On January 18, 2013, Dr. John Birkmeyer requested that the Centers of Medicare and Medicaid Services remove Bariatric Surgery Facility Accreditation. Dr. Jaime Ponce ASMBS President asked Dr. John Morton ASMBS Secretary-Treasurer to lead ASMSBS efforts in response to this letter. Regarding this issue of facility accreditation, ASMBS leadership sought the counsel of its members through a survey as well as convening an Executive Council meeting. ASMBS members supported facility accreditation 75% (with integrated health members supporting 87%) and the Executive Council 12-1 supported accreditation. We encouraged our members to submit comments to the CMS comment website and the results were overwhelmingly in favor of accreditation also at 76%. We encouraged both the Obesity Action Coalition and the American College of Surgeons to submit responses which they did in strong favor of facility accreditation. Our Integrated Health Members under the strong leadership of Karen Schultz and Tracy Martinez submitted a comprehensive letter of support for facility accreditation. Finally, in partnership with SAGES, The Obesity Society, American Society of Bariatric Physicians and the Academy of Nutrition and Dietetics, ASMBS submitted the below letter in favor of accreditation. ASMBS will continue to respond and safeguard its members interests now and in the future.
Jaime Ponce, MD President, ASMBS
Ninh Nguyen, MD President-Elect, ASMBS
Robin Blackstone, MD Immediate Past-President, ASMBS
John Morton, MD Secretary/Treasurer, ASMBS
February 22, 2013
Jyme H. Schafer, MD, MPH
CMS/OCSQ/Coverage and Analysis Group
7500 Security Blvd.
Baltimore, MD 21244
Dear Dr. Schafer,
The American Society for Metabolic and Bariatric Surgery has reviewed the Centers for Medicare and Medicaid Services recent re-consideration of the National Coverage Analysis (NCA) focused specifically on the Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). We fully support the continuation of the Facility Certification Requirement.
We are the largest bariatric surgery society in the world with over 4000 members including surgeons, internists, psychologists, nurses, and dieticians. We are of the strong belief that the accreditation process has been of great value to CMS enrollees. Since the advent of the accreditation process in 2004, enormous gains in patient safety and effectiveness have been achieved. There are no compelling reasons to discontinue what has been a patient safety success story. Evaluation of this re-consideration should be objective, balanced, and conducted with transparency among all of the stakeholders and interested parties with clear disclosure of interest. Continued vigilance in the pursuit of quality for our patients in need is an enduring and worthwhile pursuit. We ask you to carefully evaluate this re-consideration and continue the accreditation process that has worked successfully to date.
The Centers for Medicare and Medicaid Services (CMS) addresses coverage for bariatric surgery in section 100.1 of the Medicare National Coverage Determinations (NCD) Manual. The NCD issued in February 2006 identified certain bariatric surgery procedures that were covered if certain criteria were met. It also established at that time a requirement that identified bariatric surgery procedures were only covered when performed at facilities that were certified by the American College of Surgeons (ACS) or by the American Society of Bariatric Surgery (currently American Society of Metabolic and Bariatric Surgery (ASMBS). In 2012, the two societies, recognizing the advantage of unification, created the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).
CMS has received a formal request from Dr. John Birkmeyer for a reconsideration of the facility certification requirement part of the NCD. Questions have been raised about the facility certification requirement in the NCD and whether facility certification results in improved outcomes of bariatric surgery in Medicare beneficiaries. CMS has opened this national coverage analysis to review the available evidence on this issue.
To fully evaluate this re-consideration, a careful and objective review is required. The current literature regarding the impact of accreditation upon bariatric surgery is informative and decidedly in support for facility certification. In contradistinction to the two articles offered against facility accreditation, there are seven articles, which offer clear and compelling support to the current accreditation process.
Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.
Studies Supporting Accreditation
- Hollenbeak in a 2008 article in Surgery demonstrates the impact of bariatric centers of excellence with 14,716 patients from the Pennsylvania Health Care Cost Containment Council database. The center of excellence of model demonstrated clear reduction in Length of Stay and Mortality.
- Encinosa from the Agency for Healthcare Research and Quality detailed in a 2009 Medical Care article the steep decline in complications following the NCD including large reductions in-patient, 30-day and 180-day complications respectively, 37%, 24%, and 21%.
- Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%. Of note, in this publication, there was no evidence to indicate a decline in access for Medicare patients.
