Research
Original Investigation
Effect of Mandatory Centers of Excellence Designation on Demographic Characteristics of Patients Who Undergo Bariatric Surgery Junun Bae, MHS; Jaime Shade; Amanda Abraham; Brianna Abraham; Leigh Peterson, MHS; Eric B. Schneider, PhD; Thomas H. Magnuson, MD; Michael A. Schweitzer, MD; Kimberly E. Steele, MD, PhD
IMPORTANCE From February 21, 2006, through September 24, 2013, the Centers for Medicare & Medicaid Services (CMS) required, via the National Coverage Determination manual, that bariatric surgery be performed only in hospitals that had been designated as a Center of Excellence (COE). The effect of this certification requirement on access to bariatric surgery has been reported only anecdotally.
Invited Commentary page 649 CME Quiz at jamanetworkcme.com
OBJECTIVE To investigate whether the COE certification requirement proved to be a barrier to patients’ access to bariatric surgical procedures. DESIGN, SETTING, AND PARTICIPANTS Using the National Inpatient Sample, we retrospectively identified patients who underwent bariatric surgery from January 1, 2006, through December 31, 2011. EXPOSURE Bariatric surgery. MAIN OUTCOMES AND MEASURES Logistic regression and χ2 tests were used to examine differences in patients’ sociodemographic characteristics over time. RESULTS A total of 134 227 bariatric surgical patients were identified. The proportion of the population who were older than 64 years increased from 2.9% in 2006 to 7.0% in 2011 (P < .001) and there was a decrease in the proportion of patients who were 49 years and younger (P < .001). The percentage of female patients who underwent bariatric surgery decreased from 80.4% to 78.1% (P < .001) and the percentage of patients who were classified as black, Hispanic, or Asian or Pacific Islander increased from 12.3% to 15.1% (P < .001), 9.7% to 12.5% (P < .001), and 0.3% to 0.4% (P < .001), respectively. The proportion of patients with Medicare increased from 8.5% to 16.3% (P < .001) and those with Medicaid from 6.6% to 11.8% (P < .001). The percentage of patients with private insurance declined from 72.4% to 63.3% (P < .001). The proportion of patients in the lowest income quartile increased from 20.7% to 22.9% (P < .001) while those in the highest income quartile decreased from 25.8% to 23.9% (P < .001). CONCLUSIONS AND RELEVANCE The COE certification requirement by CMS did not appear to limit access to bariatric surgery. Future studies should determine whether CMS’s recent (2013) change in policy (ie, removing the mandatory COE certification for bariatric surgical insurance coverage) might sacrifice patient safety without addressing the real cause of limited access to health care.
Author Affiliations: Author affiliations are listed at the end of this article.
JAMA Surg. 2015;150(7):644-648. doi:10.1001/jamasurg.2015.74 Published online May 20, 2015. 644
Corresponding Author: Kimberly E. Steele, MD, PhD, The Johns Hopkins Center for Bariatric Surgery, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224 ([email protected]). (Reprinted) jamasurgery.com
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Monash University Library User on 11/24/2015
Centers of Excellence and Bariatric Surgery Patient Demographics
D
uring the past decade, the prevalence of morbid obesity has increased by 70% in the United States.1 A study from 2012 found that one-third of US adults are obese. Obesity is correlated with higher incomes among men and lower incomes among women and peaks in prevalence around middle age.2 Now a major public health concern, morbid obesity (defined as a body mass index, calculated as weight in kilograms divided by height in meters squared, of greater than 40) is associated with numerous comorbidities and high health care costs.3-6 Bariatric surgical procedures have proved to be the most effective treatment for morbid obesity.7-9 However, the frequency of bariatric surgical procedures performed in the United States has recently declined.10 Socioeconomic disparity in access to bariatric surgery has been suggested as a contributing factor to this decline.11,12 In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented a requirement that each hospital performing bariatric surgical procedures be designated as a Center of Excellence (COE).13-15 Requirements for the COE qualification addressed the following 10 factors: clinical pathways and standardized operating procedures; bariatric nurses, physician extenders, and a program coordinator; surgical volume and outcomes; appropriate equipment and instruments; longterm patient follow-up and outcomes data; an institutional commitment to excellence; a designated medical director; consultative services; surgeon dedication