This month’s On the Spot is a collaboration with Jaime Ponce, MD, outgoing president of the American Society for Metabolic and Bariatric Surgery (ASMBS). We hone in on two issues that have become debate fodder: the current role of the laparoscopic adjustable gastric band and the current role of centers of excellence (COEs).
Justin B. Dimick, MD, MPH is the Henry King Ransom Professor of Surgery, Chief of the Division of Minimally Invasive Surgery, and Associate Chair for Faculty Development at the University of Michigan.
Michel Gagner, MD is senior consultant at the Hopital du Sacre Coeur, University of Montreal, Quebec, and Clinical Professor of Surgery at the Herbert Wertheim College of Medicine, Florida International University, Miami.
John Morton, MD is Director of Bariatric Surgery and Surgical Quality at Stanford Hospital and Chief of Minimally Invasive Surgery at Stanford University, Calif.
Ninh Nguyen, MD is vice-chair of the department of surgery at University of California Irvine School of Medicine, Orange, Calif.
Paul O’Brien, MD is Director of the Centre for Obesity Research and Education (CORE) at Monash University in Melbourne.
Jaime Ponce, MD is the Medical Director for the Bariatric Surgery program at Hamilton Medical Center, in Dalton, Georgia, and Memorial Hospital in Chattanooga, Tennessee. He is the current president of the ASMBS.
Christine Ren-Fielding, MD is Professor of Surgery at NYU School of Medicine, Division Chief of Bariatric and Minimally Invasive Surgery, and the Director of the NYU Langone Weight Management Program, New York City.
Raul Rosenthal, MD is Professor and Chairman, Department of General Surgery, Director of Minimally Invasive Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic, Weston, Fla.
Matthew Weiner, MD is a solo, private practice surgeon in Commerce Township, Mich., and the president of the Michigan State Chapter of the ASMBS.
Colleen Hutchinson: Last year when we did this column, you stated that your goals as ASMBS president were to: 1) finalize and implement our new quality improvement—to improve quality, access and insurance acceptance, and offer quality process to international colleagues; 2) consolidate the new annual “Obesity Week” meeting; and 3) establish guidelines for new procedures to be recognized/approved by ASMBS. How would you say the year turned out, based on those goals?
Jaime Ponce, MD: It has been a busy, challenging and satisfactory year of accomplishments. The MBSAQIP [Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program] joint program between ACS [American College of Surgeons] and ASMBS went through a process of careful analysis, detailed discussions and evaluation of what we can and can’t do based on both organizations’ structures and governance policies, and now the standards are finalized and ready to be implemented at the beginning of 2014. We are working on the resources for verification now, including training of more than 100 surgeons to become site inspectors. The data points for the MBSAQIP programs database have been carefully analyzed to eliminate unnecessary data points, ensuring centers and surgeons will not waste time collecting and entering unneeded data. The first national QIP is being released at Obesity Week and will be named DROP [Decreased Readmissions through Opportunities Provided], with the goal of decreasing readmissions by 50%.
Obesity Week is shaping up to be the best ASMBS meeting in history, with a superb program; and in conjunction with The Obesity Society and multiple level 2 and 3 society groups participating, it will be the largest and most comprehensive obesity meeting in the world. The program committee and ASMBS staff have done a tremendous job in accomplishing this milestone. We also will be celebrating the 30th anniversary of the ASMBS, so please visit www.asmbs30.org for details.
In addition to a new meeting and new accreditation standards, we have released a newsmagazine called “Connect.” We have established new interaction with all our ASMBS state chapters (providing web, administrative, CME and other support), developed a new ASMBS website, and next year will release a new ASMBS textbook.
This year, we worked hard to improve access, establish a process through the research committee to study and recognize new procedures, develop revisional surgery guidelines, build collaboration with other societies, and increase political advocacy and communication with all private payors to align them with our accreditation process, and more.
It has been an honor to serve as president of ASMBS.
CH: What would you say incoming president Ninh Nguyen’s biggest challenge(s) will be over the next year, and what advice would you give to him?
