Declaring obesity a disease: The good, the bad, the ugly

Reuters

An obese patient speaks with surgeon Dr. Alexandre Lesage in his office to prepare for surgery at the Saint Jean d'Angely Hospital, in Saint Jean d'Angley, southwestern France, January 24, 2013.

The AMA has declared obesity a disease. Now what?  This turns out to be far from a simple question to answer.  If we're lucky, the good news will be that the AMA announcement will result in more patients getting better care, an eventual decline in the current number-about 90 million-who are officially designated as obese and perhaps even an attendant decline in the costs imposed by obesity. The bad news is that the net effects on health spending and public health may well be the opposite of those intended. The ugly news is that these adverse effects may be greatly compounded to the extent that the AMA's declaration stimulates the same sort of regulation by litigation regime imposed on the tobacco industry two decades ago.

It's worth noting that the vote by the A.M.A. House of Delegates contravened the conclusions of the AMA's own Council on Science and Public Health, which had been tasked to study the issue this past year. Admittedly, the council rested its decision principally on the concern that the measure usually used to define obesity (BMI, body mass index) is simplistic and flawed. In contrast, an expert panel commissioned by The Obesity Society in 2008 likewise had recognized the flaws in the BMI measure, but finessed similar concerns by simply defining obesity as an excess of body fat sufficiently large to cause reduced health or longevity. That same expert panel concluded that the question of whether obesity is a disease is ill posed and does not admit an answer from a scientific perspective due to the lack of a clear, specific, widely accepted and scientifically applicable definition of "disease." Instead, they answered the question of "should we consider obesity a disease" largely on utilitarian grounds that the social benefits of doing so will outweigh the costs.

To help clarify the issues at stake, let us use the same standard to evaluate whether the benefits of the AMA's declaration of obesity as a disease will outweigh its potential costs.

The Good: Focusing Attention and Resources on Obesity

The premise of the AMA declaration is that it will focus more attention on obesity; this could increase the amount of research dollars allocated towards obesity, expand obesity-related public health initiatives, and help improve reimbursement and services for obesity counseling and education, drugs, and surgery. From where I sit, all these effects are likely to be modest to negligible.

Obesity-Related Research Funding. First, it's not clear that research funding priorities are going to change much given how late the AMA is to the party. After all, treatment guidelines for obesity issued by the National Heart, Lung, and Blood Institute declared nearly two decades ago (1995) that "obesity is a complex multifactorial chronic disease developing from multiple interactive influences of numerous factors." Moreover, a decade earlier (1985), "an NIH Consensus Development Conference was held on the health implications of obesity. This conference provided important national recognition that obesity is a serious health condition that leads to increased morbidity and mortality. The Consensus Development Conference concluded that both prevention and treatment of obesity were medical priorities in the United States." By FY 2010, NIH was plowing nearly a billion dollars annually into obesity research and a new Strategic Plan for NIH Obesity Research, published in 2011, was issued to accelerate a broad spectrum of research toward developing new and more effective approaches to address the tremendous burden of obesity. Today, NIH offers nearly 50 different research funding solicitations related to obesity research: in fact, there are hundreds of NIH-funded clinical research studies on obesity and weight management currently being conducted around the country. Consequently, it is dubious that the AMA's recent declaration is going to appreciably alter this picture since the importance of obesity and research dollars allocated to it already are quite high.

Obesity-Related Public Health Initiatives. The same can be said for the impact of the AMA's decision as it relates to public health. The public health community recognized decades ago that obesity was a major factor contributing each year to huge numbers of premature deaths and avoidable costs. A plethora of public health initiatives to address this problem has ensued in recent years:

  • For 3 decades, the Public Health Service's Healthy Peoplereports has established science-based, 10-year national objectives for improving the health of all Americans and monitored progress against these quantitative benchmarks over time.
    • For example, the 2000 report (issued in 1990) called for reducing overweight prevalence among adults to no more than 20% and among children to no more than 15%.
    • The 2020 report (issued in 2010) calls for a 10% reduction in the percentage of adults who are obese.
    • Apart from setting outcome goals, the 2020 report also includes concrete process goals for achieving these outcomes, such as increasing by 10% the proportion of physician office visits made by adult patients who are obese that include counseling or education related to weight reduction, nutrition, or physical activity.
  • The 2001 Surgeon General's Call to Action on Prevent and Decrease Overweight and Obesity was released in the face of finding that each year, 300,000 premature deaths and $117 billion in direct and indirect costs were attributable to overweight and obesity.
  • In February 2009, the First Lady of the United States, Michelle Obama, announced an ambitious national goal of solving the challenge of childhood obesity within a generation, and has established the "Let's Move" initiative designed to engages every sector of society that impacts children.
  • As part of this effort, President Obama signed a Presidential Memorandum that created the Task Force on Childhood Obesity that reviewed all programs and policies related to child nutrition and physical activity and developed a national action plan to maximize Federal resources and set concrete benchmarks toward the First Lady's national goal.
  • The Office of the HHS Secretary established the Healthy Weight Taskforce to ensure that there is communication and coordination across agencies regarding the many initiatives related to obesity.
  • The Agency for Healthcare Research and Quality has identified obesity related interventions on its innovations website.