- Farell in a 2010 Journal of the American College of Surgeons publication articulated support for the accreditation process utilizing the largest, all-payor database in the US. With 102,069 surgeriesanalyzed from over eight years, the authors demonstrated accreditation provided improved outcomes. This study is note-worthy in that the authors modeled volume as a continuous variable and used the same database employed by Livingston in his article against accreditation.
- Nguyen in a 2012 Journal of the American College of Surgeons (JACS) publication specifically examined outcomes in accredited vs. non-accredited centers. Utilizing the University Health Consortium database and 35, 284 bariatric surgery patients, there was a significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758). The article further illustrated that the reduction in mortality was most likely due to the enhanced ability of accredited centers to recognize and rescue patients with complications. The ability to recognize and rescue patients with complications at accredited centers is most likely due to having the appropriate education, resources, and personnel available at these centers. Without accreditation, appropriate education, resources, and personnel available at these centers might not be available to provide rescue and recognition as the article indicates.
- Flum in his 2011 Annals of Surgery article The Use, Safety and Cost of Bariatric Surgery Before and After Medicare’s National Coverage Decision (NCD) clearly demonstrates the value of the accreditation process in the very patient population that is of interest to CMS namely Medicare beneficiaries. From 2004-2008, forty-seven thousand thirty patients underwent bariatric surgery procedures. 90-day mortality pre-NCD was 1.5% and post-NCD was 0.7% (P < 0.001). The 90-day readmission rates decreased 25% post-NCD (19.9% to 15.4%), reoperation rates declined by 33% (3.2% to 2.1%) and payments fell 20% ($24,363 to $19,746; P for all <0.001). Access remained steady during the time period.
- Kwon in a 2012 Surgery for Obesity and Related Diseases publication showed the value of accreditation using the national MarketScan Commercial Claims and Encounter Database (2003–2009). In this study, the accredited centers had significant reductions in inpatient mortality (.3% to .1%; P =. 02), 90-day reoperations (.8% to .5%; P=. 006), complications (36.4% to 27.6%; P<. 001), and readmissions (10.8% to 8.8%; P <. 001).
These seven articles provide strong and compelling evidence in favor of the facility certification wisely begun by CMS in 2006. Since that National Coverage Determination, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened.
Studies Against Facility Accreditation
In the request prompting this reconsideration, two studies were offered as evidence against accreditation. The first study offered was from a 2009 Archives of Surgery publication by Livingston. This study did not find a mortality difference between accredited and non-accredited centers. It should be noted that the study utilized 2005 Nationwide Inpatient Sample data, which predates the NCD as well as the laparoscopic revolution in bariatric surgery. It also bears mentioning that the Farrell 2010 Journal of American College of Surgeons publication utilized the same database with a longer timeframe and reached the conclusion that accreditation did render a significant benefit. The second article cited against facility certification was from Birkmeyer in a JAMA 2010 article. The Michigan Bariatric Surgery Collaborative is a unique and outstanding experiment benefiting from significant dominant payor support and an exclusive surgeon/facility environment. At the time of study, it should be noted that of the 25 hospitals participating in the MBSC 19 were Centers of Excellence. Given the homogeneity of the small Michigan hospital sample and rarity of mortality as an outcome, it is entirely likely that the study does not have enough signal to detect a difference between accredited and non-accredited centers. Furthermore, there are many requirements for participation in the MBSC including volume, data registry, annual site visits, data auditing, and quality improvement projects. Participation in MBSC has similar elements as the current accreditation process and Michigan hospitals could not participate without the financial assistance that is afforded them through the BCBS reimbursement for data collection and reimbursement of cases. In addition, in closer examination of the study, there is a question of how applicable these results are for the population of interest namely Medicare patients. In the MBSC, the average BMI and Age was a modest 46 with a maximum of 56 for both demographic measures. This MBSC population may not be generalizable to the Medicare population, which tends to be older and heavier (Yuan SOARD 2009).
