Obesity: Getting Bigger
© 2004 Milliman All Rights Reserved
M I L L I M A N
Research
Report
Obesity: A Big Problem Getting Bigger
Kate Fitch, RN, MEd, CCM
Bruce Pyenson, FSA, MAAA
Steven Abbs
Margaret Liang
Peer Review by Tom Ruehle, FSA, MAAA; Kathy Zaharias, RN, MBA
MILLIMAN RESEARCH REPORT
March 2004
Obesity: A Big Problem Getting Bigger
PAGE
I.
EXECUTIVE SUMMARY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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II.
DEFINITION OF OBESITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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INCREASING PREVALENCE OF OBESITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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IV.
HEALTH RISKS ASSOCIATED WITH OBESITY . . . . . . . . . . . . . . …show more content…
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TREATMENT OF OBESITY
Dietary Therapy . . . . . . .
Exercise . . . . . . . . . . .
Behavior Therapy . . . . . .
Prescription Drug Therapy. .
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XI.
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
XII.
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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MILLIMAN RESEARCH REPORT
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March 2004
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BENEFIT PLAN DESIGN CONSIDERATIONS .
Who is Covered and When. . . . . . . . . . . . .
Medical Management Decisions . . . . . . . . . .
Benefit Decisions . . . . . . . . . . . . . . . . . .
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SAMPLE PRICING OF A BARIATRIC SURGERY BENEFIT . . . . . . . . . . . . . . . . . . . . . . . . .
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THE MEDICAL COSTS OF OBESITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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VIII.
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STATE MANDATES FOR OBESITY TREATMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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X.
SURGICAL TREATMENT OF SEVERE OBESITY
Types of Bariatric Surgery . . . . . . . . . . . . . .
Indications for the Procedure . . . . . . . . . . . .
Complications and Death Following Surgery . . . .
Follow-up Care . . . . . . . . . . . . . . . . . . . .
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MILLIMAN RESEARCH REPORT
March 2004
EXECUTIVE SUMMARY
Obesity in the United States poses a significant and growing health risk. Some have speculated that because of the growing prevalence of obesity, today’s generation of young Americans may have a shorter average life span than their parents.1 The prevalence of obesity has doubled since 1980 and is now seen by the Centers for
Disease Control (CDC) as one of the top threats to the health of the nation.2 Approximately one out of every four Americans is considered obese, according to the CDC National Health Interview 2003 findings.3 The disease has been estimated to account for 9.1% of annual US medical expenditures4 and 5% of medical costs for
US business.5
A significant finding of our research is that the obesity diagnosis is coded on medical claims far too infrequently. This dramatic under coding makes it difficult to quantify the true impact of obesity. Without proper coding, disease management and wellness programs face a difficult obstacle identifying and encouraging obese patients to enter management programs. As obesity has become the focus of policy makers, public health experts, and employers, we expect increased emphasis on coding obesity as a primary or secondary diagnosis in medical claims.
Obesity treatments raise numerous cost and effectiveness challenges for patients, employers, and insurers. Some highly publicized treatments for the morbidly obese (e.g., gastric bypass surgery) come with high costs. Highprofile pharmaceutical treatments for obesity have been withdrawn from the market, and one has attracted numerous lawsuits with claims in the billions of dollars. Although evidence-based clinical guidelines on the
Identification, Evaluation, and Treatment of Overweight and Obesity in Adults were published in 1998,6 the prevalence of obesity continues to increase.
This report summarizes currently available information on prevalence, medical cost, and medical treatment of obesity, with a focus on the impact on employers and insurers for the commercial population (insured, nonMedicare, non-Medicaid). Disability, absenteeism, wellness, and life insurance costs are certainly increased by obesity, but these issues fall outside the scope of this report. This report is not a substitute for professional medical or legal advice, and the reader should consider that medical advances can render today’s knowledge obsolete. While we hope benefits and formulary decision makers will find this report useful, we also hope the pace of medical discovery or societal change will render many of the details obsolete in a few years.
March 2004
MILLIMAN RESEARCH REPORT
1
DEFINITION OF OBESITY
Everyday language describes people as “overweight” or “obese,” but what counts is the portion of body weight that is fat. The most common measure of obesity is body mass index (BMI), the measurement tool recommended for practitioners by the National Institute of Health (NIH) expert panel.7 BMI correlates with the portion of body weight that is fat. The generally accepted formula for BMI (Table 1) takes a person’s body weight, divides by the square of his or her height and multiplies by a units factor.8
TA B L E 1
BMI has limitations as a measure of body
FORMULAS FOR CALCULATING BMI fat. For example, BMI overestimates body fat in persons who are muscular and can
Metric formula
Non-metric conversion formula underestimate body fat in persons who have lost muscle mass. Yet, BMI is easy to weight (kg) weight (pounds)
703 x calculate and provides a more accurate height (m)2 height (inches)2 measure of total body fat than relying on weight alone. The Metropolitan Life
Insurance Tables, published for years by that life insurer, rely on weight, height, frame (small, medium, and large), and gender, and reflect desired weight (characteristics with the lowest mortality rates). They were developed primarily from white, higher socioeconomic status populations. Such tables have limited value when addressing obesity issues. 9
(
)
TA B L E 2
Overweight is defined as a BMI of 25.0 to
29.9. Obesity is defined as a BMI of 30 or greater. Extreme obesity (often referred to as morbid obesity) is defined as a BMI of 40 or greater.10 Table 2 shows the classification of overweight and obesity described by the
NIH. Obesity class correlates with risk of disease and treatment recommendations.11
CLASSIFICATION
OF
OVERWEIGHT
Weight Status
Underweight
Normal weight
Overweight
Obesity
Extreme obesity
AND
BMI
<18.5
18.5 - 24.9
25.0 - 29.9
30.0 - 34.9
35.0 - 39.9
≥40
OBESITY
BY
BMI
Obesity Class
I
II
III
A body mass index table, from the NIH
Values are the same for both genders guidelines,12 appears in Table 3. To use the table, first find the person’s height in the left-hand column labeled Height. Next, move across in the same row to the person’s weight. The corresponding
BMI is the number in bold at the top of the weight column.
2
MILLIMAN RESEARCH REPORT
March 2004
TA B L E 3
Height (Inches)
BODY MASS INDEX (BMI)
FOR
ADULTS
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
58
91
96
100
105
110
115
119
124
129
134
138
143
148
153
158
162
167
172
177
181
186
191
59
94
99
104
109
114
119
124
128
133
138
143
148
153
158
163
168
173
178
183
188
193
198
60
97
102
107
112
118
123
128
133
138
143
148
153
158
163
168
174
179
184
189
194
199
204
61
100
106
111
116
122
127
132
137
143
148
153
158
164
169
174
180
185
190
195
201
206
211
62
104
109
115
120
126
131
136
142
147
153
158
164
169
175
180
186
191
196
202
207
213
218
63
107
113
118
124
130
135
141
146
152
158
163
169
175
180
186
191
197
203
208
214
220
225
64
110
116
122
128
134
140
145
151
157
163
169
174
180
186
192
197
204
209
215
221
227
232
65
114
120
126
132
138
144
150
156
162
168
174
180
186
192
198
204
210
216
222
228
234
240
66
118
124
130
136
142
148
155
161
167
173
179
186
192
198
204
210
216
223
229
235
241
247
67
121
127
134
140
146
153
159
166
172
178
185
191
198
204
211
217
223
230
236
242
249
255
68
125
131
138
144
151
158
164
171
177
184
190
197
204
210
216
223
230
236
243
249
256
262
69
128
135
142
149
155
162
169
176
182
189
196
203
210
216
223
230
236
243
250
257
263
270
70
132
139
146
153
160
167
174
181
188
195
202
209
216
222
229
236
243
250
257
264
271
278
71
136
143
150
157
165
172
179
186
193
200
208
215
222
229
236
243
250
257
265
272
279
286
72
140
147
154
162
169
177
184
191
199
206
213
221
228
235
242
250
258
265
272
279
287
294
73
144
151
159
166
174
182
189
197
204
212
219
227
235
242
250
257
265
272
280
288
295
302
74
148
155
163
171
179
186
194
202
210
218
225
233
241
249
256
264
272
280
287
295
303
311
75
152
160
168
176
184
192
200
208
216
224
232
240
248
256
264
272
279
287
295
303
311
319
76
156
164
172
180
189
197
205
213
221
230
238
246
254
263
271
279
287
295
304
312
320 328
Weight (Pounds)
The definition of overweight for children is gender and age specific. BMI references gender-specific growth charts for children and teens aged 2 to 20 years. If a child or adolescent meets or exceeds the 95th percentile of the historical gender-specific BMI for age growth charts, they are considered overweight.13 Obesity in children is not specifically defined.
March 2004
MILLIMAN RESEARCH REPORT
3
INCREASING PREVALENCE OF OBESITY
According to the National Health and Nutrition Examination Survey (NHANES) 1999-2000, the age-adjusted prevalence of obesity was 30.5%—an increase from 22.9% as reported in NHANES III (1988-1994). The prevalence of overweight also increased during this period from 55.9% to 64.5%, and extreme obesity increased from
2.9% to 4.7%. The 1999-2000 survey results were based on height and weight measurements of 4,115 adult men and women who are a nationally representative sample of the US civilian non-institutionalized population.14 The prevalence of obesity was highest among women aged 40 to 59 years (37.8%) and 60 to 74 years (39.6%). Among the ethnic groups, the age-adjusted prevalence of obesity was highest among non-Hispanic black women (49.7%) and lowest among non-Hispanic white men (27.3%).
The prevalence of super obesity, defined as a BMI ≥ 50, also causes concern. The prevalence rate is reported to have increased from one in 2,000 to one in 400 from 1986 to 2000.15
Perhaps the most disturbing recent trend is the increase in overweight children and adolescents. Based on
NHANES survey data, the prevalence of overweight was 15.5% among 12- through 19-year-olds, 15.3% among
6- through 11-year-olds, and 10.4% among 2- through 5-year-olds (NHANES 1999-2000), increasing from
10.5%, 11.3% and 7.2%, respectively, as reported in 1988-1994 (NHANES III).16 “Overweight” in this case is defined as BMI at or above the 95th percentile according to the standard pediatric growth charts in use since the late 1970s.
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MILLIMAN RESEARCH REPORT
March 2004
HEALTH RISKS ASSOCIATED WITH OBESITY
Obesity significantly worsens health and quality of life and shortens life expectancy. A prospective study of more than one million adults found that the risk of death rose with increasing BMI in all age groups and for all categories of causes of death.17 Estimates of the annual deaths of US adults due to causes related to obesity range from
280,000 to 325,000.18 A recent study concluded that obesity in adulthood is associated with a decrease in life expectancy of about seven years in both men and women.19
NIH Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults report the following health risks of overweight and obesity, based on an extensive review of randomized controlled trials.20
Hypertension (defined as mean systolic blood pressure ≥ 140 mm Hg, mean diastolic ≥ 90 mm Hg, or currently
taking anti-hypertensive medication)
Data from NHANES III show that the age-adjusted prevalence of high blood pressure in adults with BMI ≥
30 is 38.4% for men and 32.2% for women, respectively.
In contrast, the corresponding prevalence rates for adults with a BMI < 25 are 18.2% for men and 16.5% for women.
High total cholesterol (defined as ≥ 240 mg/dL)
Data from NHANES III and several large longitudinal studies report a higher body weight associated with increased cholesterol levels.
Diabetes
For each additional unit of BMI > 22, the relative risk of diabetes rises by roughly 25%. Studies also show that 46% of diabetics have a BMI ≥ …show more content…
30.
