FLORIDA
The federal government announced that 51 hospitals will pay more than $23 million related to allegations involving cardiac devices that were implanted on Medicare patients, according to officials.
Only patients with certain clinical characteristics and risk factors qualify for cardioverter defibrillator, or ICD under Medicare, officials said Wednesday.
The 51 hospitals are located in 15 states: Click here for the listing: Hospitals
Most of the settlements like this one are a result of whistleblowers who brought these cases to light under the False Claims Act, officials said.
In this case, a lawsuit was filed in federal district court in Florida by Leatrice Ford Richards, a cardiac nurse and Thomas Schuhmann, a health care reimbursement consultant.
Richards and Schuhmann will receive more than $3.5 million from the settlements as a result of their shedding light on this medical problem, according to federal authorities.
These recent settlements represent the final stage of a nationwide investigation into the practices of hundreds of hospitals improperly billing Medicare for these devices.
With these additional agreements, the Justice Department’s investigation has now yielded settlements with more than 500 hospitals totaling more than $280 million, federal officials said.
“These settlements demonstrate the Department’s continued vigilance in pursuing hospitals and health systems that violate Medicare’s national coverage rules,” said Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We will hold accountable those who do not abide by the government’s rules in order to protect the federal fisc and, more importantly, patient health.”
Here is what a ICD does when it is implanted, according to authorities:
- An implantable cardioverter defibrillator, or ICD, is an electronic device that is implanted near and connected to the heart.
- It detects and treats chaotic, extremely fast, life-threatening heart rhythms, called fibrillations, by delivering a shock to the heart, restoring the heart’s normal rhythm.
- It is similar in function to an external defibrillator (often found in offices and other buildings) except that it is small enough to be implanted in a patient’s chest.
Medicare coverage for the device, which costs approximately $25,000, is governed by a National Coverage Determination or NCD
The Centers for Medicare and Medicaid Services implemented the NCD based on clinical trials and the guidance and testimony of cardiologists and other health care providers, professional cardiology societies, cardiac device manufacturers and patient advocates.
The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty.
The medical purpose of a waiting period – 40 days for a heart attack and 90 days for bypass/angioplasty – is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary.
The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD.
“The settlements announced last October and today demonstrate the Department of Justice’s commitment to protect Medicare dollars and federal health benefits,” said U.S. Attorney Wifredo A. Ferrer 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. 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.”
“We will not stand idly by while Medicare coverage rules are ignored,” said Inspector General Daniel R. Levinson of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “OIG worked closely with the Department of Justice to ensure such violators made substantial payments to settle these false billing claims.”
The department previously settled with 457 hospitals for more than $250 million.