A Study Of The Treatment Of Obesity
South Carolina Department of Health and Human ServicesReport toThe Committee on Medical, Military, Public, and Municipal AffairsIn ResponsetoConcurrent Resolution (S.1379)A Study of the Treatment of ObesityUndertaken byThe University of South CarolinaInstitute for Families in Society Health Services Research UnitJanuary 2011
USC/IFS Research TeamAna Lòpez–De Fede, PhDKathy Mayfield–Smith, MA, MBAChristopher Finney, MSAcknowledgementThe research staff would like to extend our appreciation to the SC Budget and Control Board, Office ofResearch and Statistics for their help in generating the data for this study. The members of the AdvisoryCommittee provided valuable insights on the ways to frame this study consistent with the legislativemandate. This study would not have been possible without their contributions and commitment of timeto this effort. We also wish to acknowledge the important contributions made by South Carolina Department of Health and Human Services staff in coordinating the Advisory Committee and study activities.The study investigators do not have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflictwith material presented in the report. This report is based on research conducted by the University of South Carolina,Institute for Families in Society, under contract to the South Carolina Department of Health and Human Services(DHHS). The findings and conclusions in this document are those of the author(s), who are responsible for its content,and do not necessarily represent the views of DHHS.Suggested CitationLòpez-De Fede, A., Mayfield-Smith, K., and Finney, C. (2011). A Study of the Treatment of Obesity. University of SouthCarolina, Institute for Families in Society: Columbia.Document layout and design prepared by Dawn Sudduth, Health Services Research Unit, Institute for Families in Society.
Bariatric Study Advisory Committee MembersSenator Darrell JacksonSouth Carolina SenateRepresentative Anton GunnSouth Carolina House of RepresentativesAntjuan SeawrightLegislative Aide to Senator Darrell JacksonThomas PeacockPresident, South Carolina Associationof Health UnderwritersPalmetto Insurance Group, LLCLarry MarchantExecutive DirectorSouth Carolina Association of Health PlansDr. Kaylene WeirCoxPremier Surgical Group, LLCDr. Neil McDevittBeaufort Memorial Hospital Bariatric Surgery ProgramDr. Fred VolkmanMedical Directors’ RepresentativeMedicaid Managed CareLathran WoodardChief Executive OfficerSouth Carolina Primary Health Care AssociationRosalyn GoodwinSouth Carolina Hospital AssociationScott RichardsonDirector, South Carolina Department of InsuranceKendall R. BuchananLegislative LiaisonSouth Carolina Department of Insurance
TABLE OF CONTENTSEXECUTIVE SUMMARY . 2INTRODUCTION . 6Alarming Trend: Obesity in the United States and South Carolina . 6Obesity and Poor Health Outcomes . 7The Cost of Obesity . 8Obesity and Bariatric Surgery. 9Bariatric Surgery Center of Excellence Designation . 10STUDY APPROACH . 11Project Timeline . 11Study Sample. 11Study Participant Inclusion Criteria . 12Data File . 13Data Analysis . 14STUDY FINDINGS . 14Patient Characteristics . 14Bariatric Surgery Outcomes . 17Complication Rates . 17Comorbid Conditions . 18Mortality Rates . 19Health Care Service Use and Paid Charges . 19CONCLUSION . 23Study Limitations . 23REFERENCES . 25Appendix A . 29Appendix B . 30Appendix C . 31
EXECUTIVE SUMMARYThe South Carolina Legislative concurrent resolution (S.1379) tasked the South Carolina Department ofHealth and Human Services (SCDHHS) and the Department of Insurance (DOI) jointly to undertake astudy of the treatment of obesity, including the compilation of data on the treatment of obesity throughbariatric surgery performed at facilities certified by the American Society for Bariatric Surgery (ASBS) ascertified Bariatric Surgery Centers of Excellence (BSCOE) compared to facilities not certified by theAmerican Society for Bariatric Surgery. Under contract with the SC Department of Health and HumanServices, the Institute for Families in Society at the University of South Carolina conducted this study.For this report, obesity refers to a formula based on height and weight — called the body mass index(BMI)1. Adults with a BMI of 30 or higher are considered obese. Extreme obesity, also called severeobesity or morbid obesity, occurs with a BMI of 40 or more. Surgery is indicated for persons with severeobesity (body mass index (BMI) of 40 kg/m2 or more) or for