BOSTON – The Centers for Medicare & Medicaid Services may have dropped its accreditation requirement for bariatric surgery centers, but that hasn’t stopped the flow of data calling into question that decision.
A new analysis of 72,615 patients at 145 U.S. hospitals found that, compared with unaccredited centers, accredited centers have significantly decreased mortality (0.07% vs. 0.13%; P = .019) and improved failure to rescue rates (0.55% vs. 0.97%; P = .046).
Patrice Wendling/Frontline Medical News
Dr. John M. Morton
They also have fewer complications (11.3% vs. 12.3%; P = .001) and lower average total costs ($42,212 vs. $51,189; P less than .0001).
"We found improved outcomes for these bariatric surgery patients," study author Dr. John M. Morton of Stanford (Calif.) University Medical Center said at the annual meeting of the American Surgical Association.
The September 2013 determination by CMS that "continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries" has been opposed by several medical societies, which cited results from 7 of 10 studies supporting accreditation.
Among the most outspoken supporters are the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS), which jointly manage a certification program.
During a discussion of the results, Dr. John Kellum Jr. of the Virginia Commonwealth University, Richmond, remarked, "I do wonder though if we aren’t raising a straw dog, which is somewhat self-serving. If you look at the P values, they’re very tiny."
He also pointed to regional variances in performance identified by the analysis and said, "In my opinion, the real advantage of accreditation is the record keeping that goes with it."
Dr. Morton responded, "I think your last point is exactly right. The ability to maintain the data and collect them allows you to have quality improvement. You can’t manage what you don’t measure. . . . Mortality has become pretty rare in bariatric surgery, but I think it’s what I’d call a sentinel event."
The current analysis comprised 62% of bariatric surgery discharges from 62% of hospitals in 2010-2011 in the Nationwide Inpatient Sample database, the largest all-payer, nonfederal database in the U.S.
The 66 unaccredited hospitals and 79 accredited hospitals had similar mean volumes (279 patients vs. 265 patients). Significantly more unaccredited hospitals were teaching hospitals (66.2% vs. 58%), while significantly more accredited hospitals were high-volume centers (81% vs. 53%), defined as at least 125 gastric bypass cases yearly.
Most patients (83%) underwent surgery at accredited hospitals, with both accredited and unaccredited hospitals favoring laparoscopic Roux-en-Y gastric bypass surgery (60.3%; 69.5%) followed by lap band surgery (25.7%; 15.6%), and laparoscopic sleeve gastrectomy (14% vs. 14.8%).
In multivariable regression analysis, procedure type did not exert an influence on outcomes. Unaccredited status, however, was a positive predictor of in-hospital complication (odds ratio, 1.09; P = .005) and in-hospital mortality (OR, 2.26; P = .007), Dr. Morton reported. The analysis controlled for teaching status; hospital high-volume status; patient age, sex, race, insurance, and Charlson Comorbidity Index score.
Discussant Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, asked whether the analysis could speak to the suggestion that accreditation has limited access to care and whether it will be possible to acquire the data necessary to satisfy the doubts of CMS and others regarding the value of bariatric surgery accreditation.
Dr. Morton said that with more than 729 bariatric surgery centers in the United States, there is "ample opportunity to access care," and that no study to date has shown that any of the accreditation programs has decreased the number of surgeries being performed. If anything, two studies have shown an increase.
He observed that it would be difficult to get definitive randomized trial evidence on the value of accreditation because all hospitals will have to deal with the accreditation process independent of CMS. The "hope, belief, and desire" is for a single accreditation process where there is less administrative burden for hospitals and a single reporting scheme, as may exist currently with the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).
"I believe CMS will rightly take a look at what’s happened since they have suspended the certification process," Dr. Morton said. "They have created a natural experiment that bears further scrutiny to see what happens to these Medicare patients after the withdrawal of the certification for them."
Dr. Morton reported having no financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston is anticipated to be published in the Annals of Surgery, pending editorial review.