Last week Sen. Lamar Alexander (R-TN) and Rep. John Kline (R-MN) introduced the Preserving Employee Wellness Programs Act in Congress. The proposed law seeks to counter the recent court cases filed by the Equal Employment Opportunity Commission (EEOC). In these cases, the EEOC charged that some wellness programs violate the Americans with Disabilities Act (ADA) and the Genetic Information Non-Discrimination Act (GINA).
The ADA permits workplace wellness programs, as long as they are voluntary, and GINA permits voluntary disclosure of family health information. The EEOC cases question whether wellness programs are truly voluntary if employees can be fired, lose all employer subsidy of health insurance, or face large penalties for declining to participate. In effect, the EEOC says that some employers use incentives to coerce or unduly influence employees to participate in wellness programs.
Do incentives change the voluntary nature of wellness programs? Does the type or size of the incentives matter? The proposed law attempts to answer these questions by stating explicitly that workplace wellness programs do not violate the ADA or GINA as long as they comply with other existing laws, including the Affordable Care Act (ACA).
One place to look for ways to think about incentives is the ethics of research on human subjects. Medical ethicists have been exploring the issue at least since the Belmont Report, a core research ethics document issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report followed public outrage over abuses of research participants, such as the infamous Tuskeegee syphilis study. The report states that participation in research should be voluntary and that the decision to participate should be free from coercion or undue influence by researchers. However, defining coercion and undue influence, the boundary between them, and their applicability to specific research projects has not been easy.
The Office of Human Research Protection (OHRP) in the US Department of Health and Human Services oversees research on human subjects. OHRP defines coercion as “an overt or implicit threat of harm … intentionally presented by one person to another in order to obtain compliance.” An example is a doctor telling a patient that the doctor will no longer treat the patient if the patient refuses to participate in a research study.
OHRP defines undue influence as “an offer of an excessive or inappropriate reward or other overture in order to obtain compliance.” For example, a professor exercises undue influence by telling students that the only way to earn extra credit is to participate in a research study.
These concepts are implemented by Institutional Review Boards (IRBs), which have the ethical responsibility to approve research projects. Most research involving human subjects requires IRB approval. Many ethicists have written about the meaning of coercion and undue influence and about the way IRBs interpret the terms. Not surprisingly, scholars have reached various conclusions.
Some scholars believe that paying for participation in research is not coercive and does not constitute undue influence. They reason that potential research participants are not threatened by the offer of payment (so do not experience coercion as defined by OHRP), and that undue influence is rare because incentives are seldom large enough to skew research subjects’ evaluation of potential harm. Some scholars found that any research properly approved by an IRB will not expose research subjects to serious harm, so an incentive payment in such programs can never constitute undue influence.
Others have reached different conclusions. Many IRBs have struggled with appropriate levels and types of incentives as they evaluate projects. IRBs question whether research subjects should be paid differently depending on their level of income; whether there should be a difference between incentives given to healthy volunteers and patients who could benefit from the research; whether there is a difference between making the incentive contingent on completing a study and providing partial payments along the way; and whether there is a difference between cash and other kinds of incentives, such as free medical care. In the minds of some IRB members even a small change in the amount or type of compensation could shift a finding about the presence or absence of undue influence.
Since employers offer wellness incentives to their employees, an additional consideration is whether the employment relationship introduces new factors into the ethical analysis of incentives. OHRP examined employee participation in research.
This discussion addresses both the overt penalties (losing employer health insurance subsidies or paying large penalties) and the fears about covert penalties (fear of losing promotions or salary increases). OHRP notes that sometimes undue influence is subtle. It specifically recognizes social pressure as a means to exert undue influence. The EEOC cases touch on all these issues.
Some ethicists dismiss concerns about coercion and undue influence in workplace wellness programs by noting that employers are not obligated to provide health insurance to employees. Simply by providing health insurance on any terms, employers make employees better off. Under this reasoning, setting terms for health insurance benefits cannot be coercive, by definition. The terms of health insurance are part of the overall employment offer, which includes salary, location, duties and responsibilities, and more. Since no one must accept any particular job, no one must accept or keep a job that offers health insurance with wellness incentives. This view is reinforced by the contention that workplace wellness programs benefit employees by identifying health risks early and helping employees improve their health and wellbeing.
The ethical issues surrounding the use of incentives in wellness programs are complex because of the inherent power imbalance in the employment relationship. Saying that people can simply walk away from a job if they don’t want to participate in wellness programs is unrealistic. Nor can most people afford to give up their employer-provided health insurance. Federal law now mandates that individuals maintain health insurance or pay a penalty. Those who walk away from employer-provided coverage are ineligible for subsidies under the ACA.
There is also increasing evidence that wellness programs do not improve health or lower healthcare costs. Instead, they may lead to overtesting, overdiagnosis and overtreatment, all of which carry risks to participating employees. Incentives tied to achieving certain levels cholesterol, BMI or blood pressure also affect individual choices on, among other things, whether to take drugs or accept other medical interventions in order to achieve the level prescribed by the employer’s health plan. By linking financial incentives to medical outcomes, wellness programs challenge the fundamental principle of medical ethics that decisions about medical treatment should be left to the individual or made by an individual and her physician.
Unfortunately, the Preserving Employee Wellness Programs Act does not address or acknowledge any of the ethical issues raised by wellness incentives. The EEOC wants to have the debate about these issues in court, and this is one way to resolve these types of policy conundrums. However, it would be better if the debate took place as part of a rulemaking process to reconcile wellness incentives with ADA and GINA requirements. Such a process would allow us to have a meaningful debate about ethical issues raised by wellness program incentives, with all points of view represented and all types of incentives considered. In addition to outcomes-based incentives, which are regulated (and limited) under the ACA, we need to discuss unlimited participation incentives, “gated” health plans where participation in wellness initiatives serves as the “gate,” and wellness incentives unconnected with health plans. A bill that initiates this conversation could be a reasonable starting point.