Tag Archives: safeway amendment

EEOC Caves on Wellness Programs

In a deep dark recess of the Federal Register this week, large corporations quietly received permission to “play doctor” with their employees. Corporations can now impose even more draconian and counterproductive wellness schemes on their workers. The hope of the corporations is to claw back a big chunk of the insurance premiums paid on the behalf of employees who refuse to submit to these programs or who can’t lose weight.

A Bit of Background on Wellness

The Affordable Care Act (ACA) allowed employers to force employees to submit to wellness programs under threat of fines. Specifically, the ACA’s “Safeway Amendment” — named after the supermarket chain whose wellness program was highlighted as a shining example of how corporations could help employees become healthier — encouraged corporations to tie 30% to 50% of the total health insurance premium to employee health behaviors and outcomes. (As was revealed while ACA was being debated, Safeway didn’t have a wellness program. The fictional Safeway success was a smokescreen for corporate lobbyists to shoehorn this withholding of money into the ACA.)

Once this 30% to 50% windfall became apparent, many corporations figured out what this vendor (Bravo Wellness) advertised: There is much more money to be made in clawing back large sums of money from employees who refuse to submit to these programs than in improving the health of employees enough to allegedly reduce spending many years from now. “Allegedly” because — unlike simply collecting fines or withholding incentive payments — improving employee health turns out to be remarkably hard and ridiculously expensive to do. It is so hard and expensive that:

Most importantly, the complete lack of regulation has allowed the wellness industry and health plans to expose employees to significant potential harms to maximize revenue.

See also: Wellness Promoters Agree: It Doesn’t Work

The Federal Government Green Lights “Wellness-or-Else” Programs

There are no regulations, licensure requirements or oversight boards constraining the conduct of wellness vendors, and there is only one agency — the Equal Employment Opportunity Commission (EEOC) — providing any recourse for employees. The Business Roundtable has taken on the latter at every opportunity. First, the Business Roundtable threatened President Obama with withdrawing its support for the ACA unless he declawed the EEOC. Then, the Business Roundtable arranged for sham Senate hearings titled “Employer Wellness Programs: Better Health Outcomes and Lower Costs.” Finally, it threatened to push the “Preserving Employee Wellness Programs Act” to legislatively eviscerate the EEOC’s protections.

But it turns out the legislation was not necessary; the EEOC has now caved in. These programs are defined as “voluntary,” yet, as of now, employees can be forced to hand over genetic and family history information or pay penalties. So, as in 1984, where “war” means “peace,” employees can now be required to voluntarily hand over this information.

Let’s be clear. Genetic information isn’t about employee wellness programs, which do not work. It is all about the penalties. Genetic information is worthless in the prevention of heart disease and diabetes, as Aetna just showed in a failed experiment on its own employees.

Knowing family history does have some predictive value, but it is unclear how employees are going to benefit from employers collecting it. Self-insured employers could either fire the employee or do nothing. Neither is useful for the employee. If the employer is fully insured, this information is akin to a “pre-existing condition” in the old days. The employer’s premiums will increase as long as employees with bad family histories remain on their payroll.

See also: The Yuuuuge Hidden Costs of Wellness

The Good News, Part 1: Corporations Wising Up

The Business Roundtable — and its friends at the U.S. Chamber of Commerce — might want to connect their computers to the Internet. It turns out that many companies are finally realizing that compelling employees to submit to medical screens just to claw back some insurance money isn’t worth the morale hit.

Increasingly, employers are learning that what the national data shows is also true for themselves: These programs simply do not work. For example:

And the morale hit? A formerly obscure faculty member who led the successful employee revolt against the Penn State wellness program was just elected president of the Penn State Faculty Senate — largely because employees were so grateful for his leadership in that revolt.

The Good News, Part 2: Wellness for Employees

As a result, many companies are deciding that clawing back some insurance money is not worth the damage done to their workforces. They are replacing “wellness done to employees” with “wellness done for employees.” These companies are improving the work environment, upgrading their food service, encouraging fitness or simply adding features like paternal leave or financial counseling. They might still hold a “health fair” every now and then, but their medical tests are conducted infrequently (based on actual clinical guidelines) instead of allowing vendors to screen the stuffing out of employees to find diseases that do not exist.

Or, companies are actually focusing efforts where they can make a difference, such as steering employees to safer hospitals or educating employees on how to purchase healthcare services wisely. (Disclosure: My own company, Quizzify, is in the business of teaching employees how to do the latter.)

Notwithstanding this disruption and regardless of the harm it has caused, the $7 billion wellness industry has excelled in perpetuating its own existence. Industry thought leaders recently proposed a scheme to encourage companies to disclose how fat their employees are and have even managed to get a few large employers to sign on to it.

The sheer audacity of that scheme and the complete disregard for its consequences on overweight employees means the war on “voluntary” wellness-or-else programs is by no means over. Like every other industry threatened by reality but supported by deep-pocketed allies such as the Business Roundtable, the wellness industry can rely on the government to delay the inevitable.

