One of the most critical elements of quality seems self-evident, but it is to know your own outcomes. Most surgeons respond to their data in a forthright way. First, they do not believe the information; then, they question whether it is adjusted for the level of risk of the patient; and finally, they accept it and immediately begin to try and figure out how to improve. While data collection has always been the hallmark of the academic surgeon, because of the strong effect that knowing outcomes has on surgeon behavior, in 2013 it has become required for all surgeons in practice as part of maintenance of certification part IV [6]. In addition, accumulating high-quality data through well-designed prospective, randomized studies that includes strict study design, data collection, and publication occurs in such a long cycle of time that it may become irrelevant to some degree in terms of the use of data to impact quality immediately and improve care for individual patients at the local level of care in real time and on an ongoing basis. In addition, once results of these trials are published, the individual surgeon/program has to know of the data and be able to integrate it into their own course of care—a daunting task for busy clinical practitioners. While level 1 data remains the gold standard, questions about cost and applicability to community practice have been raised leading to a movement led by the Institute of Medicine to define and revise the clinical trial infrastructure [7].

Initial efforts were made to establish a voluntary bariatric registry by Edward Mason, MD. He writes:

We began the International Bariatric Surgery Registry (NBSR/IBSR) in 1985 with Kathleen Renquist as Manager. The goal was to assist in continuing improvement of results. IBSR was run in the Department of Surgery. We had full financial support from one of the staple companies for the first two years. Subsequent support was to come from participating surgeons who were voluntary members and had the additional expense of their satellite program of data collection and reporting. We had a computer programmer, who worked full time or part time as needed. A graduate student from the College of Preventive Medicine assisted the Manager. There was a full-time secretary for a few years. A professor from Preventive Medicine provided advice regarding statistical work and consultation for the graduate student. I functioned as director. We used the University Computer Center for storage of data and our own computers in the IBSR office for preparing reports of results, publishing the Newsletter and papers for journals. IBSR provided software, training and instruction manuals for collecting, storing, and preparing reports of local data for comparison with the total data reported. Reports of local results for lectures or publication could be prepared using the IBSR software, which was provided to each satellite for data collection. Special reports from IBSR pooled data were provided when requested for cost of preparation. Direct access to the Registry data was limited to those working in the central office. The manager published quarterly reports to each satellite surgical practice, which provided comparison of the contributed results with total IBSR results. A newsletter containing two sections was published twice a year. I wrote a section for surgeons and Kathleen wrote a section for the people who were collecting and reporting data. The ultimate closure of IBSR resulted mainly from inadequate financing. There is no access now to the data collected or reports and publications.

At this early stage, community surgeons may not have seen a clear need to participate in data collection. However, a confluence of events forced bariatric surgery into the glare of public opinion, accelerating the need for a national approach to quality.

One pivotal event came in 1999 when Wesley Clarke, MD, and Alan Wittgrove, MD, documented performance of a gastric bypass with laparoscopic access. This one controversial change in approach to the procedure heralded the acceleration of adoption by patients who were seeking help for obesity—in part because of the publicity that surrounded the laparoscopic gastric bypass of Carnie Wilson, a popular singer who told her story in People magazine. In the early part of that decade, general surgeons—many of whom had never practiced bariatric surgery—took a weekend course and, with little training or program structure, started offering the procedure. The number of bariatric cases increased rapidly to a peak in 2009 (Fig. 14.2) [8]. What had been heralded as a step forward quickly led to a host of complications and deaths that threatened to swamp the nascent specialty and close down access to care. Payers, employers, and others began to drop the procedure as the cost of surgery mounted. In one single year (2005), the entire State of Florida lost all effective access to care unless a patient was able to self-pay for a procedure. Malpractice claims jumped, causing insurance to become extremely expensive if it was available. Bariatric surgery, and the patients who need surgical therapy for obesity and related disease, was in crisis and patients were on the verge of losing all access to the procedures.

Payers were not pleased with the red ink they saw from the increase in complications. Faced with increasing demand by employers and patients, they stepped up to manage the situation. Payers had experience in managing high-risk specialties, having had to manage transplantation networks for many years. In conjunction with employers, they began designing similar systems to try and control access to bariatric surgery. In Las Vegas, several unions and employers expressed concerns regarding data indicating expensive complications for an elective surgical procedure. However, people suffering from obesity who worked for Caesar’s Entertainment group were unrelenting in their applications for coverage to the management of Caesar’s. Finally, a junior executive, Mr. Scott Haverlock, partnered with First Health and designed a request for application (RFA) to participate in a small, exclusive network in order to provide bariatric surgery to employees of Caesar’s Entertainment group. Their consultant identified 11 programs in the Southwest that had outcomes/program structure that he thought was acceptable and the RFA was sent out to those programs. Nine programs responded and three were invited to come to Las Vegas to meet with Mr. Haverlock and the First Health team at Caesar’s to determine if they could provide safe care and be good business partners. Two programs were selected and then the negotiation of the actual contracts took place. By early 2005, this prototype of the payer/employer-driven center of excellence was in place and patients were being referred only into this network.