Coronary Heart Disease
Studies show that as BMI levels increase, so do the risks of nonfatal myocardial infarction and coronary heart disease (CHD) death. The Nurses’ Health Study21 found the relative risk for CHD was doubled at BMIs of
25 to 28.9 and more than tripled at BMIs of 29 or greater, compared with BMIs of less than 21.
Congestive Heart Failure
Studies show that congestive heart failure is often a complication of severe obesity and a major cause of death.
The duration of the obesity serves as a strong predictor of congestive heart failure.
Stroke
Recent prospective studies demonstrate that the risk of stroke shows a gradual increase as BMI rises, including findings that ischemic stroke risk is 137% higher in women with BMI > 32, compared with women having a
BMI < 21.
Osteoarthritis
Many studies associate overweight or obesity with an increased risk for the development of osteoarthritis, especially the risk for knee osteoarthritis.
March 2004
MILLIMAN RESEARCH REPORT
5
Gallstones
As adult weight increases, so does the risk of gallstones. The prevalence of gallstone disease among women increases from 9.4% in the first quartile of BMI to 25.5% in the fourth quartile of BMI according to
NHANES III data. Male gallstone disease prevalence climbs from 4.6% in the first quartile of BMI to 10.8% in the fourth quartile of BMI. Risk of either gallstones or cholecystectomy reaches a peak of 20 per 1,000 women per year when BMI exceeds 40, compared with three per 1,000 among women with BMI < 24.
Sleep apnea
Several studies show obesity, especially upper body obesity, is a risk factor for sleep apnea and has been shown to be related to its severity. Another significant finding is that a majority of people with sleep apnea have a
BMI > 30.
Cancer
A prospectively studied population of more than 900,000 US adults showed that individuals with a BMI ≥ 40 had mortality rates from all cancers combined that were 52% higher (for men) and 62% (for women) than the corresponding rates in normal-weight men and women.22
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MILLIMAN RESEARCH REPORT
March 2004
TREATMENT OF OBESITY
The National Research Council’s Committee on Diet and Health states that overweight and obesity result from a complex interaction between genes and environment. This interaction is characterized by a long-term energy imbalance and is tied to a sedentary lifestyle and excessive consumption of calories.23 The “super sizing” of food portions and lack of physical activity have been cited as primary causes for the rise in obesity. According to a recent study by the National Center for Health Statistics, less than one-third of US adults engage in regular leisure-time physical activity and only about one-fifth of adults engage in a high level of overall physical activity.24
A two-step process of health risk assessment and management should be used in treating an obese patient. An individual’s health risk status is assessed by determining the degree of overweight or obesity based on BMI, waist circumference, and the presence of concomitant cardiovascular risk factors or comorbidities including coronary heart disease, peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, type 2 diabetes, and sleep apnea. Individuals are considered to have incremental health risks above those that are associated with these risk factors if they are physically inactive or have high serum triglyceride levels (obesity is commonly accompanied by elevated serum triglycerides).25 The treatment of these risk factors and comorbidities, along with a weight-loss program, is essential.
The assessment and documentation of patient motivation is critical before beginning a weight-loss therapy program. The NIH expert panel reports that weight reduction involves a major investment of time and effort on the part of the healthcare team, as well as significant expense to the patient. Consequently, a demonstrated high level of motivation for weight loss should be present prior to commencing clinical therapy. After motivation is confirmed, the patient and clinician should jointly devise goals and the treatment strategy.
According to the NIH recommendations, the initial goal of weight-loss therapy should be to reduce body weight by approximately 10% from baseline. With success, further weight loss can be attempted, if indicated. Weight loss should be at a rate of about one to two pounds per week for a period of six months, followed by re-evaluation of the need for further weight loss.
According to the NIH expert panel, there are three major components to the most successful therapy for weight loss and weight maintenance: dietary therapy, increased physical activity, and behavior therapy. In addition, pharmacotherapy should be considered as an adjunct to these lifestyle therapies in patients with a BMI ≥ 30 with no concomitant obesity-related risk factors or diseases, or for patients with a BMI ≥ 27 with concomitant obesityrelated risk factors or diseases including hypertension, dyslipidemia, coronary heart disease, type 2 diabetes, and sleep apnea. Certain patients may be candidates for weight-loss surgery. The literature suggests that weight-loss and weight-maintenance therapies that are provided over the long-term, and provide a higher frequency of contacts between the patient and the practitioner, lead to more successful weight loss and weight maintenance.
The following paragraphs summarize the treatment recommendations from the NIH expert panel on the
Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, based on an extensive review of published scientific literature.26
March 2004
MILLIMAN RESEARCH REPORT
7
Dietary Therapy
A key element of the current recommendation is the use of a moderate reduction in caloric intake to achieve a slow but progressive weight loss.
•
Low calorie diets are recommended for weight loss in overweight and obese persons. Reducing fat as part of a low calorie diet is a practical way to reduce calories.
•
Reducing dietary fat alone without reducing calories is not sufficient for weight loss. However, reducing dietary fat along with reducing dietary carbohydrates can facilitate caloric reduction.
•
A diet that is individually planned to help create a deficit of 500 to 1,000 kcal/day should be an integral part of any program aimed at achieving a weight loss of one to two pounds per week.
Exercise
•
Physical activity is recommended as part of a comprehensive weight-loss therapy and weight-loss maintenance program because it: (1) modestly contributes to weight loss in overweight and obese adults, (2) may decrease abdominal fat, (3) increases cardiorespiratory fitness, and (4) may help with maintenance of weight loss.
•
Physical activity should be an integral part of weight-loss therapy and weight maintenance. Initially, moderate levels of physical activity for 30 to 45 minutes, three to five days per week should be encouraged. All adults should set a long-term goal to accumulate at least 30 minutes or more of moderate-intensity physical activity on most, and preferably all, days of the week.
Behavior Therapy
Behavior therapy provides means and opportunities for modifying eating and physical activity habits as well as breaking down obstacles to compliance with dietary therapy and increased physical activity. Behavioral therapy and counseling often involve certified clinical psychologists and weekly or bi-weekly meetings. The psychologist and obese person work together to formulate strategies most conducive to the person establishing healthy weight loss habits.
NIH guidelines make the following recommendations:
•
Behavior therapy is a useful adjunct when incorporated into treatment for weight loss and weight maintenance.
•
Practitioners need to assess the patient’s motivation to enter weight-loss therapy and then take appropriate steps to motivate the patient for treatment.
•
Behavior therapy strategies to promote diet and physical activity should be used routinely, as they help achieve weight loss and weight maintenance.
Experience reveals that lost weight usually will be regained unless a weight-maintenance program combining dietary therapy, physical activity, and behavior therapy is continued indefinitely. This is why an accurate assessment of patient motivation is critical to the success of a weight-loss program. After six months of weight loss treatment, the rate of weight loss frequently decreases and levels off; efforts to maintain weight loss should be put in place. If more weight loss is needed, another attempt at weight reduction can be made requiring further adjustment of the diet and physical activity prescriptions. For patients unable to achieve significant weight reduction, prevention of further weight gain is an important goal.
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MILLIMAN RESEARCH REPORT
March 2004
Prescription Drug Therapy
There has been an increased interest in the treatment of obesity with prescription drugs because of the poor outcomes often associated with behavior therapy, diet, and physical activity over the long-term. According to the
NIH recommendations, weight-loss drugs approved by the US Food and Drug Administration (FDA) may be used as part of a comprehensive weight-loss program, including diet and physical activity, for patients with a BMI
≥ 30 with no concomitant obesity-related risk factors or diseases, and for patients with a BMI ≥ 27 with concomitant obesity-related risk factors or diseases. Drugs should never be used without being accompanied by lifestyle modification. Drug therapy must be continually assessed for effectiveness and safety.
Following are indications for obesity prescription drug use recommended for weight loss, based on Milliman evidence-based clinical guidelines:27
•
Indications for pharmacotherapy for treatment of obesity
Indicated when ALL of the following are present:
❖
ANY ONE of the following:
- BMI > 30
- BMI between 27 and 30 and at least one major comorbidity
❖
NONE of the following contraindications are present:
- Pregnant or lactating
- Unstable cardiac condition or other serious medical condition
- Psychiatric disorder
- Patient taking incompatible drug
❖
Pharmacotherapy is part of a basic weight loss program
■
The following is a list of prescription drugs frequently used for weight loss:
•
Sibutramine (Meridia)
May be used for up to one year
■
Adverse effects include dry mouth, anorexia, and constipation
Orlistat (Xenical)
■
Indicated for short-term use
■
Side effects include oily stools and possible malabsorption of fat-soluble vitamins
Diethylpropion HCL (Tenuate)
■
Only short-term usage is required
■
Indicated in those with mild to moderate hypertension
■
Carries a potential low risk of physical or psychological dependence
■
Side effects include restlessness, dry mouth, and constipation
Mazindol HCL
■
Indicated for short-term usage
■
Contraindicated in those with severe hypertension or coronary vascular disease
■
Adverse effects include stimulant effect, insomnia, agitation, and dizziness
■
Abuse potential is low
Phentermine (Adipex-8, Pro-fast SA)
■
FDA approval for short-term use only
■
No case reports of heart valve abnormalities, but large-scale data on monotherapy are limited
■
•
•
•
•
The Milliman Care Guidelines® contain full citations of the evidence base along with comprehensive treatment guidelines.
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The field of pharmaceutical treatment is changing rapidly, and additional products may be available in coming years.
According to the studies analyzed by the NIH, pharmacotherapy using dexfenfluramine, sibutramine, orlistat, or phentermine/fenfluramine for six months to one year, when combined with lifestyle modification including diet and physical activity, results in weight loss in obese adults. The amount of weight lost as a result of prescription drug therapy varies by individual, but generally a person loses between 4.4 and 22 pounds over and above what they would be expected to lose through treatment that does not involve medication. Most of the weight loss occurs within the first six months of medication initiation. Unfortunately, most patients regain weight once any drug therapy is discontinued, and the success of pharmacotherapy demands lifestyle changes in diet, exercise, and behavior to increase its effectiveness.28 According to NIH recommendations, drugs should be discontinued if significant weight loss is not achieved—i.e., at least 4.4 pounds or more in the first four weeks of drug therapy. Studies have shown individuals who do not achieve this amount of weight loss have a low likelihood of long-term response.
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SURGICAL TREATMENT OF SEVERE OBESITY
Published reports indicate that severely obese adults who are treated with non-operative methods alone do not often achieve medically significant long-term weight loss. Most of these patients regain all the weight lost over the next five years.29
Surgery for severe obesity, referred to as bariatric surgery, began in the early 1950s. The techniques and clinical outcomes from bariatric surgery have improved dramatically over the years. The NIH expert panel’s review of recent studies reports that surgical intervention in adults with a BMI ≥ 40, or a BMI ≥ 35 with comorbid conditions, results in substantial weight loss. NIH recommendations state that when less invasive methods of weight loss have failed, surgical intervention is an option for carefully selected patients with clinically severe obesity (a
BMI ≥ 40 or a BMI ≥ 35 with comorbid conditions) who are at high risk for obesity-associated morbidity and mortality. Compared to other available interventions, surgery has produced the longest period of sustained weight loss in severely obese individuals.30
With recent publicity among celebrity figures undergoing bariatric surgery, the demand for surgery and facilities performing the surgery has increased. Health plans report an increase in requests for pre-certification of bariatric surgery. The American Society for Bariatric Surgery reports that 60,000 procedures were performed in 2002, and that number is expected to rise to 100,000 in 2003.31
Types of Bariatric Surgery
The aim of bariatric surgery (often referred to as gastric restrictive or gastric bypass procedures) is to modify the gastrointestinal tract to reduce net food intake. Bariatric procedures fall into two major designs:
•
Malabsorptive procedures involve rearrangement of the small intestine to decrease the functional length or efficiency of the intestinal mucosa for nutrient absorption. Malabsorptive procedures restrict both food intake and the amount of calories and nutrients the body absorbs. These are the most commonly performed bariatric procedures:
■
Roux-en-Y Gastric Bypass (RYGB)
Roux-en-Y Gastric Bypass is the most common of the malabsorptive surgeries. First, a small stomach pouch is created, thus restricting food intake. Next, a Y-shaped section of the small intestine is attached to the pouch to allow food to bypass the lower stomach and the first and second segments of the small intestine (duodenum and first portion of the jejunum). The bypass reduces the amount of calories and nutrients absorbed by the body. Laparoscopic RYGB is now being performed in some patients.