Accreditation Quality Improvement
In addition, the letter from Dr. Birkmeyer calling for removal of the facility certification process made several assertions that merit response. First, the letter asserts that there is a minimal volume effect in bariatric surgery. Hospital volume does have an effect in bariatric surgery with the effect most likely between 50-100 annual hospital stapled cases. The new ASMBS/ACS MBSAQIP Quality Program will reflect the evidence for hospital volume and most likely institute a lower hospital volume than 125 annual bariatric cases. All of the seven studies supporting accreditation support provide evidence for hospital volume as part of the accreditation process. In addition, there are multiple studies confirming that volume is a cornerstone of the accreditation process including the systematic review by Zevin in Annals of Surgery 2012. It should be noted that participation in the MBSC has a volume requirement of 40 cases annually. Additional studies supporting volume in bariatric surgery include the Birkmeyer study as well as the following: Courcoulas, Surgery 2003; Liu, American Surgeon 2003; Flum, JACS 2004; Nguyen, Annals of Surgery 2004; Smith, SOARD 2010; Flum, JAMA 2005; Weller, JACS 2007; Murr, Annals of Surgery 2007; Parker, Surgical Endoscopy 2007; Kelles, Obesity Surgery 2009; Birkmeyer, JAMA 2010.
Another assertion made in the letter calling for removal of the facility accreditation process is that the current accreditation process has not been used to assess quality, provide feedback, or outcomes as a component of COE determinations. The accreditation process has in numerous circumstances been employed to provide feedback to individual institutions regarding opportunities for improvement, from mortality prevention to the need for VTE prophylaxis to identifying needed resources. Feedback to the institution from the accrediting body is and has always been a required component for the accreditation process. This prior experience will be augmented by our new plan for robust data collection on the MBSAQIP platform. Primary collaboratives at the hospital level for all surgeons to share outcomes and engage in quality improvement will be the cornerstone of this new process.
In addition, numerous publications from both accrediting bodies, which have now merged, have been published in order to provide quality assessment and guidance for participating centers. These publications include the following from the ASMBS: Maciejewski SOARD 2012 (risk stratification), Nelson Archives of Surgery 2012 (comparative effectiveness of duodenal switch and gastric bypass), Winegar SOARD 2011 (VTE risk factors), Li Journal of Vascular Surgery 2012 (Outcomes for IVC Filter Placement and Bariatric Surgery), Inabnet JACS 2012 (Prognostic Factors for Metabolic Syndrome Remission), Messiah SOARD 2012 (comparative effectiveness adults and adolescents), and Demaria Annals of Surgery 2010 (Prognostic Factors for Diabetes Remission). The American College of Surgeons Bariatric Surgery Center Network also provided a publication from Hutter in Annals of Surgery in 2011 on comparison between gastric bypass, gastric banding and sleeve gastrectomy.
Integrated Health Services as Part of an Accredited Facility
In addition to safeguarding patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Pre-existing medical conditions should be optimally controlled prior to surgery. This optimization may require the input of various medical specialists, including cardiologists, pulmonary specialists and gastroenterologists. The Registered Dietitian (RD) skilled in pre- and postoperative bariatric care should interact with the patient preoperatively for their evaluation and initiate a continuing nutrition education experience within the accredited facility. A comprehensive preoperative evaluation should be performed on all patients seeking bariatric surgery. Accredited bariatric surgery programs in the United States require that candidates undergo a mental health evaluation prior to surgery. Insurance companies, who will not provide reimbursement for surgery without mental health clearance, require these evaluations. Without the facility accreditation requirement for such evaluation, these needed services may not be provided or supported. In general, the psychosocial evaluation serves two purposes (Wadden & Sarwer, SOARD 2006). First, it can identify potential contraindications to surgery, such as substance abuse, poorly controlled depression or other major psychiatric illness. The evaluation also can help identify potential postoperative challenges and facilitating behavioral changes that can enhance long-term weight management.
Private Payors and Centers of Excellence
The letter calling for removal of facility accreditation also mentioned that there is a movement among private payors to abandon bariatric surgery accreditation. This assertion that payors are moving away from accreditation is not accurate. As noted below, the four main private payors have embraced and continue to support bariatric surgery facility accreditation as confirmed by ASMBS leadership in phone conference this past month. Specifically, private payor facility accreditation for bariatric surgery includes the following (all accessed Feb 2013).
