The settlements did not include any determinations of liability.
The Cleveland Clinic said in a statement Wednesday that the treatment its hospitals provided was "life-saving and life extending" and that the health system would provide the same treatment again if presented with the same illnesses. The question in the investigation, the system said, wasn't one of medical necessity but rather of Medicare reimbursement.
"While we believe that the charges were appropriate, we chose to settle the matter rather than engaging in expensive litigation that distracts from our mission," the Cleveland Clinic said in the statement.
Dignity also said in a statement it settled to avoid the expense of continued litigation, and it denied wrongdoing.
“The billing disputes, which cover a time period from 2003 to 2010, reflect widespread confusion in the health care industry regarding federal standards for covering cardioverter defibrillator implantations and patient admissions,” Dignity said. “As a result, it is often challenging for physicians to ensure their documentation adequately reflects their decision making in order to comply with complex regulations when making their best medical judgments.”
Sisters of Charity Leavenworth also noted in a statement Wednesday that, “The safety and well-being of SCL Health patients was never an issue” and said that it also has made no admission of wrongdoing.
Northwell Health also denied in a statement doing anything wrong and said it settled to avoid costly, protracted litigation.
Bryan Vroon, the attorney for the whistle-blowers in Atlanta, called the investigation “historic” and said he believes it's the largest number of hospitals ever to settle as part of a False Claims Act investigation.
The devices, which cost about $25,000 and are also known as ICDs, are implanted near the heart to detect and treat fibrillation—fast, life-threatening heart rhythms—by delivering a shock to the heart.
Their use increased after Medicare changed its rules in January 2005 allowing them for primary prevention of arrhythmia. The rules say Medicare won't pay for devices implanted within 40 days of a heart attack or 90 days of bypass surgery or angioplasty, but many doctors have chosen to implant them in such circumstances anyway.
Some legal experts have said the investigation represents a new way for whistle-blowers to pursue allegations against large numbers of hospitals: by mining data.
“I think it was an effective and important way to bring an important and national compliance issue to the attention of the Justice Department,” Vroon said. “Not many cases like this have been done.”
The whistle-blowers in this case, Leatrice Ford Richards, a cardiac nurse and consultant, and Thomas Schuhmann, a healthcare reimbursement consultant, originally filed their lawsuit in 2008. They were able to make their allegations against more than 500 hospitals after reviewing codes submitted by hospitals to Medicare, Vroon said. The Justice Department then also reviewed diagnosis and procedure codes and medical charts, he said.
Some legal experts suspect the settlements could encourage more potential whistle-blowers with access to similarly wide-ranging data to come forward on other matters.
The investigation, however, has also spurred criticism from physicians who argue that Medicare's coverage rules for the devices conflict with other medical guidelines.
The purpose of making physicians wait either 40 or 90 days before implanting the devices in patients who've had heart attacks or bypass/angioplasty, respectively, is to give the heart a chance to improve on its own, according to the Justice Department. If a patient's heart improves enough, the device may not be necessary. But medical professionals say the Medicare coverage guidelines don't jibe with clinical guidelines developed by medical societies.
The whistle-blowers snagged more than $3.5 million from the settlements announced Wednesday. That's in addition to more than $38 million they received from an earlier round of settlements with more than 450 other hospitals.