persons with a BMI of 35 kg/m2 or moreand serious co-morbidities such as diabetes, coronary heart disease, or obstructive sleep apnea.Alarming Trend: Obesity in the United States and South CarolinaAdult obesity rates have doubled over the past three decades, with more than 20 percent of the adultpopulation in the United States now classified as obese1, 2. The highest rates of obesity are in thesoutheast2 with women and African-Americans reporting higher BMI rates compared to men and otherracial ethnic groups2. Overall, obese individuals have poorer health outcomes and higher death ratesthan those with normal BMI rates1- 21. In South Carolina, obesity is a major risk factor among the top tenchronic conditions associated with the leading causes of death.The Cost of ObesityObesity is associated with increased health use and costs 2, 4, 6, 23. The annual direct medical cost to treatobesity-related illness in South Carolina is estimated to be four billion dollars with Medicare andMedicaid financing half of the medical care 23, 24.Obesity and Bariatric SurgeryA review of research studies documenting the long-term effects of obesity treatments found that weightloss from surgical and non-surgical interventions - diet and exercise and pharmacotherapy - for peoplesuffering from obesity was associated with decreased risk of development of diabetes, and a reductionin cholesterol and blood pressure25. While counseling and pharmacotherapy can promote weight loss,bariatric surgery-induced weight loss is a key intervention associated with sustained weight loss, healthcare costs savings and improving clinical health outcomes 26, 27, 28. Bariatric surgery, a last intervention2
for obese patients29, 30, 31, should be used as a treatment option for patients with morbid obesity whohave first attempted medical therapy and other non-surgical options.Bariatric Surgery Center of Excellence DesignationThe literature documents a growing body of research on the efficacy and safety of bariatric surgeryprocedures 36-53. In 2005, responding to the growing rate of bariatric procedures, the American Collegeof Surgeons and the American Society for Metabolic and Bariatric Surgery implemented programs foraccrediting hospitals as centers of excellence (COE) in bariatric surgery33. Standards for COE certificationvary somewhat between the programs, but they generally include minimum procedure volumestandards, availability of specific protocols and resources for managing morbidly obese patients, andsubmission of outcomes data to a central registry54. In February 2006, the Centers for Medicare andMedicaid Services determined that bariatric surgery is covered when conducted at medical facilities thatmeet stringent quality and safety criteria in their bariatric surgery programs54. The facility must berecognized as a Bariatric Surgery Center of Excellence (BSCOE) by the Centers for Medicare & MedicaidServices (CMS) as certified by the American Society for Metabolic and Bariatric Surgery or recognized byCMS as a Level One Bariatric Surgery Center as designated by the American College of Surgeons 42.KEY FINDINGSA total of 98,658 patients were included in the study with 5,576 in the bariatric surgery cohort and93,082 patients in the obesity group. The bariatric surgery groups are matched by gender and raceacross certification status.Patient Characteristics Patients undergoing procedures in BSCOE were more likely to have private and other federalinsurance programs. Severely obese individuals were more likely to have public insurance (Medicaidand Medicare) and other federal sources of insurance. The average age of the study population ranged between 40 and 49 years. Across all age groups,the volume of procedures was greater for facilities not certified as a BSCOE and for patientsbetween the ages of 40 and 49. The rate of bariatric surgery procedures substantially increased for each of the study anchor years,i.e., 2000 to 2006. Procedures performed at BSCOE have grown at a higher rate than procedures atnon-BSCOE facilities.3