“Institutes of Quality Bariatric Surgery Facilities”
Anthem Blue Cross and Blue Shield / Wellpoint
“Blue Distinction Centers for Bariatric Surgery”
“3 Star Quality Bariatric Centers”
United Healthcare / Optum Health
This letter helps provide strong support for continued CMS facility accreditation for bariatric surgery. Bariatric patient safety, cost and effectiveness have been vastly improved without decrease in access as a direct result of the 2006 Medicare National Coverage Determination for Bariatric Surgery. Regarding access, there are two studies to indicate that there has been no long-term impact upon access for Medicare enrollees (Flum Annals of Surgery 2011 and Nguyen Archives of Surgery 2010). Also, bariatric surgery is no different from other surgeries benefiting from selective referral. As Adams noted in JAMA 2000, selective referral to appropriate centers can save lives and does not add undue burden upon the patient, particularly when there are more than 700 accredited bariatric surgery centers nationwide. There is also reason to believe that the bariatric surgery facility accreditation can have a positive effect on all obese patients who are hospitalized at that institution, not just those patients undergoing bariatric surgery. Decreasing readmissions is a key CMS initiative. In a recent 2012 Surgery article, Reinke demonstrated that obesity is a risk factor for elderly surgery patients readmissions regardless of the type of surgery. The resources and experience that an accredited facility for bariatric surgery can provide can be of benefit for all obese patients. The resources and experience that an accredited bariatric surgery facility provides can benefit all obese patients.
Without a facility accreditation process, there will be no mechanism to replace this needed practice. The Michigan model is unique and cannot be exported at this time given that it is fully financially supported in a single geographic region by a dominant payor. It is apparent that MBSC program provides high quality program administration
Bariatric surgery facility accreditation was established to improve outcomes for patients. Removing the facility accreditation process will not benefit patients and a real question arises as to who would actually benefit if the facility accreditation process were removed. Quality and patient safety is an enduring effort, which can best be accomplished by the bariatric surgery facility accreditation. Since the National Coverage Determination, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. We appreciate the opportunity to review the many benefits of Bariatric Surgery Facility Accreditation and strongly urge you to continue this valuable process for your beneficiaries.
Jaime Ponce, MD President, ASMBS
Ninh Nguyen, MD President-Elect, ASMBS
John Morton, MD Secretary/Treasurer, ASMBS
Robin Blackstone, MD Immediate Past-President, ASMBS
Bruce Wolfe, MD Senior Past-President, ASMBS
Marc Bessler, MD Councilperson-at-Large, ASMBS
Stacy Brethauer, MD Councilperson-at-Large, ASMBS
Samer Mattar, MD Councilperson-at-Large, ASMBS
Alfons Pomp, MD Councilperson-at-Large, ASMBS
Raul Rosenthal, MD Councilperson-at-Large. ASMBS
Ethan Bergman, PhD R.D. President, AND
David Bryman, D.O. President, ASBP
Harvey Grill, Ph.D. President, TOS
W. Scott Melvin, MD, President, SAGES
cc: President Barack Obama and Secretary Kathleen Sebelius
February 22, 2013
Centers for Medicare & Medicaid Services (CMS)
National Coverage Analysis (NCA)
Regarding certification for “Surgery for the Treatment of Morbid Obesity”
The role of the Integrated Health team approach in the care of the bariatric surgical patient was officially recognized in the 1991 NIH Consensus Development Statement and reemphasized in 2000 by both the ACS and ASBS/SAGES recommendations for bariatric surgery practice. Building on this momentum, accreditation programs were developed by both the American Society of Metabolic and Bariatric Surgery (ASMBS) and American College of Surgery (ACS) which further ensured that all aspects of the multidisciplinary team were implemented to create a well-trained, safe and effective environment for the complex medical patient in the ongoing clinical pathway of bariatric surgery.
Respectfully, the leadership and majority representation of the Integrated Health Section of the ASMBS strongly reject the assumption that the safety profiles of non-BSCOE programs would have developed in the absence of the influence of the BSCOE standards. Clearly, the BSCOE standards have been the leading impetus for the research, dissemination of knowledge, mentorship, and coordinated trainings that have enhanced the safety of bariatric surgeries. Further, we believe there to be little doubt that rescinding the need to meet these standards would significantly jeopardize the availability of integrated bariatric healthcare services to patients, thereby disregarding the mounting evidence demonstrating the importance of multidisciplinary resources for insuring best patient outcomes and cost effectiveness. Following is a concise summary of empirical evidence supporting our position.
Prior to and across the continuum of bariatric surgery, patients undergo assessment, treatment and education from the multidisciplinary team of Integrated Health professionals including but not limited to nurses, dietitians, behavioral health specialists, exercise specialists and obesity medicine physicians.
