Neutral Approach B. Reasonable Design CONCLUSION INTRODUCTION
Sustained growth in healthcare spending has prompted employers to seek options for reducing their overall medical costs. (1) One widespread approach has been to invest in workplace wellness programs, which incentivize workers to identify health issues and take steps to improve their well-being. (2) The underlying logic of these programs is that employers can mitigate total insurance costs by promoting employee health. (3) As such, wellness programs typically encourage workers to stop smoking, join a gym, lose weight, or get preventive health screenings in order to make them healthier and more productive. (4) These programs are now available to over sixty million U.S. employees, and the revenue of the wellness industry has more than quadrupled to eight billion dollars since 2011. (5) A handful of states have also started expanding wellness programs into Medicaid. (6) In short, the programs are a highly complex and entrenched feature of U.S. employment.
Policymakers have frequently assumed that the benefits of such programs are self-evident; intuitively, investing in employee health seems good for employees. (7) However, a thorough look at the scientific literature on wellness programs supports a more skeptical view. Specifically, the presumption that programs benefit health or influence costs is far from substantiated by the literature. (8) Meanwhile, these programs have come under scrutiny, and some have raised doubts about whether the programs harm participants. (9) Given the lack of conclusive data on wellness programs' benefits and harms, one would expect such programs to be subject to significant regulatory oversight in order to protect program participants.
Yet the laws governing wellness programs are currently precarious. Typically, federal statutes prohibit employers from soliciting employees' health information or varying their insurance benefits based on health status. (10) However, these statutes make exceptions for wellness programs that are "voluntary" for participants and "reasonably designed" to improve health, and what these regulatory standards mean in practice remains unclear. (11) Administrative agencies have issued conflicting guidance, and district courts have disagreed about what features make a program voluntary. (12) Effective January 2019, a D.C. federal judge struck down the latest regulatory attempt at defining what constitutes a voluntary program, and no new regulations have been proposed. (13) As a result, the legal scope of wellness programs is in flux, signaling a need for better guidance.
Now the U.S. District Court of Connecticut has a case before it that could start dismantling these programs. In July 2019, Yale employees filed a complaint stating that the university's wellness program is not voluntary. (14) The outcome of this case could set an important precedent for how wellness programs will be implemented in the future as well as affect how voluntariness will be conceptualized in the law more broadly.
This Article synthesizes the empirical, legal, and policy literatures on workplace wellness programs. In Parts I and II, we will provide an extended analysis of programs' potential benefits and risks, arguing that wellness programs do not necessarily have a favorable effect. A detailed view of the scientific literature on wellness programs indicates that program efficacy is quite disputed. We will argue that it is no longer appropriate to assume that individual programs are "reasonably designed" to positively affect health, suggesting that employers should have to meet a higher evidentiary burden to establish the programs' effectiveness. Our goal in these Parts is to push back against the original policy approach that crafted easily satisfied regulatory requirements because programs appeared to be clearly beneficial. Given our argument that the regulatory approach is inadequate, we then turn in Part III to the statutes, regulations, and judicial decisions relevant to the regulation of wellness programs in order to assess whether there is an opportunity to pivot towards more rigorous oversight. We argue that voluntariness and reasonable design are frequently interpreted loosely and applied inconsistently, but that these standards can be strengthened. To that end, Part IV provides a conceptual analysis of the factors that would render a program voluntary and reasonably designed. Our analysis is framed to help guide the implementation of wellness programs while avoiding some of their potential pitfalls.
THE DUBIOUS EVIDENCE ON PROGRAM BENEFITS
Broad initial support for wellness programs was based on empirical literature that pointed to wellness as a promising avenue for influencing health and healthcare costs. Several well-publicized case studies of Johnson & Johnson (1986), Bank of America (1993), the California Public Employees Retirement System (1994), and Citibank Health Management Program (1999) demonstrated sizable healthcare savings by implementing programs. (15) In 2009, Safeway reported that its program had saved the company approximately 40 percent in medical expenses. (16) A high-profile meta-analysis published in 2010 found that for every dollar spent on a program, medical costs fell by about $3.27 and absenteeism costs fell by about $2.73. (17) These findings and others occasioned sustained interest in wellness programs. (18)
In addition to empirical and anecdotal support, encouraging such programs had extensive, bipartisan political appeal. President Obama, for example, highlighted wellness as a central tenet of the Affordable Care Act (ACA):
Our federal government also has to step up its efforts to advance the cause of healthy living. Five of the costliest illnesses and conditions--cancer, cardiovascular disease, diabetes, lung disease, and strokes--can be prevented. And yet only a fraction of every health care dollar goes to prevention or public health. That is starting to change with an investment we are making in prevention and wellness programs that can help us avoid diseases that harm our health and the health of our economy. (19) Similarly, excitement about Safeway's wellness program motivated public comment from Mitch McConnell and John McCain. In a speech on the Senate floor, Mitch McConnell stated, "The Safeway program has proven so successful that the company wants to increase its incentives for rewarding healthy behavior. Unfortunately, current laws restrict it from doing so." (20) A substantive result was the passage of the ACA's "Safeway Amendment," an homage to Safeway's program that eased regulatory barriers and authorized grants for wellness programs. (21) In short, the early evidence showed promise for wellness programs' ability to achieve health goals, which prompted policymakers to support their expansion.
Reassessing the Evidence
However, the weakness of the evidence supporting wellness programs has increasingly been recognized, calling into question the foundation on which these programs are based. In this Section, we outline the state of understanding about the benefits of these programs. We show that common problems have been noted throughout the wellness literature, including self-selection, attrition, small sample sizes, short measurement periods, inexact case-control matching, overutilization of self-report measures, and lack of valid measures, among others. Altogether, these shortcomings call into doubt the quality of the existing evidence, suggesting a more circumspect estimation of wellness programs' benefits.
A close read of the early literature undercuts policymakers' early enthusiasm for wellness programs. For example, a 1996 review summarizing the literature on the health effects of...