and Growing Chorus
On June 27, 2013, the Centers for Medicare & Medicaid Services (CMS) issued a draft decision memo that would reverse its 2006 decision requiring certification of facilities that perform bariatric surgery, a move the American Society for Metabolic and Bariatric Surgery (ASMBS) and other groups say could be dangerous to Medicare patients.
In a statement released July 22, 2013, ASMBS President Jaime Ponce, MD, commented, "Facility certification, which has been in place since 2006, has clearly worked. It has saved lives, improved patient outcomes, reduced costs and expanded access to quality care. 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."
One big piece of new evidence is a study that finds non-accredited bariatric centers had an in-hospital mortality rate that was more than three times higher than accredited centers (0.22% vs. 0.06%, respectively) with similar volume. The ASMBS will submit this new study along with other supporting evidence to CMS as the agency considers a final ruling on the need for certification, which is expected by September 25, 2013.
"The study suggests 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," said Ninh T. Nguyen, MD, FACS, ASMBS President-elect and co-author of the study in press for publication in Surgical Endoscopy.
Dr. Nguyen along with University of California Irvine Department of Surgery researchers analyzed 277,760 laparoscopic gastric stapling procedures performed between 2006 and 2010 using the Nationwide Inpatient Database. Dr. Nguyen is urging CMS to reconsider its proposed decision to drop the facility certification requirement "as it may lead to unnecessary deaths."
Previous studies have also supported facility accreditation, including another Dr. Nguyen study published in the Journal of the American College of Surgeons (JACS) last year that showed almost identical differences in mortality between non-accredited and accredited academic bariatric centers (0.21% vs. 0.06%, respectively). This study utilized the University HealthSystem Consortium, a database of academic centers.
When CMS first announced it was opening a national coverage analysis (NCA) in January 2013, it received 214 comments, the vast majority supporting continuation of the certification requirement. As of Monday, July 22, there were about 270 public comments with nearly 200 supporting continuation of certification and disagreeing with the CMS proposed decision.
Those against, argue certification limits patient access and has "increased bureaucracy and cost" without improving patient outcomes.
The vast majority of comments, however, say accreditation has led to a "culture of quality and accountability," increases patient safety and improves outcomes. A comment from a Medicare beneficiary who had bariatric surgery urged CMS to continue certification and "protect Medicare beneficiaries from unregulated programs who may not have the quality of care to sustain the outcomes currently being reported."
Another commenter asks, "How can any medical or surgical group look be encouraged to improve the outcomes, create the data and transparency so desperately needed by our patients and our evolving health care system if our efforts will be so roundly defeated as seeming to 'limit' access by the same federal govt who are demanding accountability
ASMBS members and the public may continue to post comments on the proposed decision at the CMS website until July 27, 2013.
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) greater-than or equal to 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, such as laparoscopic
"Whether you agree or disagree with the CMS proposed decision to abandon certification, let your voices be heard. The stakes are high," said ASMBS Secretary-Treasurer John Morton, MD. "Those of us who have seen the substantial gains made through certification should make it known. Our patients are counting on us."
"The future of institutional support for the Integrated Health team makes certification of bariatric programs critically important, and is currently at risk," ASMBS Integrated Health President Karen Schulz, RN, MSN, CBN and Chris Bauer, MSN, RN, CBN, ASMBS Integrated Health President-elect said in a letter to members earlier this month. "Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported," the letter further stated.
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 (TOS), Academy of Nutrition and Dietetics, American Society of Bariatric Physicians (ASBP) and Society for American Gastroenterological Surgeons (SAGES).