Practical Perspectives on the Management of Overweight and Obesity

March 20, 2014
Robert S. Gregory, RPh, MS, MBA

,
Yehuda Handelsman, MD, FACP, FACE, FNLA

,
Edmund J. Pezalla, MD, MPH

,
Dan Pikelny, MA, MBA

Supplements and Featured Publications, Practical Perspectives on the Management of Overweight and Obesity, Volume 20, Issue 3 Suppl

The prevalence of obesity, defined as a body mass index of 30 or more, has reached epidemic proportions in the United States. Obesity is associated with an increased risk of multiple conditions, including type 2 diabetes mellitus, cardiovascular disease, arthritis, and sleep apnea. To discuss issues related to obesity in the workplace, healthcare, and managed care settings, stakeholders from these areas participated in a roundtable discussion on several topics, including the management of obesity, managed care coverage policies for obesity treatments, and potential strategies for improving patient outcomes. Participants agreed that obesity is a challenging condition to treat. Lifestyle modification, one of the most commonly recommended treatment modalities, is often inadequate on its own, as patients are unable to maintain weight loss over time. Although lifestyle modification remains important, additional tools are needed. In patients who undergo bariatric surgery, lifestyle modification is also necessary for long-term weight maintenance; however, surgery is not appropriate for all patients. Pharmacologic treatment may also be considered, but cost and managed care coverage policies have the potential to limit patient access to this treatment modality. Increased awareness and additional efforts on the part of all stakeholders are needed to improve outcomes for patients affected by obesity.

(Am J Manag Care. 2014;20:S64-S75)

This article is based on discussions from a recent roundtable meeting that explored the impact of obesity and related conditions in the workplace, healthcare, and managed care settings. Participating in the roundtable meeting were Edmund J. Pezalla, MD, MPH (vice president and national medical director for pharmacy policy and strategy, Aetna, Hartford, CT); Dan Pikelny, MA, MBA (director of compensation, benefits, and health, Navistar, Inc, Lisle, IL); and Yehuda Handelsman, MD, FACP, FACE, FNLA (medical director and principal investigator, Metabolic Institute of America, Tarzana, CA; and chair and program director, 12th Annual World Congress on Insulin Resistance, Universal City, CA). The panel was moderated by Robert S. Gregory, RPh, MS, MBA (president, Rx Gregory Consulting, LLC, Johns Island, SC).

A very serious obesity epidemic exists in the United States. Based on estimates from the Centers for Disease Control and Prevention, in 2007 to 2008, more than one-third of adults were obese, up from 23% in 1998 to 1994.1 Obesity is a chronic condition that has increased in prevalence over the past 30 years based on a number of factors, including increased consumption of high-calorie food, decreased physical activity, and increased sedentary behavior.2 Obesity has been associated with a number of adverse consequences including increased cardiovascular risk and reductions in quality of life. Obesity is also associated with many comorbid conditions, including gallbladder disease, hypertension, type 2 diabetes mellitus (T2DM), sleep apnea, cancer, stroke, asthma, and osteoarthritis.3 Furthermore, obese patients are at increased risk for early death4 and they incur greater healthcare expenditures than normal-weight patients.5

Obesity is associated with high direct costs. In 2008, obesity was estimated to account for $147 billion, or almost 10%, of all medical costs.6 With each 1 kg/m2 increase in body mass index (BMI) over 19 kg/m2, medical costs rise nearly 4% among males and by over 2% among females.5 It has been estimated that lost productivity associated with obesity costs approximately $11.7 billion per year.7 Obese workers are 194% more likely to use paid time off than normal-weight workers.7,8 In terms of productivity losses, it has been estimated that absenteeism accounts for $79 to $132 per obese individual per year and presenteeism (ie, attending work while sick) accounts for $350 lost per obese individual per year.7,9

Obesity is a multifactorial condition that should be viewed as a chronic disorder requiring perpetual care, support, and followup. Several organizations have declared that obesity is a disease. Most recently, the American Medical Association (AMA) has announced its recognition of obesity as a disease based on the wide-ranging effects of obesity on patient quality of life, comorbidities, and care costs. As a disease, obesity impairs normal functioning of the body, is recognized by characteristic signs or symptoms, and is associated with harm or morbidity.10 According to the AMA, "Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately 1 in 3 Americans. The AMA is committed to improving health outcomes and is working to reduce the incidence of cardiovascular disease and T2DM, which are often linked to obesity."11 It is hoped that the declaration of obesity as a disease by one of American's largest physician groups will help improve reimbursement for obesity drugs, lifestyle interventions, counseling, and surgery. Other organizations have similarly recognized the importance of obesity. In 2008, The Obesity Society (TOS) recognized obesity as a disease.12 In 2004, the Centers for Medicare & Medicaid Services (CMS) removed language in its National Coverage Determinations Manual stating that "Obesity itself cannot be considered an illness." Generally, services related to the treatment of obesity are covered by CMS when part of treatment for a medical condition; the treatment of obesity unrelated to illness is not covered.13 In 2011, CMS issued a decision memo providing for coverage of intensive behavioral therapy for obesity; the therapy is delivered by a primary care practitioner and consists of obesity screening, dietary assessment, and behavioral counseling regarding diet and exercise.14

