thesis pointers

T R E N D S

TRENDS

Use And Costs Of Bariatric Surgery And Prescription Weight-Loss Medications Treatment for obesity has skyrocketed since 1998, but coverage poiicies remain uneven across insurers.

by William E. Encinosa, Didem IVi. Bernard, Claudia A. Steiner, and

Chi-Chang Chen

ABSTRACT: The extent of use of bariatric surgery and weight-ioss medications is unknown. Using the Nationwide Inpatient Sampie, we estimate that the number of bariatric surgeries grew 400 percent between 1998 and 2002; such surgeries were performed on 0.6 percent ofthe 11.5 miiiion aduits ciinicaiiy eiigibie in 2002. Hospitai costs for bariatric surgery grew sixfoid to $948 miiiion in 2002. The inpatient death rate declined 64 percent. Among em- ployers that covered weight-loss drugs in 2002, less than 2.4 percent of adults ciinicaiiy eli- gibie for these drugs used them, with average annual spending of $304 per user.

T HE OBESITY EPIDEMIC has recently pharmaceutical pipeline, with two currently been brought to the forefront of the na- in Phase III development.^ tional consciousness. As a result, much These bariatric treatments have substantial

attention is now drawn to two medical treat- health benefits. A recent meta-analysis found ments for obesity: bariatric surgery and bar- that the percentage of excess weight loss was iatrie pharmacotherapy. Bariatric surgery, 61.6-70.1 percent with gastric bypass, the most one of the fastest-growing surgical proce- commonbariatricsurgery. As a result, diabetes dures in the United States, involves restrict- was completely resolved in 76.8 percent of pa- ing the size of the stomach and bypassing tients.' Another recent study found that gas- part of the intestines to reduce the absorption trie bypass patients had an 89 percent reduced of food. Bariatric pharmacotherapy involves relative risk of death.'' prescription weight-loss medications that ei- Although bariatric surgery is recom- ther reduce the absorption of fat or suppress mended only for morbidly obese persons with the appetite. Xenical (orhstat), a drug that a body mass index (BMI) of 40 or more, bariat- bloeks about one-third of ingested fat, was ric drug therapy is recommended for obese the third most heavily advertised drug in people with a BMI of 30 or more.' A recent 1999: $76 million was spent on advertising it meta-analysis found that bariatric medica- to consumers.' There are about twenty-two tions result in a net weight loss of fewer than new anti-obesity drug compounds in the ten pounds (over the placebo weight loss) at

William Encinosa ([email protected]) is a senior economist in the Center for Delivery, Organization, and Markets, Agency for Healthcare Research and Quality, in Rockville. Maryland; Claudia Steiner is a senior research physician there. Didem Bernard is a senior economist in the AHR^Center for Financing, Access, and Cost Trends. Chi-Chang Chen is a postdoctoral fellow at the University of Maryland School of Pharmacy in Baltimore.

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DOI 10.1377/hlthaff.24.4.1039 O2005 Project HOPE-T/ic Peopk-to-People Health Foundation, Inc.

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one year, but this amount may still be clinically significant in reducing diabetes and high blood pressure.*

There are no national estimates of the use and costs of bariatric surgery and weight-loss prescription drugs. In this paper we address this data gap using national hospital and in- surance claims data.

Study Data And Methods Our first data source was the Nationwide

Inpatient Sample (NIS) ofthe Healthcare Cost and Utilization Project (HCUP) for 1998 and 2002.'' The NIS is a nationally representative inpatient care database containing data from about 1,000 hospitals sampled to approximate a 20 percent stratified sample of U.S. commu- nity hospitals. Total charges reported in the NIS are used with hospital-specific cost-to- charge ratios to estimate hospital costs for bar- iatric surgeries.^

Our second source of data was the Medstat 2002 MarketScan Commercial Claims and En-

counter Database, which contains claims for inpatient care, outpatient care, and prescrip- tion drugs for enroliees under age sixty-five in the employer-sponsored benefit plans of forty- five large employers across the country. The MarketScan data include 5.6 million people— a 3 percent sample of Americans with em- ployer-sponsored health insurance coverage (5.1 million of these have drug coverage).

First, we used the NIS and the Medstat data to examine the use and costs of bariatric surgery Next, we used the Medstat data to study use of and spending for prescription weight-loss medications.

