LAP-BAND^® Fact Sheet

1. What is Obesity?

Obesity is a disease that affects nearly one-third of the adult American population (approximately 60 million). The number of overweight and obese Americans has continued to increase since 1960, a trend that is not slowing down. Today, 64.5 percent of adult Americans (about 127 million) are categorized as being overweight or obese. Each year, obesity causes at least 300,000 excess deaths in the U.S., and healthcare costs of American adults with obesity amount to approximately $100 billion.

Obesity is the second leading cause of unnecessary deaths.

• Despite its toll taken in death and disability, obesity does not receive the attention it deserves from government, the health care profession or the insurance industry.

• Research is severely limited by a shortage of funds.

• Inadequate insurance coverage limits access to treatment.

• Discrimination and mistreatment of persons with obesity is widespread and often considered socially acceptable.

Did You Know?

• Obesity is a chronic disease with a strong familial component.

• Obesity increases one's risk of developing conditions such as high blood pressure, diabetes (type 2), heart disease, stroke, gallbladder disease and cancer of the breast, prostate and colon.

• Health insurance providers rarely pay for treatment of obesity despite its serious effects on health.

• The tendency toward obesity is fostered by our environment: lack of physical activity combined with high-calorie, low-cost foods.

• If maintained, even weight losses as small as 10 percent of body weight can improve one's health.

• The National Institutes of Health annually spends less than 1.0 percent of its budget on obesity research.

• Persons with obesity are victims of employment and other discrimination, and are penalized for their condition despite many federal and state laws and policies.

2. Obesity - A Global Epidemic

The prevalence of overweight and obesity is increasing worldwide at an alarming rate in both developing and developed countries. Environmental and behavioral changes brought about by economic development, modernization, and urbanization have been linked to the rise in global obesity. Obesity is increasing in children and adults, and true health consequences may become fully apparent in the near future.

Social Structure

• Developed countries have high obesity rates, food deprivation is unusual, and physical activity levels have decreased greatly. Lower income households are reported to feature diets composed of foods that tend to be high in calories and fat - contributors to overweight and obesity - since vegetables, fruits and whole grain cereals are more expensive.

• Developing countries have lower obesity rates, particularly in areas of lower SES populations. People who live in these areas are limited in their ability to provide enough food, have little access to public transportation and engage in moderate to heavy manual labor.

General Trends

• In many developing countries, obesity co-exists with under-nutrition – a Body Mass Index (BMI) less than 18.5.

• In economically advanced regions of developing countries, prevalence rates of obesity may be as high as in industrialized countries.

• Globally, women generally have higher rates of obesity than men do, although men may have higher rates of overweight.

• Prevalence of obesity in children and adolescents is on the rise in both developed and developing regions.

3. Obesity in the U.S.

Obesity is a complex, multi-factorial chronic disease involving environmental (social and cultural), genetic, physiologic, metabolic, behavioral and psychological components. It is the second leading cause of preventable death in the U.S.

Overweight and obesity are part of the U.S. Department of Health and Human Services' health agenda that have steadily moved away from their established targets for improvement. Today, public health leaders recognize obesity as a "neglected public health problem." This fact sheet will demonstrate the impact of overweight and obesity on millions of Americans of all ages and both genders.

Overall Prevalence

• Approximately 127 million adults in the U.S. are overweight, 60 million obese, and 9 million severely obese.

• Body Mass Index (BMI) is a measurement tool used to determine excess body weight. Overweight is defined as a BMI of 25 or more, obesity is 30 or more, and severe obesity is 40 or more.

• The number of adults who are overweight or obese has continued to increase. Currently, 64.5 percent of U.S. adults, age 20 years and older, are overweight and 30.5 percent are obese. Severe obesity prevalence is now 4.7 percent, up from 2.9 percent reported in the 1988 - 1994 National Health and Nutrition Examination Survey (NHANES) by the Centers for Disease Control and Prevention (CDC).

Health and Social Impact

• Obesity increases the risk of illness from about 30 serious medical conditions.

• Obesity is associated with increases in deaths from all-causes.

• Earlier onset of obesity-related diseases, such as type 2 diabetes, are being reported in children and adolescents with obesity.

• Individuals with obesity are at higher risk for impaired mobility.