Bariatric Surgery Outcomes Complication Rates: The seven-year average 180-day complication rate for gastroplasty procedureswas statistically higher for patients undergoing procedures at facilities not accredited as a BariatricSurgery Center of Excellence (BSCOE) compared to facilities with the designation. Comorbid Conditions: The percent of patients with claims associated with obesity related comorbidconditions declined substantially for patients who underwent bariatric surgery compared to severelyobese patients who did not undergo bariatric surgery. Health Care Service Use and Paid Charges: In the two-years after the bariatric surgery or severeobesity diagnosis, there was no statistically significant difference in the increase in visit rate per1,000 patients for the three outcome measures, i.e., emergency department (ED), inpatient hospitalstays (IP), and outpatient visits (OP). During the same period, the average number of inpatienthospital stays and paid charges increased for all groups. These findings would suggest the need toexamine these outcomes beyond two-years of the index event to determine adequately the costeffectiveness of bariatric surgery. The index event is not included in the analysis (Tables 4-5). Outcomes and paid charges for bariatric and non-bariatric patients: Excluding the index event preand post charges for OP, IP, and ED visits, the analysis found inpatient hospital stays to besignificantly higher for patients undergoing bariatric procedures. Inpatient hospital stay charges and visits were significantly higher for bariatric surgery patients. Aspreviously noted, this study examined post-charges within two-years of the index or anchor yearlimiting potential cost gains associated with reduced outpatient, inpatient, and emergencydepartment visits resulting from improved health outcomes. Paid insurance charges based on bariatric surgery facility status: Patients undergoing bariatricsurgery at non-BSCOE facilities were more likely to have higher rates of comorbid obesity-relatedconditions with Medicaid or Medicare as their primary source of insurance. Table 6 indicates anassociation between source of insurance and paid charges excluding the bariatric surgery procedure.The findings indicate higher paid charges for patients with Medicare insurance. Conversely, thelowest paid charges were for patients with Medicaid as their source of insurance. This pattern ofdifference between paid charges and source of insurance remains true for bariatric surgeryprocedures. Several factors associated with Medicare and Medicaid insured patients influence paidcharges. Medicare and Medicaid insured patients have higher inpatient hospital days,comorbidities, emergency room visits, and mortality compared to privately insured and othersources of insurance. In order to adequately address differences in patient populations, futurestudies must adequately control for these factors.4
CONCLUSIONOverall, this study supports the growing body of evidence documenting bariatric surgery as a promisingpractice in the treatment of severe obesity36 -60. It is a preliminary study requiring further examinationof bariatric procedures to adequately document the efficacy and cost effectiveness of these surgicalprocedures across differing segments of the population. As the initial retrospective study on bariatricsurgery in South Carolina, it documents several key findings. First, the rapid growth of bariatric surgeryin South Carolina among BSCOE facilities in South Carolina provides a viable option to meet the needs ofseverely obese patients. Second, documenting 180-day complication and mortality rates provides abaseline from which future long-tem studies can document outcome changes. Although somedifferences were identified, our study suggests the need for further analysis to document the differencein outcomes associated with bariatric procedures undertaken at Bariatric Surgery Centers of Excellencecompared to other facilities.Study LimitationsA major strength of this study is the design and use of a large claims database from all sources ofinsurance, allowing for better generalizability of bariatric surgery outcomes to severely obese patients inSouth Carolina. This study has several limitations that affect the study findings. The claims databasedoes not allow the confirmation of information in the medical record, such as body mass index,diagnosis of either obesity or comorbid conditions necessary to establish a matched cohort population.While the retrospective study design seems to be the best way to answer the study questions, picking acomparison group may introduce other confounders that may skew the results. The baseline healthstatus of patients seeking bariatric surgery, as compared with that of control subjects, is also unknown.A limitation of the claims database provided by the SC Budget and Control Board is the lack ofidentifiable information for each facility that would allow