Study Results • Bariatric surgery: use and costs. Ex-

hibit 1 presents national estimates for use, to- tal hospital costs, and cost per surgery by payer based on the NIS data. The total number of surgeries more than quadrupled, from an es- timated 13,386 in 1998 to 71,733 in 2002. In 2002, privately insured patients accounted for

EXHiBiT 1 Nationai Estimates

Payer/use and cost measure

Number of surgeries Total Private Medicare Medicaid Seif-pay Other

Hospitai costs (miiiions) Totai Private iVIedicare Medicaid Seif-pay

Mean cost per surgery Aii payers Private Medicare Medicaid Seif-pay

Of Bariatric Surgery

1998

13,386 (2,021) 10,167 (1,528) 1,106 (209)

940 (218) 704 (197) 469 (192)

$157 (24) 117 (18) 15(3) 12(3) 8(2)

$11,705 (578) 11,494 (614) 13,865 (1,069) 12,785 (1,611) 10,866 (1,228)

Use And Costs, By

2002

71,733 (8,704) 59,497 (7,284) 4,261 (537) 3,463 (615) 2,479 (704) 2,033 (544)

$948 (120) 777 (102) 67(9) 52 (13) 25(5)

$13,215 (728) 13,048 (738) 15,903 (1,073) 15,051 (2,581) 9,828 (1,097)

Payer, 1998 And 2002

Percent change. 1998-2002

436 486 285 268 252 334

503 564 347 333 213

12.9 13.5 14.6 17.7 -9.6

SOURCE: iHeaithcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS), 1998 and 2002.

NOTES: All costs are in 2002 dollars and include inpatient costs only. Standard errors are in parentheses.

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83 percent of surgeries, while Medicare, Medic- aid, and self-pay accounted for 6, 5, and 3 per- cent, respectively. The remaining 3 percent were paid for by other government sources, a military plan for civilians, and charity.

National hospital costs for bariatric surger- ies increased more than sixfold, from an esti- mated $157 million in 1998 to $948 million in 2002, in constant 2002 dollars.' Mean cost per surgery increased 12.9 percent, from $11,705 in 1998 to $13,215 in 2002. The largest increase in average costs was for Medicaid-covered sur- geries, with an increase of 17.7 percent, despite a decline in length-of-stay from 5.8 days to 4.9 days (data not shown).

Exhibit 2 presents national estimates of the number of surgeries, lengths-of-stay, and inpa- tient death rates, by age and sex. Focusing on 2002, patients ages 18-54 accounted for 88 percent of all surgeries, while the near-elderly (ages 55-64) accounted for 11 percent. Adoles- cents and the elderly accounted for the re- maining 1 percent.'" The fastest growth in bar- iatric surgeries between 1998 and 2002—a tenfold increase—occurred among the near- elderly.

Overall, lengths-of-stay declined 24 per- cent for all surgeries, and the inpatient death

rate declined 64 percent (Exhibit 2). Both length-of-stay and mortality generally in- creased with age.

Women were more likely than men to un- dergo bariatric surgery in both years. In 2002 women accounted for 84 percent of all surger- ies. However, both lengths-of-stay and inpa- tient death rates were higher among men. Although the inpatient death rate for men de- clined greatly between 1998 and 2002, it was still three times higher than the rate among women.

Based on national estimates of surgeries for 2002, we next estimated the prevalence of bar- iatric surgery among those who were clinically eligible." Using the clinical guidelines de- scribed above, we estimated that there were at least 11.5 million adults eligible for bariatric surgery in 2002.'̂ Adjusting for multiple sur- geries per patient, we estimated that there were a total of 70,124 adult bariatric patients in 2002." Thus, of the 11.5 million adults who were clinically eligible for the surgery, only 0.6 percent received the surgery in 2002.