• Overweight or obese individuals experience social stigmatization and discrimination in employment and academic situations.

4. Obesity in Minority Populations

Overweight and obesity in the U.S. occur at higher rates in racial / ethnic minority populations such as African American and Hispanic Americans, compared with White Americans. Asian-Americans have a relatively low prevalence for obesity. Women and persons of low socioeconomic status within minority populations appear to particularly be affected by overweight and obesity. Cultural factors that influence dietary and exercise behaviors are reported to play a major role in the development of excess weight in minority groups.

Prevalence

• The prevalence of overweight (Body Mass Index (BMI) of 25 or more) and obesity (BMI of 30 or more) increased over the last decade across racial / ethnic groups, as shown in Table 1.

• Mexican American and black (non-Hispanic) adults in the U.S. are considerably more overweight and obese than white (non-Hispanic) adults.

Health Disparities

Many obesity-related diseases including diabetes, hypertension, cancer and heart disease are found in higher rates among various members of racial-ethnic minorities compared with whites.

• Diabetes

• Cancer
  Heart Disease

• Hypertension

Behavioral Risk Factors Diet & Exercise

• Cultural factors related to dietary choices, physical activity, and acceptance of excess weight among African Americans and other racial-ethnic groups, appear to play a role in interfering with weight loss efforts.

• Sedentary life style, which can contribute to the development of obesity, has been reported by 44 to 60 percent of Native American men and 40 to 65 percent of women.

• African Americans and whites report that they exercise less as they get older, however, African American women of all ages report participating in less regular exercise than white women.

• African American men, age 45 and older, report less regular exercise than white women.

5. Women and Obesity

Obesity plays a significant role in causing poor health in women, negatively affecting quality of life and shortening quantity of life. More than half of adult U.S. women are overweight, and more than one-third are obese. The life expectancy of women in the U.S. is approaching 80 years of age, and more women than ever are expected to turn 65 in the second decade of the new millennium. Prevention and early treatment of obesity are crucial to ensuring a healthy population of women of all ages.

Prevalence

• For women, ages 20 to 74, 62 percent are overweight (Body Mass Index (BMI) of 25 or more) and about half of that population (34 percent) is obese (BMI of 30 or more).

• Middle-age women are at a particularly high risk of becoming obese. The prevalence of obesity among middle-age women (ages 35 to 64) has increased at a minimum of 2 percentage points per year over a 40-year time period from 1960 to 2000. Table 4 indicates prevalence changes in obesity (BMI of 30 or more) between 1960 and 2000 for U.S. women in various middle-age groups.

• Low-income women in minority populations appear most likely to be overweight.

• Obesity appears to have a strong inverse relationship with SES (obesity increases as income level decreases) among women in developed societies such as the U.S.

• A direct association has been found between body weight and deaths from all-causes in women, ages 30 to 55.

• Among U.S. adults, black (non-Hispanic) women have the highest prevalence of overweight (78 percent) and obesity (50.8 percent).

6. Obesity in Youth

Diabetes, hypertension and other obesity-related chronic diseases that are prevalent among adults have now become more common in youngsters. The percentage of children and adolescents who are overweight and obese is now higher than ever before. Poor dietary habits and inactivity are reported to contribute to the increase of obesity in youth.

Today's youth are considered the most inactive generation in history caused in part by reductions in school physical education programs and unavailable or unsafe community recreational facilities. In the U.S., only the state of Illinois requires daily physical education for students in grades K to 12.

This fact sheet outlines many factors related to obesity in youth that make it the major health care challenge for the 21st century.

Overweight and Obesity Defined

• Overweight and obesity for children and adolescents are defined respectively as being at or above the 85th and 95th percentile of Body Mass Index (BMI).

• Some researchers refer to the 95th percentile as overweight and other as obesity. The Centers for Disease Control and Prevention (CDC), which provides national statistical data for weight status of American youth, avoids using the word "obesity," and identifies every child and adolescent above the 85th percentile as "overweight."

• Obesity Surgery Specialists use the 95th percentile as criteria for obesity because it:

  1. corresponds to a BMI of 30 which is obesity in adults. The 85th percentile corresponds to a BMI of 25, adult overweight.

  2. is recommended as a marker for when children and adolescents should have an in-depth medical assessment.