Consequently, it might be quite some time before the inevitable course of reality overcomes the wellness-or-else pox on the healthcare system.

Workplace Wellness Shows No Savings

During the last decade, workplace wellness programs have become commonplace in corporate America. The majority of US employers with 50 or more employees now offer the programs. A 2010 meta-analysis that was favorable to workplace wellness programs, published in Health Affairs, provided support for their uptake. This meta-analysis, plus a well-publicized “success” story from Safeway, coalesced into the so-called Safeway Amendment in the Affordable Care Act (ACA). That provision allows employers to tie a substantial and increasing share of employee insurance premiums to health status/behaviors and subsidizes implementation of such programs by smaller employers. The assumption was that improved employee health would reduce healthcare costs for employers.

Subsequently, however, Safeway’s story has been discredited. And the lead author of the 2010 meta-analysis, Harvard School of Public Health Professor Katherine Baicker, has cautioned on several occasions that more research is needed to draw any definitive conclusions. Now, more than four years into the ACA, we conclude that these programs increase, rather than decrease, employer spending on healthcare, with no net health benefit. The programs also cause overutilization of screening and check-ups in generally healthy working-age adult populations, put undue stress on employees and provide incentives for unhealthy forms of weight-loss.

Through a review of the research literature and primary sources, we have found that wellness programs produce a return-on-investment (ROI) of less than 1-to-1 savings to cost. This blog post will consider the results of two compelling study designs — population-based wellness-sensitive medical event analysis and randomized controlled trials (RCTs). Then it will look at the popular, although weaker, participant vs. non-participant study design. (It is beyond the scope of this posting to question vendors’ non-peer-reviewed claims of savings that do not rely on any recognized study design, though those claims are commonplace.)

Population Based Wellness-Sensitive Medical Event Analysis

A wellness-sensitive medical event analysis tallies the entire range of primary inpatient diagnoses that would likely be affected by a wellness program implemented across an employee population. The idea is that a successful wellness program would reduce the number of wellness-sensitive medical events in a population as compared with previous years. By observing the entire population and not just voluntary, presumably motivated, participants or a “high-risk” cohort (meaning the previous period’s high utilizers), both self-selection bias and regression to the mean are avoided.

The field’s only outcomes validation program requires this specific analysis. One peer-reviewed study using this type of analysis — of the wellness program at BJC HealthCare in St. Louis — examined a population of hospital employees whose overall health status was poor enough that, without a wellness program, they would have averaged more than twice the Healthcare Cost and Utilization Project (HCUP) national inpatient sample (NIS) mean for wellness-sensitive medical events. Yet even this group’s cost savings generated by a dramatic reduction in wellness-sensitive medical events from an abnormally high baseline rate were offset by “similar increases in non-inpatient costs.”

Randomized Controlled Trials and Meta-Analyses

Authors of a 2014 American Journal of Health Promotion (AJHP) meta-analysis stated: “We found a negative ROI in randomized controlled trials.” This was the first AJHP-published study to state that wellness in general loses money when measured validly. This 2014 meta-analysis, by Baxter et al., was also the first meta-analysis attempt to replicate the findings of the aforementioned meta-analysis published in February 2010 in Health Affairs, which had found a $3.27-to-1 savings from wellness programs.

Another wellness expert, Dr. Soeren Mattke, who has co-written multiple RAND reports on wellness that are generally unfavorable, such as a study of PepsiCo’s wellness program published in Health Affairs, dismissed the 2010 paper because of its reliance on outdated studies. Baicker et. al.’s report was also challenged by Lerner and colleagues, whose review of the economic literature on wellness concluded that there is too little credible data to draw any conclusions.

Other Study Designs

More often than not wellness studies simply compare participants to “matched” non-participants or compare a subset of participants (typically high-risk individuals) to themselves over time. These studies usually show savings; however, in the most carefully analyzed case, the savings from wellness activities were exclusively attributable to disease management activities for a small and very ill subset rather than from health promotion for the broader population, which reduced medical spending by only $1 for every $3 spent on the program.

Whether participant vs. non-participant savings are because of the wellness programs themselves or because of fundamentally different and unmatchable attitudes is therefore the key question. For instance, smokers self-selecting into a smoking cessation program may be more predisposed to quit than smokers who decline such a program. Common sense says it is not possible to “match” motivated volunteers with non-motivated non-volunteers, because of the unobservable variable of willingness to engage, even if both groups’ claims history and demographics look the same on paper.

A leading wellness vendor CEO, Henry Albrecht of Limeade, concedes this, saying: “Looking at how participants improve versus non-participants…ignores self-selection bias. Self-improvers are likely to be drawn to self-improvement programs, and self-improvers are more likely to improve.” Further, passive non-participants can be tracked all the way through the study because they cannot “drop out” from not participating, but dropouts from the participant group — whose results would presumably be unfavorable — are not counted and are considered lost to follow-up. So the study design is undermined by two major limitations, both of which would tend to overstate savings.