• Bariatric surgery prices. Exhibit 3 presents use and spending by type of surgery, using the 2002 Medstat employer data. While Exhibit 2 presents hospital costs. Exhibit 3

EXHIBIT 2 National Estimates Of Bariatric Surgery Use And Outcomes, By Age And Sex, 1998 And 2002

Number of surgeries Length-of-stay (days) Inpatient death rate (percent)

Age (years) 12-17 18-34 35-44 45-54 55-64 65+

1998

- 4,336 (636) 4,825 (638) 3,320 (472)

772 (114) -

2002

178 (31) 19,554 (2,202) 23,404 (2,667) 20,264 (2,124)

7,719 (941) 615 (107)

1998

- 4.4 (0.2) 4.9 (0.2) 5.6 (0.3) 5.7 (0.5) -

2002

3.5 (0.3) 3.4 (0.1) 3.6 (0.1) 4.1 (0.2) 4.3 (0.2) 6.1(1.1)

1998

- 0.47 (0.21) 1.10 (0.40) 0.91 (0.38) 0.00 (0.00) -

2002

0.00 (0.00) 0.05 (0.04) 0.23 (0.07) 0.43 (0.11) 0.93 (0.26) 1.71 (1.23)

Sex Male Female

Totai

2,527 (365) 10,859 (1,650)

13,386 (2,021)

11,289 (1,530) 60,444 (6,976)

71,733 (8,704)

5.9(0.3) 4.8 (0.2)

4.99 (0.21)

4.0 (0.2) 3.8 (0.1)

3.80 (0.13)

2.76 (0.65) 0.46(0.15)

0.89 (0.20)

0.79 (0.18) 0.24 (0.05)

0.32 (0.05)

SOURCE: Healthcare Cost and Utilization Project (HCUP) Nationwide inpatient Sampie (NIS), 1998 and 2002. NOTES: Standard errors are in parentheses. The number of surgeries in age groups 12-17 and 65+ for 1998 is too smaii to provide a reliabie estimate.

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EXHIBIT 3 Average Barlatric Surgery Spending In A Sample Of Large Employers, 2002

Type of surgery

Banding and gastroplasty without bypass

Gastric bypass: Roux-en-Y Other gastric bypass Revision oniy Totai

Non-iaparoscopic Laparoscopic Total

Without revision With revision Totai

Number of surgeries

117 2,531

276 64

2,988

2,577 411

2,988

2,855 133

2,988

Average payments ($)

Total

15,704 19,375 19,914 22,387 19,346

19,623 17.608 19,346

19,031 26,105 19,346

Hospital

13,320 16,781 16,566 19,293 16,679

16,977 14,813 16,679

16,378 23,134 16,679

Physician

2,385 2,595 3,348 3,094 2,667

2,646 2,795 2,667

2,653 2,970 2,667

Out of pocket

673 643 604 421 635

576 1,009

635

623 901 635

Health plan

15,032 18,733 19,310 21,967 18,710

19,047 16,600 18,710

18,408 25,203 18,710

SOURCE: iVIedstat, iViarketScan 2002 (5.6 miiiion noneiderly covered iives in empioyer-sponsored heaith plans).

NOTES: "Other gastric bypass" includes long limb bypass and biiopancreatic diversion. Ail payments are for inpatient hospitai

presents the prices actually transacted. In 2002 the average price for a surgical procedure was $19,346. Physician payments accounted for 14 percent ($2,667), while hospital pay- ments accounted for 86 percent ($16,679) of total payments." On average, patients paid 3.3 percent of expenditures in the form of copay- ments or deductibles, and health plans paid the remainder.

Detailed information in the Medstat data (CPT-4 codes for procedures) enabled us to examine use and spending by type of bariatric surgery. Exhibit 3 groups the surgeries into four types. The first type (gastric banding and gastroplasty without bypass) simply reduces the size of the stomach, either by stapling the stomach (gastroplasty) or by placing a tight band around the stomach. The second type (Roux-en-Y gastric bypass) includes a reduc- tion in the size of the stomach and a bypassing of part of the intestines to reduce the absorp- tion of food. The third type (other gastric by- pass) is a more advanced technique in which longer lengths of the intestine are bypassed under biiopancreatic diversion or duodenal switch gastric bypass.'' The fourth type of sur- gery (revision only) is a follow-up surgery that may involve readjusting the band, revising the

surgical joining of the bypass, or dealing with a comphcation.

The less intensive banding, or gastroplasty without gastric bypass, accounted for 4 per- cent of surgeries, while Roux-en-Y gastric by- passes accounted for 84.7 percent. Other gas- tric bypasses made up 9.2 percent of surgeries, while revision-only surgeries accounted for the remaining 2 percent. Payments increased as surgeries became more advanced from banding/gastroplasty to Roux-en-Y to other gastric bypass. Also, doctors were paid more as the surgeries became more advanced.

