DOJ reaches settlements with 51 hospitals for allegedly improperly implanting ICDs

The Department of Justice (DOJ) announced on Feb. 17 that it had reached settlements worth a total of more than $23 million with 51 hospitals in 15 states for allegedly improperly implanting implantable cardioverter defibrillators (ICDs) cardiac devices in Medicare patients.

The claims were allegations, and the DOJ did not determine the hospitals were liable, according to a news release.

In October, the DOJ settled similar allegations worth $250 million with 457 hospitals in 43 states. In all, it has reached settlements worth more than $280 million with more than 500 hospitals.

The DOJ said the most recent settlements were the final ones related to hospitals allegedly improperly billing Medicare for ICDs.

Six hospitals affiliated with the Cleveland Clinic Foundation and the Mount Sinai Medical Center in Miami Beach, Fla., were among the 51 hospitals to settle on Feb. 17.

“Cleveland Clinic would provide the same treatment again if presented with the same illness,” the Cleveland Clinic said in a statement to “The only question was whether Medicare would reimburse part of the cost of the treatments. 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.”

According to the DOJ, the hospitals that reached settlement agreements each allegedly improperly implanted ICDs from 2003 to 2010. Each ICD costs Medicare approximately $25,000.

Under Medicare’s national coverage determination (NCD), ICDs are only appropriate for certain patients and should not usually be implanted in patients who had a recent MI or underwent a recent heart bypass surgery or angioplasty. The NCD notes that hospitals should typically wait 40 days following an MI and 90 days following a heart bypass surgery or angioplasty before implanting and ICD.

“These settlements demonstrate the Department’s continued vigilance in pursuing hospitals and health systems that violate Medicare’s national coverage rules,” Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, said in a news release. “We will hold accountable those who do not abide by the government’s rules in order to protect the federal fiscal and, more importantly, patient health.”  

Most of the hospitals were mentioned in a whistleblower lawsuit brought under the False Claims Act. Cardiac nurse Leatrice Ford Richards and healthcare reimbursement consultant Thomas Schuhmann filed the lawsuit in federal district court in the Southern Division of Florida.

Richards and Schuhmann received more than $3.5 million from the settlements, according to the DOJ.

“The settlements announced last October and today demonstrate the Department of Justice’s commitment to protect Medicare dollars and federal health benefits,” U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida said in a news release. “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. In terms of the number of defendants, this is one of the largest whistleblower lawsuits in the United States and represents one of this office’s most significant recoveries to date. Our office will continue to vigilantly protect the Medicare program from potential false billing claims.”