Bariatric surgery action brings disappointment

Bariatric surgery action brings disappointment

Facility accreditation no longer required by Medicare

Despite strong opposition from leading surgical and medical groups, the Centers for Medicare & Medicaid Services (CMS) has ruled it will no longer require Medicare patients to undergo bariatric surgical procedures at accredited facilities. CMS ruled on Sept. 24 that eligible Medicare patients may have bariatric operations performed at any center they choose, even those facilities with little experience in handling high-risk patients.

"We are disappointed and in strong disagreement with a ruling that appears to disregard overwhelming scientific evidence and medical opinion that bariatric accreditation programs save lives, improve patient outcomes, and enhance the quality of care," said Jaime Ponce, MD, president of the American Society for Metabolic and Bariatric Surgery (ASMBS).

David B. Hoyt, MD, FACS, executive director of the American College of Surgeons (ACS), said, "The standards required for accreditation provide important lifesaving safeguards for patients, particularly for Medicare beneficiaries, who have a higher risk of morbidity and mortality than the general bariatric surgery population. We encourage Medicare patients to continue to select an accredited center for bariatric surgery."

In addition to those two groups, other professional groups supporting accreditation and opposing the new CMS ruling are the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), The Obesity Society, Academy of Nutrition and Dietetics, American Society of Bariatric Physicians (ASBP), and American Association of Clinical Endocrinologists (AACE).

About 750 inpatient and outpatient bariatric centers throughout the United States are accredited by the ASMBS or ACS. Last year, the two surgical societies combined their respective programs and formed the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) (http://www.mbsaqip.org). That organization was created to establish a national standard for accreditation and quality improvement that requires participating facilities to undergo a peer-evaluation process, follow data submission requirements, and demonstrate experience in managing bariatric surgical patients before, during, and after their procedures in order to receive accreditation.

John Morton, MD, ASMBS secretary/treasurer and associate professor of surgery at Stanford (CA) University, said, "MBSAQIP will continue to build upon bariatric surgery’s legacy of quality improvement, which has previously included a four-fold decline in mortality over the past decade, by initiating a new program in decreasing readmissions."

The new ruling marks a reversal of a CMS policy enacted in 2006 that made facility accreditation a requirement for Medicare coverage. It also makes CMS the only major insurer that does not require bariatric surgical procedures be performed at an accredited center. Blue Cross Blue Shield, Aetna, Cigna, and United Healthcare have each embraced and continue to support accreditation.

Back in July 2013, when CMS still was considering whether to continue or drop its accreditation requirement, the medical societies sent the agency a letter voicing their concern that "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 societies cited studies including one in the journal Surgical Endoscopy (July 2013), that found in-hospital mortality rates at non-accredited centers were more than three times higher than the mortality rate at accredited centers (0.22% vs. 0.06%). For the study, University of California Irvine researchers analyzed 277,760 bariatric procedures performed between 2006 and 2010. An earlier 2012 study published in the Journal of the American College of Surgeons last year showed nearly identical differences in mortality between non-accredited and accredited academic bariatric centers (0.21% vs. 0.06%, respectively).

Ponce said, "We have made great strides in surgical techniques, patient care, and in identifying potential risks and managing complications, but we cannot become complacent when it comes to patient safety and procedure effectiveness. We are committed to continuous quality improvement, and accreditation is the mechanism by which we can best achieve it."

CMS also decided that no changes be made to the bariatric surgery procedures that are deemed covered in section 100.1 of the National Coverage Determination (NCD) Manual. 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. (Editor’s note: On Oct. 14, we tweeted about a new drug regimen that reduces postop nausea and vomiting by 80% in bariatric surgery patients. To catch breaking news as it happens, follow us @SameDaySurgery.)