the research team to match the facility to COEdesignation with patient volume. Finally, given the highly competitive marketplace for bariatric surgery,BSCOE certification may provide a distinct advantage in the types of patients served by the facility, e.g.Medicare and Medicaid patients. Future studies must find mechanisms to receive identifiable data foreach facility while protecting their identity by grouping them into categories to assist sensitivity analysis.In conclusion, the study findings provide baseline data supporting the efficacy of bariatric surgery as aviable option for severely obese patients. It suggests the need for long-term data collection linked tomedical records and follow-up with patients regarding quality of life, patient satisfaction, and healthcare resource use.5
INTRODUCTIONUnder a concurrent resolution (S.1379), the South Carolina Department of Health and Human Servicesand the Department of Insurance are jointly tasked to undertake a study to examine the treatment ofobesity. The study is to include the compilation of data on the treatment of obesity through bariatricsurgery performed at facilities certified by the American Society for Bariatric Surgery (ASBS) as certifiedBariatric Surgery Centers of Excellence (BSCOE) compared to facilities not certified by the AmericanSociety for Bariatric Surgery. Under contract with the SC Department of Health and Human Services, theInstitute for Families in Society at the University of South Carolina undertook this study.For this report, obesity refers to a formula based on height and weight — called the body mass index(BMI) 1. Adults with a BMI of 30 or higher are considered obese. Extreme obesity, also called severeobesity or morbid obesity, occurs with a BMI of 40 or more. Surgery is indicated for persons with severeobesity (body mass index (BMI) of 40 kg/m2 or more) or for persons with a BMI of 35 kg/m2 or moreand serious co-morbidities such as diabetes, coronary heart disease, or obstructive sleep apnea.Alarming Trend: Obesity in the United States and South CarolinaAdult obesity rates have doubled over the past three decades, with more than 20 percent of the adultpopulation now classified as obese1, 2. Historical data indicate a slight increase in the rate of obesitybetween 1960 and 1980, followed by a marked increase over the subsequent three decades up totoday2.Figure 1: Trends in Overweight and Obese Adults6
Since the 1990s, obesity rates have doubled in the United States4 with more than 60 million,approximately 30 percent of, adults classified as obese1, 2. This trend is not limited geographically;however, certain states and population groups are more likely to have higher prevalence rates. SouthCarolina ranks ninth in the nation with twenty-nine percent of the adult population (2,748,599)classified as obese 1, 2.Figure 2: US Obesity Trend, 1990 - 2009Obesity Trends* Among U.S. AdultsBRFSS, 1990, 1999, 2009(*BMI 30, or about 30 lbs. overweight for 5’4” person)199919902009No Data 10%10%–14%15%–19%20%–24%25%–29% 30%Source: Behavioral Risk Factor Surveillance System, CDC.The highest rates of obesity are in the southeast2 with women and African-Americans reporting higherBMI rates compared to men and other racial ethnic groups2 (Appendix A). In South Carolina, highobesity rates are associated with lack of physical activity and with meals high in fat and sugar content3.Obesity and Poor Health OutcomesNot surprisingly, obesity is associated with health complications and poor health outcomes 4, 5, 6. Obesityis associated in the literature as the cause or contributing to the presence of the following medicalconditions: hypertension (high blood pressure)7, 8 heart disease and stroke7, 8 respiratory disorders (asthma; bronchitis; chronic obstructive pulmonary disease)9, 10 diabetes and related complications (blindness, kidney failure, amputation)11, 127