Perioperative nursing care following bariatric and metabolic surgery entails diligent, prudent, and specific assessment skills. The numerous co morbidities associated with severe obesity significantly increase the risk for postoperative complications. The nurse must possess in-depth knowledge of potential complications and the training and experience to quickly recognize and effectively manage these complications. Often, the signs and symptoms of emergent complications can be quite subtle, yet even brief delays in astute assessment and intervention may well lead to the demise of the bariatric surgical patient. The importance of the diverse roles fulfilled by specialized nurses in achieving a comprehensive continuum of care was recognized in 2007 when the ASMBS initiated the Bariatric Nurse Certification. To date there are over 1100 certified bariatric nurses.
The role of the specialized registered dietitian is invaluable. Performing a comprehensive nutritional assessment to determine a nutrition diagnosis and implementing a nutrition intervention using evidence-based nutrition guidelines is an important correlate with patient success. All patients undergoing bariatric and metabolic surgery are at risk of vitamin and mineral deficiencies, as well as possible macronutrient deficiencies. Therefore, monitoring and evaluating an individual’s progress over subsequent visits with the registered dietitian is important to help prevent surgery specific vitamin and mineral deficiencies.
Behavioral health specialists fulfill a critical role in promoting successful bariatric surgery outcomes. Preceding surgery, psychosocial evaluation is utilized as a specialist consultation in the patient selection and education process with the aim of identifying potentially relevant psychosocial factors and formulating a set of recommendations intended to minimize post-surgical challenges and improve treatment safety and effectiveness. This is important because short-term improvements in psychosocial functioning are common but not ubiquitous; these effects may decline over time for a subset of patients. Postoperative psychological and behavioral difficulties, including disturbances in eating patterns, relational issues, management of pre-existing psychiatric disorders, possible risk for alcohol misuse, and even potential risk for intentional self-harm, may drastically undermine weight loss, weight maintenance, and health-related quality of life. Even in the absence of these concerns, specialists in behavioral and lifestyle modification provide essential guidance via individual, couples, family, and support group counseling to help patients who may deviate from recommended postoperative treatment recommendations.
Increasing evidence supports the role of habitual physical activity (PA) in optimizing bariatric surgery outcomes. However, research employing objective PA assessments indicates that a vast majority of patients do not engage in habitual PA and are highly sedentary preoperatively. Physical activity is recommended postoperatively for improving general health, weight loss, and weight loss maintenance. Given considerable difficulties that patients face in adopting and/or maintaining habitual PA, there is a clear role for the exercise specialist to deliver appropriate counseling, training, and support in the context of a multidisciplinary surgical treatment program aimed at achieving long-term weight loss, resolution of co morbidities, and improves health-related quality of life.
Currently, the specialty of obesity medicine physicians is growing with the recent development of the American Board of Obesity Medicine. Obesity medicine specialists bring a comprehensive understanding of the treatment of obesity, incorporating genetic, biologic, environmental, physiologic factors that contribute to obesity. They increasingly make a significant impact in the pre and post operative care of the patient. Their role in medical readiness for surgery and post operative surveillance of co morbidities has been documented as beneficial.
It is widely recognized that the integrated team is vital to the management and success of the bariatric patient. Both early and long term follow up is imperative for optimal outcomes and safety. Unfortunately there still remains a high prevalence of bias, stigma and misconceptions about severe obesity among medical health professionals. Research strongly supports this fact. Therefore, it makes sense that those taking care of this patient population have the specialized skills as well as empathy, understanding and a desire to work in this field. The accreditation process initiates the requirement and validates that specialized disciplines are available to every bariatric surgical patient.
Karen Schulz, RN CNS CBN,ASMBS IH President
Christine Bauer, RN CNS CBN,ASMBS IH President-Elect
Julie Parrott, MS RD CPT, ASMBS IH Secretary
Laura Boyer, RN CBN, ASMBS IH Immediate Past President
Tracy Martinez, BSN RN CBN ASMBS IH Multidisciplinary Care Committee Chair
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The American College of Surgeons (ACS) is a scientific and educational association of surgeons, founded in 1913, to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. On behalf of the more than 78,000 members of the ACS, we appreciate the opportunity to address recent concerns regarding National Coverage Decision (NCD) Facility Certification Requirement for Bariatric Surgery for the Treatment of Morbid Obesity (CAG- 00250R3). The NCD covers bariatric surgery procedures that are accredited by the ACS or the American Society of Metabolic and Bariatric Surgeons (ASMBS) in order to promote continuous quality improvement and patient safety. The ACS supports the continuation of the NCD certification requirement because it contributes greatly to the advancement of quality and safety in the field of bariatric surgery.