Reported median percentage excess weight loss after RYGB is 56% after four years.32 Dumping syndrome (stomach contents move too rapidly through the small intestine causing nausea, weakness, sweating, faintness, and sometimes diarrhea after eating) is a frequent side effect, and vitamin deficiency is common. This procedure comprises about 75% of bariatric surgical procedures.
■
Bilio-Pancreatic Diversion with Duodenal Switch (BPD-DS)
The BPD-DS involves removal of about 60% of the stomach and rerouting the food stream around a majority of the intestine—thus limiting the amount of nutrients that can be absorbed.
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This type of surgery is highly effective in inducing weight loss in supermorbidly obese patients (BMI ≥
50). Significant metabolic complications can occur. Currently this surgery accounts for approximately
10% of bariatric surgical procedures performed.
•
Restrictive operations do not bypass the stomach, but reduce the stomach size by restricting the size of the upper portion of the stomach.
■
Vertical Banded Gastroplasty (VBG)
The VBG is the most common restrictive operation for weight control. A small stomach pouch is formed through surgical stapling, reducing the capacity of the stomach to approximately one ounce. In order to prevent stretching, the outflow from the pouch into the rest of the stomach is reinforced with a band. The opening to the remainder of the stomach is approximately 3/4 of an inch.
One study reports that at five years post VBG surgery, no patient had sustained an excess weight loss of over 50%.33 VBG currently accounts for about 15% of bariatric surgical procedures performed.
Indications for the Procedures
Milliman evidence-based clinical guidelines include the following clinical indications for surgery or invasive treatment: 34
Gastric Restrictive Procedure with Gastric Bypass
•
Procedure is indicated when ALL of the following present:
Treatment indicated by ANY ONE of the following:
❖
Patient is at least 100 lbs over ideal weight or has a body mass index exceeding 40 kg/m2
❖
Patient’s body mass index is over 35 kg/m2 and a clinically serious condition exists (e.g., obesity hypoventilation, sleep apnea, diabetes, hypertension, cardiomyopathy, musculoskeletal dysfunction)
■
Surgical intervention indicated because patient has ALL of the following present:
❖
Failure to lose weight significantly or regaining of weight despite compliance with a multidisciplinary nonsurgical program including low or very low-calorie diet, supervised exercise, behavior modification, and support
❖
No specifically correctable cause for obesity (e.g., an endocrine disorder)
❖
Full growth
❖
Patient is receiving treatment in a surgical program experienced in obesity surgery, characterized by surgeons experienced with Roux-en-Y gastric bypass and a multidisciplinary approach, including ALL of the following:
- Preoperative medical consultation and approval
- Preoperative psychiatric consultation and approval
- Nutritional counseling
- Exercise counseling
- Psychological counseling
- Support group meetings
■
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Gastric Restrictive Procedure without Gastric Bypass
•
Procedure is indicated when ALL of the following present:
Treatment indicated by ANY ONE of the following:
❖
Patient is at least 100 lbs over ideal weight or has a body mass index exceeding 40 kg/m2
❖
Patient’s body mass index is over 35 kg/m2 and a clinically serious condition exists (e.g., obesity hypoventilation, sleep apnea, diabetes, hypertension, cardiomyopathy, musculoskeletal dysfunction)
■
Surgical intervention indicated because patient has ALL of the following present:
❖
Failure to lose weight significantly or regaining of weight despite compliance with a multidisciplinary nonsurgical program including low or very low-calorie diet, supervised exercise, behavior modification, and support
❖
No specifically correctable cause for obesity (e.g., an endocrine disorder)
❖
Full growth
❖
Patient is receiving treatment in a surgical program experienced in obesity surgery, characterized by surgeons experienced with vertical-banded gastroplasty and a multidisciplinary approach, including ALL of the following:
- Preoperative medical consultation and approval
- Preoperative psychiatric consultation and approval
- Nutritional counseling
- Exercise counseling
- Psychological counseling
- Support group meetings
■
The Care Guidelines also include protocols for inpatient care and full citations of the evidence base.
Complications and Death Following Surgery
Data from nearly 11,000 operations performed during 2000 and 2001 indicate an approximate 2% rate of major complication during the 30 days following bariatric surgery and a mortality rate associated with the surgery of less than 1%.35
Some patients require follow-up operations, such as abdominal hernia repair and abdominoplasty, that are considered minor surgery. Nearly 30% of patients develop nutritional deficiencies that can be avoided with vitamin and mineral supplements. Some patients experience gastrointestinal discomfort associated with eating.36
Follow-up Care
The following summarizes typical care issues following bariatric surgery. These are assembled from various bariatric program sources. Follow-up care forces the patient to bear a significant burden, which is why high patient motivation is required for success.
Nutrition
•
A regular diet starts about eight weeks or later after bariatric surgery, and patients are advised to eat smaller, more frequent meals, chew food thoroughly and eat slowly. A registered dietician often provides an individualized diet plan.
•
Long-term vitamin and mineral supplements are often necessary as a smaller stomach or bypass of the stomach makes it more difficult for the body to absorb essential vitamins and nutrients. Diets should be high in protein and low in fat, sugar, calories, and fiber.
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•
Adequate hydration is essential; however, as with food intake, drinking must be done in small amounts.
Generally speaking, a post-surgical patient should slowly drink six cups of fluids each day, drinking one cup of fluid between each meal and making sure to stop drinking 45 to 60 minutes before meals.
Exercise
A person undergoing bariatric surgery should be prepared to engage in physical exercise before the surgery to enhance flexibility, muscle strength, mobility, and endurance. Sufficient, regular exercise, begun well in advance of the procedure and resumed immediately following, helps a person feel better, recover more quickly and minimize the risk of post-surgical complications. At least 30 to 40 minutes of daily exercise following surgery is important to maintaining a healthy post-surgical life.
Behavior Therapy
A person’s lifestyle changes drastically following bariatric surgery, as patients must change old habits. It may be helpful for a post-surgical patient to undergo behavioral counseling/therapy or attend bariatric surgery support group meetings. Such therapy and meetings are typically provided through a hospital’s bariatric program.
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STATE MANDATES FOR OBESITY TREATMENT
Insured health benefits sold by insurance companies or HMOs are subject to state regulation. Several states have mandated coverage of treatments for morbid obesity, and the increasing prominence of the issue suggests more states will follow. States also often follow Medicare rules, and Medicare does cover bariatric surgery. Self-insured programs, which are regulated by ERISA, are generally not subject to such mandates. However, plan sponsors, when designing obesity benefits, often consider state mandates along with considerations such as cost, the quality of life for employees and spouses, and the potential reduction in absenteeism or future medical costs.
As with other mandates, state mandates for obesity will vary in their application and scope. A state may require health plans to cover morbid obesity treatment, or the state may simply require health plans to offer coverage of the treatment—the buyer can choose whether to purchase it. The mandate may apply to individual or group insurance, or to HMOs. Typically, the mandate text uses terms that are defined elsewhere in the regulations, and a review of that context is critical for correct interpretation.
Table 4, which summarizes the mandates for four states, illustrates that variability. Because state mandates often change, Table 4 should be considered illustrative.
TA B L E 4
STATE MANDATES
State
FOR
OBESITY TREATMENT
Scope and Application of Mandate
Georgia
Any individual or group health insurance plan or policy issued or delivered in Georgia, which provides major medical benefits, must offer coverage for the treatment of morbid obesity. 37
Maryland
Individual or group health insurance plans or policies issued or delivered in Maryland, which provide hospital, medical, or surgical benefits, must provide coverage for morbid obesity treatment. 38
Virginia
Any individual or group health insurance plan or policy issued or delivered in Virginia, which provides hospital, medical, or surgical benefits, or major medical benefits, must offer coverage for the treatment of morbid obesity. 39
Indiana
An Indiana HMO that provides group health insurance coverage must offer coverage for non-experimental, surgical treatment of morbid obesity. 40
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THE MEDICAL COSTS OF OBESITY
Health plans or employers trying to determine the medical costs of obesity through claims data will likely grossly underestimate aggregate costs. Currently, few obese patients will have any claims coded with an obesity diagnosis, although the increased focus on obesity may lead to improved coding by practitioners. We believe that the patients associated with obesity codes tend to be those with morbid obesity or those undergoing treatment explicitly for obesity.
We examined a large 2001 claims database from group employer-employee coverage. Claims databases have diagnosis codes but do not contain details such as height, weight, or BMI. For purposes of claim analysis, we defined obesity as the appearance of at least two physician claims or one hospital claim with the following International
Classification of Diseases (ICD) 9 codes:
278.00 Obesity, unspecified
278.01 Morbid obesity
The prevalence of obesity in the claims data demonstrates gross under coding. Only 0.3% of the insured population had these codes, in sharp contrast to population estimates of about 30% for obesity or 5% for morbid obesity. These differences are too large to be explained by demographic variation or the likelihood that some obese people would not have any physician or hospital claims in a year.
Because of under coding, the results of this database search cannot be used to characterize total costs. However, some of the results for this limited, probably relatively sick cohort are interesting.
•
Per-person claim costs for those identified as obese are about triple those for the average member.
•
A hospital admission rate of about 350 per 1,000. This contrasts to an admission rate of about 50 per 1,000 for an average commercial population. The admission rate for these obese or morbidly obese individuals is comparable to that of a Medicare population.
•
Cesarean section/total delivery rate of almost 50% of deliveries, more than double that of a typical commercial population.
•
About 25% of the admissions (corresponding to about 8% of individuals identified) were for Diagnosis
Related Group (DRG) 288—Operating Room Procedures for Obesity. This confirms our view that practitioners code obesity much more often when the medical treatment is immediately connected with obesity.
•
Although those coded for obesity accounted for 0.3% of the population, they accounted for a high portion of plausibly obesity-related admissions (see Table 5 on page 17).
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TA B L E 5
PEOPLE CODED
WITH
OBESITY GENERATE A DISPROPORTIONATE SHARE
(COMMERCIAL POPULATION)
Discharge Condition
OF
ADMITS
DRG
People Coded with Obesity (0.3% of population) generate this portion of total admits for each condition
88 to 91
2%
Heart Failure and Shock
127
3%
Chest Pain
143
2%
Stomach, Esophageal, and Duodenal procedures
154 & 155
21%
Hernia procedures
159 & 160
6%
209
5%
Bone Diseases and specific arthropathies
244 & 245
7%
Cellulitis
277 & 278
4%
Psychosis
430
2%
Chronic Obstructive Pulmonary
Disease and Pneumonia
Hip/Knee Joint replacements, etc.
As dramatic as these results are, the data do not come close to showing the true impact of obesity because of under coding.