  3. identifies children that are very likely to have obesity persist into adulthood.

  4. is associated with elevated blood pressure and lipids in older adolescents, and increases their risk of diseases.

  5. is a criteria for more aggressive treatment.

  6. is a criteria in clinical trials of childhood obesity treatments.

7. Health Effects of Obesity

Persons with obesity are at risk of developing one or more serious medical conditions, which can cause poor health and premature death. Obesity is associated with more than 30 medical conditions, and scientific evidence has established a strong relationship with at least 15 of those conditions. Preliminary data also show the impact of obesity on various other conditions. Weight loss of about 10% of body weight, for persons with overweight or obesity, can improve some obesity-related medical conditions including diabetes and hypertension.

Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis (RA), Cancers, Breast Cancer, Cancers of the Esophagus and Gastric Cardia, Colorectal Cancer, Endometrial Cancer (EC), Renal Cell Cancer, Birth Defects, Cardiovascular Disease (CVD), Carpal Tunnel Syndrome (CTS), Chronic Venous Insufficiency (CVI), Daytime Sleepiness, Deep Vein Thrombosis (DVT), Diabetes (Type 2), End Stage Renal Disease (ESRD), Gallbladder Disease, Gout, Heat Disorders, Hypertension, Impaired Immune Response, Impaired Respiratory Function, Infections Following Wounds, Infertility, Liver Disease, Low Back Pain, Obstetric and Gynecologic Complications, Pain, Pancreatitis, Sleep Apnea, Stroke, Surgical Complications, Urinary Stress Incontinence, Other:

Several other obesity-related conditions have been reported by various researchers including:

• abdominal hernias, acanthosis nigricans, endocrine abnormalities, chronic hypoxia and hypercapnia, dermatological effects, depression, elephantitis, gastroesophageal reflux, heel spurs, hirsutism, lower extremity edema, mammegaly (causing considerable problems such as bra strap pain, skin damage, cervical pain, chronic odors and infections in the skin folds under the breasts, etc.), large anterior abdominal wall masses (abdominal paniculitis with frequent panniculitis, impeding walking, causing frequent infections, odors, clothing difficulties, low back pain), musculoskeletal disease, prostate cancer, pseudo tumor cerebri (or benign intracranial hypertension), and sliding hiatil hernia.
  
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8. Obesity Treatment

A statistic frequently used about obesity treatment is that 95 percent of people who lose weight gain it all back. That statistic, based on a small study from 1959, is no longer valid. Much has changed in the way of obesity treatment since then. Thousands of people have succeeded in losing weight and keeping it off -- an encouraging fact for many that are discouraged by outdated information. There are several different types of effective treatment options to manage weight including: dietary therapy, physical activity, behavior therapy, drug therapy, combined therapy and surgery.

Weight loss of about 10 percent of excess body weight is proven to benefit health by reducing many obesity-related risk factors. Recommendations for treatment are now focusing on 10 percent weight loss to help patients with long-term maintenance of weight loss. Health professionals including physicians, nutritionists, exercise physiologists, psychologists and bariatric surgeons help persons with overweight and obesity to determine the most appropriate treatment.

• Assessment of Weight

• Dietary Therapy

• Physical Activity

• Behavior Therapy

• Drug Therapy

• Combined Therapy

• Surgery

9. Obesity Research

In the last four decades of obesity research, progress has been made in identifying causes and treatments. Research has provided a greater understanding of obesity as a chronic disease caused by a complex interaction of genetic, metabolic, behavioral, psychological and environmental (social and cultural) factors. Despite the advances in research, however, children, adolescents and adults are continuing to become overweight and obese in record high numbers. Due to the complexity of obesity, more research is needed in a variety of areas particularly in prevention to control the spread of this epidemic.

Funding Inequities

• Public research funding for obesity is appallingly low given that it is a major public health crisis.

• The National Institutes of Health (NIH) has a budget of more than $15.6 billion and is the largest public funder of medical research. In setting the priorities of its budget, the NIH has virtually neglected obesity research.

• Obesity-related medical conditions such as diabetes and hypertension, receive far greater funding than the causative condition itself, as shown in Figure 1. Poor diet and inactivity, which contribute to obesity, is reported to be the second leading cause of preventable death in the U.S. Yet AIDS, another cause of preventable death, receives over 10 times more research funding than obesity.
  