We also found that payments varied by the type of health plan. For example, for Roux-en- Y, the average total payment was only $16,222 under capitated health maintenance organiza- tions (HMOs). For fee-for-service plans, point-of-service HMOs, and preferred pro- vider organizations (PPOs), the total pay- ments were $17,749, $20,154, and $21,698, re- spectively Length-of-stay was 3.9 days for all health plans.

Bariatric surgeries may be conducted in two ways. The non-laparoscopic approach re- quires the abdomen to be opened, while the laparoscopic method is a less invasive method in which surgeons, guided by a video camera.

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gain access to the abdomen through several small incisions. Fourteen percent of bariatric surgeries were laparoscopic (94 percent of these laparoscopies occurred in Roux-en-Y bypass). Laparoscopic surgeries were less costly than non-laparoscopic surgeries; how- ever, doctors were paid 6 percent more for lap- aroscopy (Exhibit 3). Moreover, the patient's out-of-pocket payment was 75 percent higher for laparoscopy.

Of all surgeries, 3.8 percent involved a revi- sion; 2 percent had a revision during a follow- up surgery, and L8 percent, during the initial surgery. Surgeries with revisions were 37 per- cent more costly than surgeries without revi- sions (Exhibit 3).

• Prescription weight-loss medica- tions. As of 2002, eight drugs had been ap- proved for weight loss. Of these, sibutramine (Meridia) and orlistat (Xenical) are approved for up to two years of use.'* The other medica- tions are sympathomimetic amphetamine-like drugs; phentermine, phenylpropanoiamine, benzphetamine, phendimetrazine, diethylpro- pion, and mazindoi.''' These amphetamine-hke drugs are labeled for short-term use (up to twelve weeks).'^ Orlistat is a lipase inhibitor, which blocks fat absorption, while the other seven drugs are appetite suppressants.

Exhibit 4 presents prescription weight-loss

medication use and spending among the 2002 Medstat employer sample. Of the 5.1 miUion with drug coverage, about 4 million had bar- iatric drug coverage. Of that 4 million, 21,931 used bariatric prescription drugs. Among the users, 45 percent used orhstat, 30 percent used sibutramine, and 35 percent used sympatho- mimetics (10 percent used multiple drugs). Close to 71 percent of the sympathomimetic prescriptions were for phentermine.

Although orlistat and sibutramine are rec- ommended for long-term use (up to two years), the average number of days of medica- tion supphed per patient per year was 110 days for orhstat and 102 days for sibutramine. This may suggest that the discomfort of side effects reduces adherence." The average number of days of medication supphed per patient per year was 111 days for sympathomimetics. The average total supply of drugs per patient per year was 118 days, which reflects the fact that 10 percent of patients in the data took multiple weight-loss medications.

Patients spent an average of $304 each for weight-loss medications each year; patients paid 26 percent of this amount, and health plans, 74 percent. This annual total payment per person increased with age, from $192 per person for ages 8-17 to $361 for ages 55-64. Al- though only 22 percent of users were men.

EXHIBIT 4 Average Spending For Prescription Weight-Loss Medications in A Sample Of Large Empioyers, 2002

Type of drug Number of patients

Average number of days supplied per patient

Average annual payment per patient ($)

Total Out of pocket

Health plan

Lipase inhibitor Orlistat

Appetite suppressants Sibutramine Sympathomimetics

Totai

9,827

6,376 7,820

21,931

110

102 111

118

356

317 147

304

29

38 21

29

327

289 126

275

SOURCE: Medstat, MarketScan 2002 drugfiie (5.1 miiiion nonelderiy covered iives in empioyer-sponsored heaith pians with drug coverage). NOTES: Number of patients and days suppiied do not add up to the totai since 10 percent of patients took more than one type of drug. Sibutramine is a long-term appetite suppressant. Sympathomimetics are short-term appetite suppressants that include phenyipropanoiamine. phentermine, benzphetamine. diethyipropion, mazindoi, and phendimetrazine.

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men spent more on average on the drugs than women ($327 versus $297), because men used these drugs longer than women (122 days ver- sus 117 days per year) and because a greater proportion of men than women used the most costly drug, orlistat (44 percent versus 36 per- cent) (data not shown).

