Unclear terms

Placing an unnecessary stent inside a patient's heart is “a crime of unthinkable proportions,” according to one of the government's top Medicare watchdogs, Nicholas DiGiulio, special agent in charge of HHS' inspector general's office for the Philadelphia region.

But the doctors and hospitals who are targets in these high-stakes cardiac-care investigations complain that it's not clear what “unnecessary” means—a crucial definition given the lengthy jail terms and outsize potential fines in cardiac overuse cases. Physicians say the government is wading into dangerous territory by second-guessing clinical decisions on which reasonable people may have legitimate disagreements.

“No specific Medicare or Medicaid regulation defines 'medical necessity' as to the use of stents or as to required symptoms requiring compliance,” Jackson, Tenn.-based cardiologist Dr. Elie Korban wrote in a legal filing last September, responding to a whistleblower complaint filed against him by the U.S. Justice Department alleging overuse of angioplasty procedures.

The stents, metal mesh tubes, hold open clogged arteries following angioplasty procedures that use precisely inflated balloons to unblock coronary vessels. Each year, Americans receive more than 600,000 of them, and the interventions cost about $12 billion a year, according to a July 2011 study in the Journal of the American Medical Association.

That study found that 49% of stents inserted on an elective, nonemergency basis in 2009 and 2010 were either “inappropriate” or used for “uncertain” reasons. (The study found that 98% of stents used after heart attacks or chest pains were appropriate.)

Dr. Ralph Brindis, an interventional cardiologist and medicine professor at the University of California, San Francisco, with expertise in appropriateness research, said he has estimated that eliminating inappropriate angioplasties could save about 200 lives a year in the U.S.

“So it's not just about the money,” Brindis said.

However, doctors who are actually accused of overuse say the government is meddling in matters of medical discretion.

“The prosecution of Dr. (John) McLean comes down to a debate between his treatment decisions regarding his patients and the latter-day judgments of the government's medical experts,” McLean's lawyers wrote in a brief to the 4th U.S. Circuit Court of Appeals in Richmond, Va. “This cannot be a constitutionally acceptable standard upon which to impose criminal liability.”

McLean, 59, of Salisbury, Md., is slated to have oral arguments before the court this month in his attempt to overturn an eight-year prison sentence. The case follows a decision last year by the 11th U.S. Circuit Court of Appeals in Atlanta to reject the vagueness argument and uphold a 10-year jail term for cardiologist Dr. Mehmood Patel, 67, of Lafayette, La., for similarly unneeded heart care.

Yet legal experts say cases of cardiac overuse are tough to prove in court, because juries are reluctant to convict doctors in cases where medical experts disagree over the initial treating physician's judgment. Doctors might disagree over how to interpret test results for arterial blockages, or on extenuating circumstances that could override one common industry guideline that a 70% blockage is needed to justify stenting.

That's why many of the cases that are filed tend to involve some alleged evidence of wrongful intent. McLean and Patel were accused of not only implanting unneeded stents, but falsifying medical records after the fact to make it appear that arterial blockages justified the procedures.

Jesse Witten, a partner with Drinker Biddle & Reath and former co-chairman of a Justice Department healthcare fraud task force, said the allegations that lead to formal cases usually involve written evidence that purports to show bad intent.

“If the doctor was creating a false record, it undermines the claim that he truly was exercising medical judgment,” Witten said. “I think it's so obvious to the DOJ that these are difficult cases to bring that they are not going to file a case unless there is something really egregious that has occurred.”

The scrutiny, though, is having effects on both doctors and the hospitals they work in.

At least four hospitals in the past two years have come to multimillion-dollar settlements over allegations of unneeded cardiac procedures. For-profit hospital chain HCA disclosed in securities filings last year that interventional cardiology was being investigated at a dozen of its Florida hospitals.

EMH Healthcare in Elyria, Ohio, announced this month that it would pay $3.8 million to settle overuse allegations without admitting wrongdoing—even though the cardiologists involved were independent physicians who simply used the hospital facilities for treatment.

Healthcare lawyers say the lesson that health system executives ought to take away from such cases is that government officials have come to believe hospitals bear some level of culpability for medical decisions of nonstaff physicians.

“Hospitals should proactively be mining their own data on these types of procedures, to see, hospitalwide or from particular physicians, if there are any aberrant trends,” said Brian Roark, head of the healthcare fraud task force at Bass Berry Sims in Nashville. “If there is a doctor on staff who is performing a whole lot more stents than similar doctors, hospitals need to know that so that they can ask some questions.”