For more than 100 years, ACS has led national and international initiatives to improve quality in hospitals as well as the more specific fields of trauma, cancer and surgical quality. The ACS Inspiring Quality Campaign was more recently launched to drive awareness of innovative quality improvement programs across the country including Commission on Cancer, Committee on Trauma and the ACS National Surgical Quality Improvement Program (ACS NSQIP). These initiatives are built on four key principles: setting the standards, building the right infrastructure, using the right data and verifying with outside experts. Together, these principles form a continuous loop of quality improvement in which organizations and providers learn to improve and keep improving. Accreditation has proven to be a successful way to incorporate the four key principals of care and improve quality for participating centers and their patients. ACS Committee on Trauma Verification centers have demonstrated improvement in clinical indicators (such as timing of clinical evaluation in the emergency department (ED), intensive care unit (ICU) stay, nurse charting), up to 47 percent decreased mortality in severely injured patients, decreased overall length of stay, and increased hospital profitability 1,2,3,4. ACS Trauma Verification has also provided leverage for improved administrative and clinical resources, increased personnel, and improvement in education and quality improvement programs5.
In response to the national obesity epidemic and the growing need to advance highquality surgical care for patients who undergo bariatric surgical procedures, the ACS extended its established quality improvement practices beyond its successful Trauma Verification and Cancer Accreditation programs thereby creating the ACS Bariatric Surgery Center Network (BSCN) Accreditation Program in 2005. The accreditation programs of the ACS and ASMBS have successfully created consistent care and standards across accredited facilities. The program requirements ensure that facilities will commit to resources to best serve special needs of obese patients including patient education, specially trained staff, and facilities and equipment tailored to patient needs, to name a few. Accreditation also allows centers to gain negotiating leverage within the center’s affiliated hospital and/or medical system to obtain resources toward improving patient outcomes.
The ACS and ASMBS programs are multifaceted to promote the highest standards of quality for the bariatric surgery patient by holding hospitals and personnel accountable. In March 2012 the ACS and ASMBS signed a memorandum of understanding to begin the unification of their respective accreditation programs to form the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). At this time, both accreditation programs aligned their data reporting criteria to require 100 percent capture of all bariatric cases in a single, longitudinal outcomes database, under a single set of national standards, which streamlines data collection and creates national benchmarks. This is the only nationwide outcomes database dedicated to bariatric surgery. The sharing of data also promotes advancement in field knowledge on the outcomes of surgical procedures and patient trends while contributing to evidence and scientific literature regarding the efficacy and outcomes of innovative and emerging IRB quality-based surgical procedures. This facilitates strategic and focused quality improvement at the accredited centers. The ACS Bariatric Surgery Database shares a similar data collection process with ACS National Surgical Quality Improvement Program (NSQIP).the most successful surgical outcomes registry recognized as the best in the nation by the Institute of Medicine6. A recent study, which included bariatric surgery, demonstrated that over 80% of the ACS NSQIP participating hospitals statistically significantly decreased their surgical complication rates, and over 60% significantly decreased their mortality rates7.
We appreciate comments from Dr. John D. Birkmeyer and colleagues from the University of Michigan. These comments help the bariatric surgery community to continue to reevaluate the status quo in order to offer the highest standard of care for bariatric surgical patients. However, we do not support the recommendation to remove accreditation as a requirement for Medicare reimbursement. We are greatly concerned by this recommendation because removal of accreditation would halt efforts that promote the highest standard of care. Specifically, removal of the requirement will: 1) eliminate the ability to track outcomes for quality improvement in a centralized database with over 750 hospitals currently participating nationwide; 2) reimburse bariatric procedures without regard to the standards that should be monitored to meet the unique needs of bariatric patients; and 3) take away needed resources which facilitate strategic and focused quality improvement critical to addressing the national obesity epidemic.
The nation is in need of more, rather than less, support for evaluating and improving care for the diverse population of obese patients. The ACS disagrees that the NCD should be removed based on the rationale that the safety profile for bariatric surgery has improved since the inception of the facility certification requirement. Obesity is a leading public health concern.more than one-third of US adults were obese in 2009- 20108. To this end, we believe it is critically important to address obesity as a disease rather than a surgical procedure. Accreditation is a critical component to addressing obesity as a disease by setting national standards and providing organizational support for a “system” of care. Without the protections afforded by the accreditation process, the alteration could result in poorer quality of care. The NCD facility certification requirement provides this necessary platform by which obesity may be more effectively addressed.