Finally, we estimated the prevalence of bar- iatric medicine use among obese adults with employer coverage for the drugs. From our 2002 MarketScan sample, we | ^ ^ ^ estimated that 918,000 non- elderly adults with bariatric drug coverage were clinically eligible to use bariatric pre- scription drugs.^° However, only 21,797 (2.4 percent) of these adults took bariatric medications.

"If Medicare decides to expand coverage for bariatric surgery In the near future,

the potential demand by the elderly may be

quite large." Discussion And Policy impiications

As bariatric surgeons perform more surger- ies and outcomes continue to improve, it is likely that more people will opt for the surgery. This potential demand may be quite large since the number of bariatric surgeries has grown 400 percent in just five years. This growth will likely continue, given that only 0.6 percent of the 11.5 million eligible people underwent the surgery in 2002. '̂

Use of weight-loss medications declined in 1997 wdth the removal of fenfluramine and dexfenfluramine from the market (because of heart value abnormaUties), but it picked up again in 1999, when orlistat entered the mar- ket.22 The industry reports that total U.S. sales for weight-loss medications in 2002 were $362 milhon.^' In 2002 an estimated 63.3 million U.S. adults were clinically ehgible for weight- loss medications but these drugs were used by less than 2.4 percent of those eligible. Thus, us- age could greatly increase, given that many new, more effective prescription weight-loss medications are being developed. '̂' Some of the new drugs in the pipeline, such as rimonabant (Acompha), will block a pathway in the brain that produces the craving for food. In recent trials of rimonabant, 44 percent of subjects

lost more than 10 percent of body weight at one year compared with 10 percent of subjects taking placebo.̂ ^ Other new drugs will block the hormone ghrelin, which is sent from the stomach to the brain to create an appetite.^* Some drugs vM instead stimulate beta 3 recep- tors to increase fat burning within the body. '̂ These new medications will likely increase the demand for weight-loss drug therapy

For the elderly, the Medicare program cov- ers bariatric surgery only for those patients with coexist- ing conditions such as diabe- tes.̂ ^ The rate of increase in bariatric surgery between 1998 and 2002 was highest among the near-elderly (ages 55-64), at 900 percent. An es- timated 395,000 elderly peo- ple (ages 65-69) will be clini- cally eligible for bariatric

surgery in 2005.^' By 2010 this number could grow to 475,000. Thus, if Medicare decides to expand coverage for bariatric surgery in the near future, the potential demand by the el- derly may be quite large.

Bariatric drugs are not included in the final version of U.S. Pharmacopeial Convention (USP) Model Guidelines created under the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The act excludes agents used for weight loss. How- ever, according to the final rules recently re- leased by the Centers for Medicare and Medic- aid Services (CMS), bariatric drugs can be covered by Medicare Part D if they are pre- scribed for a "medically accepted indication" such as morbid obesity. Thus, it is not yet clear to what extent the 500 potential drug plans in Medicare Part D wHl choose to include bariat- ric medications on their formularies. We esti- mate that about 3.3 million Medicare benefi- ciaries ages 65-69 will be clinically eligible for bariatric drugs in 2005.'°

Our results show a clear difference be- tween the sexes in the use of bariatric treat- ments. We estimated that 43 percent of the adults clinically eligible for drug therapy in 2002 were men; however, only 22 percent of

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adults taking bariatric prescription drugs were men. In contrast, while 57 percent of those clinically eligible were women, women accounted for 78 percent of drug users. Also, 31 percent of adults eligible for bariatric surgery in 2002 were men, but only 16 percent of pro- cedures among adults were performed on men.'' In contrast, while 69 percent of those el- igible for surgery were women, women ac- counted for 84 percent of the surgeries. More- over, men had worse in-hospital mortality rates than the women in their same age group. The higher inpatient mortality for men is con- sistent with higher coexisting illnesses or higher BMI at the time of surgery.'̂

This research was funded by the Agency for Healthcare Research and Quality (AHR$). The views herein do not necessarily reflect the views or policies o/AHR^, or the U.S. Department of Health and Human Services. The authors thank the thirty-five data organizations in states that contributed data to the "Nationwide Inpa- tient Sample. They also thank the editors, two anony- mous reviewers, and Scott Smith for their insightful comments.

