Archive for January, 2013

Myths, Presumptions and Facts About Obesity

January 31st, 2013

David Allison and 19 prestigious researchers have published an article in the New England Journal of Medicine on the Myths, Presumptions and Facts About Obesity. The myths they identify as being widely held are:

  1. Small, sustained changes in energy intake or expenditure will produce large, long-term weight changes.

  2. Setting realistic goals for weight loss is important, because otherwise patients will become frustrated and lose less weight.

  3. Large, rapid weight loss is associated with poorer long-term weight-loss outcomes, as compared with slow, gradual weight loss.

  4. It is important to assess the stage of change or diet in order to help patients who request weight-loss treatments.

  5. Physical education classes, in their current form, play an important role in reducing or preventing childhood obesity.

  6. Breast-feeding is protective against obesity.  (See my recent post on breastfeeding and obesity.)

  7. A bout of sexual activity burns 100 to 300 kcal for each participant.

They go on to identify six presumptions, which are widely accepted beliefs that have neither been proved nor disproved, so that we may move forward to collect solid data to support or refute them.

  1. Regularly eating (versus skipping) breakfast is protective against obesity.

  2. Early childhood is the period in which we learn exercise and eating habits that influence our weight throughout life.

  3. Eating more fruits and vegetables will result in weight loss or less weight gain, regardless of whether any other changes to one’s behavior or environment are made.

  4. Weight cycling (i.e. yo-yo dieting is associated with increased mortality.

  5. Snacking contributes to weight gain and obesity.

  6. The built environment, in terms of sidewalk and park availability, influences the incidence or prevalence of obesity.

They authors posit nine facts that we do know about obesity. The first two are:

  1. Although genetics plays a role, heritability is not destiny.

  2. Diets reduce weight but trying to go on a diet o recommending someone go on a diet generally does not work well in the long-term.

The remaining facts address specific tools: physical activity, maintenance, parent-child interventions, meal replacements, pharmacology and bariatric surgery.

An excellent discussion of the myth around how many calories does it take to make one overweight is the blog from Arya Sharma.

The article does not discuss a couple of observations. First, the media is a powerful tool in perpetuating many of these myths and presumptions. Second, policy-makers, especially at the federal level, repeat these myths when they know, or should know better. Third, it may be that our brains do not do a good job in analyzing data to overcome assumptions and stereotypical views.

We will have more on the myths and presumptions and role in policy-making in the days ahead.

 

Research Flaws and Poor Outcomes for Employer Weight Wellness Programs

January 30th, 2013

One of the criteria for a mandatory health contingent wellness program is that it “must be reasonably designed to promote health or prevent disease. For this purpose, it must have a reasonable chance of improving health or preventing disease, not be overly burdensome, not be a subterfuge for discriminating based on a health factor and not be highly suspect in method.”

It would be one thing if there were evidence that employer ‘wellness’ programs for weight management had a “reasonable chance of improving health or preventing disease”.  They do not.

Methodological Flaws

Financial incentives for weight loss have been studied for 30 years. Independent reviewers of the literature have found methodological flaws in many studies, including small sample size, few with a randomized controlled trial design, do not report attrition, short follow-up periods, selection bias, and publication bias. Furthermore, studies have not clearly distinguished voluntary, participatory programs and mandatory health-contingent wellness plans.

According to a recent posting, “The studies proclaiming wellness program success are subject to more than the usual set of limitations, because by definition there is no “intent to treat” control. Almost invariably, all voluntary participants are in one group and those who didn’t want to participate compromise the control, or else the control is a passive matched control on paper, with no indication of whether the control group consists largely of motivated or unmotivated people. In both cases, only motivated participants are included in the study group. This limitation is especially problematic in wellness, because, unlike a drug trial, motivation is by far the most important factor in success in wellness, which is basically an incentivized self-help program.  This critical flaw in the analytic framework produces the anomaly that virtually every desirable wellness outcome is found in voluntary participants only. This aberration permeates not only the peer-review literature, but also the claims made generally by wellness vendors and their corporate customers.” Health Affairs Blog, Al Lewis and Vik Khanna, Is It Time to Re-Examine Workplace Wellness ‘Get Well Quick Schemes, http://healthaffairs.org/blog/author/kellerman/ Jan. 16, 2013.

