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U.S. reaches settlement with 457 hospitals over cardiac device

U.S. reaches settlement with 457 hospitals over cardiac device

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WASHINGTON • The Justice Department announced Friday that hundreds of hospitals will give back $257 million in Medicare payments because doctors implanted cardiac devices in violation of government rules.

The settlements encompass nearly 500 hospitals in 43 states where cardioverter defibrillators were implanted in Medicare patients too soon after they suffered a heart attack, had heart bypass surgery or angioplasty.

Hospital companies included in the settlement include several with headquarters in the St. Louis area. They are Ascension Health, based in Edmundson, which will pay $14.9 million; Mercy Health of Chesterfield, $1.11 million; and SSM Health of Creve Coeur, $4.1 million. In addition, Dallas-based Tenet Healthcare, which owns Des Peres Hospital and is the former owner of St. Louis University Hospital, is paying $12.1 million.

Medicare sets waiting periods of up to 90 days before implanting the $25,000 devices, which deliver mild electric shocks to restore a normal heart rhythm. Clinical trials have shown the heart often recovers its own rhythm during that time, making the pricey defibrillators unnecessary.

“The settlements announced today demonstrate the Department of Justice’s commitment to protect Medicare dollars and federal health benefits,” said Wifredo Ferrer, U.S. Attorney for the Southern District of Florida. “Guided by a panel of leading cardiologists and the review of thousands of patients’ charts, the extensive investigation behind the settlements was heavily influenced by evidence-based medicine.”

A 2011 study led by researchers at Duke University of 111,707 patients that received cardioverter defibrillators found that nearly a quarter received no clinical benefit. Those patients were also shown to develop significantly more post-procedural complications, including death.

The settlements, said to be among the largest of their kind, are the result of a federal whistleblower lawsuit filed in Florida seven years ago by cardiac nurse Leatrice Ford Richards and Thomas Schuhmann, a health care reimbursement consultant.

Under the False Claims Act, the whistleblowers will reap about $38 million from the settlements. They were represented by Bryan Vroon, an Atlanta-based lawyer.

Among the large health-care providers involved, Hospital Corporation of America, based in Nashville, Tenn., agreed to pay $15.8 million. Franklin, Tenn.-based Community Health Systems, a chain that owns hospitals in Illinois and Missouri, among other states, is paying $13 million.

Ascension, one of the nation’s largest health care systems, has 32 affiliated hospitals affected by the settlement.

“We are pleased to have reached an agreement with the U.S. Department of Justice on this matter. We are proud and appreciative of the cardiac care provided by our physicians, nurses and other caregivers nationwide to individuals in the communities we serve,” Nick Ragone, chief communications and marketing officer, said in a statement.

SSM Health, which had eight affiliated hospitals affected, said in a statement that it had settled the case to “minimize litigation times and costs.” SSM also said it continually strives to implement “industry-best practices,” and has “implemented new monitoring policies to ensure closer alignment with the CMS (Centers for Medicare and Medicaid Services) guidelines.”

Mercy, with nine of its hospitals affected, said in a statement: “The settlement was due to very strict billing rules for Medicare coverage requirements and was not due to any concerns regarding patient safety. Mercy will continue to work diligently to comply with all billing requirements.”

Tenet, which had 19 of its hospitals affected, said in a statement about Des Peres Hospital that the government’s “investigation did not question the quality, efficacy or the medical necessity of these procedures. We are committed to fully complying with all Medicare program requirements and are confident our current compliance program enables us to do so.”

Although three of the four St. Louis area-based health care companies are involved in the settlement, only a few area hospitals are named. They include Mercy St. Louis, DePaul, St. Clare, St. Joseph, St. Mary’s, Des Peres Hospital and St. Louis University Hospital.

St. Louis BJC HealthCare is not among the hospital companies named in the settlement.

The Justice Department says it continues to investigate additional hospitals.

The Post-Dispatch contributed to this report by The Associated Press.

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