Research has shown that as body mass increases, so do healthcare utilization and costs.41 One study suggests obesity increases health costs for inpatient and ambulatory care 36% and medication costs 77% compared to people in a normal weight range.42
Employers and businesses bear a sizable portion of costs associated with treating obesity-related conditions, primarily in terms of lost productivity and paid sick leave and the increased cost of health, life, and disability insurance.
Studies of overweight and obese employees have shown that obese employees take more sick leave than non-obese employees, are twice as likely to have high-level absenteeism (seven or more absences due to illness during the past six months), and one-and-a-half times more likely to have moderate absenteeism (three to six absences due to illness during the past six months).43
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SAMPLE PRICING OF A BARIATRIC SURGERY BENEFIT
This section describes how to estimate the cost of a bariatric surgery benefit exclusive of costs of weight-loss programs that may be a prerequisite for surgery. This technology is relatively new and the number of people who could potentially benefit from the surgery is not well-defined. Consequently, cost estimates have greater uncertainty than longer established procedures or benefits, such as spinal fusion, dental, or maternity care.
A well-defined benefit description is the customary starting point for pricing. However, for emerging medical technology such as bariatric surgery, the pricing process itself can uncover issues that could lead to an improved benefit description. We recommend that the pricing actuary work closely with medical, compliance, and network management experts and to expect an iterative process.
Cost offsets and future health plan cost reductions as a result of bariatric surgery seem likely, as a goal of the surgery is improved health. We have not considered any such offsets in this report.
•
Step 1: Translate the benefit description into particular services and identify the unit cost of those services.
■
Hospital inpatient costs are commonly paid on a case-rate, per-diem, or discounted charges basis. Unit costs may be defined by diagnosis-related group (DRG) or by some other mechanism. Because many hospitals do not perform bariatric surgery, it would be an oversimplification to apply the plan’s average reimbursement. Often, hospitals performing advanced surgery are the more expensive, tertiary hospitals.
While bariatric surgery naturally falls into DRG 288 (Operating Room Procedures for Obesity), we believe that hospitals often code DRGs 154-155 (Stomach, Esophageal, and Duodenal Procedures), which bring higher reimbursement from Medicare. The hospital cost for bariatric surgery can vary greatly, depending on the health plan’s hospital contracts and the geographic region. As a rough reference, for typical PPO plans, we find that DRG 288 cases cost about $25,000 and DRGs 154-155 cost about twice that amount.
■
Professional costs for the surgery involve the surgeon, of course, but will also include anesthesiologist services and may include an assistant surgeon. There are several different types of bariatric surgery, and choosing the appropriate current procedural terminology (CPT) codes is important. The fee schedule chosen should be appropriate for the professionals or network likely to perform the surgery.
As a rough reference for cost, for 2004, the national average Medicare (RBRVS) reimbursement for most bariatric surgery is above $1,500, and surgeons at prominent institutions often receive more than
Medicare fees for commercial patients. The actual amount will vary by locale and health plan reimbursement policy. Assistant surgeons often charge approximately one-half the fee of the primary surgeon.
Uncomplicated bariatric surgery is generally performed in about two hours. Anesthesiologists charge by
15-minute units. As a rough guide, in many areas, commercial plans pay anesthesiologists in excess of $60 per 15-minute unit. In addition, there may be inpatient consultations by specialists during the pre- and post-operative period.
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•
■
Pre-surgical screening and treatments—A variety of services and pharmaceuticals may be associated with preparation for surgery. Some of these, such as pre-surgical testing, may be included in the hospital fee. Other services, such as office visits, consultations, behavioral services, and diagnostic radiology may add costs.
■
Post-surgical services—After surgery, patients will need follow-up care, counseling, nutritional products, prescriptions, and monitoring.
■
Complications—Bariatric surgery has risk, and some patients will suffer complications. Extra services may include longer lengths of stay, extra physician visits, or rehabilitation. Our database investigation suggests that some patients will suffer complications that could cause much higher costs. For example, we observed that some bariatric surgery patients received ventilator care or extensive surgery not obviously related to the bariatric procedures. In addition, some patients received revisions or reversals of bariatric surgery.
Step 2: Estimate the utilization for each service.
When a plan first offers bariatric surgery as a covered benefit, it may see a surge in utilization as the “pentup” demand is released.
■
A useful starting point is to estimate the maximum number of people who would potentially qualify for bariatric surgery based on the plan criteria. The plan is not likely to have data on individuals’ BMI measures, so population data from sources such as NHANES may be used for this
purpose.
■
The maximum number of patients eligible for surgery will be too high as an annual utilization estimate because some people will have contraindications to surgery and many others will not choose surgery.
Experience from insurers or consultants who have data from other programs can help create an “uptake” percentage. Adverse selection may cause the uptake percentage to exceed expectations.
■
In our 2001 database, we identified a frequency of about 0.3 bariatric surgeries per 1,000 insureds. This means that fewer than one out of 100 of the morbidly obese obtained bariatric surgery. While the popularity of the surgery is likely to increase, and more facilities will develop appropriate expertise, the number of patients in any year will likely remain far below the number of morbidly obese.
■
Creating a “tree” of services for each type of patient or type of surgery is a useful way to build a cost model. Some services, such as counseling and nutritional supplements, may extend beyond the usual 12month health benefit period.
■
The number of pre- and post-surgical services may be estimated with insight from clinical judgment or clinical protocols. Certain pre-surgical services such as office visits might not be truly additional services— the patient might have obtained those services even without preparing for surgery. Other pre-operative services, such as endoscopy or psychiatric testing, may generate additional costs. Post-surgical services are likely to be truly additional.
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•
•
Step 3: Consider the impact of benefit limits and cost-sharing.
■
Bariatric surgery is expensive, and the patients are expensive to treat. Patients will likely exceed typical out-of-pocket limits even before surgery, and some patients may reach policy limits.
■
Some services, such as counseling, may be covered under capitated carve-out contracts. As such, they may cause no extra costs to the health plan in the short-term.
Step 4: Total claim costs.
The product of utilization and unit cost, net of cost-sharing, plus administrative costs produces the cost to the health plan. If the program includes a step-therapy approach (e.g., pharmacotherapy or behavioral therapy for weight loss before attempting surgery), those costs will need to be included as well.
Using this approach, a typical case of bariatric surgery can easily cost a health plan $60,000, using the above assumptions. Assuming a 5% population of morbidly obese patients, and bariatric surgery for 1%, or one out of
100 of these morbidly obese individuals, the corresponding per member per month (PMPM) cost would be approximately $2.50. Higher or lower costs are certainly possible, and costs can vary year-to-year. Any particular plan will have costs that likely vary from this sample calculation because of demographic characteristics, plan design, cost levels, the popularity of surgery, and other factors.
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BENEFIT PLAN DESIGN CONSIDERATIONS
In this section, we discuss the benefit design considerations for obesity treatment coverage. Obesity raises coverage issues for two broad categories of benefits:
•
•
Wellness and health promotion
Aggressive medical treatment
While this report focuses on the costs of aggressive medical treatment, we note that wellness and health promotion addressing obesity and exercise can be low-cost. For example, the CEO can champion a healthy lifestyle.
Other programs can be relatively inexpensive, such as improving healthy food choices in the employee cafeteria or encouraging employees to walk more. Some programs can be expensive, such as the construction and maintenance of on-site health clubs or subsidies for health club memberships. Programs can raise tax-deductibility issues for the benefits provided. Charging obese people higher contributions (as is sometimes done with smokers) raises discrimination issues.
Aside from state mandates, there appears to be little consensus on covering aggressive obesity treatment. Some benefit plans are adding coverage, while others that had coverage are dropping it. The following lists considerations relevant to obesity treatment benefits. As with all other plan benefits, coverage must be communicated effectively to members and pass legal review.
Who is Covered and When?
Coverage decisions should consider medical appropriateness. For example, aggressive surgical treatment for adolescents may be controversial because of the lifelong changes in eating habits that surgical treatment requires. Coverage decisions also need to consider the potential for adverse selection—for example, where an employee “shops” for an employer whose benefit program covers bariatric surgery, perhaps with information from self-help groups. Waiting periods and pre-existing condition limitations may only partially control these risks. Other decisions involve whether retirees are covered and the effective date for coverage. Obesity prevalence in the over 60 age group is about as high as that for the under 60 age group.
Medical Management Decisions
A carrier or medical management vendor will often use evidence-based medical criteria to determine the following:
•
Policies for pre-certification.
•
Criteria for aggressive surgical treatment—for example, BMI measures or comorbidities, or failure of more conservative therapies.
•
Exceptions for efficient sequencing of care.
•
Which treatments and follow-up care are covered?
•
Does it make sense to restrict services to “Centers of Excellence” on quality grounds?
Evidence-based criteria use scientific data and can help medical management decisions avoid inappropriate care and improve the quality of care. We expect an increasing number of plans will require documented failures of more conservative treatments and high patient motivation before approving surgery.
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Benefit Decisions
Health benefit programs have dollar limits, cost-sharing, and network limitations. These features should be reviewed relative to medical management processes and must be reflected in the Plan Document and the Summary
Plan Description (SPD). Managers examining obesity treatment coverage should consider the following:
•
How do plan maximums, cost-sharing, etc. apply to obesity treatment?
•
Will bariatric surgery be subject to its own limits?
•
Will the plan cover the cost of less aggressive weight-loss programs that may be a prerequisite to surgery?
•
Will food and nutritional supplements following the surgery be covered?
•
How will initial evaluations, psychological testing, and follow-up monitoring be covered? Some of these services may appear to fall under behavioral health programs, which often have distinct benefit structures.
•
Will treatment be restricted to “Centers of Excellence” or network providers?
•
Will stop loss carriers impose limitations or rate changes if the health plan adds obesity benefits?
All of these considerations can involve legal, financial, and employee satisfaction consequences.
Although obesity promises to become one of the great public health issues of the early 21st century, costs will be borne by the private sector, and the private sector will be part of the solution.
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ACKNOWLEDGEMENTS
Special thanks to Avi Freedman, FSA, MAAA of Milliman for his assistance in extracting and summarizing data.
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Willett WC, Manson JE, Stampfer MJ, et al. Weight, weight change, and coronary heart disease in women.
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Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. New England Journal of Medicine, 2003; 348: 1625-1629.
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Barnes PM, Schoenborn CA. Physical activity among adults: United States, 2000. Advance Data from Vital and Health Statistics, 2003; 333:1-24.
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National Heart, Lung, and Blood Institute (NHLBI). Clinical guidelines on the identification, evaluation and treatment of overweight and obesity in adults, the evidence report. NIH Publication No. 98-4083. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed November 14, 2003.
26
ibid.
27
Schibanoff JM. Milliman Care Guidelines Ambulatory Care, 8th Edition. Seattle: Milliman USA; 2002.
28
National Heart, Lung, and Blood Institute (NHLBI). Clinical guidelines on the identification, evaluation and treatment of overweight and obesity in adults, the evidence report. NIH Publication No. 98-4083. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed November 14, 2003.
29
National Task Force on the Prevention and Treatment of Obesity. Very low calorie diets. JAMA, 1993; 270:
967-974.
30
National Heart, Lung, and Blood Institute (NHLBI). Clinical guidelines on the identification, evaluation and treatment of overweight and obesity in adults, the evidence report. NIH Publication No. 98-4083. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed November 14, 2003.
31
Private communication with American Society for Bariatric Surgery Executive Director Georgeann Mallory
2/25/04.
