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Medicare is dropping its requirement that bariatric surgery facilities be certified.
In a controversial move, officials at the Centers for Medicare and Medicaid Services (CMS) announced Sept. 24 that the evidence is sufficient to conclude that certification does not improve health outcomes for Medicare beneficiaries. As a result, the agency will no longer make certification a condition of Medicare coverage.
Dr. Jaime Ponce
The decision reverses the agency’s February 2006 requirements. Since then, Medicare has covered bariatric procedures only when performed at facilities that were either certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or certified by the American Society for Metabolic and Bariatric Surgery (ASMBS) as a Bariatric Surgery Center of Excellence.
In their announcement, CMS officials said they were leaning in this direction in June when they proposed to lift the certification requirement and asked for public comments.
The response overwhelmingly supported certification. Of the 483 comments received, only 92 favored eliminating the certification requirement.
The change was opposed by physician groups including the ASMBS and the ACS, which operate the certification programs referenced in the previous CMS coverage policy. The groups warned the CMS that dropping the certification requirement would put the safety of vulnerable Medicare patients at risk.
Dr. Jaime Ponce, ASMBS President, said in a statement that he was "disappointed" in the Medicare decision but encouraged that private insurers such as Blue Cross Blue Shield, Aetna, Cigna, and Optum/United Healthcare continue to support accreditation.
The CMS agreed that there is a role for accreditation programs going forward, but said that they are not necessary to ensure safe outcomes for Medicare beneficiaries.
"The removal of a coverage requirement does not require facilities to discontinue practices which they find beneficial," according to the decision memo.
Facilities may choose to continue with certification in order to distinguish themselves from the competition, for instance.
"While CMS agrees with the value of the multidisciplinary team approach and structure, we do not believe that every valued endeavor needs to be buttressed by a Medicare mandate," the memo states. "We expect all facilities to strive to provide the proper equipment and services to meet the needs of its patient population."
CMS officials reviewed nine studies to determine if certification meaningfully improved health outcomes for Medicare beneficiaries. The results were "mixed," the agency said, but overall the evidence showed "no consistent statistical or clinically meaningful difference." Further, nothing in the literature suggested a worsening of outcomes without certification.
The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed, the CMS wrote.
The policy switch was requested by health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the Center for Healthcare Outcomes and Policy at the University of Michigan, Ann Arbor. The scientists asserted that certified facilities were no safer than noncertified ones and that mortality and serious complication rates for bariatric surgery had declined across the country.
The CMS coverage decision did not make changes to the bariatric procedures covered by the agency. Medicare 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 in those with at least one comorbidity related to obesity who previously have been unsuccessful with medical treatment for obesity.