Is Bariatric Surgery Safer When Performed in an Accredited Bariatric Surgery Center of Excellence?
On February, 21 2006 the Centers for Medicare & Medicaid Services (CMS) issued a national coverage decision requiring that all CMS beneficiaries undergoing bariatric surgery needed to have that surgery done at an accredited Bariatric Surgery Center of Excellence (COE). This determination was reached because of data at the time indicating excessive complications, a high percentage of poor outcomes, and great variability depending on where the bariatric surgery was performed. Clearly, some bariatric centers had inferior results when compared to others and CMS acted on behalf of patients to protect them by requiring that their surgery be done in a setting within certain standards.
At the time two existing surgical organizations, the American College of Surgeons (ACS) & the American Society for Bariatric & Metabolic Surgery (ASMBS), had already independently established credentialing guidelines and certification protocols for designating bariatric surgery centers of excellence so these two were chosen to fulfill the CMS requirement. Both organizations had already been focused on quality of care and improving patient outcomes from bariatric surgery beginning their programs in 2004 for the ASMBS and 2005 for the ACS.
With a rapid increase in both the obesity epidemic and numbers of bariatric surgeries being performed in the year 2000 and beyond, visionary leaders from both the ASMBS and ACS realized the importance of setting practice standards for patient management in bariatric surgery to ensure optimal outcomes. This was a time of rapid adoption of new techniques and the learning curve for both surgeons and hospitals determining how to best take care of and perform surgery on complex morbidly obese patients resulted in variable outcomes with some centers performing far better then others. The protocols introduced focused on training & equipment requirements, a minimum volume of 125 surgical cases per year, and patient outcome measures. These parameters for improved outcomes where similar to other areas in surgery so bariatric surgery is not entirely unique.
Simultaneously with the adoption of ACS/ASMBS COE, many health insurance companies, state health departments, and surgeon liability carriers became acutely aware of the variability’s in patient outcomes that were occurring and increased awareness with further regulation followed. All of these factors rapidly affected the status of bariatric surgery. Soon it became clear that a facility could not offer these procedures until a certain level of competence and capability was both demonstrated and in place. Patient outcomes improved, variability decreased.
Even before the 2006 CMS decision, surgical results were already improving. In addition to the above factors, the procedures themselves were changing from higher risk open gastric bypass to minimally invasive laparoscopic: gastic bypass, adjustable banding, and eventually sleeve gastrectomy.
As we approach 2014, the status of bariatric surgery is significantly different then just 8 years ago. Newer data has shown that surgical outcomes can be good in different venues, including non COE’s. Surgery can now be performed in ambulatory settings with patients being discharged several hours postoperatively. When the COE concept was introduced, certain centers became nonviable and closed with patient access being compromised, especially in more rural areas. Travel may be an obstacle to care.
With this new information CMS has reversed its decision effective September 24, 2013. Medicare beneficiaries may now have surgery in non COE bariatric centers. Not all private insurance companies have agreed with this and so there are still some restrictions depending on individual insurance plans. Time will tell if this CMS decision will affect outcomes and careful monitoring will be ongoing.
It is likely that the protocols put in place by both the ACS and ASMBS, then subsequently required by CMS until recently, have resulted in widespread training, expertise acquisition, and competence that has resulted in a comfort level that can lead to good patient outcomes. Experienced surgeons and hospitals performing adequate volumes of bariatric surgery, using appropriate equipment, sound protocols, and well trained staff will likely have good outcomes with or without COE designation. It behooves the patient to inquire about and be sure these things are in place. The COE designation describes a certain level of competence. A non COE may have less, similar, or better depending on individual circumstances but does not have ACS/ASMBS oversight.
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