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10. Obesity and Health Insurance

Many insurance plans do not provide reimbursement for weight loss treatment. According to many practitioners, few private insurance indemnity plans or managed care organizations appear to cover the costs of obesity treatment regardless of whether the service is a medically supervised program of weight reduction or maintenance, nutrition counseling, surgery or a pharmaceutical product. The countless number of available insurance plans and ever changing policies have made it difficult to assess the extent to which obesity treatment and prevention services are covered by third party insurers. More data and better tracking is necessary to determine the health needs of persons with obesity.

Insurance Coverage Trends

A typical employer insurance plan could be similar to that of Wal-Mart. Benefits listed in their employee benefits booklet (1999) as “not payable for treatment or services” include charges from:

• medications and diet supplements which result from diet programs

• appetite control

• weight control

treatment of obesity or morbid obesity, including gastric bypasses and stapling procedures even if the participant has other health conditions which might be helped by the reduction of weight.

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11. Obesity, Medicaid and Medicare

Medicaid does not cover obesity, and under Medicare, hospital and physician services for obesity are clearly excluded. Medicaid is a government program that provides health insurance to qualified individuals whose income level is below a certain point. Recipients of Medicaid are primarily women and children who are poor and members of minority groups. Given the high prevalence of obesity among those populations, it could be presumed that many Medicaid recipients are likely to have obesity. Medicare provides health insurance coverage to elderly citizens and disabled Americans who qualify by meeting criteria of the Social Security Administration (SSA) and completing a two-year waiting period.

Medicaid

• In 1990, Congress enacted the Omnibus Budget Reconciliation Act (OBRA), which funds state programs to provide pharmaceutical products to Medicaid recipients.

• A State may choose to exclude or restrict drugs or classes of drugs, or their medical uses for certain purposes. A State choosing to include outpatient drugs within its Medicaid program must cover, for their medically accepted indications, all Food and Drug Administration (FDA) approved prescription drugs of manufacturers that have entered into drug rebate agreements, with a few limited exceptions.

• Exceptions include drugs when used for: anorexia, weight loss or weight gain; to promote fertility; for cosmetic purposes or hair growth; for the symptomatic relief of cough and colds; or to promote smoking cessation.

• As a result of OBRA, the Department of Health and Human Services ordered states to cover Viagra for the treatment of erectile dysfunction while continuing to exclude anti-obesity agents.

• Nine states cover anti-obesity pharmaceutical products including Alaska, California, Kentucky, Montana, North Carolina, Oregon, Rhode Island, Washington and Wisconsin.

• One state, Arizona, covers products by specific managed health care plan.

• In 23 states, there is no specific language regarding coverage under Medicaid.

• In 29 states, anti-obesity products are specifically excluded in state Medicaid programs.
  
  Medicare

• The Medicare Coverage Manual defines obesity and the justification for certain treatment coverage by stating that:

• Obesity itself cannot be considered an illness. The immediate cause is a caloric intake, which is persistently higher than caloric output.

• Program payment may not be made for treatment of obesity alone since this treatment is not reasonable and necessary for the diagnosis or treatment of an illness or injury.

• However, although obesity is not in itself an illness, it may be caused by illnesses such as hypothyroidism, Cushing's disease, and hypothalamic lesions. In addition, obesity can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Therefore, services in connection with the treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of those illnesses.

Medicare’s limited coverage of obesity is difficult to understand when considering that it does cover services such as inpatient and outpatient alcohol detoxification and rehabilitation, inpatient and outpatient drug rehabilitation, and services for sexual impotence. It also covers chemical aversion therapy for the treatment of alcoholism even though the FDA has not approved the drugs commonly used in chemical aversion therapy for this application.

Gastric Bypass Surgery
Surgery for the treatment of obesity is covered on a limited basis. According to the Medicare Coverage Manual:

• gastric bypass surgery, which is a variation of the gastrojejunostomy, is performed for patients with extreme obesity. Gastric bypass surgery for extreme obesity is covered under the program if:

  1. it is medically appropriate for the individual to have such surgery.

  2. the surgery is to correct an illness, which caused the obesity or was aggravated by the obesity.