In response to the crisis, the leadership of the American Society for Bariatric Surgery (ASBS) stepped up to put in place a unique and controversial solution: accreditation for programs in bariatric surgery with a qualifying volume of 125 cases per year. This vote for the program occurred during the annual business meeting chaired by President Alan Wittgrove, MD. Walter Pories, MD, delineated a description of the concept to the surgeons at the business meeting. Discussion ensued with respect to the idea of stratification put forth by invited guest Thomas Russell, MD, president of the American College of Surgeons (ACS). Finally, the motion to approve the concept of Bariatric Surgery Centers of Excellence (BSCOE) without stratification was approved by an overwhelming majority of the surgeons present. When the program was implemented, the impact was severe with approximately 1/3 of programs leaving the field as insurance carriers began to limit their networks to just the programs within the BSCOE. There was a contraction in access to bariatric surgery, particularly in rural areas. In a landmark national coverage decision on bariatric surgery in 2006, the Centers for Medicare and Medicaid Services (CMS) chose to allow procedures only at centers accredited by the ACS or ASMBS [9]. Gradually access rebounded to pre-NCD levels [10].

The original goals of the ASMBS BSCOE program are stated in an article authored by Ken Champion, MD, and Walter Pories, MD, published in Surgery for Obesity and Related Diseases (SOARD) in 2005: “The purpose of a COE program is to provide the means for the public and interested parties to identify programs in bariatric surgery that provide a comprehensive and standardized program of surgical care and long-term follow-up and management of the morbidly obese patient. The routine reporting and compiling of outcomes from bariatric surgical patients will provide an opportunity to assess and verify risks and benefits of therapy, which can potentially resolve many of the conflicts over the role of surgery in severe obesity. In addition, the COE program may challenge inadequate programs to improve their standards, education, and training to meet the guidelines” [11].

When the BSCOE program was developed in 2004, the ASMBS established ten standards by which facilities and surgeons would be evaluated as providing excellent quality of care in bariatric surgery (Table 14.1). The BSCOE designation became a commercially valuable designation, with some insurance payers, including the Centers for Medicare and Medicaid Services (CMS) requiring the designation in order to participate in their network of care.

The society established an outside not-for-profit company, called the Surgical Review Corporation (SRC), to administer the program. The ASMBS and SRC entered into an initial 6-year contract in 2004. The registry, Bariatric Outcomes Longitudinal Database (BOLD), was established in 2006 and fully subscribed to as a requirement for members to participate in 2008/2009. At the time the SRC was established, the leadership of ASMBS believed that establishing a separate not-for-profit company to remain at arm’s length from the actual designation of programs would protect the integrity of that process. The result, however, was that as the terms of office of the original board members expired, they were rotated off. The board began to reflect less involvement of the current leadership of ASMBS, weakening communication. The leadership of ASMBS believed that they had no direct control of the program that granted accreditation under its name through the contract that had been executed. Although bariatric surgeons who were ASMBS members populated the committees at SRC, ASMBS leadership believed there was no control through the Executive Council of decisions made by SRC and that impacted the program or the membership. This included the use of funds for development of the program, the strategy of the programs development, and contracting for release of data to outside parties. Most importantly, the program was growing organically through decisions made by the SRC committees. These decisions had secondary consequences to programs that were outside the oversight of the society. Throughout time, these difficulties in communication, direction, and oversight led to frustration on the part of ASMBS leadership. This began during the presidency of Phil Schauer, MD, when SRC established the International Centers of Excellence program (not sanctioned or supported by ASMBS), apparently with funds generated by the fees that had been paid to SRC through the accreditation of programs by the ASMBS. This distraction in the business model diverted time, money, and attention away from SRC’s primary service to the society. Difficulties continued through the presidencies of Kelvin Higa, MD, and Scott Shikora. MD. Finally, during the presidency of John Baker, MD, a new 5-year contract was negotiated in an attempt to address the concerns. It was executed in June 2010. This new contract sought to establish a clear relationship between the ASMBS and SRC in terms of control of the program. SRC was designated to manage the application process, site visits, and the collection of data in BOLD. ASMBS was responsible for establishing the guidelines and direction of the program as well as directing the use of BOLD data through the ASMBS Research, Data Access, and Data Dissemination Committees. All proposals for the use or release of data from BOLD were required to come through ASMBS committees and leadership. Income generated from any release of BOLD data was to come to ASMBS. The SRC had by this time established other programs, including the International Center of Excellence (ICE) program and the American Association of Gynecologic Laparoscopists (AAGL) Center of Excellence program. SRC had the contractual authority to develop other programs, although the resources of the ASMBS BSCOE program were contractually segregated financially from the use in other programs. The ASMBS also was assured of SRC’s ability to establish new BSCOE programs. Of note, the SRC was contractually prohibited from interacting with payers on behalf of the ASMBS BSCOE. The support of the program by members of the society was robust (Table 14.2).

