Korban's case is civil, because prosecutors in western Tennessee opted not to proceed criminally, court records say. But the 70% rule applies to the civil proceeding as well, according to the lawsuit that was filed by a former co-worker of Korban's and later joined by government.
The allegations say Korban routinely flouted the generally accepted industry guideline published by cardiologist groups that patients' arteries must have blockages stopping at least 70% of blood-flow in order to justify inserting the stent to keep the blood vessel open.
Last month, lawyers for the Justice Department filed a notice in the case (PDF), pending in federal district court in Jackson, Tenn., that said Korban had reached a “handshake” agreement to settle the matter, though the final agreement has not been published.
It was the second time in that month alone that a cardiologist settled allegations of wrongdoing involving the 70% blockage criteria.
Dr. Sandesh Patil, 51, of London, Ky., became the third cardiologist in the nation to be convicted of Medicare fraud involving the use of stents after he admitted that he changed one patient's record to make it look as if patients had arterial lesions blocking at least 70% of their blood flow.
“For a cardiac stent procedure to qualify as a medical necessity, it is generally accepted that a patient must have at least 70% blockage of an artery and symptoms of blockage,” Justice Department attorneys wrote. “Patil admitted that he placed stents in arteries that had substantially less than 70% blockage. Patil nonetheless recorded blockage of 70% or more in patient documents to guarantee payment from Medicare and Medicaid.”
Korban and others facing such charges have argued that the 70% guideline does not exist.
Dr. John McLean of Salisbury, Md., who was convicted in 2011 of altering patient medical records to meet the 70% threshold, argued all the way the 4th U.S. Circuit Court of Appeals in Richmond, Va., that the guidelines were not clear enough to justify the eight-year prison sentence he is now serving for needlessly implanting stents in Medicare and Medicaid patients.
McLean even put a witness on the stand who argued that at least until 2006, 50% blockage was clinically sufficient to justify stenting when combined with evidence of heart stress from other tests. The 4th Circuit disagreed, finding that the evidence that he changed patient records proved he knew he was engaged in fraud.
“The healthcare fraud statute is not a medical malpractice statute, it is a simple fraud statute,” the 4th Circuit panel wrote in April. “It prohibited McLean from knowingly and willfully defrauding insurers by falsely certifying that the stents he placed in arteries with little to no blockage were reasonable and medically necessary in order to obtain reimbursement. Although the statute does not enumerate every possible fraud scheme, an average person would understand that this kind of conduct is prohibited.”
Frank Sheeder, a partner in healthcare compliance and enforcement defense with DLA Piper in Dallas, said hard and fast rules such as the 70% guideline allow regulators to have a clarity of hindsight that might not be available during treatment.
“While it's convenient sometimes to have 20/20 hindsight and to question the physician's judgment, it's a dangerous prospect if the regulators and enforcers don't wield that power carefully,” Sheeder said. “If two reasonable physicians can reach a different conclusion about the course of treatment, to me, that shouldn't result in a criminal matter.”
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