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CMS policy criticised

CMS should “re-evaluate” Center of Excellence policy

Study claims there is no significant difference between institutions
Policy is unintentionally restricting access to bariatric surgery
Outcomes for both institutions were improving before policy change

Researchers have called for the Centers for Medicare and Medicaid Services (the federal agency that administers the Medicare, a health insurance programme primarily for people age 65 or older, CMS) to reconsider its policy of paying for bariatric surgery only when it is performed at a designated Center of Excellence, after they found that there were no significant differences in complication rates between those institutions with a designation and those without.

As well as offering little evidence of improving patient outcomes, the study, Bariatric Surgery Complications Before vs After Implementation of a National Policy Restricting Coverage to Centers of Excellence, which is published in the Journal of the American Medical Association, also claims that the policy is restricting access to bariatric surgery.

“The CMS policy restricting coverage to Centers of Excellence has not been associated with improved outcomes for bariatric surgery, but may have had the unintended consequence of reducing access to care. These findings suggest that the CMS should re-evaluate this policy,” the authors write.

In 2006, the CMS issued a national coverage decision that limited reimbursement of weight-loss surgery to Centers of Excellence, accredited by the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery. However, the policy has been criticised by some who claimed that there is no evidence to suggest that these centres have better outcomes than non-accredited institutions.

To evaluate whether the policy was associated with improved bariatric surgery outcomes in CMS patients, Dr Justin B Dimick and colleagues looked at hospital discharge data from 12 states between 2004 and 2009 on 6,723 Medicare patients who had surgery before the coverage decision and 15,854 who had it after. They also assessed a non-Medicare population of 95,558 patients who had surgery before the decision and 155,117 who had it after.

Results

The researchers found that bariatric surgery outcomes improved during the study period in both Medicare and non-Medicare patients. Crucially, this change was already underway prior to the CMS coverage decision.

The study found that after accounting for patient factors, changes in procedure type and pre-existing trends toward improved outcomes, there were no statistically significant improvements in outcomes after (vs. before) implementation of the CMS national coverage decision for any complication (8.0% vs. 7.0%), serious complications (3.3% vs. 3.6%), and reoperation (1.0% vs. 1.1%).

The authors also reported no “significantly different rates” for patients undergoing bariatric surgery at hospitals with the Center of Excellence designation vs. hospitals without designation with regard to complications (5.5% vs. 6.0%), serious complications (2.2 %vs. 2.5%), and re-operation (0.83% vs. 0.96%).

The paper notes that there were changes in procedure patterns during the study period, with laparoscopic surgery increasing for all patients undergoing bariatric surgery. Meanwhile, the use of open gastric bypass decreased for both Medicare (45% before and 10% after the coverage decision; p<0.001) and non-Medicare patients (40% before and 9% after the coverage decision; p<0.001).

There was also a substantial improvement in perioperative outcomes during the study period and the authors claim these improvements might have been attributable to evolving surgical technique and the use of different types of procedures, this included transitioning from open to laparoscopic procedures and the increased use of laparoscopic adjustable gastric banding.

"Rather than the CMS policy restricting bariatric surgery to a Center of Excellence, we found that the improvement in outcomes over time could be explained in part by the evolution away from higher risk toward lower risk procedures," the researchers note. “Although this finding is no doubt in part attributable to the expanded coverage of laparoscopic adjustable gastric banding, the disproportionate increase in Medicare patients suggests that increased scrutiny of bariatric surgery in this population influenced physician decision making.”

Conclusions

The researchers acknowledge that they were not able to examine the association of the CMS coverage decision with longer-term outcomes, including patient satisfaction, weight loss, and comorbidity resolution. Nevertheless, the study identified large improvements in bariatric surgery outcomes over time, even after adjusting for changes in procedure use. They said that the improved outcomes were probably due numerous factors related to the maturing of bariatric surgery as a clinical specialty.

Editorial

In an accompanying editorial, Promoting Quality Surgical Care - The Next Steps, Dr Caprice Greenberg, University of Wisconsin, wrote that CMS is currently re-evaluating the need for bariatric surgery Center of Excellence designation.

"As the CMS and the surgical societies re-examine the policy in bariatric surgery, there is an opportunity for them to be creative, to catapult surgical outcomes science forward through scalable approaches to data sharing measurement, collaborative networks, and comparative effectiveness research; and to design a program that can not only identify high-quality hospitals, but also provide a sustained mechanism for quality improvement."

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