Achieving and maintaining weight loss confers benefits to patients, managed care organizations, and employers. Successful weight loss is defined as persistent loss of at least 10% of body weight,15 but evidence shows that a reduction in body weight of as little as 5% may improve glycemic control and improve cardiovascular outcomes, with greater reductions in body weight improving outcomes even further.16

Results from major long-term studies suggest that maintaining weight loss for extended durations of time may require chronic management; these studies include the 4-year Look AHEAD trial,17 the 10-year Diabetes Prevention Program (DPP) study,18 and the 4-year WOMAN study.19 The weight losses reported during these studies ranged from 2 kg (2%) at 10 years in the DPP study18 to 3.4 kg at 4 years in the WOMAN study19 and a weight loss of 4.7% at 4 years in the Look AHEAD trial.17 In these trials, patients initially lost greater amounts of weight but were unable to maintain the weight loss over the long term. For example, the DPP study revealed that patients who practiced lifestyle interventions gradually regained 1 kg of their weight loss (patients treated with metformin maintained their modest weight loss). Results from the Look AHEAD trial also demonstrated that patients had difficulty maintaining weight loss; they regained 25% of their weight loss between the first and second year of follow-up, and 20% between years 2 and 3. In the WOMAN study, 31% of patients successfully reported weight loss at 30 months, but only 21% of patients reported successful weight loss by 48 months.17-19

An Overview of Treatment Guidelines

Currently, bariatric surgery, pharmacologic therapy, and lifestyle interventions are the mainstays of managing obesity and weight-related comorbidities. Clinical guidelines can help managed care organizations and clinicians decide when the various treatment options are appropriate. These guidelines include criteria for the initiation of treatment with lifestyle interventions, how to approach lifestyle interventions, and the use of bariatric surgery (Table 1).2,20-22

The European Society Guidelines (ESG) are not specific to obesity; rather, they suggest treating obesity as a component of cardiovascular disease prevention. Of note, the ESG stress that lifestyle interventions often fail as a long-term therapy for obesity, and consequently recommend the concomitant use of medical therapy or bariatric surgery.20 The oldest guidelines, published by the National Heart, Lung, and Blood Institute (NHLBI) in 1998, provide an algorithm for obesity management that recommends treatment based on BMI, waist circumference, and risk status (ie, presence of established coronary heart disease, other atherosclerotic disease, T2DM, and/or sleep apnea, which are classified as very high risk for further complications and mortality).21 Although the NHLBI guidelines mention the use of pharmacotherapy in certain situations, several pharmacologic agents have become available (Table 2)23-31 since these guidelines were published more than 15 years ago. Due to this, there is a need for updated guidelines that include the newer pharmacologic agents.

Most recently, the American Heart Association (AHA), American College of Cardiology (ACC), and TOS jointly published guidelines on the treatment of obesity to update the 1998 guidelines of the NHLBI. These guidelines were based on rigorous, systematic evidence-based reviews conducted in response to critical questions about how weight loss affected morbidity and mortality, including the association between BMI and risk or overall mortality; the impact of dieting strategies and lifestyle interventions; and the efficacy of bariatric surgery. The AHA/ACC/TOS guidelines provide a comprehensive algorithm for the treatment of obesity based on a rigorous review of the aforementioned topics, despite the fact that they did not review the evidence for weight loss with pharmacotherapy treatment.2 Other guidelines come from the American Association of Clinical Endocrinologists (AACE) along with TOS and the American Society for Metabolic and Bariatric Surgery (ASMBS), which published recommendations for bariatric surgery. Its surgical guidelines offer comprehensive advice about appropriate candidate selection, preoperative care, procedure type, and follow-up care, among other topics.22