32
Oh CH, Kim HJ, Oh S. Weight loss following transected gastric bypass with proximal Roux-en-Y. Obesity
Surgery, 1997;7:142-147.
33
Howard L, Malone M, Michalek A, Carter J, Alger S, Van Woert J, Gastric bypass and vertical banded gastroplasty-a prospective randomized comparison and 5 year follow up. Obes Surg, 1996; 5: 55-60.
34
Schibanoff JM. Milliman Care Guidelines Inpatient and Surgical Care, 8th Edition. Seattle: Milliman USA;
2002.
35
American Society for Bariatric Surgery. Rationale for the surgical treatment of morbid obesity updated
11/29/01. Available at: http://www.asbs.org/html/rationale/rationale.html. Accessed November 14, 2003.
36
National Institute of Diabetes and Digestive and Kidney Diseases. Gastrointestinal surgery for severe obesity.
NIH Publication No. 01-4006. Available at: http://www.niddk.nih.gov/health/nutrit/pubs/gastric/gastricsurgery.htm. Accessed December 15, 2003.
March 2004
MILLIMAN RESEARCH REPORT
25
37
Georgia code § 33-24-59.7. Morbid Obesity Anti-discrimination Act.
38
Maryland Insurance Article § 15-839. Coverage for treatment of morbid obesity.
39
Virginia code § 38.2-3418.13. Coverage for the treatment of morbid obesity.
40
Indiana code § 27-13-7-14.5. Coverage for nonexperimental, surgical treatment of morbid obesity.
41
Heirhoff KA, Cuffel BJ, Kennedy S, Peters J. The association between body mass and health care expenditures. Clinical Therapeutics. 1997; 19: 811-820.
42
Sturm R. The effects of obesity, smoking, and drinking on medical problems and costs. Health Affairs, 2002;
21: 245-253.
43
Tucker LA, Friedman GM. Obesity and absenteeism: an epidemiologic study of 10,825 employed adults.
American Journal of Health Promotion, 1998:12:202-207.
26
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M I L L I M A N
Research
Report
Obesity: A Big Problem Getting Bigger
Kate Fitch, RN, MEd, CCM
Bruce Pyenson, FSA, MAAA
Steven Abbs
Margaret Liang
Peer Review by Tom Ruehle, FSA, MAAA; Kathy Zaharias, RN, MBA
MILLIMAN RESEARCH REPORT
March 2004
Obesity: A Big Problem Getting Bigger
PAGE
I.
EXECUTIVE SUMMARY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
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DEFINITION OF OBESITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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III.
INCREASING PREVALENCE OF OBESITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
IV.
HEALTH RISKS ASSOCIATED WITH OBESITY . . . . . . . . . . . . . . …show more content…
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TREATMENT OF OBESITY
Dietary Therapy . . . . . . .
Exercise . . . . . . . . . . .
Behavior Therapy . . . . . .
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ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
XII.
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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BENEFIT PLAN DESIGN CONSIDERATIONS .
Who is Covered and When. . . . . . . . . . . . .
Medical Management Decisions . . . . . . . . . .
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SURGICAL TREATMENT OF SEVERE OBESITY
Types of Bariatric Surgery . . . . . . . . . . . . . .
Indications for the Procedure . . . . . . . . . . . .
Complications and Death Following Surgery . . . .
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MILLIMAN RESEARCH REPORT
March 2004
EXECUTIVE SUMMARY
Obesity in the United States poses a significant and growing health risk. Some have speculated that because of the growing prevalence of obesity, today’s generation of young Americans may have a shorter average life span than their parents.1 The prevalence of obesity has doubled since 1980 and is now seen by the Centers for
Disease Control (CDC) as one of the top threats to the health of the nation.2 Approximately one out of every four Americans is considered obese, according to the CDC National Health Interview 2003 findings.3 The disease has been estimated to account for 9.1% of annual US medical expenditures4 and 5% of medical costs for
US business.5
A significant finding of our research is that the obesity diagnosis is coded on medical claims far too infrequently. This dramatic under coding makes it difficult to quantify the true impact of obesity. Without proper coding, disease management and wellness programs face a difficult obstacle identifying and encouraging obese patients to enter management programs. As obesity has become the focus of policy makers, public health experts, and employers, we expect increased emphasis on coding obesity as a primary or secondary diagnosis in medical claims.
Obesity treatments raise numerous cost and effectiveness challenges for patients, employers, and insurers. Some highly publicized treatments for the morbidly obese (e.g., gastric bypass surgery) come with high costs. Highprofile pharmaceutical treatments for obesity have been withdrawn from the market, and one has attracted numerous lawsuits with claims in the billions of dollars. Although evidence-based clinical guidelines on the
Identification, Evaluation, and Treatment of Overweight and Obesity in Adults were published in 1998,6 the prevalence of obesity continues to increase.
This report summarizes currently available information on prevalence, medical cost, and medical treatment of obesity, with a focus on the impact on employers and insurers for the commercial population (insured, nonMedicare, non-Medicaid). Disability, absenteeism, wellness, and life insurance costs are certainly increased by obesity, but these issues fall outside the scope of this report. This report is not a substitute for professional medical or legal advice, and the reader should consider that medical advances can render today’s knowledge obsolete. While we hope benefits and formulary decision makers will find this report useful, we also hope the pace of medical discovery or societal change will render many of the details obsolete in a few years.
March 2004
MILLIMAN RESEARCH REPORT
1
DEFINITION OF OBESITY
Everyday language describes people as “overweight” or “obese,” but what counts is the portion of body weight that is fat. The most common measure of obesity is body mass index (BMI), the measurement tool recommended for practitioners by the National Institute of Health (NIH) expert panel.7 BMI correlates with the portion of body weight that is fat. The generally accepted formula for BMI (Table 1) takes a person’s body weight, divides by the square of his or her height and multiplies by a units factor.8
TA B L E 1
BMI has limitations as a measure of body
FORMULAS FOR CALCULATING BMI fat. For example, BMI overestimates body fat in persons who are muscular and can
Metric formula
Non-metric conversion formula underestimate body fat in persons who have lost muscle mass. Yet, BMI is easy to weight (kg) weight (pounds)
703 x calculate and provides a more accurate height (m)2 height (inches)2 measure of total body fat than relying on weight alone. The Metropolitan Life
Insurance Tables, published for years by that life insurer, rely on weight, height, frame (small, medium, and large), and gender, and reflect desired weight (characteristics with the lowest mortality rates). They were developed primarily from white, higher socioeconomic status populations. Such tables have limited value when addressing obesity issues. 9
(
)
TA B L E 2
Overweight is defined as a BMI of 25.0 to
29.9. Obesity is defined as a BMI of 30 or greater. Extreme obesity (often referred to as morbid obesity) is defined as a BMI of 40 or greater.10 Table 2 shows the classification of overweight and obesity described by the
NIH. Obesity class correlates with risk of disease and treatment recommendations.11
CLASSIFICATION
OF
OVERWEIGHT
Weight Status
Underweight
Normal weight
Overweight
Obesity
Extreme obesity
AND
BMI
<18.5
18.5 - 24.9
25.0 - 29.9
30.0 - 34.9
35.0 - 39.9
≥40
OBESITY
BY
BMI
Obesity Class
I
II
III
A body mass index table, from the NIH
Values are the same for both genders guidelines,12 appears in Table 3. To use the table, first find the person’s height in the left-hand column labeled Height. Next, move across in the same row to the person’s weight. The corresponding
BMI is the number in bold at the top of the weight column.
2
MILLIMAN RESEARCH REPORT
March 2004
TA B L E 3
Height (Inches)
BODY MASS INDEX (BMI)
FOR
ADULTS
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
58
91
96
100
105
110
115
119
124
129
134
138
143
148
153
158
162
167
172
177
181
186
191
59
94
99
104
109
114
119
124
128
133
138
143
148
153
158
163
168
173
178
183
188
193
198
60
97
102
107
112
118
123
128
133
138
143
148
153
158
163
168
174
179
184
189
194
199
204
61
100
106
111
116
122
127
132
137
143
148
153
158
164
169
174
180
185
190
195
201
206
211
62
104
109
115
120
126
131
136
142
147
153
158
164
169
175
180
186
191
196
202
207
213
218
63
107
113
118
124
130
135
141
146
152
158
163
169
175
180
186
191
197
203
208
214
220
225
64
110
116
122
128
134
140
145
151
157
163
169
174
180
186
192
197
204
209
215
221
227
232
65
114
120
126
132
138
144
150
156
162
168
174
180
186
192
198
204
210
216
222
228
234
240
66
118
124
130
136
142
148
155
161
167
173
179
186
192
198
204
210
216
223
229
235
241
247
67
121
127
134
140
146
153
159
166
172
178
185
191
198
204
211
217
223
230
236
242
249
255
68
125
131
138
144
151
158
164
171
177
184
190
197
204
210
216
223
230
236
243
249
256
262
69
128
135
142
149
155
162
169
176
182
189
196
203
210
216
223
230
236
243
250
257
263
270
70
132
139
146
153
160
167
174
181
188
195
202
209
216
222
229
236
243
250
257
264
271
278
71
136
143
150
157
165
172
179
186
193
200
208
215
222
229
236
243
250
257
265
272
279
286
72
140
147
154
162
169
177
184
191
199
206
213
221
228
235
242
250
258
265
272
279
287
294
73
144
151
159
166
174
182
189
197
204
212
219
227
235
242
250
257
265
272
280
288
295
302
74
148
155
163
171
179
186
194
202
210
218
225
233
241
249
256
264
272
280
287
295
303
311
75
152
160
168
176
184
192
200
208
216
224
232
240
248
256
264
272
279
287
295
303
311
319
76
156
164
172
180
189
197
205
213
221
230
238
246
254
263
271
279
287
295
304
312
320 328
Weight (Pounds)
The definition of overweight for children is gender and age specific. BMI references gender-specific growth charts for children and teens aged 2 to 20 years. If a child or adolescent meets or exceeds the 95th percentile of the historical gender-specific BMI for age growth charts, they are considered overweight.13 Obesity in children is not specifically defined.
March 2004
MILLIMAN RESEARCH REPORT
3
INCREASING PREVALENCE OF OBESITY
According to the National Health and Nutrition Examination Survey (NHANES) 1999-2000, the age-adjusted prevalence of obesity was 30.5%—an increase from 22.9% as reported in NHANES III (1988-1994). The prevalence of overweight also increased during this period from 55.9% to 64.5%, and extreme obesity increased from
2.9% to 4.7%. The 1999-2000 survey results were based on height and weight measurements of 4,115 adult men and women who are a nationally representative sample of the US civilian non-institutionalized population.14 The prevalence of obesity was highest among women aged 40 to 59 years (37.8%) and 60 to 74 years (39.6%). Among the ethnic groups, the age-adjusted prevalence of obesity was highest among non-Hispanic black women (49.7%) and lowest among non-Hispanic white men (27.3%).
The prevalence of super obesity, defined as a BMI ≥ 50, also causes concern. The prevalence rate is reported to have increased from one in 2,000 to one in 400 from 1986 to 2000.15
Perhaps the most disturbing recent trend is the increase in overweight children and adolescents. Based on
NHANES survey data, the prevalence of overweight was 15.5% among 12- through 19-year-olds, 15.3% among
6- through 11-year-olds, and 10.4% among 2- through 5-year-olds (NHANES 1999-2000), increasing from
10.5%, 11.3% and 7.2%, respectively, as reported in 1988-1994 (NHANES III).16 “Overweight” in this case is defined as BMI at or above the 95th percentile according to the standard pediatric growth charts in use since the late 1970s.