Dr. Ponce: I think Ninh will have big opportunities to continue to improve and expand the goals and mission of the ASMBS. Our educational offerings will continue to be the best; implementation of new standards and quality improvement will be better understood; and insurance companies’ alignment with the MBSAQIP will increase. My advice is to continue with a strong collaboration among all parties to gain consensus to improve patient safety and outcomes. And as always, try to be open and transparent with the process to allow everybody to participate!
Ninh will represent us very well as president of ASMBS.
CH: What are your thoughts on the two issues in this installment of On the Spot, namely the role of the gastric band and the state of COEs?
Dr. Ponce: I agree that the number of LAGB [laparoscopic adjustable gastric band] procedures has decreased; I believe that it’s still a viable option for some patients, specifically patients with a better understanding, who don’t have geographic or financial limitations for access to care, who are not experiencing severe diabetes, and who have lower body mass index (BMI). Also, it is important that these patients get band adjustments and care at centers that are willing to dedicate the necessary efforts to care for band patients. It is not a procedure for every patient and every center. For many potential patients who are afraid of stapling procedures, the band still is a better option than continuation of failed medical weight loss management.
In regard to accreditation/COE, there’s no question that we have seen tremendous benefits since the concept was established—from hospitals dedicating resources and staff, to establishing a safer patient environment, to now having the ability to gather data at a national level. Bariatric surgery is a complex procedure that is performed in a higher-risk patient who requires more long-term care than with many other surgical procedures. Accreditation is a venue through which to develop and implement the appropriate infrastructure, dedicated staff, specific process of care, and data collection, and is the pathway to establishing quality improvement. I personally think the surgeons from Michigan have created a very good quality collaborative with financial support that, by itself, is their “state accreditation.”
The argument about accreditation decreasing access should be addressed in relation to patient safety. Access will increase as centers become better and safer, as they have via accreditation. The argument about accreditation being an administrative burden is well known, but it exists with private payors’ accreditation requirements as well. The goal will be to work with insurance companies to decrease the burden to programs. Finally, the volume argument will diminish as the new standards require less volume, according to the evidence we have gathered from the data. We have made big improvements in patient safety over the past decade, and we don’t want to see the examples we had in the past with higher mortality among Medicare patients (as described by Flum et al), that showed mortality in the range of 2% [data on Medicare patients having bariatric surgery from 1997 to 2002] (JAMA 2005;294:1903-1908).
Statement:The number of laparoscopic adjustable gastric band cases has decreased significantly in the past couple of years, and the band is no longer accepted as a viable option by many.
Michel Gagner, MD: Agree! After peaking in 2008 at 42.3% of worldwide procedures, banding has plummeted to 17.8% in 2011 (Obes Surg 2013;23:427-436). This trend will continue, while sleeve gastrectomy has increased exponentially to fill this gap, from 5.3% to 27.8% in the past three years of that survey. It also took more than 20 years for the Angelchik prosthesis (a silicone ring around the esophagus to treat gastroesophageal reflux disease) to be withdrawn from the market. Any foreign body around the gastrointestinal tract is not a good long-term solution; it is a violation of the basic principles of tissue healing.
We hear a defective ethical and moral discourse, with statements that the procedure has the lowest morbidity and mortality initially, and because we have so many to treat, we should allow it. Really? Why? It is faulty reasoning, because the frequent failures, conversions and reoperations have greater risks and mortality, jeopardizing the success of the next procedures. Although some teams have been successful with their patients, that success is not due to the surgical procedure itself, but rather an intensive follow-up with positive psychological reinforcement, which is not applicable or realistic within most practices around the world. Resources are limited, and the treatment of obesity requires more than just simple adjustable restriction (an attractive concept).
But what is killing the gastric band is that surgeons are tired of observing failures and dealing with “not enough” or “too much” restriction constantly; patients want to have their devices removed and be replaced with something else; and the public sees this shift. An FDA trial permitted a relatively safer introduction of the band in the United States (2001), later than the rest of the world, creating a lag phase of 10 years in the United States. Worldwide, more bands are removed than inserted, and the first country that used it (Sweden) has seen its use disappear. Insurance plans should stop covering it, in favor of more stapling procedures.