gallbladder disease12 cancer (endometrial, breast, and colon)13, 14 degenerative osteoarthritis and joint stress15 high cholesterol and triglyceride levels7, 8,16 sleep apnea17 premature death18 poor perinatal outcomes and birth defects19, 20 work disability21Overall, obese individuals have poorer health outcomes and higher death rates than those with normalBMI rates 1- 21. In South Carolina, obesity is a major risk factor among the top ten chronic conditionsassociated with the leading causes of death: heart disease (1st); cancer (2nd), strokes (3rd), Alzheimer'sDisease (non-obesity related) (4th), respiratory disorders (5th) and diabetes (6th)22.Figure 3: US Prevalence of Obesity by Race and EthnicityState-specific Prevalence of Obesity* AmongU.S. Adults, by Race/Ethnicity, 2006-2008White non-HispanicBlack non-HispanicHispanic(*BMI 30)Source: CDC Behavioral Risk Factor Surveillance System.The Cost of ObesityObesity is associated with increased health use and costs 2, 4, 6, 23. Recent estimates of the annualnationwide medical costs of obesity are as high as 147 billion23. On average, obese individuals havemedical costs that are 1,429 more than the costs of persons of normal-weight23. Currently, obeseindividuals will pay forty-two percent more in health care costs than normal-weight individuals will pay8
for health care23. The annual direct medical cost to treat obesity-related illness in South Carolina isestimated to be four billion dollars with Medicare and Medicaid financing half of the medical care 23, 24.The reported obesity-related costs will continue to increase without a strategic effort to curb thisalarming trend. Given the increased obesity rates and their impact on the well-being of SouthCarolinians, the next section summarizes key information on the role of bariatric surgery in addressingthis trend.Obesity and Bariatric SurgeryResearch studies have documented age, sex and ethnicity as key risk factors for weight gain1-3. A reviewof research studies documenting the long-term effects of obesity treatments found that weight lossfrom surgical and non-surgical interventions - diet and exercise and pharmacotherapy - for peoplesuffering from obesity was associated with decreased risk of development of diabetes, and a reductionin cholesterol and blood pressure25. While counseling and pharmacotherapy can promote weight loss,bariatric surgery-induced weight loss is a key intervention associated with sustained weight loss, healthcare costs savings and improving clinical health outcomes 26, 27, 28.Bariatric Surgery is the last intervention for obese patients29, 30, 31. In 1991, the National Institute ofHealth approved bariatric surgery as a treatment option for patients with morbid obesity. The NIHConsensus Conference on Surgical Treatment of Morbid Obesity (1998) states that obesity surgeryshould be reserved only for patients who have first attempted medical therapy: “Weight loss surgeryshould be reserved for patients in whom efforts at medical therapy have failed and who are sufferingfrom the complications of extreme obesity 31.”Candidates for bariatric surgery must meet the following criteria established by the National Institutesof Health32: Have a Body Mass Index (BMI) of 40 or more (about 100 lbs or more over ideal body weight); ora BMI of 35 or more with serious medical conditions related to obesity that would improve withweight loss. Have attempted (and failed) previous weight loss efforts with diet, exercise, lifestyle changes, ormedications. Be able to understand the possible risks, benefits, and side effects of the procedure. Understand and be committed to the lifestyle changes necessary to succeed. Be committed to lifestyle changes and long-term follow-up. Not have any medical, psychiatric, or emotional condition that would prohibit surgery. Be motivated and have realistic expectations of the surgery as a tool to help the patient loseweight.9
Surgical weight loss occurs by reducing energy intake with the optional procedure controlling theabsorption of food. Weight stability results balancing energy intake with energy outflow. While some ofthe changes are due to diet and weight loss alone, others are the result of anatomical changes in thegastrointestinal tract. Bariatric surgery procedures fall into two major categories 33:1) Restrictive surgery limits a patient’s ability to ingest large quantities of food while slowing downthe speed at which food empties the stomach.2) Combination surgery combines restrictive and absorptive approaches. This procedure restrictsfood intake and bypasses segments of the small intestines.The increased rates of bariatric surgery procedures have resulted in it becoming the second mostperformed abdominal operation in the United States34,35.Bariatric Surgery Center of Excellence DesignationThe literature documents a growing body of research on the efficacy and safety of bariatric surgeryprocedures36-53. In 2005, responding to the growing rate of bariatric procedures, the American Collegeof Surgeons and the American Society for Metabolic and Bariatric Surgery implemented programs