Whistleblower Alleges Fraudulent Stent Use


In another example of the continuing scrutiny being given to cardiac procedures, a cardiologist has filed a whistleblower suit against former colleagues, alleging that they knowingly bilked federal health programs over a 4-year period, from 2001-2005.

The suit was filed by Dr. Tullio Emanuele in the U.S. District Court for the Western District of Pennsylvania. It was under seal until Oct. 2011, and was served on the defendants on Jan. 17. The defendants have 20 days to respond.

Dr. Emanuele is now based in Kentucky, but had worked in an Erie-based practice, Medicor Associates. In his suit, he claims that his former colleagues at Medicor and at Flagship Cardiac, Vascular, and Thoracic Surgery of Erie – along with the UPMC Hamot Medical Center of Erie – engaged in billing practices that defrauded Medicare, Medicaid, and Tricare, among other insurers.

Carly Manino, manager of media relations at UPMC Hamot, said that the hospital would not comment. "It’s our policy not to comment on pending litigation," she said.

Whistleblower or "qui tam" suits are filed under the False Claims Act. Such suits allow private citizens with knowledge of false claims against the government to bring a lawsuit on behalf of the United States and to share in any recovery, according to the U.S. Department of Justice.

So far, the federal government has declined to intervene in the case, but the suit can be advanced by private litigators, according to Andy Stone, cocounsel on the Emanuele suit. The government may intervene at a later point, said Mr. Stone, whose practice is in Pittsburgh. The government can seek triple the amount of damages determined by the courts. Mr. Stone said that it’s not clear how much might be at stake in the case before discovery, but that given the potential number of claims, it could be millions of dollars.

The Pennsylvania suit also accuses the cardiologists and the hospital of violating the antikickback statutes that prohibit improper patient referrals.

In addition, the suit alleges that the named physicians performed unnecessary medical procedures, including cardiac catheterizations and vascular surgeries.

Mr. Stone said that he believes that cases alleging overuse of stents or other percutaneous interventions may be brought more often.

"These are important cases because the dollar amounts are big. The incentives are there – and substantial patient risk. You put those two things together and that makes for a real serious abuse situation," he said.

Indeed, the Emanuele suit seems to be the latest in a high-profile battle over the appropriateness of cardiac procedures, particularly stent placement. Last spring, Greensburg, Pa.–based Excela Health said that it had found that stents had been unnecessarily placed in almost 200 patients. In a turnaround, that health system has just won accreditation under the Accreditation for Cardiovascular Excellence (ACE) program that is sponsored by the Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Foundation.

Those two organizations, along with the Maryland Chapter of the ACC, have been working to head off regulation of stent procedures, according to an editorial in the Journal of the American College of Cardiology. Instead, they are hoping to convince the state to require all Maryland hospitals to submit to a mandatory accrediting process through the groups’ ACE program.

The state of Maryland began looking into stenting as the result of another qui tam suit filed by three cardiologists against St. Joseph Medical Center in Towson, Md. The hospital settled for $22 million. The suit alleged that St. Joseph paid kickbacks in return for referrals from MidAtlantic Cardiovascular Associates.

St. Joseph also settled charges that cardiologist Mark Midei performed unnecessary stent procedures.

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