In a parallel effort, the ACS established their own Bariatric Surgery Center Network (BSCN), with somewhat similar standards and reporting requirements. The ACS had established twin missions of education and quality and had partnered with societies on programs in trauma—established the Committee on Trauma in February 1976 in collaboration between the ACS and the AAST (the American Association for the Surgery of Trauma)—and cancer. This equivalent effort in bariatric surgery by ACS, rather than a collaborative one, resulted largely from a disagreement between ASMBS and ACS regarding the need for outside stakeholders to participate in the executive direction of the program by being part of the SRC board and the use of a third-party (SRC) to administer the program instead of partnering directly with the ACS. It was the position of the ACS that the specialty society (ASMBS) is best able to determine what constitutes quality in our field and that arm’s length relationships were not necessary. The ACS also was concerned that some interests by individuals involved in SRC might not be in alignment with the mission of the college. An examination of the ACS BSN program demonstrated some philosophical and practical differences between ASMBS and ACS:

Finally, in an effort to provide a solution for low-volume programs, the ACS BSCN had evolved to include a level 2 designation for programs with lower volumes of cases within a specific window of risk-adjustment requirements. Data began to accumulate on these centers that showed similar outcomes at lower volumes within the context of an accreditation program.

As of October 2011, the ACS BSCN reported a total of 137 programs at the October Bariatric Surgery Committee meeting (Table 14.3). There was no evidence that an arm’s length relationship was necessary to establish credibility with outside stakeholders. In fact, all payers similar to the ASMBS program including Medicare accepted the ACS program. The effort in bariatric surgery was part of a strategy to promote quality across all disciplines in surgery through the National Surgery Quality Improvement Program (NSQIP) [12]

The MBSC (2006) is a voluntary group of hospitals and surgeons performing bariatric surgery in Michigan organized with a goal to decrease complications from bariatric surgery. The Northern New England Cardiovascular Disease Study Group (detailed previously) pioneered the model that was adapted in Michigan. The model has three major components:

This model was adopted in the state of Michigan in partnership with Blue Cross Blue Shield (BCBS) of Michigan (representing 47 % of covered lives in Michigan) that funds the central administration of the program and reimburses surgeons/facilities to enter the data. The data are confidential and not accessible to BCBS. The data is collected through a central data management center with independent third-party abstractors. There is an annual audit of the data reported by the hospitals. Approximately 6,000–8,000 patients per year participate in the program, and all but one bariatric program/surgeon in Michigan participates [13].

The serious complication rate in Michigan has declined from approximately 5 to 2.5 % in the most recent publications, a result that is directly related to the program’s Collaborative Quality Initiatives (CQI) [14]. Gradually in Michigan, even surgeons who were initially skeptical or reluctant have come around to be supportive. One surgeon said, “quality and performance are going to drive our collective future, it is nice to have guidance and ownership in the process.” The strength of the program revolves around the integrity and quality of the data and the leadership of the collaborative effort. The Michigan program was organized around the idea of improving all programs/surgeons who cared to join, a rising tide lifts all boats [15]—a marked difference in philosophy from choosing only the best programs (exclusionary philosophy) invoked by the ASMBS in its first BSCOE effort.

Ideally, the model for statewide collaboration could be adopted by state chapters within ASMBS, as in all but five states the top one or two insurers have market shares of more than 50 % and in 18 states they have shares higher than 75 % [16].

