More than 450 hospitals, including several in Georgia, will pay a total of more than $250 million to settle allegations that cardiac devices were implanted in Medicare patients in violation of the program’s coverage requirements, the Department of Justice announced Friday.

Georgia hospitals involved in the settlements include Emory University Hospital and Emory University Hospital Midtown in Atlanta, Saint Joseph’s Hospital of Atlanta, the Medical Center of Central Georgia in Macon, St. Mary’s Hospital in Athens, and Redmond Regional Medical Center in Rome.

The case involved an implantable cardioverter defibrillator (ICD), an electronic device that is implanted near the heart and connected to it. The device detects and treats chaotic, life-threatening heart rhythms, called fibrillations, by delivering a shock to the heart, restoring its normal rhythm.

Medicare coverage for the device, which costs about $25,000, is governed by a National Coverage Determination, which provides that an ICD generally should not be implanted in a patient who recently suffered a heart attack or recently had heart bypass surgery or angioplasty, the Justice Department said.  

The medical purpose of a waiting period – 40 days for a heart attack and 90 days for bypass/angioplasty – is to give the heart a chance to improve on its own and possibly make an ICD unnecessary, the Department of Justice said. The National Coverage Determination, which governs Medicare coverage for a service, expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions.

DOJ alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the coverage rules.

The case was originally filed in 2008 by two whistleblowers represented by Atlanta attorney Bryan Vroon. The whistleblowers, Leatrice Ford Richards, a cardiac nurse, and Thomas Schuhmann, a health care reimbursement consultant, have received more than $38 million from the settlements.

The Department of Justice is continuing to investigate additional hospitals and health systems in the case.

Vroon said the settlement was the largest ever in terms of numbers of hospitals under the False Claims Act.

The case, Vroon told GHN, “is a window into a much larger issue – what’s happening clinically on unnecessary treatment or treatment not based in science.”

The implanted devices cited in the case, he said, “were premature at best and maybe not necessary.”

Other Georgia hospitals involved in the settlements were Fairview Park Hospital in Dublin and East Georgia Regional Medical Center in Statesboro.

U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida said in a statement, “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.”

Settlement amounts vary

The claims resolved by these settlements are allegations only, and there has been no determination of liability, federal officials said.

Emory Healthcare issued a statement Friday that said, “The government’s review of the providers focused on whether hospitals properly billed the ICDs, not on the quality of the patient care provided.”

“Emory has cooperated fully with the government since first being notified of the investigation in 2010,’’ the statement continued. “Emory completed a voluntary review of about 230 ICD claims and its policies and procedures, and worked with the government under its resolution model to reach a settlement of $2.4 million.”

The original complaint named more than 1,000 hospitals identified by data obtained through the Medicare claims payment data, the Emory statement said. “The complainant had no connection to many of the hospitals, including Emory, but based on data analysis claimed that the strict clinical criteria outlined under Medicare payment rules were not being followed,”  Emory said.

The Medical Center of Central Georgia’s settlement is $1.6 million, according to federal officials. Navicent Health, the owner of the Macon hospital, declined comment Friday on the settlement.

Redmond and Fairview Park are part of a HCA’s $15.8 million, 42-hospital settlement. St. Mary’s and Saint Joseph’s are among the 13 hospitals under the settlement with Catholic Health East for $11 million. East Georgia comes as part of Health Management Associates’ $7.2 million settlement for 27 hospitals.

HCA on Friday referred a reporter to its August SEC filing, which said, in part, that the Nashville-based company “makes no admission of wrongdoing in the settlement.’’