Raul Rosenthal, MD: Disagree. We are experiencing a decrease in banding and bypass cases due to the growing demand for and excellent outcomes of sleeve gastrectomy. Sleeve gastrectomy most likely will become, by the end of this year, the most popular bariatric procedure worldwide. Gastric banding will remain a valid treatment modality, but the number of cases most likely will stay low for years to come and increase again once we have safe and effective anorectic drugs that we can combine with it.
Christine Ren-Fielding, MD: I agree. The number of these operations being performed has decreased significantly around the world and the band is no longer accepted by many; however, this does not mean the adjustable gastric band is not or should not be a viable option for the treatment of morbid obesity.
Just like all other bariatric operations, the excitement of the band as a new treatment option was embraced and the number of operations peaked. In addition, many surgeons who performed gastric banding due to financial gain rather than medical care realized that the aftercare is just as important, if not more important, than the operation itself. The time and financial resources necessary to provide this aftercare is consuming and has become unpalatable for many; but without it, the weight loss outcomes are poor and reoperations are high.
Just as the band is not a “quick fix” for the patient, it is not a “quick buck” for the surgeon. Instead, the success of the adjustable gastric band relies on dedicated long-term management by both the surgeon and the patient. This realization over the past decade has clarified the importance of patient selection and surgeon selection, in order to maximize the advantages this operation offers and decreases the disadvantages, thus resulting in an appropriate decrease in the number of cases being performed. This has happened with the gastric bypass and surely will occur with the sleeve gastrectomy.
Paul O’Brien, MD: Yes, gastric band numbers are decreasing across several continents. So too, is gastric bypass. And the rise in the sleeve does not come close to equaling the losses. Bariatric surgery, in general. is not doing well. We are not winning the hearts and minds of the 80 million obese people in the United States or the 300 million-plus people worldwide. We now have better data than ever proving safety, substantial and durable weight loss, clear health benefits, improved quality of life and cost-effectiveness. All current bariatric procedures are effective, yet we are losing ground. Why could this be so?
Perhaps we are expending too much effort trying to prove one approach is better than another and not enough convincing physicians and their patients that bariatric surgery does work. It is, arguably, the most powerful treatment we have in medicine today because it achieves weight loss. The gastric band is a safe, simple outpatient procedure, but it does require significant effort in aftercare to get the best results. It is your call. You can either say “No, the aftercare is just a bit too hard” and walk away, or like us, you can do it properly and enthusiastically. We are able to do this, both at my clinic in Australia and at the American Institute of Gastric Banding in Texas, where I’m the national medical director. If you want to try the second option and you would like some help, please let me know. I am happy to share our methods with you. And please do not blame the patients and say it is their decision. They still want it. At both sites, we are treating more people than ever.
Statement:The Bariatric Surgery Center of Excellence accreditation process has been proven to improve safety and outcomes. However, the Centers for Medicare & Medicaid Services (CMS) has just removed its requirement that Medicare patients undergo bariatric surgery procedures at accredited facilities. This decision reflects an incomplete review and analysis of overwhelming scientific evidence and medical opinion that bariatric accreditation programs save lives, improve patient outcomes and enhance patient quality of care, and the proven assertion that accreditation is a critical venue for improving quality measures in bariatric surgery. In addition, this decision will place the higher-risk Medicare population at risk.
Matthew Weiner, MD: Disagree! The very checkered past of the bariatric surgery community’s experience with accreditation programs has come to an end, thankfully, with the recent CMS decision. Accreditation programs permit surgery at some centers, while forbidding it at others. The exclusionary nature of these programs forces surgeons and hospitals to jump through hoops to get a seat within the inner circle. Accreditation programs are not in our best interest, nor the interest of our patients.
Our experience in Michigan with a quality improvement program that is open to all surgeons and hospitals and that fosters collegiality between competing centers serves as a model for the entire country. Although many may look at the CMS decision as a crushing blow to the yet to-be-finalized MBSAQIP standards, I predict that it will be viewed historically in a much more favorable light. CMS’s decision to remove the COE requirement will allow the MBSAQIP standards to focus on accurately tracking outcomes and providing feedback to surgeons and hospitals, rather than performing site visits and reviewing meeting minutes and call schedules. It will force the MBSAQIP to become a true quality improvement program, not another accreditation program enforcing meaningless processes that discourage the creation of new programs in a time when we need to ensure better access to care for all patients suffering from obesity.