In 2010, an article was published in the Journal of the American Medical Association (JAMA) by John Birkmeyer, MD, and members of the MSBC that illustrated that the incidence of serious complications was unrelated to whether a program was an ASMBS BSCOE or not [17]. This prompted BCBS to remove the requirement that programs in Michigan had to be a part of the ASMBS BSCOE in order to operate on BCBS patients. In addition, some questions had been raised about access to care after Medicare limited bariatric surgery to the BSCOE and BSCN networks [18]. Although both papers were widely viewed by society leadership as flawed (outlined in the commentary of the paper by Bruce Wolfe, MD), they raised questions about the differences between the accreditation program and the collaborative effort based on evaluation of outcomes in Michigan. A critical evaluation of the BSCOE program revealed the following opportunities to evolve:

In this changing environment, questions arose for the leadership: What is the ASMBS goal in identifying centers of excellence? Are we establishing a threshold of quality that is an acceptable minimum standard? Are we trying to determine which programs offer the best care? Are we providing a template for new programs to begin and practice safely at all times? Are we trying to provide a platform for the study of outcomes and process improvement?

Expectations by patients, hospital administrators, government, and private payers to improve the value (quality/cost) and patient experience of care are fast becoming a reality. The ASMBS BSCOE program had to be updated or it would have become irrelevant, a dangerous problem for patients if access improved and the number of surgeons doing these procedures once again expanded rapidly.

It was this analysis and these questions that provided the basis for the society to begin a reevaluation of its own accreditation program in order to meet the challenges of the future. In February of 2011, Bruce Wolfe, MD, and the Executive Council of ASMBS established a new committee, the ASMBS Quality and Standards Committee, to provide oversight of the BSCOE program and to undertake a complete evaluation of the program in the context of the current science of quality. This committee was made up of a wide group of stakeholders representing different constituencies in the society and the SRC, and also included stakeholders that represented the other groups in the United States who developed quality programs in bariatric surgery (ACS and the Michigan Bariatric Surgery Collaborative) (Table 14.4). This effort was designed to facilitate collaboration between all groups on a future integrated program that would eventually replace the initial adoption of accreditation by ASMBS and ACS and seek to correct deficiencies in the current programs to facilitate improved patient safety and further the culture of safety by surgeons and program teams.

After the formation of the committee, the leadership met with the SRC in March 2011 to discuss the committee and ensure their participation as the long-standing vendor of the program. At that meeting, it was decided that the responsibility for management of the data would be transferred to the ASMBS under the leadership of the Research Committee as had been outlined in the contract. Ranjan Sudan, MD, the ASMBS Research Committee Chair, and Debbie Winegar, PhD, from SRC developed an organizational document regarding the transfer of responsibility. In addition, Dr. Provost, Dr. Winegar, and Lynne Thompson, RN, were designated by the SRC to participate in the committee as official representatives. Dr. Blackstone; past-President Bruce Wolfe, MD; and SRC BOLD database expert Debbie Winegar, PhD, met with John Birkmeyer, MD; Nancy Birkmeyer, MD; and Justin Dimick, MD, of the Michigan Bariatric Surgery Collaborative in August 2012 to understand the strengths of the Michigan Collaborative. Following that meeting, Dr. Blackstone met with the SRC—including Neil Hutcher, MD, Medical Director for SRC; Michael Hartney, ESQ, in-house council for SRC; David Provost, MD; Wayne English, MD; Debbie Winegar, PhD; Lynne Thompson, RN; and Georgeann Mallory, RD, Executive Director ASMBS, in Raleigh, NC—to discuss the future direction of the program. There was unanimous consensus to move forward with this process. In late August, a white paper laying out the scientific arguments for change was developed by the president of ASMBS Robin P. Blackstone, MD; this was widely circulated for comment and input to the leadership of the QSC, SRC and Executive Council, and those comments adopted into the document. In September, the ASMBS Executive Council unanimously endorsed moving forward with the evolution of the quality program based on the evidence provided in the white paper in September of 2011. A specific process was outlined including possible collaboration on an integrated program with ACS. Senior Past ASMBS President John Baker, MD, in December 2010, had initiated initial contact with ACS. David Hoyt, MD, the Executive Director of ACS, gave the Mason lecture at the annual ASMBS meeting in 2011. In late September 2011, a pivotal meeting took place with David Hoyt, MD; Clifford Ko, MD; and Matt Hutter, MD, representing the ACS in Chicago. Robin Blackstone, MD, President; Jaime Ponce, MD, President-Elect; and Ninh Nguyen, MD, Secretary/Treasurer with the results reported to the Executive Council, represented ASMBS leadership. After that meeting, initial interest in possible collaboration was confirmed by both parties. A subsequent meeting was held with the Board of Regents Committee on Research and Optimal Patient Care in October 2012. Based on the recommendation by the Committee, the Board of Regents during that annual clinical congress in 2012 voted unanimously to endorse the process of integration of the two programs. In November and December, an extensive series of webinar town halls were presented to a large segment of the leadership with broad consensus that the society was moving in the correct direction. To quote our founder, Ed Mason, MD, after attending one of the town hall meetings, “it is easy to gain consensus with the truth.” During this time, a selected group of almost 40 members of ASMBS including members of the QSC and other member surgeons of ASMBS representing a broad spectrum of practice settings within bariatric surgery practice were reworking the white paper to establish the interlocking set of initial proposals that were presented to the membership for public comment in December 2012.