Obesity Counseling and Education. In the context of the foregoing, it's disappointing that only 28.9 percent of physician office visits of adult patients who are obese included counseling or education related to weight reduction, nutrition, or physical activity in 2007. Admittedly, things may well be very different today since in 2012, the U.S. Preventive Services Task Force (USPSTF) first began to recommend "screening all adults for obesity. Clinicians should offer or refer patients with a body mass index (BMI) of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions." Similarly, since 2010, the USPSTF has recommended "that clinicians screen children aged 6 years and older for obesity and offer them or refer them to comprehensive, intensive behavioral interventions to promote improvement in weight status." As well, under USPSTF guidelines, children may receive Body Mass Index measurements at five different ages between birth and 18. Because both recommendations have been given a USPSTF grade of B, they are automatically covered as preventive health services with no cost sharing under the Affordable Care Act. This means that reimbursement for screening and counseling services already were going to be more than adequately covered under the ACA. The AMA decision will not change any of that.

Obesity Treatment. But what about treatment for obesity?  There's two issues. First, the FDA already has begun approving pharmaceutical treatments for obesity, including Qsymia and Belviq approved in the past year.  Similarly, FDA regulations for dietary supplements already recognize obesity as a disease and preclude manufacturers from making claims that their products treat obesity (they are permitted to claim products cause weight loss or eliminates risk of weight gain since such claims are structure/function claims. So once again, I don't picture the AMA decision having any influence on what the FDA already is doing. Likewise, the IRS recognized obesity as a disease more than a decade ago, meaning that taxpayers can claim weight loss expenses as a medical deduction so long as they are participate in a weight-loss program for medically valid reasons (i.e., under a doctor's supervision). That said, insurance coverage for obesity treatment varies substantially depending on what kind of coverage you have.

Medicaid Coverage for Obesity-Related Services. For children under age 21 enrolled in Medicaid, the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit already covers all medically necessary services which can include obesity-related services. For adults, states elect which services to provide; in a 2010 report to Congress, Secretary Sebelius reported that all State Medicaid programs covered at least one obesity treatment modality for adults (the experts who conducted this survey assessed coverage for three obesity treatments: nutritional consultation, drug therapy, and bariatric surgery). The survey further found that eight States (DE, IA, IN, LA, MI, SC, VA, and WI) covered all three recommended treatments. As well, the ACA provides for states to design public awareness campaigns to educate Medicaid enrollees on the availability and coverage of obesity and preventive services.

In light of the extreme funding pressures states will be under to bankroll the expected enrollment of currently eligible-but-not-enrolled beneficiaries[2], any expansion in adult obesity treatment will be driven far more by fiscal constraints than the change in the AMA's posture towards obesity. Proof of this is found in how EPSDT benefits have been handled over the years. EPSDT was enacted in 1967 to ensure adequate screening services for children, but it was not until 2004 that the Centers for Medicaid and Medicare services deleted language in the official Coverage Issues Manual that explicitly stated obesity was not a disease. While this technically opened the door for reimbursement for obesity screening, as of 2010 only four states included treatment standards for childhood obesity in their Medicaid child health provider manuals and only nine states included details on how to assess for obesity. Consequently, reportedly, "the billing incentive to screen for childhood obesity remains relatively unknown."[3] In short, even though federal rules have permitted states to include obesity coverage for nearly a decade, states have not necessarily leaped to make this happen. It seems dubious to this skeptic that states have been waiting for the AMA to weigh in before making a move.

Medicare Coverage for Obesity-Related Services. Likewise, Medicare already covers a) an initial assessment of eating and activity habits; b) counseling on diet and physical activity; c) education on how to improve diet and changes that will help beneficiaries lose weight and improve health; and d) follow-up visits to monitor your diet and weight loss progress. In short, the prevention/counseling piece of the puzzle. As for treatment, Medicare will cover certain weight loss services and programs a) when weight loss is a necessary part of treatment for diseases such as hypothyroidism, Cushing's disease, hypothalamic lesions, cardiovascular diseases, respiratory diseases, diabetes, and hypertension (and others); or b) before surgery, when the weight loss is necessary to reduce possible complications posed by obesity. However, to ensure that these benefits are not misused, Medicare requires the physician to end the program if a patient does not lose 6.6 lbs. after 6 months of counseling. As well, Medicare already covers bariatric surgery but only for those who meet very stringent criteria.[1]