So, we cannot assume that marginally positive outcomes from studies in voluntary, participatory plans can be applied to mandatory, health-contingent plans.

Outcomes by systematic reviews, meta-analyses, selected studies

  • A review of worksite wellness programs by Rand researchers reported on 12 of 33 studies which evaluated physiological markers such as Body Mass Index, cholesterol levels, and blood pressure. Six of these found improvements in 1 or more outcomes, including BMI or weight, diastolic blood pressure and body fat mass. Effects included decreases in BMI by 0.04 kg/m2 among program participants, 4.3% reduction in BMI, and a 1% reduction of diastolic blood pressure. Of these 6 studies, 3 used a randomized clinical trial (RCT) design and 3 used a non-experimental comparison group or an observational design. None of the RCT studies showing a positive effect had a sample size larger than 100. Of the 6 studies not reporting a positive impact, 3 were RCTs and 3 were observational studies. The authors state, “While most studies found improved outcomes, our results confirm the concern that programs are often not evaluated with strong research designs. When evaluations use observational designs, positive effects were found for three-fourths of the outcomes, whereas positive effects were found for only about half of the outcome evaluated with RCTs. Without an RCT design a causal effect between the programs and outcome cannot be drawn reliably, and nonexperimental designs are more prone to selection bias. Additional limitations of these studies include small sample sizes and short follow-up periods. Only 2 studies had more than 120,000 participants, while others had as few as 50 to 200 participants. Follow-up was 2 years or less for 70% of the studies, and studies with shorter follow-up tended to show more positive results…Use of self-reported findings in 21 of the 33 studies may also impact the validity, especially if participants were aware of program assignment. Typical incentive amounts were small and below the level authorized by the HIPAA Nondiscrimination Requirements. Osilla KC, et al Systematic Review of the Impact of worksite wellness programs. Am J Manag Care 2012 Feb 1:18(2); e68-81.

    • A paper released by the Department of Labor with the proposed regulations assessed wellness marketplace focusing on diet, “Diet was another commonly targeted health behavior. Twelve studies evaluated diet, and six (50%) found significant improvements including higher fruit and vegetable consumption and lower fat and energy intake. Programs consisted of group- and individual-level counseling, web-based self-help programs, and access to farmers markets and health expos. Overall, effects were typically small to moderate, such as consumption of an average of 0.2 fewer fast food meals per week, reduction of fat intake by 3 grams (from 51 to 48.1 grams) per day, or an increase of 0.7 servings (from 2.9 to 3.6 servings) of fruits and vegetables per day.” Regarding physiological markers such as BMI, the authors found, “Programs were multifaceted offering virtual support for activity logging, telephone support from health professionals, and health education materials…Six of these studies found beneficial effects in one or more outcomes, including BMI or weight, diastolic blood pressure, and body fat. Three studies found that participants showed a modest decrease in weight of 0.8 kg or BMI of 0.14kg/m2, while nonparticipants showed slight increase in weight of 0.6kg and BMI or 0.42kg/m2. Though the magnitude between the groups is small, wellness programs may help reverse weight gain over time.” The study noted returns on investment of workplace programs have been declining from around 6 to 1 in a 2005 study to around 3.1 today. “In any case, the expectations of very high cost savings may not materialize.” Mattke S, Schnyer C, Van Busum KR, A Review of the U.S. Workplace Wellness Market. Click here.

  • A 2011 meta-analysis of workplace physical activity and dietary behavior looked at weight outcomes in 22 studies. They found that the majority of studies had only fair or poor quality. They found that there was moderate quality evidence of physical activity and dietary behavior interventions resulting in only a loss of 1.9 kg. They found moderate quality evidence that such interventions reduced BMI by only 0.34 kg/m2. Verweij LM, Coffeng J, van Mechelen W, Proper KI, Meta-analysis of workplace physical activity and dietary behavior interventions on weigh outcomes. Obes Reviews 2011;12:406-429.