and qualified call coverage; and patient support groups. Within each of these areas are multiple specifications, ranging from a minimum of 125 qualifying bariatric surgical procedures in the year before COE certification to an established location for the center’s patients who underwent bariatric surgery.16 The decision to limit coverage was based on data suggesting that positive surgical outcomes were more frequent in hospitals that performed a high volume of procedures yearly (>125 cases); restricting patients to such hospitals was hoped to increase patient safety.13,17-19 In 2013, the CMS overturned its policy on COE facilities owing to increasing evidence that the surgical outcomes for COE facilities and nonCOE facilities were not different.13 Several studies have questioned the benefit of the National Coverage Determination (NCD) restriction to COE facilities. In 2010, Livingston10 calculated the distance to travel to a COE bariatric program vs a non-COE bariatric program and concluded that the COE restriction increased the travel distance for patients with Medicare, thereby reducing access to care. Livingston10 further argued that such patients were sicker, less mobile, and less able to travel great distances to receive bariatric medical care. While the differences in bariatric surgical outcomes between COE facilities and non-COE facilities remained uncertain, the requirement became highly controversial for impeding access to care.13 As a result, CMS decided to expand the coverage to hospitals that were not COE certified for bariatric procedures in 2013.13,20-22 The question remains as to whether the implementation of the COE requirement for bariatric surgical coverage created the unintended adverse effect of reducing access to health care in the name of improving quality. By examining the sociodemographic trends associated with relevant bariatric surgical procedures, we investigated whether jamasurgery.com
Original Investigation Research
coverage determination, established in 2006 and continued through 2013, was truly a barrier to accessing such procedures.
Methods Study Population We used data from January 1, 2006, through December 31, 2011, obtained from the Nationwide Inpatient Sample (NIS), which was developed by the Healthcare Cost and Utilization Project.23 The most recent NIS database, created in 2011, included approximately 20% of all US hospital discharges and was designed to be representative of approximately 97% of all hospital discharges in the United States.23 This data set contains representative inpatient clinical and nonclinical data, which allows for the exploration of year-specific differences in bariatric surgical procedures, in-hospital complications, and patient characteristics. Institutional review board approval was waived by Johns Hopkins Medicine because the NIS is publicly available data. Morbidly obese inpatients who underwent bariatric surgery were identified by the International Classification of Diseases, Ninth Revision (ICD-9), and by diagnosis-related group codes. Diagnoses for morbid obesity were confirmed with ICD-9 code 278.01. Morbidly obese patients who underwent bariatric surgery were identified via ICD-9 codes 43.89, 44.68, 44.95, 44.31, 44.38, and 44.39 and diagnosis-related group code 288. We excluded patients with ICD-9 codes for malignant neoplasm of the esophagus, stomach, and small intestine, including the duodenum, pancreas, and unspecified sites (codes 150, 151, 152, 157, and 199). We also excluded patients with ICD-9 codes for gastric ulcer, duodenal ulcer, and peptic ulcer without specification of site (codes 531-533) as a primary diagnosis.
Patient Characteristics Key patient characteristics of the analysis were age, age category, sex, annual income, type of insurance, comorbidity, and race/ethnicity. Age was treated as a continuous variable. The age category consisted of the following 4 groups: 18 to 34 years, 35 to 49 years, 50 to 64 years, and older than 64 years. Annual income was also stratified into 4 income quartiles: less than $36 000, $36 000 to $44 999, $45 000 to $59 999, and $60 000 or greater. Income was stratified based on the reported quartile of income levels. The types of insurance were categorized into Medicare, Medicaid, private insurance, self-pay, no charge, and other. We grouped patients by their number of comorbidities (0, 1, or 2). There were no patients with more than 2 comorbidities in this sample. We also used the Charlson Comorbidity Index, which calculates the probability of mortality in a given period based on existing comorbidities.24 Race/ethnicity was categorized into the following groups: white, black, Hispanic, Asian or Pacific Islander, Native American, and other.
