Under scrutiny

In an era of rising scrutiny of cardiac care, physicians are learning that their legal fates may hinge on one number—70%.

That's how much blockage in a coronary artery the government says should be documented to justify the placement of a cardiac stent, the wire mesh device that can keep a clogged blood vessel open.

Stent surgeries are more profitable for hospitals' cardiac-care departments, compared with less-intensive therapies that in many cases work just as well for patients. Studies show stents are overused in elective surgeries, and cardiologists vary widely from region to region in how often they implant them.

Closely following the research showing overuse are a growing number of criminal and civil cases alleging interventional cardiologists knowingly implanted stents in patients who had little if any blockage, needlessly exposing them to the risks of invasive procedures. At least four hospitals have settled civil cases in the past two years, and three cardiologists have been convicted of criminal fraud related to stent overuse. Many more civil cases against doctors are pending.

This has led to much discussion of the federal government's position that a coronary artery must be at least 70% blocked to justify using a stent. In cases where that criterion has been challenged, federal judges are agreeing with the government—even though physicians and their lawyers continue to stress the danger of limiting physicians' discretion in diagnosing and treating cardiac problems.

Dr. Tom Stys, medical director and interventional cardiologist at Sanford Heart Hospital in Sioux Falls, S.D., said there is heavy scrutiny of cardiology because it accounts for a large share of total healthcare spending, and it tends to embrace rapid innovations faster than other fields.

He agreed that the oversight results in a “certain degree of a loss of autonomy” for individual doctors. But, he argued, they still should be following widely accepted clinical guidelines such as the 70% criterion, even though observers agree that two doctors may see different levels of blockage in the same test results.

“There is definitely room for some variation in interpretation,” Stys said. “Keeping that in mind, a lesion that is less than 70% usually should not be resulting in any adverse clinical consequences for the patient, and we do not intervene on those cases.”

Other doctors say the issue is murkier than that.

Already this year, the 4th U.S. Circuit Court of Appeals upheld an eight-year prison sentence for interventional cardiologist Dr. John McLean of Salisbury, Md., who was convicted of Medicare fraud for altering patient medical records to meet the 70% threshold.

The 70% criterion was described by a prosecution witness as “generally accepted in the medical community.” But McLean argued that was unconstitutionally vague as a guideline to define criminal fraud. McLean presented an expert witness who testified that at least until 2006, 50% blockage was considered sufficient to justify stenting when combined with evidence of heart stress from other tests.

The court disagreed, finding the evidence that McLean changed patient records proved he knew he was engaged in fraud. The decision came about a year after the 5th U.S. Circuit Court of Appeals rejected an almost identical argument from Dr. Mehmood Patel, a cardiologist in Lafayette, La., who also lost a bid to overturn his Medicare fraud conviction.

Last month, in London, Ky., Dr. Sandesh Patil accepted a plea agreement sending him to prison for at least two years after he was charged with implanting one unneeded stent in a patient whose medical record he later altered to show a 70% blockage. Patil was the third criminal target in a stent case nationally.

Experts in the field say physicians should pay close attention to appropriate-use criteria first published by the American College of Cardiology and other groups in 2009, and updated in 2012. The guidelines eschew blunt definitions of medical necessity used by prosecutors in favor of a 1-10 appropriateness scale for stenting that incorporates medical history and test results.

Dr. John Harold, a cardiologist with the Cedars-Sinai Heart Institute in Los Angeles and president of the American College of Cardiology, said physicians who follow the criteria and document their actions and decisionmaking processes should be able to avoid legal problems in most cases.

“The extreme outliers, who put patients at risk for overuse for personal gain, should face the consequences,” Harold said. “The overwhelming majority do the right thing, and it is unfortunate that a few outliers like this will continue to generate publicity.”

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