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HEALTH RISKS ASSOCIATED WITH OBESITY
Obesity significantly worsens health and quality of life and shortens life expectancy. A prospective study of more than one million adults found that the risk of death rose with increasing BMI in all age groups and for all categories of causes of death.17 Estimates of the annual deaths of US adults due to causes related to obesity range from
280,000 to 325,000.18 A recent study concluded that obesity in adulthood is associated with a decrease in life expectancy of about seven years in both men and women.19
NIH Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults report the following health risks of overweight and obesity, based on an extensive review of randomized controlled trials.20
Hypertension (defined as mean systolic blood pressure ≥ 140 mm Hg, mean diastolic ≥ 90 mm Hg, or currently
taking anti-hypertensive medication)
Data from NHANES III show that the age-adjusted prevalence of high blood pressure in adults with BMI ≥
30 is 38.4% for men and 32.2% for women, respectively.
In contrast, the corresponding prevalence rates for adults with a BMI < 25 are 18.2% for men and 16.5% for women.
High total cholesterol (defined as ≥ 240 mg/dL)
Data from NHANES III and several large longitudinal studies report a higher body weight associated with increased cholesterol levels.
Diabetes
For each additional unit of BMI > 22, the relative risk of diabetes rises by roughly 25%. Studies also show that 46% of diabetics have a BMI ≥ …show more content…
30.
Coronary Heart Disease
Studies show that as BMI levels increase, so do the risks of nonfatal myocardial infarction and coronary heart disease (CHD) death. The Nurses’ Health Study21 found the relative risk for CHD was doubled at BMIs of
25 to 28.9 and more than tripled at BMIs of 29 or greater, compared with BMIs of less than 21.
Congestive Heart Failure
Studies show that congestive heart failure is often a complication of severe obesity and a major cause of death.
The duration of the obesity serves as a strong predictor of congestive heart failure.
Stroke
Recent prospective studies demonstrate that the risk of stroke shows a gradual increase as BMI rises, including findings that ischemic stroke risk is 137% higher in women with BMI > 32, compared with women having a
BMI < 21.
Osteoarthritis
Many studies associate overweight or obesity with an increased risk for the development of osteoarthritis, especially the risk for knee osteoarthritis.
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Gallstones
As adult weight increases, so does the risk of gallstones. The prevalence of gallstone disease among women increases from 9.4% in the first quartile of BMI to 25.5% in the fourth quartile of BMI according to
NHANES III data. Male gallstone disease prevalence climbs from 4.6% in the first quartile of BMI to 10.8% in the fourth quartile of BMI. Risk of either gallstones or cholecystectomy reaches a peak of 20 per 1,000 women per year when BMI exceeds 40, compared with three per 1,000 among women with BMI < 24.
Sleep apnea
Several studies show obesity, especially upper body obesity, is a risk factor for sleep apnea and has been shown to be related to its severity. Another significant finding is that a majority of people with sleep apnea have a
BMI > 30.
Cancer
A prospectively studied population of more than 900,000 US adults showed that individuals with a BMI ≥ 40 had mortality rates from all cancers combined that were 52% higher (for men) and 62% (for women) than the corresponding rates in normal-weight men and women.22
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TREATMENT OF OBESITY
The National Research Council’s Committee on Diet and Health states that overweight and obesity result from a complex interaction between genes and environment. This interaction is characterized by a long-term energy imbalance and is tied to a sedentary lifestyle and excessive consumption of calories.23 The “super sizing” of food portions and lack of physical activity have been cited as primary causes for the rise in obesity. According to a recent study by the National Center for Health Statistics, less than one-third of US adults engage in regular leisure-time physical activity and only about one-fifth of adults engage in a high level of overall physical activity.24
A two-step process of health risk assessment and management should be used in treating an obese patient. An individual’s health risk status is assessed by determining the degree of overweight or obesity based on BMI, waist circumference, and the presence of concomitant cardiovascular risk factors or comorbidities including coronary heart disease, peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, type 2 diabetes, and sleep apnea. Individuals are considered to have incremental health risks above those that are associated with these risk factors if they are physically inactive or have high serum triglyceride levels (obesity is commonly accompanied by elevated serum triglycerides).25 The treatment of these risk factors and comorbidities, along with a weight-loss program, is essential.
The assessment and documentation of patient motivation is critical before beginning a weight-loss therapy program. The NIH expert panel reports that weight reduction involves a major investment of time and effort on the part of the healthcare team, as well as significant expense to the patient. Consequently, a demonstrated high level of motivation for weight loss should be present prior to commencing clinical therapy. After motivation is confirmed, the patient and clinician should jointly devise goals and the treatment strategy.
According to the NIH recommendations, the initial goal of weight-loss therapy should be to reduce body weight by approximately 10% from baseline. With success, further weight loss can be attempted, if indicated. Weight loss should be at a rate of about one to two pounds per week for a period of six months, followed by re-evaluation of the need for further weight loss.
According to the NIH expert panel, there are three major components to the most successful therapy for weight loss and weight maintenance: dietary therapy, increased physical activity, and behavior therapy. In addition, pharmacotherapy should be considered as an adjunct to these lifestyle therapies in patients with a BMI ≥ 30 with no concomitant obesity-related risk factors or diseases, or for patients with a BMI ≥ 27 with concomitant obesityrelated risk factors or diseases including hypertension, dyslipidemia, coronary heart disease, type 2 diabetes, and sleep apnea. Certain patients may be candidates for weight-loss surgery. The literature suggests that weight-loss and weight-maintenance therapies that are provided over the long-term, and provide a higher frequency of contacts between the patient and the practitioner, lead to more successful weight loss and weight maintenance.
The following paragraphs summarize the treatment recommendations from the NIH expert panel on the
Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, based on an extensive review of published scientific literature.26
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Dietary Therapy
A key element of the current recommendation is the use of a moderate reduction in caloric intake to achieve a slow but progressive weight loss.
•
Low calorie diets are recommended for weight loss in overweight and obese persons. Reducing fat as part of a low calorie diet is a practical way to reduce calories.
•
Reducing dietary fat alone without reducing calories is not sufficient for weight loss. However, reducing dietary fat along with reducing dietary carbohydrates can facilitate caloric reduction.
•
A diet that is individually planned to help create a deficit of 500 to 1,000 kcal/day should be an integral part of any program aimed at achieving a weight loss of one to two pounds per week.
Exercise
•
Physical activity is recommended as part of a comprehensive weight-loss therapy and weight-loss maintenance program because it: (1) modestly contributes to weight loss in overweight and obese adults, (2) may decrease abdominal fat, (3) increases cardiorespiratory fitness, and (4) may help with maintenance of weight loss.
•
Physical activity should be an integral part of weight-loss therapy and weight maintenance. Initially, moderate levels of physical activity for 30 to 45 minutes, three to five days per week should be encouraged. All adults should set a long-term goal to accumulate at least 30 minutes or more of moderate-intensity physical activity on most, and preferably all, days of the week.
Behavior Therapy
Behavior therapy provides means and opportunities for modifying eating and physical activity habits as well as breaking down obstacles to compliance with dietary therapy and increased physical activity. Behavioral therapy and counseling often involve certified clinical psychologists and weekly or bi-weekly meetings. The psychologist and obese person work together to formulate strategies most conducive to the person establishing healthy weight loss habits.
NIH guidelines make the following recommendations:
•
Behavior therapy is a useful adjunct when incorporated into treatment for weight loss and weight maintenance.
•
Practitioners need to assess the patient’s motivation to enter weight-loss therapy and then take appropriate steps to motivate the patient for treatment.
•
Behavior therapy strategies to promote diet and physical activity should be used routinely, as they help achieve weight loss and weight maintenance.
Experience reveals that lost weight usually will be regained unless a weight-maintenance program combining dietary therapy, physical activity, and behavior therapy is continued indefinitely. This is why an accurate assessment of patient motivation is critical to the success of a weight-loss program. After six months of weight loss treatment, the rate of weight loss frequently decreases and levels off; efforts to maintain weight loss should be put in place. If more weight loss is needed, another attempt at weight reduction can be made requiring further adjustment of the diet and physical activity prescriptions. For patients unable to achieve significant weight reduction, prevention of further weight gain is an important goal.
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Prescription Drug Therapy
There has been an increased interest in the treatment of obesity with prescription drugs because of the poor outcomes often associated with behavior therapy, diet, and physical activity over the long-term. According to the
NIH recommendations, weight-loss drugs approved by the US Food and Drug Administration (FDA) may be used as part of a comprehensive weight-loss program, including diet and physical activity, for patients with a BMI
≥ 30 with no concomitant obesity-related risk factors or diseases, and for patients with a BMI ≥ 27 with concomitant obesity-related risk factors or diseases. Drugs should never be used without being accompanied by lifestyle modification. Drug therapy must be continually assessed for effectiveness and safety.
Following are indications for obesity prescription drug use recommended for weight loss, based on Milliman evidence-based clinical guidelines:27
•
Indications for pharmacotherapy for treatment of obesity
Indicated when ALL of the following are present:
❖
ANY ONE of the following:
- BMI > 30
- BMI between 27 and 30 and at least one major comorbidity
❖
NONE of the following contraindications are present:
- Pregnant or lactating
- Unstable cardiac condition or other serious medical condition
- Psychiatric disorder
- Patient taking incompatible drug
❖
Pharmacotherapy is part of a basic weight loss program
■
The following is a list of prescription drugs frequently used for weight loss:
•
Sibutramine (Meridia)
May be used for up to one year
■
Adverse effects include dry mouth, anorexia, and constipation
Orlistat (Xenical)
■
Indicated for short-term use
■
Side effects include oily stools and possible malabsorption of fat-soluble vitamins
Diethylpropion HCL (Tenuate)
■
Only short-term usage is required
■
Indicated in those with mild to moderate hypertension
■
Carries a potential low risk of physical or psychological dependence
■
Side effects include restlessness, dry mouth, and constipation
Mazindol HCL
■
Indicated for short-term usage
■
Contraindicated in those with severe hypertension or coronary vascular disease
■
Adverse effects include stimulant effect, insomnia, agitation, and dizziness
■
Abuse potential is low
Phentermine (Adipex-8, Pro-fast SA)
■
FDA approval for short-term use only
■
No case reports of heart valve abnormalities, but large-scale data on monotherapy are limited
■
•
•
•
•
The Milliman Care Guidelines® contain full citations of the evidence base along with comprehensive treatment guidelines.
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The field of pharmaceutical treatment is changing rapidly, and additional products may be available in coming years.
According to the studies analyzed by the NIH, pharmacotherapy using dexfenfluramine, sibutramine, orlistat, or phentermine/fenfluramine for six months to one year, when combined with lifestyle modification including diet and physical activity, results in weight loss in obese adults. The amount of weight lost as a result of prescription drug therapy varies by individual, but generally a person loses between 4.4 and 22 pounds over and above what they would be expected to lose through treatment that does not involve medication. Most of the weight loss occurs within the first six months of medication initiation. Unfortunately, most patients regain weight once any drug therapy is discontinued, and the success of pharmacotherapy demands lifestyle changes in diet, exercise, and behavior to increase its effectiveness.28 According to NIH recommendations, drugs should be discontinued if significant weight loss is not achieved—i.e., at least 4.4 pounds or more in the first four weeks of drug therapy. Studies have shown individuals who do not achieve this amount of weight loss have a low likelihood of long-term response.
