If you are a bariatric surgeon with interest in the recent center of excellence (CoE) or accreditation struggle, it is hard to not be cynical. What our leaders promised us in 2006 has never been fulfilled despite the majority of our practices participating in a CoE process. There has been little useful information shared across practices, and access to care and insurance reimbursement have not increased.
For those unfamiliar, a short recap is necessary. Approximately 10 years ago, it was deemed essential that an accreditation program be created for bariatric surgery. Media reports of poor outcomes created concern that without an active CoE program, bariatric surgery would be in danger of being blacklisted. After lengthy discussion, both the American College of Surgeons (ACS) and the American Society for Metabolic and Bariatric Surgery (ASMBS) introduced separate programs.
To administer the ASMBS program, a new independent entity called Surgical Review Corporation (SRC) was formed. A majority of the ASMBS membership and their hospitals decided to participate in the SRC program because it was less expensive. A major reason was that participation in the ACS program for level 1 centers mandated use of the National Surgical Quality Improvement Program (NSQIP), which was very expensive.
Achieving CoE status included the development of pathways, credentialing, documentation of equipment and consultant availability. A volume threshold of 125 cases was mandated. No differentiation was made for case or patient difficulty. The CoE programs' strongest benefit was the 2006 national coverage decision by the Centers for Medicare & Medicaid Services (CMS), which stated that for coverage for bariatric surgery, the procedure would need to be performed at a center approved by either the ACS or ASMBS.
As can be expected with any new process, flaws in the methodology were uncovered. Certainly the system required updating and improvement. However, without collecting feedback from member surgeons or hospitals involved with the SRC, ASMBS leadership decided to end their contract with SRC. (The members of the ASMBS have never been told what happened or why a new system was needed. Two working systems existed at the time.) Members were told about the great opportunity to unite our program with the ACS. With great enthusiasm, the leaders outlined a system that would be based on the Michigan Surgical Collaborative. An attractive aspect of this system was that doctors were able to share data across practices easily. Discussions with John Birkmeyer, MD, medical director of the Michigan Surgical Collaborative, took place on integrating the ASMBS CoE system into the collaborative. However, it soon became apparent that this was not going to be a practical solution.
As a result, an integrated committee of sincere surgeons comprised of representatives from the ACS and ASMBS was assigned to write new standards for the combined program. However, instead of creating a simple effective process, a very rigid blueprint for bariatric practice was suggested in an attempt to proliferate what they believed to be best-practice standards. Surgeons were told what operations they could do, and when and where they should be performed. Additionally, the proper ages for surgical treatment and which procedures required institutional review board approval were described. Rather than have the center determine how to contact patients for follow-up and how to participate in performance improvement, strict adherence to their policy was mandated. Failure to follow these guidelines would result in termination of the CoE designation.
The old program of broad principles to be filled in by the practices was replaced with strict rules. Thankfully, some of our past presidents and members of ASMBS saw this and raised the alarm. Furthermore, our field moves faster than documents like this can be written. As a result, even if we could agree on the best methodology, it would be outdated before it could be disseminated.
During the period of time that we were discussing issues with our new system, Dr. Birkmeyer sent a well-written and researched letter to Medicare questioning whether CoE status was necessary and suggesting that CMS should allow Medicare beneficiaries to have bariatric surgery in any facility. He noted that outcomes in bariatric surgery have improved throughout the country. Two large studies showed no improved outcomes at CoE centers compared with non-CoE centers (Arch Surg 2009;144:319-325; JAMA 2010;304:435-442). Therefore, the requirement for coverage that bariatric surgical procedures be performed at a center certified by the ACS or ASMBS should be withdrawn, he argued. Dr. Birkmeyer is well respected and a former adviser to CMS. Based on his letter, CMS decided to open the national coverage decision and ask for public comment on this issue.
This leads us to the question of whether we need a CoE program in 2013. Many argue that an accreditation program is essential to maintain the integrity and trust of the public. The question is, does it really do this? If we think back to the original stated goals of the CoE process, we would have to say it has not delivered on its promise. Thus, many may believe that we do not need a CoE process.
Unfortunately, what seems simple is often not. The Michigan Collaborative sounds like a perfect system until you peel away the layers. Blue Cross of Michigan, which controls 70% of the insured lives in the state, sponsored the collaborative. This fact alone makes us even more convinced that we need an independent CoE system. If we do not develop an effective accreditation process, groups like the collaborative (owned by Blue Cross) will own the only large collection of outcomes data. Data can have multiple interpretations, and if we don’t have other large collections of data we will not have the facts or evidence to oppose whatever the insurance companies say. Thus, an independent physician database (or databases) is our best professional protection.
Although the ASMBS has made errors, it is still our society. It is owned by us, those involved in patient care, and is not sponsored by an insurance company. Likewise, it is not a software company either. We should seek out partners who can aggregate data and share the de-identified data with all members of the society much like we do with our journals. Surgeons will want to participate because it will make them better surgeons. This means we need to scrap the document that was up for public comment. It was a poor imitation of The Michigan Collaborative that relied on force to achieve compliance. Instead, we should find a creative method to find a flexible accreditation system that accumulates the relevant data on primary procedures at reasonable cost.
Whether we should combine with the ACS, create an independent solution or resuscitate the SRC should all be discussed and considered. What also needs to be understood is that the cost of failure will be very large in the future. It will mean that the most detailed outcomes on bariatric surgery will be owned by an entity sponsored by Blue Cross. If at some point, they do not have our patients' best interests in mind, we will not have the necessary facts to protect our patients or our practices.
Dr. Cottam is director of the Surgical Weight Loss Center of Utah, and the Bariatric Medical Institute, Salt Lake City; Dr. Roslin is chief of bariatric and metabolic surgery, Lenox Hill Hospital/North Shore-LIJ, New York City.