foraccrediting hospitals as centers of excellence (COE) in bariatric surgery33. Standards for COE certificationvary somewhat between the programs, but they generally include minimum procedure volumestandards, availability of specific protocols and resources for managing morbidly obese patients, andsubmission of outcomes data to a central registry54. In February 2006, the Centers for Medicare andMedicaid Services determined that bariatric surgery is covered when conducted at medical facilities thatmeet stringent quality and safety criteria in their bariatric surgery programs 54. The facility must berecognized as a Bariatric Surgery Center of Excellence (BSCOE) by the Centers for Medicare & MedicaidServices (CMS) as certified by the American Society for Metabolic and Bariatric Surgery or recognized byCMS as a Level One Bariatric Surgery Center as designated by the American College of Surgeons42.These combined policy actions have substantially increased the opportunities for health care coverageand regulatory oversight associated with bariatric surgery procedures.The research on BSCOE certification status and patient outcomes is inconclusive. Initial studies using theBariatric Surgery Longitudinal Research studies document a general association between hospitalprocedure volume and lower complication rates – around 10 percent – with the most commoncomplaint being nausea/vomiting and lower mortality rates55. A recent study found that patients whoundergo bariatric surgery at hospitals designated as centers of excellence do not appear to have lowermortality rates or lower rates of complications than those whose procedures are performed at otherhospitals55, 56. Conversely, Medicare patients tend to do better when their procedures are performed athigh-volume centers or when they receive laparoscopic bariatric surgery at facilities certified by the ACSor ASMBS designation as a bariatric surgery center of excellence42. In the first federally funded,multicenter clinical studies to evaluate the overall risks, benefits and long-term impact of bariatricsurgery, researchers have found the overall risk of death and other adverse outcomes is low and variesconsiderably from patient to patient57, 58, 59.10
Building on this initial body of evidence and in response to the SC General Assembly's S.1379Concurrent Resolution, this study will examine bariatric surgery performed at facilities certified by theAmerican Society for Bariatric Surgery (ASBS) as certified Bariatric Surgery Centers of Excellence (BSCOE)compared to facilities not certified by the American Society for Bariatric Surgery (Non-BSCOE). It will bethe first study in South Carolina to examine bariatric surgery patient outcomes as a function of inpatientand emergency department visits, complications and mortality rates, and costs. The University of SouthCarolina Institute for Families in Society conducted this study under a contract with the South CarolinaDepartment of Health and Human Services.STUDY APPROACHProject TimelineTo meet the January 2011 report submission deadline, the following schedule of activities shaped thestudy approach: Appoint Advisory Committee – September 2009 Advisory Committee Meets Quarterly – Starting October 2009 Data Protocol and Approach Approved – October 2009 Case Sample Data Collection Instruments Approved – December 2009 Case Sample Data Collection and Analysis – January 2010 – December 2010 ORS Multiyear Data Linkages and Analysis – January 2010 – December 2010 Preliminary Draft Findings and Recommendation to Advisory Committee – October 2010 Draft Report – December 2010 Final Report to SC General Assembly – January 2011Study SampleThe study draws on data from the SC Budget and Control Board, Office of Research Statistics (ORS)inpatient hospital files to obtain two samples: (1) patients who had undergone bariatric surgery(bariatric surgery group), and (2) a matched cohort of severely obese patients who had not undergonebariatric surgery (obese group). ORS receives claims data from hospitals and outpatient facilities for allpatients across public and private sources of insurance. The bariatric surgery and obese patients werematched by age, race, gender, z
For this report, obesity refers to a formula based on height and weight — called the body mass index (BMI)1. Adults with a BMI of 30 or higher are considered obese. Extreme obesity, also called severe obesity or morbid obesity, occurs with a BMI of
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