The glaring exception is that Part D of Medicare specifically excludes drugs for weight loss or gain, even if used for non-cosmetic purposes, such as to treat morbid obesity. The reason is that when Part D was enacted, there were no widely‐accepted, FDA‐approved obesity drugs on the market. However, in recognition of the recent FDA approvals of Osymia and Belviq, on June 19, several House members introduced a bipartisan, bicameral bill to lift the ban on obesity drug reimbursement under Medicare and encourage intensive behavioral counseling. However, if a patient doesn't respond to drug therapy by losing 5% of their weight within 12 weeks-i.e., 11 pounds for a typical mildly obese male-product labeling directs that the patient be taken off the drug (i.e., it would no longer qualify for Medicare reimbursement on "medical necessity" grounds).

Private Health Insurance Coverage for Obesity-Related Medical Services. Only a handful of states require coverage for obesity-related counseling or treatment (including surgery) in the individual and small group market. A larger number permit obesity to be included as a factor in setting premiums (something the Affordable Care Act prohibits) or allow health plans to offer financial incentives up to a limit (e.g., 5% of premiums) to encourage people to voluntarily enroll in wellness programs that could include obesity counseling etc. Since insurers recognized long ago that obesity increases the costs of health coverage (more below), they are rationally receptive to paying for services expected to pay for themselves. However, as we will see, whether obesity-related medical services meet that test is at least an open question.
The Bad: Higher Costs and Worse Health Outcomes

Why Obesity Treatment is Unlikely to Reduce Health Spending. There's no doubt that obesity is an expensive medical condition. Obesity adds 9.1% to the nation's personal health spending, or about $222 billion in 2013; this varies by payer, with obesity accounting for 8.5% of Medicaid spending, 11.8% of Medicaid spending and 12.9% of private health insurance spending.

On a per capita basis, the most severely obese individuals have medical expenses that may be thousands of dollars more a year than their counterparts of normal weight (see figure). As a rough approximation, each pound of extra weight adds anywhere from $6 to $13 a year in added medical spending among men who are working and about -$5 to $45 among working women, depending on whether one is moving from being overweight to slightly obese or from slightly obese to moderately obese etc.

These figures allow us to do a very crude estimate of the extent to which obesity-related treatments may potentially be cost saving from the perspective of the medical care system. The USPSTF found that "behaviorally based treatment resulted in 3-kg (6.6-lb) greater weight loss in intervention than control participants after 12 to 18 months," i.e., roughly a 4% weight reduction.  Thus, such a reduction in weight would save $40 to $90 in annual medical costs for men and cost $33 more to saving about $300 a year for women. The intensive weight management control programs it recommends entail include 12 to 26 group and/or individual sessions in the first year alone.  It is difficult to picture the tab for such intensive therapy falling below $300.

Similarly, the drug Qsymia achieves weight loss of 22-28 pounds after 1 year-a benefit whose medical savings will amount to at most $364 for men (i.e., $13 x 28) and $1260 for women, but the drug costs $160 per month ($1920 per year).  Moreover, as a decade-old study for the USPSTF reported, "weight maintenance trials suggest that prolonged therapy with these drugs confers some benefit, but that its discontinuation may lead to rapid weight regain." Thus, if obesity is a chronic disease requiring extended or even lifetime maintenance, the prospects for net medical cost savings seem dismal indeed.  Admittedly, there is evidence that bariatric surgery may be cost-saving but a) such evidence is mixed; and b) such extreme surgical options are appropriate only for the very obese, i.e., the 5 percent and 6 percent of U.S. adults with a BMI of 35 or greater. Laparoscopic gastric banding has been found to be cost-effective (adding years of life at a reasonable cost), but not actually cost-saving.

These qualitative findings mirror those of a 2004 systematic review of the literature on the long-term effects and economic consequences of treatments for obesity: while a very small number of studies show that obesity treatment can reduce health spending, most studies instead show that obesity treatment is cost-effective rather than cost-saving. That is, it adds years to life relatively inexpensively compared to other medical interventions. That is surely good news, but we should not delude ourselves that such gains are self-financing.