One of the most important aspects of understanding and evaluating the BSCOE quality system was to evaluate the registry. The QSC reviewed all the available data registries including BOLD, BCSN (ACS), and MBSC registries. A contract for an outside evaluation of the BOLD database for strengths and weaknesses was executed. The aggregate data was taken from BOLD as of September 30, 2011, and sent for an outside third-party analysis (ArborMetrix) where the weakness and strengths of the data were evaluated. The data was used to provide initial information to the Committee and Executive Council about the relative strength of volume as compared to a composite measure for judging the safety record or a program that participated in the network.

In December, the white paper was published to the membership in five separate segments, which included the proposals for integration of the ASMBS and ACS programs and initial proposals of mechanisms for integrating the standards of both programs. In early January of 2012, a meeting was held in Dallas with multiple surgeons and integrated health members representing diverse practice settings, MBSC and ACS representatives, and data experts to discuss the proposals made in the five-segment publication and determine a future process.

The ASMBS has embarked on an evaluation of our current BSCOE program. Throughout the last 10 months, many of our colleagues have been working in ASMBS committees and sub-committees evaluating different parts of the current program and making proposals for an evolution of the program. Those proposals are now ready for member comment and input. Once you have reviewed this information, we would appreciate your comments. December 2012, Robin Blackstone, MD, President of ASMBS.

Meanwhile, in the background of this effort to evolve the ASMBS BSCOE program, difficulty in the relationship with SRC continued. The perception by the ASMBS leadership was that SRC continued to show evidence that they were unwilling to accept the leadership of the ASMBS and Executive Council and QSC in regards to the program and, in addition, ASMBS was concerned that the contract between the two parties had been breached. The ASMBS attorney and accounting firm conducted a careful analysis of the situation and presented those findings to the Executive Council. In addition, with the publication of the five segments outlining a future relationship of collaboration rather than conflict with the ACS, the SRC sent a letter indicating they would not collaborate or participate and plans were made by the SRC leadership and board to provide their own independent COE program in bariatric surgery. It was in this environment that the society sought an injunction against such action by SRC and terminated their contract effective April 1, 2012.

In January 2012, a business plan was developed that examined whether it was financial feasible for ASMBS to establish their own BSCOE program. A proposal was also developed to partner with the ACS. In January, at the Executive Council retreat, these proposals were evaluated in detail. The ASMBS, at this time, had a total endowment of just under $4 million. Based on the business proposal, ASMBS would not have been able to fund the program alone. In addition, excluding the ACS from partnership isolated ASMBS from the mainstream work going on in surgical quality. After careful consideration of all aspects of the opportunities that were presented, the Executive Council voted unanimously to support integration with the ACS into a combined program. The Board of Regents of ACS ratified this decision in a unanimous vote in February 2012. On April 1, 2012, the ASMBS and ACS integrated their two quality programs into one program: the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) (Fig. 14.3). The programs migrated to use of the BSCN registry. All programs began entering data beginning on March 1, 2012. The data that had been captured in BOLD was able to be retained and was entrusted to the Research Committee to clean and produce a public use file and to return data to the programs who had entered it.

The most important task ahead was integration of the culture of the two partners in quality. In order to do this, it was essential that the teams for integration start out small and members whether appointed by ASMBS or ACS is equal in authority. They had to be able to rigorously examine every aspect of the current quality paradigm in both societies in order to propose a system of quality. There could be no “sacred cows” and each aspect of the previous programs had to be examined. In other words, the beginning of the acculturation could not be political and it had to be patient centric. This step would include change for both groups and change is perhaps on a large scale one of the most difficult integrations to manage.

Four initial committees were formed, with each society nominating one-half of the committee members and with a shared cochairmanship. Robin Blackstone, MD, and Ninh Nguyen, MD, chaired the oversight committee for MBSAQIP. Three working committees—standards, verification, and data—were chaired by Wayne English, MD, and Ronald Clements, MD; David Provost, MD, and Dan Jones, MD; and Bruce Wolfe, MD, and Matt Hutter, MD, respectively. The Standards Committee was charged with the development of new standards. This small group of eight people, working with experienced ACS staff members (Table 14.5

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