Ninh Nguyen, MD: Agree. In a study comparing outcomes of accredited versus nonaccredited bariatric centers, published in the Journal of the American College of Surgeons in 2012 [215:467-474], our group reported more than a threefold lower mortality rate when bariatric surgery was performed at accredited centers (0.06% vs. 0.21% at nonaccredited centers). The improved outcome was particularly evident for patients who underwent complex procedures such as Roux-en-Y gastric bypass and for higher-risk patients (greater severity of illness). Medicare patients undergoing bariatric surgery are well known to be a higher-risk group of patients, and would benefit the most if their operations were performed at accredited centers.
Despite this and other scientific evidence, CMS decided to remove the requirement for facility certification that likely will place Medicare patients undergoing bariatric surgery at risk for a higher mortality rate. A decision to support accreditation should always err on the side of caution, putting patient safety first. In this case, the CMS decision errs on the side that removing the accreditation requirement will improve access to care for Medicare beneficiaries. However, data have shown that access to bariatric surgery for Medicare beneficiaries has actually improved since the 2006 National Coverage Determination.
Another important point to note is that part of the facility certification is the requirement for an annual threshold case volume. The relationship between volume and outcome in bariatric surgery has been well established. With CMS removing the need for facility accreditation, its decision also ignored the data on this volume–outcome relationship. The end point of the decision is that Medicare patients now may potentially receive their bariatric care at a center that is ill-equipped to care for the obese patient, a center without available multidisciplinary team members, and at a center that is inexperienced, where only a few cases annually are performed. I urge Medicare patients to do their homework in selecting where to receive their care, because CMS has eliminated an important mandate that would guide patients toward obtaining the optimal and safest bariatric care.
Justin Dimick, MD: Disagree. CMS recently conducted a very thorough review of the literature when it reopened the National Coverage Determination for bariatric surgery. The CMS evidence review process is widely accepted as the gold standard for making such coverage decisions. The agency’s staff includes methodological experts who weigh the relative merit of existing studies with the utmost rigor. After completing this process for the CMS bariatric surgery COE program, they summarized the literature as demonstrating no benefit of the COE program for Medicare beneficiaries. I agree with their assessment and have great faith in the rigor of their evidence review.
Two of the key studies in this evidence review were papers published in the Journal of the American Medical Association by our research group [JAMA 2010;304:435-442 and 2013;309:792-799]. The first study used clinical registry data from the Michigan Bariatric Surgery Collaborative (MBSC), a regional quality improvement collaborative. This study found no significant differences in outcomes between COEs and non-COEs. Of all the studies on the topic, this was the only one conducted using clinical registry data, and therefore the only one to have the clinical details to provide state-of-the-art risk adjustment, that is, the only one that could claim to compare apples with apples.
The second study, published this past February, was a formal policy evaluation of the CMS COE program. The Achilles’ heel of many studies evaluating the COE program is a failure to fully account for time trends. Bariatric surgery has become much safer over the past decade. A simple before-and-after comparison therefore will not yield an accurate answer—many of the existing studies use this type of study design. In our February study, we used a rigorous design to fully account for these changes in outcomes over time. Once these were subtracted out, we found no independent effect of the COE policy on outcomes. It was clear that bariatric surgery outcomes improved dramatically in the past decade, but the decline started well before the COE policy was implemented.
Perhaps most importantly, CMS already has made its decision and abandoned the COE accreditation requirement. Rather than debating the past, we need to work together to create a better future for our patients. That future should include moving beyond COE programs and focusing on improving outcomes at all centers performing bariatric surgery. The data that we collect in our registries need to be used better. The data should be used to generate risk-adjusted reports for hospitals and surgeons. This is a necessary first step, but we also should do more than just measure outcomes. We should develop regional networks of providers, like the MBSC, who can share data, learn from one another, and implement best practices to continue to improve bariatric surgery outcomes at a population level. I think this is a future we can all agree on and work together to achieve.
