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ASMBS defends accredited bariatric centres
The American Society for Metabolic and Bariatric Surgery (ASMBS) has defended the outcomes from bariatric surgery at accredited centres, following the recent announcement by the Centers for Medicare & Medicaid Services (CMS) that it is considering reversing its 2006 decision requiring certification for facilities that perform bariatric surgery on Medicare beneficiaries.
A new study, in press for publication in the journal Surgical Endoscopy, found that non-accredited bariatric centres had an in-hospital mortality rate that was more than three times higher than accredited centres (0.22% vs. 0.06%, respectively) with similar volume.
"The risk of dying from stapling bariatric procedures was significantly higher at non-accredited facilities even after adjusting for volume," said Dr Ninh T Nguyen, study co-author, vice-chair of the department of surgery at UC Irvine School of Medicine and ASMBS President-elect. "These findings suggest that the standards required for accreditation provide important pre-operative and post-operative life-saving safeguards for patients, particularly to those at high risk for complications."
The study provides new insights into the positive impact accreditation and certification can have on the safety and effectiveness of bariatric surgery, added Nguyen, who urged the CMS to reconsider its proposed decision to drop the facility certification requirement "as it may lead to unnecessary deaths."
Nguyen and colleagues analysed 277,760 laparoscopic gastric stapling procedures performed between 2006 and 2010 using the Nationwide Inpatient Database.
Previous studies have also supported facility accreditation, including a study published in the Journal of the American College of Surgeons that showed almost identical differences in mortality between non- accredited and accredited academic bariatric centres (0.21% vs. 0.06%, respectively). This study examined 35,284 bariatric procedures performed between 2007 and 2009 that used the University HealthSystem Consortium, a database of academic centres.
"These large studies further substantiate that there is a difference in mortality between accredited and non-accredited centres as the finding is reproducible using completely different database information," he said.
"Facility certification, which has been in place for Medicare patients since 2006, has clearly worked. It has saved lives, improved patient outcomes, reduced costs and expanded access to quality care," said Dr Jaime Ponce, President of the ASMBS. "We have deep concerns and new evidence that removal of the certification provision would be a major step backwards and unnecessarily lead to reduced safety and effectiveness and higher mortality rates among Medicare beneficiaries undergoing bariatric surgery."
The ASMBS will submit the new study on accreditation along with other supporting evidence for CMS to review as the agency considers a final ruling on the need for bariatric certification, which is expected by September 2013.
The public may post comments on the proposed decision at the CMS website by 27th July 27 2013.
"We strongly encourage CMS to reject the proposal to eliminate the bariatric surgery facility certification requirement. Elimination of bariatric surgery facility certification is a radical departure from previous CMS policy supporting patient safety and puts at risk the very people whom CMS is trying to protect and serve," said Dr John Morton, ASMBS Secretary-Treasurer and Associate Professor of Surgery at Stanford University. "Substantial gains have been made in bariatric surgery, but quality care and patient safety are enduring goals that best take place in an accredited facility setting. Let's not turn back the clock."
Several surgical and medical organizations have joined the ASMBS in requesting that CMS maintain its certification requirement. They include American College of Surgeons (ACS), The Obesity Society, Academy of Nutrition and Dietetics, American Society of Bariatric Physicians and SAGES.
Morton notes that if CMS eliminates facility certification for bariatric surgery, it will be the only major insurer that does not require it. Anthem, Aetna, Cigna and United Healthcare have each embraced and continue to support bariatric surgery facility accreditation.
While facility certification remains a question for CMS, bariatric surgery itself does not. The agency states that "the evidence continues to support that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) continue to be reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) ≥35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity."
It further states that under the existing policy, local Medicare Administrative Contractors have the authority to make coverage decisions for any bariatric surgery procedures not specifically identified as covered or non-covered by an NCD, like the laparoscopic sleeve gastrectomy.