NOTES 1. L. Bymark and R. Waite, Prescription Drug Use and

Expenditures in California: Key Trends and Drivers (Oakland; California HealchCare Foundation, 2001).

2. Datamonitor, Commercial and Pipeline Perspectives: Obesity (London: Datamonitor, June 2004).

3. H. Buchwald et al., "Bariatric Surgery; A System- atic Review and Meta-Analysis," joumal of the American Medical Association 292, no. 14 (2004); 1724-1737

4. N.V. Christou et al., "Surgery Decreases Long- Term Mortality, Morbidity, and Health Care Use in Morbidly Obese Patients," Annals of Surgery 240, no. 3 (2004); 416-423.

5. Bariatric surgery is also recommended for a BMI of 35 or more with serious medical condidons (such as severe sleep apnea, Pickwickian syn- drome, obesity-related cardiomyopathy, or dia- betes mellitus). Bariatric drug therapy is also rec- ommended for a BMI of 27 or more with two or more comorbidities (such as hypertension, dia- betes, or hyperlipidemia).

6. P. Shekelle et al., Pharmacolo^cal and Surreal Treat- ment of Obesity, Evidence Report/Technical Assess- ment no. 103, Prepared by the Southern CaMor-

nia-RAND Evidence-based Practice Center, Santa Monica, Calif., under Contract no. 290-02- 0003, Pub. no. O4'EO28'2 (RockvUle, Md.; Agency for Healthcare Research and Quality, July 2004).

7. Healthcare Cost and Udlizarion Project, "Data- bases," October 2003, vvww.hcup-us.ahrq.gov/ databases.jsp (11 April 2005).

8. Cost-to-charge ratios are obtained from standard accounting files at the Centers for Medicare and Medicaid Services. For the estimation of costs in HCUP, see B. Friedman et al., "Practical Options for Estimating Cost of Hospital Inpatient Stays," Joumal of HealthCareFinance 29, no. 1 (2002); 1-13.

9. We used the Consumer Price Index for aU urban consumers (CPI-U).

10. In fact, parients age sixty-five and older ac- counted for only 14 percent of Medicare bariatric surgeries in 2002 presented in Exhibit 1 (com- pared with 7 percent in 1998). Thus, patients un- der age sixty-five accounted for 86 percent of the surgeries covered by Medicare in 2002 (through the Medicare disability insurance program).

11. We did not include adolescents, since surgery is recommended for only a small subgroup; those at least age fifteen with a BMI of 50 or higher. See T.H. Inge et al., "Bariatric Surgery for Severely Overweight Adolescents; Concerns and Recom- mendations," Pediatrics 114, no. 1 (2004); 217-223.

12. Of these adults, 10.6 million have a BMI of 40 or more. About 868,000 have a BMI between 35 and 40 with diabetes, the most common comorbidity that makes this group eligible for surgery. This is based on 2002 obesity rates for adults reported in A.A. Hedley et al., "Prevalence of Overweight and Obesity among U.S. Children, Adolescents, and Adults, 1999-2002," Joumal of the American Medical Association 291, no. 23 (2004); 2847-2850. Diabe- tes rates among the obese can be found in A.H. Mokdad et al., "Prevalence of Obesity, Diabetes, and Obesity-related Health Risk Factors, 2001," Joumal of the American Medical Association 289, no. 1 (2003); 76-79.

13. In the Medstat data presented in Exhibit 3,2 per- cent of bariatric surgeries were follow-up surger- ies. We applied this rate to bariatric surgeries for the national population presented in Exhibit 1.

14. The hospital prices in Exhibit 3 are for large em- ployers, which tend to have generous benefits, while the cost estimates presented in Exhibit 1 are representative of the U.S. privately insured population as a whole. Therefore, we caution the reader against making direct comparisons of prices and costs across these exhibits.

15. R.E. Brolin, "Bariatric Surgery and Long-Term Control of Morbid Obesity," Joumal of the American Medical Association 288, no. 22 (2002); 2793-2796;

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and R. Steinbrook, "Surgery for Severe Obesity," New England Joumal of Medicine 350, no. 11 (2004); 1075-1079.

16. American Society of Health-System Pharmacists, AHFS Drug Information (Bethesda, Md.; ASHSP, 2004).

17 In November 2000, the EDA requested that phenylpropanoiamine be removed voluntarily from the market. In our 2002 data, only 2 percent of bariatric drug claims were for this drug.