Statistical Analysis Statistical analysis was conducted using Stata, version 12 (StataCorp LP). We set α = .05 for all analyses. Population proportions of bariatric surgical procedures were calculated by year. Multiple χ2 tests and unadjusted logistic regressions were conducted to test for differences in patient characteristics across time. (Reprinted) JAMA Surgery July 2015 Volume 150, Number 7
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Monash University Library User on 11/24/2015
645
Research Original Investigation
Centers of Excellence and Bariatric Surgery Patient Demographics
Table. Patient Sociodemographic Characteristics and Their Trends From the National Inpatient Sample Valuea Characteristic
2006
2007
2008
2009
2010
2011
P Valueb
Sample size
19 300
17 529
26 375
26 040
25 315
19 668
Original Investigation
Effect of Mandatory Centers of Excellence Designation on Demographic Characteristics of Patients Who Undergo Bariatric Surgery Junun Bae, MHS; Jaime Shade; Amanda Abraham; Brianna Abraham; Leigh Peterson, MHS; Eric B. Schneider, PhD; Thomas H. Magnuson, MD; Michael A. Schweitzer, MD; Kimberly E. Steele, MD, PhD
IMPORTANCE From February 21, 2006, through September 24, 2013, the Centers for Medicare & Medicaid Services (CMS) required, via the National Coverage Determination manual, that bariatric surgery be performed only in hospitals that had been designated as a Center of Excellence (COE). The effect of this certification requirement on access to bariatric surgery has been reported only anecdotally.
Invited Commentary page 649 CME Quiz at jamanetworkcme.com
OBJECTIVE To investigate whether the COE certification requirement proved to be a barrier to patients’ access to bariatric surgical procedures. DESIGN, SETTING, AND PARTICIPANTS Using the National Inpatient Sample, we retrospectively identified patients who underwent bariatric surgery from January 1, 2006, through December 31, 2011. EXPOSURE Bariatric surgery. MAIN OUTCOMES AND MEASURES Logistic regression and χ2 tests were used to examine differences in patients’ sociodemographic characteristics over time. RESULTS A total of 134 227 bariatric surgical patients were identified. The proportion of the population who were older than 64 years increased from 2.9% in 2006 to 7.0% in 2011 (P < .001) and there was a decrease in the proportion of patients who were 49 years and younger (P < .001). The percentage of female patients who underwent bariatric surgery decreased from 80.4% to 78.1% (P < .001) and the percentage of patients who were classified as black, Hispanic, or Asian or Pacific Islander increased from 12.3% to 15.1% (P < .001), 9.7% to 12.5% (P < .001), and 0.3% to 0.4% (P < .001), respectively. The proportion of patients with Medicare increased from 8.5% to 16.3% (P < .001) and those with Medicaid from 6.6% to 11.8% (P < .001). The percentage of patients with private insurance declined from 72.4% to 63.3% (P < .001). The proportion of patients in the lowest income quartile increased from 20.7% to 22.9% (P < .001) while those in the highest income quartile decreased from 25.8% to 23.9% (P < .001). CONCLUSIONS AND RELEVANCE The COE certification requirement by CMS did not appear to limit access to bariatric surgery. Future studies should determine whether CMS’s recent (2013) change in policy (ie, removing the mandatory COE certification for bariatric surgical insurance coverage) might sacrifice patient safety without addressing the real cause of limited access to health care.
Author Affiliations: Author affiliations are listed at the end of this article.
JAMA Surg. 2015;150(7):644-648. doi:10.1001/jamasurg.2015.74 Published online May 20, 2015. 644
Corresponding Author: Kimberly E. Steele, MD, PhD, The Johns Hopkins Center for Bariatric Surgery, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224 ([email protected]). (Reprinted) jamasurgery.com
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Monash University Library User on 11/24/2015
Centers of Excellence and Bariatric Surgery Patient Demographics
D
uring the past decade, the prevalence of morbid obesity has increased by 70% in the United States.1 A study from 2012 found that one-third of US adults are obese. Obesity is correlated with higher incomes among men and lower incomes among women and peaks in prevalence around middle age.2 Now a major public health concern, morbid obesity (defined as a body mass index, calculated as weight in kilograms divided by height in meters squared, of greater than 40) is associated with numerous comorbidities and high health care costs.3-6 Bariatric surgical procedures have proved to be the most effective treatment for morbid obesity.7-9 However, the frequency of bariatric surgical procedures performed in the United States has recently declined.10 Socioeconomic disparity in access to bariatric surgery has been suggested as a contributing factor to this decline.11,12 In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented a requirement that each hospital performing bariatric surgical procedures be designated as a Center of Excellence (COE).13-15 Requirements for the COE qualification addressed the following 10 factors: clinical pathways and standardized operating procedures; bariatric nurses, physician extenders, and a program coordinator; surgical volume and outcomes; appropriate equipment and instruments; longterm patient follow-up and outcomes data; an institutional commitment to excellence; a designated medical director; consultative services; surgeon dedication and