Mechanick and colleagues from the AACE have published a 4-part position statement that describes novel strategies to combat obesity as a disease. This position statement is a multi-tiered approach to improving the care of patients with obesity that involves improvements in medical education regarding obesity and suggestions for medical certifications in obesity, collaboration among professional societies, and advocacy for promoting anti-obesity strategies. Improvements in medical education would allow for the development of undergraduate, graduate, and continuing medical education modules customized to teach about the hormonal and metabolic processes intrinsic to the development of obesity rather than relying on traditional obesity training that only occurs during instruction regarding related conditions such as T2DM, hypertension, and cardiovascular disease. The certification component of the algorithm looks to incorporate a clinical certification of endocrinologists for the long-term care of obese patients. Considering the number of stakeholders in obesity medicine, the AACE hopes to work as an integral member of a multidisciplinary team that includes general internists, family medicine specialists, bariatric and metabolic surgeons, gastroenterologists, cardiologists, and others to optimize care. It is hoped that greater advocacy will also help to increase the recognition of the obesity epidemic and prompt an improvement in healthcare policy and the creation of more effective anti-obesity legislation.10

At this time, federal legislation mandated by the Affordable Care Act (ACA) allows for states to determine healthcare policy for obesity treatment. It is expected that 23 states will provide coverage for obesity treatment including metabolic or bariatric surgery as part of Essential Health Benefits (EHBs), whereas 5 states will also cover weight loss programs.32 The ACA provisions have mandated that state health exchanges provide coverage for certain services listed as EHBs, which include ambulatory patient services, prescription drug coverage, and chronic disease management. In states that exclude metabolic treatment or bariatric surgery in their exchanges, the ACA calls for mandatory obesity screening and counseling. Furthermore, beginning in 2014, all private insurance companies must cover intensive behavioral counseling.33

With the passage of the ACA, and the renewed emphasis on outcome-based reimbursement, employers and managed care organizations are placing more emphasis on reducing the long-term costs of management for patients. Clinicians, who are concerned with quality of care as well as patient wellbeing and quality of life, are interested in helping patients achieve a healthy weight and reducing the burden of the conditions associated with obesity. The successful management of obesity depends on a team approach that includes all stakeholders.

Defining the Roles of Managed Care Organizations and Employers

Reducing the burden of obesity through the appropriate utilization of available weight loss treatment modalities may help managed care organizations and employers decrease the incidence of obesity-related diseases, improve patient quality of life, and improve the productivity of employees while potentially reducing costs. Managed care professionals and employers are beginning to capitalize on opportunities to reduce the burden of obesity through the implementation of programs designed to improve outcomes in patients undergoing obesity management therapy.34 One such strategy may be the offering of financial incentives in exchange for weight loss. A recent study conducted at the University of Michigan health system evaluated the impact of financial incentives offered to members of a commercial insurance product called Healthy Blue Living who partici- pated in a weight management program (Weight Watchers, the University of Michigan Weight Management Program [WMP], or WalkingSpree, a commercial pedometer-based walking program). The results showed that clinical outcomes, including BMI and associated risk factors, improved over the course of 12 months. In the WMP group, BMI decreased from 40.4 to 36.2 kg/m2, and glycated hemoglobin decreased from 6.9% to 6.3%. Cost analyses from the same study revealed that per member per month costs ranged from $20 to $62, depending on the weight management program chosen, compared with $106 for members who did not enroll in any program.35 However, the weight loss benefits of such incentives might be limited in duration. A study of 66 obese patients in an outpatient hospital setting who participated in an 8-month study conducted to determine if financial incentives for weight loss could lead to long-term weight loss and maintenance reported that the use of a deposit contract was associated with weight loss for 32 weeks but weight was regained following the cessation of the incentives, suggesting that future research is needed regarding longer-term solutions.36

Employers may influence their employees to lose weight using a number of strategies. Suggested approaches include lowering insurance premiums in exchange for participating in specific health-related activities or meeting fitness goals, providing environmental support such as healthy onsite dining and walking paths, and arranging for employee education about the importance of healthy lifestyles and suggestions for maintaining such lifestyles.37 Other obesity-related benefits include discounted fees for health club memberships, on-site exercise facilities, classes in nutrition, and weight loss programs.38

Reimbursements for weight loss programs are likely to increase utilization, as patients are probably more likely to engage in services that are affordable compared with more expensive services or treatments. At this time, only a handful of states require private health insurance companies to provide coverage for obesity counseling, treatment, and surgery.39

Leveraging the Relationship Between Healthcare Professionals and Patients to Improve Outcomes

