CMS proposal to remove Bariatric Surgery Facility Certification may place Medicare patients at risk

Decision May Significantly Raise Risk of Mortality for Medicare Bariatric Surgical Patients

The Centers for Medicare & Medicaid Services (CMS) is considering a reversal of its 2006 decision requiring certification of facilities that perform bariatric surgery, a move the American Society for Metabolic and Bariatric Surgery (ASMBS), the American College of Surgeons (ACS), and other medical societies say could endanger Medicare patients who undergo bariatric surgery.

In a joint letter to CMS, the societies say they "believe the proposal to remove the Bariatric Surgery Facility Certification will place the highly vulnerable Medicare population at risk" and "is based upon an incomplete review and analysis of the evidence." The ASMBS and ACS, joined by The Obesity Society, American Society of Bariatric Physicians and The Society of American Gastrointestinal Endoscopic Surgeons, collectively wrote that they "strongly oppose CMS’ decision to overturn current, established policy."

"Substantial gains have been made in the quality of bariatric surgery because of certified and accredited programs,” said David B. Hoyt, MD, FACS, ACS Executive Director. “This proposed decision by CMS could be a setback, particularly for the Medicare beneficiaries, who have a higher risk of morbidity and mortality than the general bariatric surgery population." 

"The evidence shows facility certification, and all that it entails, improves patient outcomes and reduces risk," said Jaime Ponce, MD, ASMBS President. "There is very little rationale to reverse a policy that has clearly worked. We urge CMS to continue the facility certification requirement."

In its proposed decision memo, CMS said "there is little evidence that the requirement for facility certification/COE (center of excellence) designation for coverage of approved bariatric surgery procedures impacts outcomes for Medicare beneficiaries."

However, the societies counter that numerous studies point to the positive impact of facility certification, including a new study, not yet considered by CMS that found non-accredited bariatric centers had an alarming in-hospital mortality rate more than three times higher than accredited centers (0.22% vs. 0.06%). University of California Irvine researchers analyzed 277,760 bariatric procedures performed between 2006 and 2010. The study is in press for publication in the journal Surgical Endoscopy.

During its public comment period, which closed on July 26, 2013, CMS received nearly 500 comments, the vast majority opposing CMS' proposed change in policy and supporting facility certification as a condition of coverage. CMS is expected to make its final ruling by the end of September 2013.