qualified call coverage; and patient support groups. Within each of these areas are multiple specifications, ranging from a minimum of 125 qualifying bariatric surgical procedures in the year before COE certification to an established location for the center’s patients who underwent bariatric surgery.16 The decision to limit coverage was based on data suggesting that positive surgical outcomes were more frequent in hospitals that performed a high volume of procedures yearly (>125 cases); restricting patients to such hospitals was hoped to increase patient safety.13,17-19 In 2013, the CMS overturned its policy on COE facilities owing to increasing evidence that the surgical outcomes for COE facilities and nonCOE facilities were not different.13 Several studies have questioned the benefit of the National Coverage Determination (NCD) restriction to COE facilities. In 2010, Livingston10 calculated the distance to travel to a COE bariatric program vs a non-COE bariatric program and concluded that the COE restriction increased the travel distance for patients with Medicare, thereby reducing access to care. Livingston10 further argued that such patients were sicker, less mobile, and less able to travel great distances to receive bariatric medical care. While the differences in bariatric surgical outcomes between COE facilities and non-COE facilities remained uncertain, the requirement became highly controversial for impeding access to care.13 As a result, CMS decided to expand the coverage to hospitals that were not COE certified for bariatric procedures in 2013.13,20-22 The question remains as to whether the implementation of the COE requirement for bariatric surgical coverage created the unintended adverse effect of reducing access to health care in the name of improving quality. By examining the sociodemographic trends associated with relevant bariatric surgical procedures, we investigated whether jamasurgery.com
Original Investigation Research
coverage determination, established in 2006 and continued through 2013, was truly a barrier to accessing such procedures.
Methods Study Population We used data from January 1, 2006, through December 31, 2011, obtained from the Nationwide Inpatient Sample (NIS), which was developed by the Healthcare Cost and Utilization Project.23 The most recent NIS database, created in 2011, included approximately 20% of all US hospital discharges and was designed to be representative of approximately 97% of all hospital discharges in the United States.23 This data set contains representative inpatient clinical and nonclinical data, which allows for the exploration of year-specific differences in bariatric surgical procedures, in-hospital complications, and patient characteristics. Institutional review board approval was waived by Johns Hopkins Medicine because the NIS is publicly available data. Morbidly obese inpatients who underwent bariatric surgery were identified by the International Classification of Diseases, Ninth Revision (ICD-9), and by diagnosis-related group codes. Diagnoses for morbid obesity were confirmed with ICD-9 code 278.01. Morbidly obese patients who underwent bariatric surgery were identified via ICD-9 codes 43.89, 44.68, 44.95, 44.31, 44.38, and 44.39 and diagnosis-related group code 288. We excluded patients with ICD-9 codes for malignant neoplasm of the esophagus, stomach, and small intestine, including the duodenum, pancreas, and unspecified sites (codes 150, 151, 152, 157, and 199). We also excluded patients with ICD-9 codes for gastric ulcer, duodenal ulcer, and peptic ulcer without specification of site (codes 531-533) as a primary diagnosis.
Patient Characteristics Key patient characteristics of the analysis were age, age category, sex, annual income, type of insurance, comorbidity, and race/ethnicity. Age was treated as a continuous variable. The age category consisted of the following 4 groups: 18 to 34 years, 35 to 49 years, 50 to 64 years, and older than 64 years. Annual income was also stratified into 4 income quartiles: less than $36 000, $36 000 to $44 999, $45 000 to $59 999, and $60 000 or greater. Income was stratified based on the reported quartile of income levels. The types of insurance were categorized into Medicare, Medicaid, private insurance, self-pay, no charge, and other. We grouped patients by their number of comorbidities (0, 1, or 2). There were no patients with more than 2 comorbidities in this sample. We also used the Charlson Comorbidity Index, which calculates the probability of mortality in a given period based on existing comorbidities.24 Race/ethnicity was categorized into the following groups: white, black, Hispanic, Asian or Pacific Islander, Native American, and other.
Statistical Analysis Statistical analysis was conducted using Stata, version 12 (StataCorp LP). We set α = .05 for all analyses. Population proportions of bariatric surgical procedures were calculated by year. Multiple χ2 tests and unadjusted logistic regressions were conducted to test for differences in patient characteristics across time. (Reprinted) JAMA Surgery July 2015 Volume 150, Number 7
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a Monash University Library User on 11/24/2015
645
Research Original Investigation
Centers of Excellence and Bariatric Surgery Patient Demographics
Table. Patient Sociodemographic Characteristics and Their Trends From the National Inpatient Sample Valuea Characteristic
2006
2007
2008
2009
2010
2011
P Valueb
Sample size
19 300
17 529
26 375
26 040
25 315
19 668