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SURGICAL TREATMENT OF SEVERE OBESITY
Published reports indicate that severely obese adults who are treated with non-operative methods alone do not often achieve medically significant long-term weight loss. Most of these patients regain all the weight lost over the next five years.29
Surgery for severe obesity, referred to as bariatric surgery, began in the early 1950s. The techniques and clinical outcomes from bariatric surgery have improved dramatically over the years. The NIH expert panel’s review of recent studies reports that surgical intervention in adults with a BMI ≥ 40, or a BMI ≥ 35 with comorbid conditions, results in substantial weight loss. NIH recommendations state that when less invasive methods of weight loss have failed, surgical intervention is an option for carefully selected patients with clinically severe obesity (a
BMI ≥ 40 or a BMI ≥ 35 with comorbid conditions) who are at high risk for obesity-associated morbidity and mortality. Compared to other available interventions, surgery has produced the longest period of sustained weight loss in severely obese individuals.30
With recent publicity among celebrity figures undergoing bariatric surgery, the demand for surgery and facilities performing the surgery has increased. Health plans report an increase in requests for pre-certification of bariatric surgery. The American Society for Bariatric Surgery reports that 60,000 procedures were performed in 2002, and that number is expected to rise to 100,000 in 2003.31
Types of Bariatric Surgery
The aim of bariatric surgery (often referred to as gastric restrictive or gastric bypass procedures) is to modify the gastrointestinal tract to reduce net food intake. Bariatric procedures fall into two major designs:
•
Malabsorptive procedures involve rearrangement of the small intestine to decrease the functional length or efficiency of the intestinal mucosa for nutrient absorption. Malabsorptive procedures restrict both food intake and the amount of calories and nutrients the body absorbs. These are the most commonly performed bariatric procedures:
■
Roux-en-Y Gastric Bypass (RYGB)
Roux-en-Y Gastric Bypass is the most common of the malabsorptive surgeries. First, a small stomach pouch is created, thus restricting food intake. Next, a Y-shaped section of the small intestine is attached to the pouch to allow food to bypass the lower stomach and the first and second segments of the small intestine (duodenum and first portion of the jejunum). The bypass reduces the amount of calories and nutrients absorbed by the body. Laparoscopic RYGB is now being performed in some patients.
Reported median percentage excess weight loss after RYGB is 56% after four years.32 Dumping syndrome (stomach contents move too rapidly through the small intestine causing nausea, weakness, sweating, faintness, and sometimes diarrhea after eating) is a frequent side effect, and vitamin deficiency is common. This procedure comprises about 75% of bariatric surgical procedures.
■
Bilio-Pancreatic Diversion with Duodenal Switch (BPD-DS)
The BPD-DS involves removal of about 60% of the stomach and rerouting the food stream around a majority of the intestine—thus limiting the amount of nutrients that can be absorbed.
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This type of surgery is highly effective in inducing weight loss in supermorbidly obese patients (BMI ≥
50). Significant metabolic complications can occur. Currently this surgery accounts for approximately
10% of bariatric surgical procedures performed.
•
Restrictive operations do not bypass the stomach, but reduce the stomach size by restricting the size of the upper portion of the stomach.
■
Vertical Banded Gastroplasty (VBG)
The VBG is the most common restrictive operation for weight control. A small stomach pouch is formed through surgical stapling, reducing the capacity of the stomach to approximately one ounce. In order to prevent stretching, the outflow from the pouch into the rest of the stomach is reinforced with a band. The opening to the remainder of the stomach is approximately 3/4 of an inch.
One study reports that at five years post VBG surgery, no patient had sustained an excess weight loss of over 50%.33 VBG currently accounts for about 15% of bariatric surgical procedures performed.
Indications for the Procedures
Milliman evidence-based clinical guidelines include the following clinical indications for surgery or invasive treatment: 34
Gastric Restrictive Procedure with Gastric Bypass
•
Procedure is indicated when ALL of the following present:
Treatment indicated by ANY ONE of the following:
❖
Patient is at least 100 lbs over ideal weight or has a body mass index exceeding 40 kg/m2
❖
Patient’s body mass index is over 35 kg/m2 and a clinically serious condition exists (e.g., obesity hypoventilation, sleep apnea, diabetes, hypertension, cardiomyopathy, musculoskeletal dysfunction)
■
Surgical intervention indicated because patient has ALL of the following present:
❖
Failure to lose weight significantly or regaining of weight despite compliance with a multidisciplinary nonsurgical program including low or very low-calorie diet, supervised exercise, behavior modification, and support
❖
No specifically correctable cause for obesity (e.g., an endocrine disorder)
❖
Full growth
❖
Patient is receiving treatment in a surgical program experienced in obesity surgery, characterized by surgeons experienced with Roux-en-Y gastric bypass and a multidisciplinary approach, including ALL of the following:
- Preoperative medical consultation and approval
- Preoperative psychiatric consultation and approval
- Nutritional counseling
- Exercise counseling
- Psychological counseling
- Support group meetings
■
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Gastric Restrictive Procedure without Gastric Bypass
•
Procedure is indicated when ALL of the following present:
Treatment indicated by ANY ONE of the following:
❖
Patient is at least 100 lbs over ideal weight or has a body mass index exceeding 40 kg/m2
❖
Patient’s body mass index is over 35 kg/m2 and a clinically serious condition exists (e.g., obesity hypoventilation, sleep apnea, diabetes, hypertension, cardiomyopathy, musculoskeletal dysfunction)
■
Surgical intervention indicated because patient has ALL of the following present:
❖
Failure to lose weight significantly or regaining of weight despite compliance with a multidisciplinary nonsurgical program including low or very low-calorie diet, supervised exercise, behavior modification, and support
❖
No specifically correctable cause for obesity (e.g., an endocrine disorder)
❖
Full growth
❖
Patient is receiving treatment in a surgical program experienced in obesity surgery, characterized by surgeons experienced with vertical-banded gastroplasty and a multidisciplinary approach, including ALL of the following:
- Preoperative medical consultation and approval
- Preoperative psychiatric consultation and approval
- Nutritional counseling
- Exercise counseling
- Psychological counseling
- Support group meetings
■
The Care Guidelines also include protocols for inpatient care and full citations of the evidence base.
Complications and Death Following Surgery
Data from nearly 11,000 operations performed during 2000 and 2001 indicate an approximate 2% rate of major complication during the 30 days following bariatric surgery and a mortality rate associated with the surgery of less than 1%.35
Some patients require follow-up operations, such as abdominal hernia repair and abdominoplasty, that are considered minor surgery. Nearly 30% of patients develop nutritional deficiencies that can be avoided with vitamin and mineral supplements. Some patients experience gastrointestinal discomfort associated with eating.36
Follow-up Care
The following summarizes typical care issues following bariatric surgery. These are assembled from various bariatric program sources. Follow-up care forces the patient to bear a significant burden, which is why high patient motivation is required for success.
Nutrition
•
A regular diet starts about eight weeks or later after bariatric surgery, and patients are advised to eat smaller, more frequent meals, chew food thoroughly and eat slowly. A registered dietician often provides an individualized diet plan.
•
Long-term vitamin and mineral supplements are often necessary as a smaller stomach or bypass of the stomach makes it more difficult for the body to absorb essential vitamins and nutrients. Diets should be high in protein and low in fat, sugar, calories, and fiber.
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•
Adequate hydration is essential; however, as with food intake, drinking must be done in small amounts.
Generally speaking, a post-surgical patient should slowly drink six cups of fluids each day, drinking one cup of fluid between each meal and making sure to stop drinking 45 to 60 minutes before meals.
Exercise
A person undergoing bariatric surgery should be prepared to engage in physical exercise before the surgery to enhance flexibility, muscle strength, mobility, and endurance. Sufficient, regular exercise, begun well in advance of the procedure and resumed immediately following, helps a person feel better, recover more quickly and minimize the risk of post-surgical complications. At least 30 to 40 minutes of daily exercise following surgery is important to maintaining a healthy post-surgical life.
Behavior Therapy
A person’s lifestyle changes drastically following bariatric surgery, as patients must change old habits. It may be helpful for a post-surgical patient to undergo behavioral counseling/therapy or attend bariatric surgery support group meetings. Such therapy and meetings are typically provided through a hospital’s bariatric program.
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STATE MANDATES FOR OBESITY TREATMENT
Insured health benefits sold by insurance companies or HMOs are subject to state regulation. Several states have mandated coverage of treatments for morbid obesity, and the increasing prominence of the issue suggests more states will follow. States also often follow Medicare rules, and Medicare does cover bariatric surgery. Self-insured programs, which are regulated by ERISA, are generally not subject to such mandates. However, plan sponsors, when designing obesity benefits, often consider state mandates along with considerations such as cost, the quality of life for employees and spouses, and the potential reduction in absenteeism or future medical costs.
As with other mandates, state mandates for obesity will vary in their application and scope. A state may require health plans to cover morbid obesity treatment, or the state may simply require health plans to offer coverage of the treatment—the buyer can choose whether to purchase it. The mandate may apply to individual or group insurance, or to HMOs. Typically, the mandate text uses terms that are defined elsewhere in the regulations, and a review of that context is critical for correct interpretation.
Table 4, which summarizes the mandates for four states, illustrates that variability. Because state mandates often change, Table 4 should be considered illustrative.
TA B L E 4
STATE MANDATES
State
FOR
OBESITY TREATMENT
Scope and Application of Mandate
Georgia
Any individual or group health insurance plan or policy issued or delivered in Georgia, which provides major medical benefits, must offer coverage for the treatment of morbid obesity. 37
Maryland
Individual or group health insurance plans or policies issued or delivered in Maryland, which provide hospital, medical, or surgical benefits, must provide coverage for morbid obesity treatment. 38
Virginia
Any individual or group health insurance plan or policy issued or delivered in Virginia, which provides hospital, medical, or surgical benefits, or major medical benefits, must offer coverage for the treatment of morbid obesity. 39
Indiana
An Indiana HMO that provides group health insurance coverage must offer coverage for non-experimental, surgical treatment of morbid obesity. 40
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THE MEDICAL COSTS OF OBESITY
Health plans or employers trying to determine the medical costs of obesity through claims data will likely grossly underestimate aggregate costs. Currently, few obese patients will have any claims coded with an obesity diagnosis, although the increased focus on obesity may lead to improved coding by practitioners. We believe that the patients associated with obesity codes tend to be those with morbid obesity or those undergoing treatment explicitly for obesity.
We examined a large 2001 claims database from group employer-employee coverage. Claims databases have diagnosis codes but do not contain details such as height, weight, or BMI. For purposes of claim analysis, we defined obesity as the appearance of at least two physician claims or one hospital claim with the following International
Classification of Diseases (ICD) 9 codes:
278.00 Obesity, unspecified
278.01 Morbid obesity
The prevalence of obesity in the claims data demonstrates gross under coding. Only 0.3% of the insured population had these codes, in sharp contrast to population estimates of about 30% for obesity or 5% for morbid obesity. These differences are too large to be explained by demographic variation or the likelihood that some obese people would not have any physician or hospital claims in a year.
Because of under coding, the results of this database search cannot be used to characterize total costs. However, some of the results for this limited, probably relatively sick cohort are interesting.
•
Per-person claim costs for those identified as obese are about triple those for the average member.
•
A hospital admission rate of about 350 per 1,000. This contrasts to an admission rate of about 50 per 1,000 for an average commercial population. The admission rate for these obese or morbidly obese individuals is comparable to that of a Medicare population.
•
Cesarean section/total delivery rate of almost 50% of deliveries, more than double that of a typical commercial population.
•
About 25% of the admissions (corresponding to about 8% of individuals identified) were for Diagnosis
Related Group (DRG) 288—Operating Room Procedures for Obesity. This confirms our view that practitioners code obesity much more often when the medical treatment is immediately connected with obesity.
