Rethinking Centers of Excellence (and Other Well-Laid Plans)

April 5, 2013

Like operations, medications and fad diets, health care policy is usually appraised with a simple question: Does it work, or doesn’t it?

pauline w. chen

The assumption is that new regulations and practices either cut costs and improve care, or they don’t; and so, by simple extension, should be either supported or struck down.

Last month, for example, on the third anniversary of the passing of the Affordable Care Act, many a pundit and politician marked the occasion by diving headlong onto the does-it-or-doesn’t-it pigpile, freely offering their predictions of whether President Obama’s health law would work over the next 5, 10 or 15 years.

I managed to restrain myself, but I’ve certainly done my time in that fray.

Now a fascinating study asks all of us to reconsider how we judge putting health care policies into practice. Focusing on outcomes in obesity surgery, the study illustrates the breathtaking speed at which clinical medicine can progress, and how rapidly policies, along with their critics and champions, can become obsolete.

Health care policy is a moving target; and the most effective measures endure as “best practices” only until new research points the way to even better approaches.

Doctors have attempted to use surgery to treat obesity since the 1950s, but it wasn’t until the early 1990s that doctors and patients began to view bariatric surgery as an acceptable alternative to diets, exercise and medications. Fueled by dramatic and well-televised outcomes, like patients clocking in losses of 100 pounds or more, the number of operations rose exponentially despite the fact that they were still considered experimental and that complications could be significant. Pulmonary embolism, leaks from the new intestinal connections and even death were all known to result from bariatric surgery; and the rates of such mishaps were not always systematically documented.

In 2006, the Centers for Medicare and Medicaid Services (C.M.S) began restricting payment for bariatric surgery to so-called centers of excellence. To become such a center, hospitals needed first to fulfill criteria set by one of two organizations, the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery. The criteria included having two bariatric surgeons on staff and performing at least 125 obesity operations a year.

It was a heady moment for health care policy wonks everywhere; they praised the decision as a bold attempt to improve quality and impose standards on a rapidly growing specialty.

But in retrospect, the centers-of-excellence initiative looks, one might say, “so 2006.”

In the years since 2006, surgeons developed new operations, incorporated safer techniques and better equipment, and began conducting large-scale research on complication rates and safety measures. Yes, Medicare patients who had bariatric surgery after 2006 tended to do better, confirming a common belief that the C.M.S. coverage decision contributed to the improvement in outcomes and general upsurge in quality of care. But it wasn’t clear if the improvements were due to the policy, or were simply a result of the advances that had occurred over time.

To answer this question, the authors of the new study reviewed the discharge records of more than 20,000 Medicare patients who underwent bariatric surgery before and after the national coverage decision. As with previous studies, they found that Medicare patients who had their operations after 2006 did better than those who had them earlier.

The researchers then compared these outcomes to those of patients who were not covered by Medicare and therefore not restricted to having their operations done at centers of excellence. Even after adjusting for individual patient risk factors and the specific type of bariatric procedure performed, they found no differences in complication rates or outcomes between Medicare and non-Medicare patients. Moreover, they discovered that many of the improvements had been under way prior to 2006.

In other words, the much-heralded policy of funneling patients to centers of excellence has had little effect on how patients do.

“This is a cautionary tale,” said Dr. Justin B. Dimick, a bariatric surgeon who is lead author of the paper and director of policy research at the Center for Healthcare Outcomes and Policy at the University of Michigan in Ann Arbor. “While the policy might have been completely appropriate 10 years ago, it’s important to make sure that the benefits continue to outweigh the harms today.”

For patients who might benefit from weight loss surgery, those harms can include foregoing the surgery itself. For six months prior to their operation, patients are required to participate in regular support groups and meetings with their surgical team. Afterward, they need to return regularly to the hospital for close medical follow-up. Medicare patients who live far from a Center of Excellence often decide not to have the surgery because of the extensive travel costs and lost time at work; if they proceed, it is at great personal expense.

The results of this study have prompted the C.M.S. to reconsider its policy. Not all bariatric surgeons agree with lifting the 2006 coverage restrictions; but Dr. Dimick and his co-authors believe that reviewing all the research and reassessing policy choices is important, particularly in a field that has advanced as quickly as theirs.

“Policymaking has to be a dynamic process that reconsiders the evidence as it comes out,” Dr. Dimick said. “If you’re going to keep designating centers of excellence, you need to be sure they are actually excellent and actually offering better care than other institutions.”

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