  • A 2009 study analyzed data on 2,407 employees in 17 worksites who participated in a year-long worksite health promotion program that offered financial rewards for weight loss. In some cases, employees posted a bond that would be refunded at year’s end conditional on achieving certain weight loss goals. Others received no financial incentives at all and served as a control group. The investigators found that weight loss is modest; at one year is averages 1.4 pounds for those paid steady quarterly rewards and 3.6 pounds for those who posted a refundable bond. Year-end attrition was as high as 76.4%, far higher than that for other weight loss interventions, such as drug studies. Even those in the control group which received $20 a quarter for just being weighed had a drop-out rate of 48% by the last quarter. The average weight loss in the standard incentives group was 2.2 pounds. There were some impressive success stories of significant weight loss and there were also instances of weight gain in the program. Interestingly, there was a greater percentage of the control group reaching 5% weight loss than in the standard incentives group. The percentage for reaching 10% weight loss was similar (around 2.5%) for the control group, standard intervention and the modified incentives group. NIH considers a loss of 10% of baseline weight in 6 months to one year to be good progress for obese individuals.

Cawley, J, Price JA, Outcomes in a Program that Offers Financial Rewards for Weight Loss, NBER Working Paper No. 14987, May 2009.

  • A recent study from Germany did find significant weight loss, 2.6% and 2.9% higher in  the intervention groups compared to controls. The incentivized group reached 5% weight loss. However, as with many such studies, the study period was too short to capture the probability of regain. Augurszky, B, et al, Does Money Burn Fat? Evidence from a Randomized Experiment, IZA, Sept. 2012. (Germany)

So, contrary to the preamble’s language that insufficient evidence exists to justify the regulation, the fact is that there are numerous studies, systematic reviews and meta-analysis to indicate that these programs do not work to produce anything other than very small, clinically insignificant amounts of weight loss.

Furthermore, financial incentives may have adverse effects. In one study, financial incentives were contingent upon meeting behavioral goals for 3 weeks and became contingent upon merely providing data during the 4-5 month maintenance period. Financial motivation predicted a steeper rate of weight regain during the maintenance period. Financial motivation and gender reacted significantly; men had a more deleterious influence from financial motivation than women. Moller AC, McFadden HG, Hedeker D, Spring B, Financial Motivation Undermines Maintenance in an Intensive Diet and Activity Intervention, J of Obesity, 2012;2012:740519.

 

Employer Wellness Incentives Questionable Origin

January 30th, 2013

The provision of the Affordable Care Act expanding the amount of the incentive/penalty in mandated health-contingent wellness plans was put forward by Senate Republicans at the urging of Safeway CEO Steve Burd during the 2009 debate over health care reform. Burd launched a whirlwind lobbying campaign claiming great improvements in employee health and lower costs for the company. President Obama embraced the proposal. The Safeway plan, called Healthy Measures, gives employees reduction in their insurance premiums if they are, and stay, within certain limits on four medical risk factors: smoking, obesity, blood pressure and cholesterol. Rebates for achieving the goals total nearly $800 for an employee or $1,600 for a family. People who test within the limits get lower health premiums at the outset of the year. An employee who fails the obesity test can get a retroactive payment if he or she loses 10% of his or her body weight by the end of the year. But if the person’s BMI is still over 30 at the beginning of the following year, the payment is withheld until the employee reaches the permanent goal of under a BMI of 30. (See, Bensinger Gail, Corporate Wellness, Safeway style,  accessed Jan. 29, 2013)

The lobbying campaign has been controversial. In a story titled,Misleading Claims About Safeway Wellness Incentives Shape health-care Bill,” David S. Hilzenrath of the Washington Post, wrote,

It’s a seductively simple solution to rising health care costs. Require workers to pay higher premiums if they flunk tests for measures such as weight, blood pressure and cholesterol. Then, bingo: You not only get a fitter workforce, you slash medical expenses.

