More than 450 hospitals, including Redmond Regional Medical Center in Rome, 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 Redmond, Emory University Hospital and Emory University Hospital Midtown in Atlanta, Saint Joseph’s Hospital of Atlanta, the Medical Center of Central Georgia in Macon and St. Mary’s Hospital in Athens.

HCA on Saturday referred the Rome News-Tribune to its August SEC filing, which said, in part, that the Nashville-based company “makes no admission of wrongdoing in the settlement.”

HCA’s 42-hospital settlement totaled $15.8 million. The case involved an implantable cardioverter defibrillator, 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 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.

Georgia Health News, a nonprofit 501(c)3 organization, tracks state medical issues on its website georgiahealthnews.com.

(Coosa Valley News)