John Morton, MD: Agree! It is disappointing to have CMS decide to remove the bariatric surgery facility accreditation. I believe that close review of the evidence shows support in abundance for bariatric surgery facility accreditation. I have a clear and present concern for current and future Medicare beneficiaries. Evidence demonstrates that Medicare beneficiaries have higher risk than the general bariatric surgery population. A 2006 Archives of Surgery publication, by Livingston, found that Medicare status had an increased odds ratio for mortality of 4.31. It is very clear that accredited facilities will save lives in comparison to nonaccredited centers. In this current climate of patient safety and cost containment, I am dismayed that CMS would remove a quality measure like bariatric surgery facility accreditation, which improves patient safety and lowers cost.
David Flum, MD, in his 2011 Annals of Surgery article [141:1115-1120] clearly demonstrates the value of the accreditation process in Medicare beneficiaries. The 90-day mortality rate pre-accreditation was 1.5%, and post-accreditation was 0.7% (P<0.001). The 90-day readmission rate decreased 25% post-accreditation (from 19.9% to 15.4%; P<0.001). The reoperation rate declined by 33% (from 3.2% to 2.1%), and the cost fell 20% (from $24,363 to $19,746; P<0.001 for both). The 2010 JAMA study from the Michigan Bariatric Surgery Collaborative presumably found no significant differences in outcomes between COEs and non-COEs, but 19 of the 25 centers were COEs. The 2013 JAMA study asserting that nonaccredited centers had similar outcomes to accredited centers is flawed. That 2013 study found the same improvement for the Medicare population after the National Coverage Determination as did the Flum study with reductions in any complication (from 12.3% to 7.9%) and serious complications (from 7.5% to 3.4%). What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population. The authors utilize a difference-in-differences analysis and make a flawed assumption that the control group of non-Medicare patients wasn’t exposed to the policy change. By 2006, non-Medicare patients already were exposed to the accreditation process given the requirement by private payors for hospital accreditation, and that accreditation by ACS and ASMBS preceded the CMS coverage decision.
In a recent study in Surgical Endoscopy (2013 Aug 13. [Epub ahead of print]), Jafari et al address both the utility of facility accreditation and the volume threshold. They used 2006 to 2010 laparoscopic, stapled bariatric surgery data from the Nationwide Inpatient Sample database, and found that inpatient hospital mortality was 0.17% at low-volume centers and 0.07% at high-volume centers. Within the high-volume population alone, the in-hospital mortality at high-volume nonaccredited centers was 0.22% and at high-volume accredited centers was 0.06%. When corrected for confounders with multivariate analysis, nonaccredited centers had significantly higher mortality (odds ratio, 3.6). Hallmarks of accreditation include culture of commitment, proven experience, ancillary staff and bariatric-specific resources, which are critical for the rescue of these patients if they encounter complications.
The bariatric surgery accreditation process has a rich legacy of patient safety success and a bright future of quality improvement. With more than 725 accredited centers, there is broad access to quality care and absolutely no sense of exclusion. While I applaud the Michigan Collaborative efforts at quality improvement, I would like to emphasize that inclusion into the Michigan Collaborative requires significant payor support and has the same components as accreditation, including a volume standard, site visits and a data registry.
The MBSAQIP embraces new centers and quality improvement. In 2014, MBSAQIP will launch a national program to decrease readmissions called DROP. We believe there is no deadline for quality improvement; it is an enduring effort. While robust improvements for bariatric surgery may be due to greater utilization of laparoscopy, increasing surgeon experience and fellowship training, all of these drivers for improvement were accelerated by facility accreditation, which provides a vehicle for hospital resource prioritization.
While we hope that CMS will join all other major insurers in supporting bariatric surgery facility accreditation, we will continue our mission of safeguarding patient safety as we did in 2004, when we established bariatric surgery accreditation two years prior to CMS’s initial and appropriate decision to require accreditation.
Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at firstname.lastname@example.org.