Politicians of both parties have embraced that idea and expanded upon in the Senate reform bil, inspired largely by the claims of Steven A. Burd, Safeway’s chief executive. Burd says he as set an example for employers nationwide by rewarding employees for healthy behavior. “Safeway designed just such a plan in 2005 and has made continuous improvements each year,” Burd wrote in the Wall Street Journal. “The results have been remarkable,” he declared, adding that “our health care costs for four years have been constant.”

If only that were true.

In a legislative debate filled with misconceptions, few rival the myth about Safeway, which has become the poster company for a provision that big employers and insurers covet. The supermarket chain’s story show how the untested claims of interest groups can take on a life of their own and shape national policy.

As the House and Senate work to meld their bills, the Senate’s “Safeway Amendment,” which would more than double the potential rewards and penalties tied to wellness tests, has become a point of contention. Business groups have pushed for the increase, arguing that financial incentives encourage workers to take responsibility for their health. Opponents such as the American Heart Association and the American Cancer Society say the provision would undo a central element of reform – the promise that people’s premiums would no longer be influenced by their health status.

Rewarding or penalizing people based on wellness tests may save money over the long run, but Safeway hasn’t proved it. In the meantime, based on 2009 data, if the Safeway Amendment becomes law, American families with average health benefits could have $6,688 a year riding on blood tests and weigh-ins.

But a review of Safeway documents and interviews with company officials show that the company did not keep health-care cost flat for four years. The costs did drop in 2006 – by 12.5 percent. That was when the company overhauled its benefits, according to Safeway Senior Vice President Ken Shachmut. The decline did not have anything to do with tying employees to test results. That element of Safeway’s benefits plan was not implemented until 2009, Shachmut said.

After the 2006 drop, costs resumed their climb, he said…

Today costs are slightly higher than in 2005, Shachmut said.

So, when Safeway said it had flatlined costs since 2005, “we defined that, you might say, loosely,” he said. “Perhaps a more precise way to say it is that our costs today on a per capita basis are essentially the same as they were in 2005.”…

Burd’s assertions about the program’s success made him a rock star on Capitol Hill. He pressed his case in briefings for Senate Democrats and Republicans and in a May meeting with President Obama. Leading policymakers have cited Safeway as a model…

Obama has repeatedly invoked Safeway’s approach. “It’s a program that has helped Safeway cut health-care spending by 13% and workers save over 20% on their premiums,” he said in a June speech to the American Medical Association. “And we are open to doing more to help employers adopt and expand programs like this one.”

When Obama delivered those remarks, the program was less than six months old, and by Safeway’s own analysis the spending in question was on the upswing…

Safeway’s expanded incentives are rooted in a philosophy. “I have no problem with a smoker having a 10-pack-a-day habit an killing him or herself,” Shachmut said. “I mean, it’s a personal choice. It’s a free country. I just don’t want to have to pay the health-care costs of that personal choice.” (Editor’s note: This philosophy might be better grounded if the employer did not set the wages of the individual who is obese or smokes lower than peers in anticipation of extra health care costs. See these comments.)

In accessing the economic impact of incentives, it might be helpful to know who health-care expenses for employees in the voluntary Healthy Measures program with those for the rest of the Safeway workforce. Shachmut declined to provide such information. “We frankly haven’t been disclosing that,” he said. “And I would just prefer not to.” Pressed further, he said the data would not be available until April (2010) or later – long after Congress and the president aim to enact a health-care bill.” Hilzenrath D. Misleading Claims About Safeway Wellness Incentives Shape health-care Bill,” David S. Hilzenrath Washington Post, January  17,2010, accessed Jan. 30, 2013. (Hilzenrath is now editor in chief of the Project on Government Oversight, www.Pogo.org.)

 

House Democrats Call On Administration to Dump Employer Wellness Regs

January 28th, 2013

Sam Baker of The Hill paper reports today that ranking Democrats on health committees in the House of Representatives have called on the Department of Health and Human Services to withdraw the proposed regulations on mandatory health-contingent wellness programs, as I did in my comments.