18. Mosby, Mosby's Drug Ccmsult, 14th ed (St. Louis, Mo.; Mosby Inc., 2004).

19. Orlistat is recommended for one year, with treat- ment continued after one year if the patient toler- ates the drug well and sustained weight loss is documented. D.C. Dale and D.D. Eederman, eds., ACP Medicine (Danbury, Conn.; American College of Physicians, 2005). In a 104-week dinical trial, 12.9 percent of parients on orlistat dropped out of the study because of adverse effects and treat- ment failure. See J. Hauptman et al., "OrMstat in the Long-Term Treatment of Obesity in Primary Care Settings," Archives of Family Medicine 9, no. 2 (2000); 160-167

20. This is based on a 30.6 percent obesity rate among adults in 2002, reported in Hedley et al., "Prevalence of Overweight and Obesity."

21. This growth trend may be dampened by recent health plan decisions to drop coverage for bar- iatric surgery Blue Cross and Blue Shield of Elorida and Nebraska have recently dropped coverage. See R. Stein, "As Obesity Surgeries Soar, So Do Safety, Cost Concerns," Washington Post, 11 April 2004. Some health plans are instead carving out bariatric coverage as an oprional benefit. Blue Cross and Blue Shield of North Carolina introduced a new benefit. Healthy life- style Choices, designed specifically to deal with bariatric treatments. See B. McKay, "Blue Cross of North Carolina to Cover Cost of Treating Obe- sity," Wall Street Joumal 13 October 2004.

22. R.S. Stafford and D.C. Radley, "Narional Trends in Anriobesity Medicarion Use," Archives of Inter- nalMedicine 163, no. 9 (2003); 1046-1050.

23. Datamonitor, Commercial and Pipeline Perspectives: Obesity.

24. See J. Korner and L.J. Aronne, "Pharmacological Approaches to Weight Reducrion; Therapeuric Targets," Joumal of Clinical Endocrinology and Metabo- lism 89, no. 6 (2004); 2616-2621; J. Proietto et al., "Novel Anri-Obesity Drugs," Expert Opinion on In- vestigational Drugs 9, no. 6 (2000); 1317-1326; and H. Bays and C. Dujovne, "Anri-Obesity Drug De- velopment," Expert Opinion on Investigational Drugs 11, no. 9 (2002); 1189-1204.

25. Korner and Aronne, "Pharmacological Ap- proaches."

26. Bays and Dujovne, "And-Obesity Drug Develop- ment."

27 S. Vansal, "Beta-3 Receptor Agonists and Other Potenrial And-Obesity Agents," American Joumal of Pharmaceutical Education 68, no. 3 (2004); 1-10.

28. Centers for Medicare and Medicaid Services, "Narional Coverage Decision 40.5; Treatment of Obesity," 1 October 2004, www.cms.hhs.gov/ mcd/m_ncd.asp?id=40.5&tver-2 (U April 2005). For tracking CMS updates to its bariatric sur- gery coverage, see www.cms.hhs.gov/mcd/ viewncd.asp?ncd_id'=100.1fancd_version=l& basket=ncd%3A100%2El%3AGastric+Bypass+ Surgery+for+Obesity (11 May 2005). In 2004 the CMS removed the language "obesity itself cannot be considered an illness" from its manual. In late 2004 the CMS gathered the scientific evidence on bariatric surgery. Its next step is to decide whether to expand coverage for bariatric surgery to aU morbidly obese elderly people, not just those with comorbidides.

29. This is based on a 3.9 percent morbid obesity rate for adults age sixty or older, reported in Hedley et al., "Prevalence of Overweight and Obesity."

30. This is based on a 32.9 percent obesity rate among adults age sixty or older, reported in ibid.

31. This is based on obesity rate estimates by sex in K.M. Flegal et al., "Prevalence and Trends in Obe- sity among U.S. Adults, 1999-2000," Joumal of the American Medical Association 288, no. 14 (2002); 1723-1727

32. E.E. Mason, K.E. Renquist, and D. Jiang, "Peri- operadve Risks and Safety of Surgery for Severe Obesity," American Joumal of Clinical Nutrition 55, no. 2 Supp. (1992); 573S-576S.

1046 July/August 2005