Together as a team, clinicians and patients can discuss and address the consequences of excess weight and obesity. Many healthcare providers help patients make the first move toward a healthier diet and a more active lifestyle to promote weight loss. Although patients are ultimately responsible for implementing lifestyle changes, ongoing support from members of the healthcare team is critical to keeping patients motivated to continue with obesity management therapy. Guidance is also critical to success; patients may have been told to lose weight, but they are not always given instruction on how to do so successfully. The 5 As model is a useful mnemonic to aid in providing support for lifestyle modification. The model involves 5 steps: Assessing, Advising, Agreeing, Assisting, and Arranging. This model can be used to assess the severity of obesity (including risks involved and the patient's readiness for change), advise on what is needed for change (diets, food label education, need for activity), agree on a plan and weight loss goal, assist the patient in overcoming barriers, and arrange follow-up care with other healthcare professionals when needed.40

Physicians may be unwilling to bring up the subject of weight loss with their patients for a number of reasons including a lack of time, lack of reimbursement, the perceived inability to change patient behaviors, a lack of knowledge or resources to help patients in their weight loss efforts, and a perceived lack of patient interest. A study of 320 obese patients in Connecticut found that only 29% of patients received weight loss counseling.41

Expected weight loss following weight loss counseling by physicians may vary according to the strategy employed. A recent review that examined the use of lifestyle counseling in the primary care physician (PCP) setting found that the use of auxiliary staff (ie, nurses, medical assistants, and other professionals) was modestly more effective than PCP counseling alone, while the addition of weight loss medications was associated with more clinically meaningful weight losses (>5% of baseline weight). Other effective strategies included referrals to commercial programs such as Weight Watchers, the use of specialized call centers, or Web-based programs. Brief, low to moderate intensity counseling alone by PCPs did not produce clinically meaningful weight loss.42

Among patients who have undergone weight loss surgery, it is important to monitor weight following surgery during frequent follow-up visits. Factors that have influenced weight regain after surgery include adherence to follow-up visits, level of physical exercise, errors in estimating nutritional needs, and a lack of knowledge with regard to the potential for weight regain following surgery. Recommendations for successful weight loss following bariatric surgery include nutritional counseling and support to improve self-monitoring of food intake and strategies to overcome barriers to weight loss.43

The prevalence of obesity in the United States is increasing. Obesity is associated with an increased risk of many conditions, including T2DM, sleep apnea, and cardiovascular disease, and obesity also negatively impacts quality of life and workplace productivity. Obesity is a long-term condition that must be managed chronically. It is hoped that the recent AMA classification of obesity as a disease will bring more attention to obesity and its management. Patients must be educated by healthcare providers regarding realistic weight loss goals. Lifestyle modifications are a necessary cornerstone for the management of obesity but often prove ineffective for long-term weight control. When appropriate, patients should be offered other treatment modalities, such as pharmaceutical treatment and/or bariatric surgery. Although surgery is highly effective, not all patients qualify for these procedures, and weight may be regained following surgery. Changes in reimbursement policies may improve outcomes in patients with obesity by addressing potential barriers to treatment access. Novel strategies and intensified efforts on the part of all stakeholders are needed to help patients affected by obesity achieve and maintain their weight loss goals.

Author affiliations: Rx Gregory Consulting, LLC, Johns Island, SC (RSG); Metabolic Institute of America, Tarzana, CA, and 12th Annual World Congress on Insulin Resistance, Universal City, CA (YH); Office of the Chief Medical Officer, Aetna, Hartford, CT (EJP); Navistar, Inc, Lisle, IL (DP).

Funding source: supplement was supported by VIVUS, INC.

Author disclosure: Mr Gregory reports serving as a consultant/paid advisory board member for Vivus, Inc. Dr Handelsman reports serving as a consultant for Amarin, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Inc, diaDexus, Eisai, Gilead, GlaxoSmithKline, Halozyme, Janssen, LipoScience, Merck, Novo Nordisk, Sanofi, Santarus, and Vivus, Inc. Dr Handelsman also reports receipt of research grants from Amgen, Boehringer Ingelheim, Gilead, GlaxoSmithKline, Intarcia, Lexicon, Merck, Novo Nordisk, Sanofi, and Takeda. Additionally, Dr Handelsman reports serving on the speakers bureau for Amarin, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Inc, GlaxoSmithKline, Janssen, Lilly, Novo Nordisk, Santarus, and Vivus, Inc. Mr Pikelny reports receipt of lecture fees from Vivus, Inc. He also reports meeting attendance on behalf of Vivus, Inc. Dr Pezalla reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this supplement.

Authorship information: Concept and design (RSG, YH, EJP); acquisition of data (YH); analysis and interpretation of data (RSG, YH, EJP); drafting of the manuscript (RSG, YH, EJP, DP); critical revision of the manuscript for important intellectual content (RSG, YH, EJP, DP); statistical analysis (YH); provision of study materials or patients (YH); obtaining funds (YH); administrative, technical, or logistic support (YH); supervision (YH); provision of intellectual content and expertise (DP). REFERENCES

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