Proposed employer wellness regs. have multiple problems

January 25th, 2013

 

I just filed comments on the proposed regulations under the Affordable Care Act for employer wellness plans. Hint: I think they are terrible! Here is the summary.   Click here for the full 27 page comments: MorganDowney_Wellness Program Comments

Can Congress require you to buy broccoli? Evidently yes if Congress incentivizes employers to require it of their employees. Can Congress mandate  exercise program? Evidently yes if they incentivize your employer to require you to spend your free time in physical activity. Can Congress regulate the diet and physical activity of many if not most of its citizens indirectly through employers when it would be unconstitutional for them to do so directly? These are only some of the unanswered questions raised in the proposed regulations.

On November 20, 2012, the Department of the Treasury, Department of Labor and Department of Health and Human Services (hereinafter the “Departments”) proposed regulations, “Incentives for Nondiscriminatory Wellness Programs in Group Health Plans.”

The proposed regulations:

  1. are probably unconstitutional,
  2. undermine three explicit promises made by President Obama in relationship to the Affordable Care Act,
    1. that those in current plans will not be affected
    2. that no one will be charged more for a pre-existing condition, and,
    3. that life sciences research will be supported,
  3. impose unjustified additional costs on millions of middle class American workers without commensurate benefit, especially on working women with obesity in firms providing health insurance who already pay a “wage penalty.”
  4. ignore evidence employer weight management wellness plans produce marginal, if any, benefit,
  5. promote a model of an employer weight management program that conflicts with the Americans with Disabilities Act
  6. inadequately identify when a wellness program is a subterfuge for cost-shifting
  7. recognize that employer wellness programs are human experiments but do not minimum protections for animals, much less human subjects
  8. undermine federal, state and local law enforcement efforts to police weight loss frauds and scams including those of the Federal Trade Commission,
  9. have inadequate provisions for reasonable alternatives,

The regulations should be withdrawn until these major issues can be resolved.

The proposed regulations address wellness programs in group health coverage under the Affordable Care Act (ACA). The regulations provide the maximum reward permissible under a health-contingent wellness program offered in connection with a group plan, raising the maximum from 20% to 30% of the cost of health insurance coverage. (A 50% maximum would be available for programs designed to reduce tobacco use.)  The regulations clarify the definition of a “reasonable design of health-contingent wellness programs” and the reasonable alternatives that must be provided in order to avoid prohibited discrimination. These clarifications are problematic.

Prior to the enactment of the Affordable Care Act (ACA), federal law (i.e. the Health Insurance Portability Accessibility Act or HIPAA) prohibited group health plans and group health insurance issuers from discriminating against individual participants and beneficiaries in eligibility, benefits or premiums based on a health factor.  Employers are banned from varying health insurance premiums on the basis of health status. HIPPA provides an exception for premium discounts, rebates, etc. in return for participation in health promotion and disease prevention programs.

Regulations implementing HIPPA provided for two types of programs. The first are called “participatory wellness programs” in which participation is voluntary and either provides no rewards or does not provide criteria for receiving an award. The second type of program is quite different. It is called a “health-contingent wellness program” which requires an employee to attain or maintain a certain health outcome in order to obtain a reward, such as meeting a specific weight or Body Mass Index (BMI), a blood pressure measure, or other physiological metric. While the regulations avoid using the term “mandates” or “mandatory,”  that is what they are and that is what the regulatory scheme assumes. Such programs are mandatory for all employees, although the proposed regulations provide for person-by-person or a group of employees exemptions and for alternatives. Mandatory health-contingent wellness programs were not described in the original HIPAA legislation. These mandatory health-contingent wellness programs must be of “reasonable design” and a “reasonable alternative” ways to avoid the penalty.

The ACA amended federal law to raise the maximum penalty from 20% to 30% (and 50% for tobacco use cessation programs) of the total health insurance premium for the employee.  The following comments are directed primarily at the mandatory health-contingent wellness program provisions.