How the AMA Decision Could Worsen Health Outcomes. Recall that the AMA House of Delegates overrode the conclusions of the expert panel that AMA had tasked to study this issue. The Council concluded: "Given the existing limitations of B.M.I. to diagnose obesity in clinical practice, it is unclear that recognizing obesity as a disease, as opposed to a ‘condition' or ‘disorder,' will result in improved health outcomes." More specifically, the Council was concerned that "medicalizing" obesity by declaring it a disease could lead to more reliance on costly drugs and surgery rather than lifestyle changes. Or as one skeptic trenchantly put it "calling obesity a disease gives a hall pass to many who either don't care or who struggle with their food and lifestyle choices. It could cause even more of them to backslide into obesity."  Conversely, some people might be overtreated because their B.M.I. was above a line designating them as having a disease, even though they were healthy, another factor that would call into question the cost-saving potential of expanded obesity treatment.[4]

There is some evidence that obese white women incur a wage penalty compared to their normal weight counterparts: all other things equal, a woman who is 65 pounds heavier can be expected to be paid 9 percent less in wages. Another study finds that this wage penalty is experienced by all women, not just white women; moreover, the penalty appears to be concentrated in firms that offer health coverage, suggesting that lower wages are an offset for the higher costs of health coverage for such workers. That said, there is no evidence of wage adjustments for obese men, but this may be because the medical costs for obese men are not that much higher than for their non-obese counterparts. Moreover, unions, contracts, minimum wage laws, and the threat of litigation and public backlash may make it difficult for employers to fully adjust wages to offset the costs of obesity, meaning that at least some of the costs of obesity are borne by employers rather than obese workers. If so, employers may become more reluctant to hire obese workers, especially once coverage is mandated under the Affordable Care Act.

Currently, employers are not barred from discriminating on the basis of weight by the Americans with Disabilities Act, but that obviously could change in the future. The AMA decision arguably could lead to exactly such a policy change. But this also could be a mixed blessing, since pulling obesity under the ADA umbrella may also preclude employers from offering financial incentives tied to measures of obesity, including weight or BMI to those who move toward or maintain an ideal weight (even though there is evidence that such programs may be effective). It may even get in the way of employers collecting data on BMI for purposes of improving individual employee health or assessing the effectiveness of various wellness initiatives.

The Ugly: Letting the Lawyers Loose

One final concern is that the AMA decision will provide a lever to the legal community and activists to attack the food industry, thereby short-circuiting a more promising cooperative approach of producing foods with more nutrition and fewer calories. This post already is far too long. Those interested in this line of argument are encouraged to read an excellent treatment of this topic by fellow Forbes contributor Hank Cardello.

 

The bottom line is this. Like so many complicated health policy decisions, the AMA's decision will have both positive and negative effects. The experts the AMA assigned to actually study this issue in depth concluded that the negatives of declaring obesity a disease outweighed its benefits. I concur and hope that even readers inclined to view the AMA decision favorably might at least better understand the legitimate reasons for concern.

Upate 1: June 30

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has created on online body weight simulator as a tool for obesity researchers and weight management professionals to better understand how diet and exercise quantitatively contribute to weight loss and weight loss maintenance. The simulator demonstrates how much reduction in caloric intake is required to achieve a given weight reduction goal as well as how much reduction is required in the long-run to maintain that weight. Users can see how much difference it makes to add exercise of varying degrees of intensity to a diet program. This simulator takes into account the time required for a body to reach a new "steady state" equilibrium (typically measured in years).  A researcher who helped develop this model believes that the principal cause of the obesity epidemic was the overproduction of food in the U.S. (caloric intake per day for the average American rose by 1,000 calories between 1970 and today, whereas levels of physical activity have not changed much during the past 30 years).

Footnotes

[1] These criteria include:

  • Having a BMI of 35 or greater
  • Having at least one weight-related problem (diabetes, heart disease or sleep apnea)
  • Documented evidence (in medical records) of repeated failure to lose weight in medically supervised weight loss programs (diet, exercise programs/counseling or drug therapy)
  • Having a psychological evaluation
  • All other medical treatments have been ruled out
  • The surgery must be performed at a Medicare-approved "Center of Excellence"
  • The specific procedure used is approved by Medicare.

[2] Assuming all states opt for expansion-an unlikely prospect in the short term-the ACA makes up to 15 million individuals newly eligible for Medicaid (Table A), for which the federal government will provide enhanced matching funds (starting at 100% and gradually declining to 90% over a period of years). However, there's an additional 4.4 million individuals currently eligible who are likely to become enrolled once the exchanges and penalties for failure to have coverage become operational in 2014 (Table B). All states-even those that elect not to expand Medicaid-will be responsible for covering the costs of these newly-enrolled beneficiaries at regular federal matching rates (which vary from 50 to 76 percent).

[3] The quote is from a New York Times letter to the editor by Carol Duh-Leong published June 24, 2013, but it is based on findings regarding EPDST and the limited number of states that have operationalized obesity screening for Medicaid-eligible children that are reported in a detailed 2010 report put out by George Washington University.
[4] I have relied on the NY Times account of the Council's report since unfortunately the full report is not available at the AMA website.

 

 

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