Can the government prove that a stent was 'unnecessary'?

Hospitals bear responsibility for medical decisions by non-staff physicians

Although federal officials are investigating the appropriateness of certain medical procedures, the definition of an "unnecessary" procedure remains unclear, Modern Healthcare reports.

  • Cardiovascular Roundtable members can access a portal to the most recent appropriate use criteria for cardiovascular procedures and diagnostic tests.

Ralph Brindis—a researcher and cardiologist at the University of California-San Francisco—estimates that eliminating all unnecessary stenting would save about 200 lives annually. In addition, a 2011 JAMA study found that 49% of elective angioplasties performed in 2009 and 2010 were either "inappropriate" or done for "uncertain" reasons.

Guidelines exist to assist clinical decision making. However, Tennessee cardiologist Elie Korban said in response to a Department of Justice complaint alleging that he overused stents, there is "[n]o specific Medicare or Medicaid regulation [that] defines 'medical necessity' as to the use of stents or as to required symptoms requiring compliance."

Some physicians say that government investigations into stent use and other cardiac procedures interfere in matters of medical discretion.

Lawyers for John McLean—a cardiologist who is appealing his eight-year prison sentence for performing medically inappropriate angioplasties—say that medical overuse litigation amounts to "latter-day judgments of the government's medical experts." In a brief to the 4th U.S. Circuit Court of Appeals, they wrote that "[t]his cannot be a constitutionally acceptable standard upon which to impose criminal liability."

Experts: Overuse is hard to prove in court

Legal experts say that proving cardiac overuse in court is usually a difficult task because juries are reluctant to convict a physician in instances where medical experts disagree with a physician's medical decision.

Cases that have been filed typically involve evidence of wrongful intent, experts note. For example, McLean was accused of fabricating medical records to justify procedures.  "If the doctor was creating a false record, it undermines the claim that he truly was exercising medical judgment," says Jesse Witten, co-chairman of a Justice Department healthcare fraud task force.

"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," Witten adds.

Hospitals may also be in the crosshairs, attorneys warn

Modern Healthcare notes that increased scrutiny over medical inappropriateness has impacted hospitals as well. In the last two years, at least four hospitals reached multimillion-dollar settlements over accusations of medical overuse for cardiac procedures, Modern Healthcare reports.

Lawyers note that government officials have indicated that hospitals maintain some responsibility in medical decisions made by staff and non-staff physicians.

"Hospitals should proactively be mining their own data on these types of procedures, to see… if there are any aberrant trends," says Brian Roark, head of a health care fraud task force 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" (Carlson, Modern Healthcare, 1/12 [subscription required]).

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