“No one expected that the inappropriate rate should be zero,” said Dr. Manesh Patel, director of interventional cardiology at Duke University Health System, Durham, N.C., and chairman of the Task Force on Appropriate Use Criteria for the American College of Cardiology. “Therefore we changed the term to 'rarely appropriate,' which is more in keeping with the idea that there may be patients in circumstances that fall outside those windows.”
The language change comes at a time of increasing professional and public concern about overuse of stents, and increasing scrutiny by insurers and government agencies. It applies to guidelines on more than a dozen specific cardiac procedures. The revascularization guidelines, which are due to be revised in the next year, will apply the wording change to stents.
More than a half-million metal mesh tubes called stents are inserted into cardiac arteries each year to prop open blocked blood vessels that lead to the heart. Many are implanted immediately following a heart attack, and those are thought to be nearly universally appropriate. But many stents used in elective cases are increasingly seen as unnecessary.
A 2011 study published in the Journal of the American Medical Association examined 500,000 cases of percutaneous coronary intervention—which often includes implanting of a stent—and found that 12% of the elective cases were considered “inappropriate” under the clinical guidelines. Those 16,838 inappropriate cases were distributed irregularly, and some hospitals had much higher rates of “inappropriate” use than others.
In the past several years, at least four hospitals have settled stent-overuse allegations without admitting wrongdoing. Meanwhile, three cardiologists have gone to prison based on evidence that their patients didn't have enough arterial blockage to justify using stents and that they fraudulently changed the medical records to show more blockage than actually existed.
Numerous studies have found that medications can be just as effective as stents for non-emergency patients, while costing less and producing fewer long-term complications. All that has led insurers to start clamping down on procedures labeled “inappropriate” under the clinical guidelines.
But an ACC leader said sometimes a service is not “rarely appropriate,” it's always inappropriate.
Dr. John Harold, president of the ACC and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles, said inserting a cardiac stent without the degree of arterial blockage that meets clinical criteria should always be considered inappropriate. But those cases are fraud, he said, and they don't fit inside any category in the appropriateness guidelines.
“We're not defending criminal activity,” he said. “Yes, there are outliers. They have received media attention and no one in any of the societies is defending them. They should be dealt with accordingly.”
Follow Joe Carlson on Twitter: @MHJCarlson