•
Although those coded for obesity accounted for 0.3% of the population, they accounted for a high portion of plausibly obesity-related admissions (see Table 5 on page 17).
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TA B L E 5
PEOPLE CODED
WITH
OBESITY GENERATE A DISPROPORTIONATE SHARE
(COMMERCIAL POPULATION)
Discharge Condition
OF
ADMITS
DRG
People Coded with Obesity (0.3% of population) generate this portion of total admits for each condition
88 to 91
2%
Heart Failure and Shock
127
3%
Chest Pain
143
2%
Stomach, Esophageal, and Duodenal procedures
154 & 155
21%
Hernia procedures
159 & 160
6%
209
5%
Bone Diseases and specific arthropathies
244 & 245
7%
Cellulitis
277 & 278
4%
Psychosis
430
2%
Chronic Obstructive Pulmonary
Disease and Pneumonia
Hip/Knee Joint replacements, etc.
As dramatic as these results are, the data do not come close to showing the true impact of obesity because of under coding.
Research has shown that as body mass increases, so do healthcare utilization and costs.41 One study suggests obesity increases health costs for inpatient and ambulatory care 36% and medication costs 77% compared to people in a normal weight range.42
Employers and businesses bear a sizable portion of costs associated with treating obesity-related conditions, primarily in terms of lost productivity and paid sick leave and the increased cost of health, life, and disability insurance.
Studies of overweight and obese employees have shown that obese employees take more sick leave than non-obese employees, are twice as likely to have high-level absenteeism (seven or more absences due to illness during the past six months), and one-and-a-half times more likely to have moderate absenteeism (three to six absences due to illness during the past six months).43
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SAMPLE PRICING OF A BARIATRIC SURGERY BENEFIT
This section describes how to estimate the cost of a bariatric surgery benefit exclusive of costs of weight-loss programs that may be a prerequisite for surgery. This technology is relatively new and the number of people who could potentially benefit from the surgery is not well-defined. Consequently, cost estimates have greater uncertainty than longer established procedures or benefits, such as spinal fusion, dental, or maternity care.
A well-defined benefit description is the customary starting point for pricing. However, for emerging medical technology such as bariatric surgery, the pricing process itself can uncover issues that could lead to an improved benefit description. We recommend that the pricing actuary work closely with medical, compliance, and network management experts and to expect an iterative process.
Cost offsets and future health plan cost reductions as a result of bariatric surgery seem likely, as a goal of the surgery is improved health. We have not considered any such offsets in this report.
•
Step 1: Translate the benefit description into particular services and identify the unit cost of those services.
■
Hospital inpatient costs are commonly paid on a case-rate, per-diem, or discounted charges basis. Unit costs may be defined by diagnosis-related group (DRG) or by some other mechanism. Because many hospitals do not perform bariatric surgery, it would be an oversimplification to apply the plan’s average reimbursement. Often, hospitals performing advanced surgery are the more expensive, tertiary hospitals.
While bariatric surgery naturally falls into DRG 288 (Operating Room Procedures for Obesity), we believe that hospitals often code DRGs 154-155 (Stomach, Esophageal, and Duodenal Procedures), which bring higher reimbursement from Medicare. The hospital cost for bariatric surgery can vary greatly, depending on the health plan’s hospital contracts and the geographic region. As a rough reference, for typical PPO plans, we find that DRG 288 cases cost about $25,000 and DRGs 154-155 cost about twice that amount.
■
Professional costs for the surgery involve the surgeon, of course, but will also include anesthesiologist services and may include an assistant surgeon. There are several different types of bariatric surgery, and choosing the appropriate current procedural terminology (CPT) codes is important. The fee schedule chosen should be appropriate for the professionals or network likely to perform the surgery.
As a rough reference for cost, for 2004, the national average Medicare (RBRVS) reimbursement for most bariatric surgery is above $1,500, and surgeons at prominent institutions often receive more than
Medicare fees for commercial patients. The actual amount will vary by locale and health plan reimbursement policy. Assistant surgeons often charge approximately one-half the fee of the primary surgeon.
Uncomplicated bariatric surgery is generally performed in about two hours. Anesthesiologists charge by
15-minute units. As a rough guide, in many areas, commercial plans pay anesthesiologists in excess of $60 per 15-minute unit. In addition, there may be inpatient consultations by specialists during the pre- and post-operative period.
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•
■
Pre-surgical screening and treatments—A variety of services and pharmaceuticals may be associated with preparation for surgery. Some of these, such as pre-surgical testing, may be included in the hospital fee. Other services, such as office visits, consultations, behavioral services, and diagnostic radiology may add costs.
■
Post-surgical services—After surgery, patients will need follow-up care, counseling, nutritional products, prescriptions, and monitoring.
■
Complications—Bariatric surgery has risk, and some patients will suffer complications. Extra services may include longer lengths of stay, extra physician visits, or rehabilitation. Our database investigation suggests that some patients will suffer complications that could cause much higher costs. For example, we observed that some bariatric surgery patients received ventilator care or extensive surgery not obviously related to the bariatric procedures. In addition, some patients received revisions or reversals of bariatric surgery.
Step 2: Estimate the utilization for each service.
When a plan first offers bariatric surgery as a covered benefit, it may see a surge in utilization as the “pentup” demand is released.
■
A useful starting point is to estimate the maximum number of people who would potentially qualify for bariatric surgery based on the plan criteria. The plan is not likely to have data on individuals’ BMI measures, so population data from sources such as NHANES may be used for this
purpose.
■
The maximum number of patients eligible for surgery will be too high as an annual utilization estimate because some people will have contraindications to surgery and many others will not choose surgery.
Experience from insurers or consultants who have data from other programs can help create an “uptake” percentage. Adverse selection may cause the uptake percentage to exceed expectations.
■
In our 2001 database, we identified a frequency of about 0.3 bariatric surgeries per 1,000 insureds. This means that fewer than one out of 100 of the morbidly obese obtained bariatric surgery. While the popularity of the surgery is likely to increase, and more facilities will develop appropriate expertise, the number of patients in any year will likely remain far below the number of morbidly obese.
■
Creating a “tree” of services for each type of patient or type of surgery is a useful way to build a cost model. Some services, such as counseling and nutritional supplements, may extend beyond the usual 12month health benefit period.
■
The number of pre- and post-surgical services may be estimated with insight from clinical judgment or clinical protocols. Certain pre-surgical services such as office visits might not be truly additional services— the patient might have obtained those services even without preparing for surgery. Other pre-operative services, such as endoscopy or psychiatric testing, may generate additional costs. Post-surgical services are likely to be truly additional.
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•
•
Step 3: Consider the impact of benefit limits and cost-sharing.
■
Bariatric surgery is expensive, and the patients are expensive to treat. Patients will likely exceed typical out-of-pocket limits even before surgery, and some patients may reach policy limits.
■
Some services, such as counseling, may be covered under capitated carve-out contracts. As such, they may cause no extra costs to the health plan in the short-term.
Step 4: Total claim costs.
The product of utilization and unit cost, net of cost-sharing, plus administrative costs produces the cost to the health plan. If the program includes a step-therapy approach (e.g., pharmacotherapy or behavioral therapy for weight loss before attempting surgery), those costs will need to be included as well.
Using this approach, a typical case of bariatric surgery can easily cost a health plan $60,000, using the above assumptions. Assuming a 5% population of morbidly obese patients, and bariatric surgery for 1%, or one out of
100 of these morbidly obese individuals, the corresponding per member per month (PMPM) cost would be approximately $2.50. Higher or lower costs are certainly possible, and costs can vary year-to-year. Any particular plan will have costs that likely vary from this sample calculation because of demographic characteristics, plan design, cost levels, the popularity of surgery, and other factors.
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BENEFIT PLAN DESIGN CONSIDERATIONS
In this section, we discuss the benefit design considerations for obesity treatment coverage. Obesity raises coverage issues for two broad categories of benefits:
•
•
Wellness and health promotion
Aggressive medical treatment
While this report focuses on the costs of aggressive medical treatment, we note that wellness and health promotion addressing obesity and exercise can be low-cost. For example, the CEO can champion a healthy lifestyle.
Other programs can be relatively inexpensive, such as improving healthy food choices in the employee cafeteria or encouraging employees to walk more. Some programs can be expensive, such as the construction and maintenance of on-site health clubs or subsidies for health club memberships. Programs can raise tax-deductibility issues for the benefits provided. Charging obese people higher contributions (as is sometimes done with smokers) raises discrimination issues.
Aside from state mandates, there appears to be little consensus on covering aggressive obesity treatment. Some benefit plans are adding coverage, while others that had coverage are dropping it. The following lists considerations relevant to obesity treatment benefits. As with all other plan benefits, coverage must be communicated effectively to members and pass legal review.
Who is Covered and When?
Coverage decisions should consider medical appropriateness. For example, aggressive surgical treatment for adolescents may be controversial because of the lifelong changes in eating habits that surgical treatment requires. Coverage decisions also need to consider the potential for adverse selection—for example, where an employee “shops” for an employer whose benefit program covers bariatric surgery, perhaps with information from self-help groups. Waiting periods and pre-existing condition limitations may only partially control these risks. Other decisions involve whether retirees are covered and the effective date for coverage. Obesity prevalence in the over 60 age group is about as high as that for the under 60 age group.
Medical Management Decisions
A carrier or medical management vendor will often use evidence-based medical criteria to determine the following:
•
Policies for pre-certification.
•
Criteria for aggressive surgical treatment—for example, BMI measures or comorbidities, or failure of more conservative therapies.
•
Exceptions for efficient sequencing of care.
•
Which treatments and follow-up care are covered?
•
Does it make sense to restrict services to “Centers of Excellence” on quality grounds?
Evidence-based criteria use scientific data and can help medical management decisions avoid inappropriate care and improve the quality of care. We expect an increasing number of plans will require documented failures of more conservative treatments and high patient motivation before approving surgery.
March 2004
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Benefit Decisions
Health benefit programs have dollar limits, cost-sharing, and network limitations. These features should be reviewed relative to medical management processes and must be reflected in the Plan Document and the Summary
Plan Description (SPD). Managers examining obesity treatment coverage should consider the following:
•
How do plan maximums, cost-sharing, etc. apply to obesity treatment?
•
Will bariatric surgery be subject to its own limits?
•
Will the plan cover the cost of less aggressive weight-loss programs that may be a prerequisite to surgery?
•
Will food and nutritional supplements following the surgery be covered?
•
How will initial evaluations, psychological testing, and follow-up monitoring be covered? Some of these services may appear to fall under behavioral health programs, which often have distinct benefit structures.
•
Will treatment be restricted to “Centers of Excellence” or network providers?
•
Will stop loss carriers impose limitations or rate changes if the health plan adds obesity benefits?
All of these considerations can involve legal, financial, and employee satisfaction consequences.
Although obesity promises to become one of the great public health issues of the early 21st century, costs will be borne by the private sector, and the private sector will be part of the solution.
22
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March 2004
ACKNOWLEDGEMENTS
Special thanks to Avi Freedman, FSA, MAAA of Milliman for his assistance in extracting and summarizing data.
March 2004
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23
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37
Georgia code § 33-24-59.7. Morbid Obesity Anti-discrimination Act.
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Maryland Insurance Article § 15-839. Coverage for treatment of morbid obesity.
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Virginia code § 38.2-3418.13. Coverage for the treatment of morbid obesity.
40
Indiana code § 27-13-7-14.5. Coverage for nonexperimental, surgical treatment of morbid obesity.
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26
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