As an example of overstated savings, consider one study conducted by Health Fitness Corp. (HFC) about the impact of the wellness program it ran for Eastman Chemical’s more than 8,000 eligible employees. In 2011, that program won a C. Everett Koop Award, an annual honor that aims to promote health programs “with demonstrated effectiveness in influencing personal health habits and the cost-effective use of health care services” (and for which both HFC and Eastman Chemical have been listed as sponsors). The study developed for Eastman’s application for the Koop awards tested the participants-vs-non-participants equivalency hypothesis.

From that application, Figure 1 below shows that, despite the fact that no wellness program was offered until 2006, after separation of the population into participants and non-participants in 2004, would-be participants spent 8% less on medical care in 2005 than would-be non-participants, even before the program started in 2006. In subsequent presentations about the program, HFC included the 8% 2005 savings as part of 24% cumulative savings attributed to the program through 2008, even though the program did not yet exist.

Figure 1

Lewis-Figure 1

Source: http://www.thehealthproject.com/documents/2011/EastmanEval.pdf

The other common study design that shows a positive impact for wellness identifies a high-risk cohort, asks for volunteers from that cohort to participate and then tracks their results while ignoring dropouts. The only control is the cohort’s own previous high-risk scores. In studying health promotion program among employees of a Western U.S. school district, Brigham Young University researcher Ray Merrill concluded in 2014: “The worksite wellness program effectively lowered risk measures among those [participants] identified as high-risk at baseline.”

However, using participants as their own control is not a well-accepted study design. Along with the participation bias, it ignores the possibility that some people decline in risk on their own, perhaps because (independent of any workplace program) they at least temporarily lose weight, quit smoking or ameliorate other risk factors absent the intervention. Research by Dr. Dee Edington, previously at the University of Michigan, documents a substantial “natural flow of risk” absent a program.

Key Mathematical and Clinical Factors

Data compiled by the Healthcare Cost and Utilization Project (HCUP) shows that only 8% of hospitalizations are primary-coded for the wellness-sensitive medical event diagnoses used in the BJC study. To determine whether it is possible to save money, an employer would have to tally its spending on wellness-sensitive events just like HCUP and BJC did. That represents the theoretical savings when multiplied by cost per admissions. The analysis would compare that figure to the incentive cost (now averaging $594) and the cost of the wellness program, screenings, doctor visits, follow-ups recommended by the doctor, benefits consultant fees and program management time. For example, if spending per covered person were $6,000 and hospitalizations were half of a company’s cost ($3,000), potential savings per person from eliminating 8% of hospitalizations would be $240, not enough to cover a typical incentive payment even if every relevant hospitalization were eliminated.

There is no clinical evidence to support the conclusion that three pillars of workplace wellness — annual workplace screenings or annual checkups for all employees (and sometimes spouses) and incentives for weight loss — are cost-effective. The U.S. Preventive Services Task Force (USPSTF) recommends that only blood pressure be screened annually on everyone. For other biometric values, the benefits of annual screening (as all wellness programs require) may not exceed the harms of potential false positives or of over-diagnosis and overtreatment, and only a subset of high-risk people should be screened, as with glucose. Likewise, most literature finds that annual checkups confer no net health benefit for the asymptomatic non-diagnosed population. Note that in both cases, harms are compared with benefits, without considering the economics. Even if harms roughly equal benefits, adding screening costs to the equation creates a negative return.

Much of wellness is now about providing incentivizes for weight loss. In addition to the lack of evidence that weight loss saves money (Lewis, A, Khanna V, Montrose S., “It’s time to disband corporate weight loss programs,” Am J Manag Care, In press, February 2015), financial incentives tied to weight loss between two weigh-ins may encourage overeating before the first weigh-in and crash-dieting before the second, both of which are unhealthy. One large health plan offers a weight-loss program that is potentially unhealthier still, encouraging employees to use the specific weight-loss drugs that Dartmouth’s Steven Woloshin and Lisa Schwartz have argued in the Journal of the American Medical Association never should have been approved because of the drugs’ potential harms.

In sum, with tens of millions of employees subjected to these unpopular and expensive programs, it is time to reconfigure workplace wellness. Because today’s conventional programs fail to pay for themselves and confer no proven net health benefit (and may on balance hurt health through over-diagnosis and promotion of unhealthy eating patterns), conventional wellness programs may fail the Americans with Disabilities Act’s “business necessity” standard if the financial forfeiture for non-participants is deemed coercive, as is alleged in employee lawsuits against three companies, including Honeywell.

Especially in light of these lawsuits, a viable course of action — which is also the economically preferable solution for most companies and won’t harm employee health — is simply to pause, demand that vendors and consultants answer open questions about their programs and await more guidance from the administration. A standard that “wellness shall do no harm,” by being in compliance with the USPSTF (as well as the preponderance of the literature where the USPSTF is silent), would be a good starting point.