Medicare may scrap certification for bariatric surgery centers

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

Dr. Jaime Ponce

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.