In his letter, Dr. Birkmeyer concludes, based primarily on two published studies, that the criteria used for COE designation are collectively not associated with patient safety outcomes. However, ACS does not believe that this conclusion can be drawn based on evidence in the current literature. To start, Livingston et al analyzed administrative data in the first year of the ACS BSCN implementation9. We believe this data is likely not representative of the current program because accredited centers were just beginning to be implemented at the time of this study. Additionally, administrative data is widely recognized as less reliable in comparison to clinical data. A recent study demonstrated that when compared to ACS-NSQIP data, Medicare Claims data is suboptimal for evaluating surgical complications10. Administrative data does not accurately account for the nuances of comorbidities, complications, severity, and does not enable adequate risk adjustment.
Furthermore, the Livingston study uses mortality as the primary outcome in assessing the effectiveness of an accreditation program. Based on ACS NSQIP experience, mortality is a relatively rare event for which risk-adjusted models less frequently identify surgical quality outliers. ACS NSQIP mortality models consistently yield a relatively small amount of variation in hospital performance when compared to models using other outcomes. While the analysis of mortality is necessary for evaluating the program fs effectiveness, it is not sufficient. Additional outcomes such as weight loss, reduction in comorbidities overtime, quality of life, and functional status should be used in addition to mortality and morbidity when evaluating the program fs effectiveness.
The second study, by Birkmeyer and colleagues, references the evaluation of the Michigan Bariatric Surgery Collaborative (MBSC) which has a prospective clinical registry with external auditors. The study examined complication rates and relationships between procedure volume, accreditation, and hospital safety11. We commend the regional program, as it has incorporated the ACS four key principles outlined earlier: setting the standards, building the right infrastructure, using the right data and verifying with outside experts. In fact, roughly 25 of the 40 centers that participate in the MBSC are also accredited by either the ACS or ASMBS. However, despite the program fs success demonstrated in the study, we cannot assume that if the accreditation was not required for facilities across the country that they will set up similar quality improvement programs with clinical registries as seen in the MBSC. Furthermore, because many of the centers in the study are accredited by ACS or ASMBS, it may be misrepresentative to attribute the advances in bariatric surgery in Michigan to the MBSC, as is assumed in Birkmeyer fs study. The MBSC program is also unique in that it is funded by Blue Cross Blue Shield of Michigan and financially rewards participating centers. It is unlikely that other regional collaboratives would have access to this type of financial arrangement in the near future. It is clear that special circumstances contributed to the success of the MBSC program.including the application of ACS and ASMBS accreditation standards.
It is also critical to highlight that having access to high quality data is part of a successful quality initiative but not the end goal. It should not be assumed that data will be enough to improve care among providers.especially those in a non-academic setting with limited access to data. Tangible standards coupled with support and additional resources are needed for treating obese patients. In fact, it is likely that even more standards are needed to address this country’s obesity epidemic, especially when considering rising healthcare costs. In 2006, medical spending was $1,429 higher for obese patients across all payers in the US12.
ACS believes that it is critical that bariatric programs look at meaningful measures with high-quality, standardized, valid data on clinically meaningful outcomes. Quality improvement is an iterative process that must continue to develop and move forward to enable innovation, evaluation of efforts around the country, and rapidcycle learning and disseminating evidence about what works13,14. These concepts are supported by ACS and also align with the National Quality Strategy. Without accreditation, there is simply no validation for the success of such programs. CMS has also recognized the value and importance of accreditation, as seen the support of the Joint Commission Hospital Accreditation program. Hospitals accredited by the Joint Commission are audited every three years and must meet standards, which is similar to the ACS and ASMBS bariatric accreditation programs. Removing the accreditation requirement could result in a fragmented system with disconnected information and standards, which will reduce the sharing of best practices and consistent high-quality care for the obese population. To this end, we strongly support the continuation of the NCD Facility Certification Requirement for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R3).
We appreciate the opportunity to comment on this NCD. The ACS looks forward to continuing dialogue with CMS on these important issues. If you have any questions about our comments, please contact Bob Jasak, Deputy Director for Regulatory and Quality Affairs in our Division of Advocacy and Health Policy. He may be reached at firstname.lastname@example.org or at (202) 672-1508.
David B. Hoyt, MD, FACS